Review of Medicare-funded
ophthalmology services
(first-stage)
April 2011
This report was commissioned by the Medicare Benefits Division, Department of Health and Ageing,
the Australian Government.
Researchers:
Tracy Merlin
Managing Director / Senior Lecturer
Jacqueline Street
NHMRC Postdoctoral Researcher
Christine Holton
Research Fellow
Linda Mundy
Team Leader
David Tamblyn
Senior Research Officer
Benjamin Ellery
Research Officer
Vineet Juneja
Research Officer
Edith Reddin
Research Officer
Sophia Scrimgeour
Research Assistant
Sophie Hennessy
Research Assistant
Adelaide Health Technology Assessment
Discipline of Public Health
School of Population Health and Clinical Practice
University of Adelaide
This report should be referenced as follows:
Merlin T, Street J, Holton C, Mundy L, Tamblyn D, Ellery B, Juneja V, Reddin E, Scrimgeour S, Hennessy S
(2011) Review of MBS Items for specific ophthalmology services under the MBS Quality Framework.
Canberra, ACT: Commonwealth of Australia.
We would like to acknowledge the Department of Health and Ageing for their support of this project. We
particularly appreciated the assistance of Ms Kelly Cameron and Ms Amy Lambart.
TABLE OF CONTENTS
EXECUTIVE SUMMARY ..................................................................................................................................................I
1.
INTRODUCTION TO QUALITY FRAMEWORK REVIEWS.........................................................................................1
1.1
1.2
1.3
2.
REVIEW METHODOLOGY ....................................................................................................................................3
2.1
2.2
2.3
2.4
2.5
3.
MBS DATA ANALYSIS ........................................................................................................................................6
GUIDELINE CONCORDANCE ................................................................................................................................7
LITERATURE REVIEW – MINI-HEALTH TECHNOLOGY ASSESSMENTS (MINI-HTAS) ...........................................................8
ASCERTAINMENT OF CONSUMER PREFERENCES ....................................................................................................12
STAKEHOLDER NEGOTIATION ............................................................................................................................13
REVIEW OUTCOMES ......................................................................................................................................... 14
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12
3.13
3.14
3.15
3.16
3.17
3.18
3.19
3.20
4.
PRINCIPLES TO GUIDE MBS REVIEWS ...................................................................................................................2
RATIONALE FOR THE REVIEW OF OPHTHALMOLOGICAL ITEMS ....................................................................................2
OBJECTIVES OF THE REVIEW ...............................................................................................................................2
SUMMARY OF CURRENT NATIONAL USAGE OF OPHTHALMOLOGICAL SERVICES ............................................................14
GLAUCOMA SERVICES .....................................................................................................................................19
ELECTRORETINOGRAPHY SERVICES .....................................................................................................................25
EXAMINATION OF OPTIC FUNDI .........................................................................................................................27
RETINAL PHOTOGRAPHY SERVICES .....................................................................................................................30
PERIMETRY SERVICES ......................................................................................................................................32
ULTRASOUND BIOMETRY AND PCI SERVICES ........................................................................................................35
REMOVAL OF FOREIGN BODY ............................................................................................................................47
EXTIRPATION OF TARSAL CYST ...........................................................................................................................61
LACRIMAL PASSAGE SERVICES ...........................................................................................................................79
CATARACT SURGERY SERVICES ..........................................................................................................................97
CAPSULECTOMY AND LENSECTOMY SERVICES .....................................................................................................113
VITRECTOMY SERVICES ..................................................................................................................................119
CRYOTHERAPY OF RETINA ..............................................................................................................................120
RETINAL SERVICES ........................................................................................................................................131
INTRA-VITREAL INJECTION SERVICES .................................................................................................................148
LASER TRABECULOPLASTY SERVICES .................................................................................................................157
RETINAL PHOTOCOAGULATION SERVICES...........................................................................................................159
REMOVAL OF SILICONE OIL .............................................................................................................................231
SURGICAL ASSISTANCE ..................................................................................................................................245
CONCLUSIONS ................................................................................................................................................ 246
APPENDIX A: CLINICAL WORKING GROUP MEMBERSHIP ........................................................................................ 267
APPENDIX B: REFERENCE DATA FOR MBS DATA ANALYSIS ..................................................................................... 268
APPENDIX C: DESCRIPTORS FOR MBS ITEMS UNDER REVIEW ................................................................................. 269
APPENDIX D: DATA ANALYSIS ON INDIVIDUAL MBS ITEMS..................................................................................... 276
Glaucoma .........................................................................................................................................................276
Electroretinography..........................................................................................................................................282
Examination of optic fundi ...............................................................................................................................285
Retinal photography.........................................................................................................................................286
Perimetry ..........................................................................................................................................................288
Ultrasound biometry ........................................................................................................................................292
Removal of foreign body ..................................................................................................................................297
Removal of foreign body from cornea or sclera ...............................................................................................302
Extirpation of tarsal cyst ..................................................................................................................................303
Lacrimal passages ............................................................................................................................................304
Cataract surgery ...............................................................................................................................................307
Capsulectomy and lensectomy .........................................................................................................................316
Vitrectomy ........................................................................................................................................................319
Cryotherapy of retina .......................................................................................................................................320
Retinal services .................................................................................................................................................321
Intra-vitreal injection ........................................................................................................................................326
Laser trabeculoplasty .......................................................................................................................................327
Retinal photocoagulation .................................................................................................................................328
Removal of silicone oil ......................................................................................................................................329
Surgical assist ...................................................................................................................................................330
APPENDIX E: DATA ANALYSIS ON OPHTHALMOLOGY SEPARATIONS ....................................................................... 334
APPENDIX F: CLINICAL PRACTICE GUIDELINES (CONCORDANCE EXERCISE) .............................................................. 339
APPENDIX G: CRITICAL APPRAISAL OF GUIDELINES (AGREE SCORES) ....................................................................... 341
APPENDIX H: CLINICAL PRACTICE GUIDELINE RECOMMENDATIONS ........................................................................ 342
APPENDIX I: COLLATED SUMMARY OF FINDINGS .................................................................................................... 353
APPENDIX J: MINOR ITEM AMENDMENTS ............................................................................................................... 357
TABLE OF TABLES
TABLE 1
TABLE 2
TABLE 3
TABLE 4
TABLE 5
TABLE 6
TABLE 7
TABLE 8
TABLE 9
TABLE 10
TABLE 11
TABLE 12
TABLE 13
TABLE 14
TABLE 15
TABLE 16
TABLE 17
TABLE 18
TABLE 19
TABLE 20
TABLE 21
TABLE 22
TABLE 23
TABLE 24
TABLE 25
TABLE 26
TABLE 27
TABLE 28
TABLE 29
TABLE 30
TABLE 31
TABLE 32
TABLE 33
TABLE 34
TABLE 35
TABLE 36
TABLE 37
TABLE 38
TABLE 39
TABLE 40
TABLE 41
TABLE 42
TABLE 43
TABLE 44
TABLE 45
TABLE 46
TABLE 47
TABLE 48
TABLE 49
TABLE 50
TABLE 51
TABLE 52
TABLE 53
TABLE 54
OPHTHALMOLOGICAL SERVICES LISTED ON THE MEDICARE BENEFITS SCHEDULE AND UNDER REVIEW .................................... 1
MBS ITEM REVIEWS AND AMENDMENTS ................................................................................................................... 4
OPHTHALMOLOGY ITEMS RECEIVING GUIDELINE CONCORDANCE ANALYSIS ........................................................................ 7
OPHTHALMOLOGY ITEMS RECEIVING EVIDENCE-BASED ANALYSIS .................................................................................... 8
DESIGNATIONS OF LEVELS OF EVIDENCE (MERLIN T, WESTON A ET AL. 2009; NHMRC 2009) ......................................... 10
BODY OF EVIDENCE ASSESSMENT MATRIX (ADAPTED FROM (NHMRC 2009)) ................................................................ 12
OPHTHALMOLOGY ITEMS REVISED THROUGH STAKEHOLDER NEGOTIATION ..................................................................... 13
SUMMARY OF NUMBER OF REIMBURSEMENTS FOR ITEM NUMBERS DURING DEFINED PERIODS............................................ 16
SUMMARY OF OVERALL COST ($) OF ITEM NUMBERS DURING DEFINED PERIODS .............................................................. 17
PICO CRITERIA FOR EXAMINATION OF OPTIC FUNDI ................................................................................................... 28
SEARCH TERMS UTILISED FOR EXAMINATION OF OPTIC FUNDI ....................................................................................... 28
PICO CRITERIA FOR ULTRASOUND BIOMETRY AND PARTIAL COHERENCE INTERFEROMETRY ................................................. 37
SEARCH TERMS UTILISED FOR ULTRASOUND BIOMETRY AND PARTIAL COHERENCE INTERFEROMETRY .................................... 37
STUDY PROFILES AND RESULTS FOR INCLUDED STUDIES OF DIAGNOSTIC ACCURACY/MEASUREMENT CONCORDANCE FOR
ULTRASOUND BIOMETRY AND PCI ......................................................................................................................... 39
STUDY PROFILES AND RESULTS FOR INCLUDED RCTS REPORTING ON OUTCOMES OF ULTRASOUND BIOMETRY AND PCI ............ 42
SEARCH TERMS USED FOR IDENTIFYING RELEVANT LITERATURE IN JOURNAL DATABASES ..................................................... 45
WEBLOG SEARCH TERMS FOR ULTRASOUND BIOMETRY ............................................................................................... 45
PICO CRITERIA FOR INTRAOCULAR FOREIGN BODY REMOVAL ....................................................................................... 51
SEARCH TERMS UTILISED FOR INTRA-OCULAR FOREIGN BODY REMOVAL.......................................................................... 52
STUDIES OF INTRA-OCULAR FOREIGN BODY EXTRACTION ............................................................................................. 56
PICO CRITERIA FOR TARSAL CYST EXTIRPATION ......................................................................................................... 63
SEARCH TERMS UTILISED FOR TARSAL CYST EXTIRPATION ............................................................................................. 63
RANDOMISED CONTROLLED TRIALS FOR TARSAL CYST EXTIRPATION................................................................................ 66
COMPARATIVE STUDIES FOR TARSAL CYST EXTIRPATION .............................................................................................. 67
NON-COMPARATIVE STUDIES TARSAL CYST EXTIRPATION ............................................................................................. 69
SEARCH TERMS USED FOR IDENTIFYING RELEVANT LITERATURE IN JOURNAL DATABASES FOR TARSAL CYST EXTIRPATION .......... 71
GOOGLE SEARCHES TO SOURCE RELEVANT BLOGS FOR TARSAL CYST EXTIRPATION ............................................................. 72
PICO CRITERIA FOR LACRIMAL PASSAGE PROCEDURES ................................................................................................ 82
SEARCH TERMS UTILISED FOR ESTABLISHING LACRIMAL PASSAGE PATENCY ...................................................................... 83
STUDY PROFILES AND RESULTS FOR INCLUDED NON-COMPARATIVE STUDIES FOR LACRIMAL PASSAGE PROCEDURES ................ 85
SEARCH TERMS USED FOR IDENTIFYING RELEVANT LITERATURE IN JOURNAL DATABASES FOR LACRIMAL PASSAGE PROCEDURES . 91
WEBLOG SEARCH TERMS FOR LACRIMAL PASSAGE PROCEDURES ................................................................................... 92
SEARCH TERMS USED FOR IDENTIFYING RELEVANT LITERATURE IN JOURNAL DATABASES FOR CATARACT SURGERY ................ 100
WEBLOGS SEARCH TERMS FOR CATARACT SURGERY ................................................................................................. 101
MEDIA SEARCH TERMS FOR CATARACT SURGERY...................................................................................................... 102
PICO CRITERIA FOR CAPSULECTOMY AND LENSECTOMY ............................................................................................ 116
SEARCH TERMS UTILISED FOR CAPSULECTOMY AND LENSECTOMY ................................................................................ 116
PICO CRITERIA FOR RETINAL CRYOTHERAPY............................................................................................................ 122
SEARCH TERMS UTILISED FOR RETINAL CRYOTHERAPY ............................................................................................... 122
STUDY PROFILES FOR SYSTEMATIC REVIEWS FOR THE TREATMENT OF RETINOBLASTOMA .................................................. 124
PROFILES AND RESULTS OF STUDIES COMPARING CRYOTHERAPY VERSUS OBSERVATION FOR RETINOPATHY OF PREMATURITY... 127
PICO CRITERIA FOR RETINAL CRYOTHERAPY............................................................................................................ 134
SEARCH TERMS UTILISED FOR RETINAL CRYOTHERAPY ............................................................................................... 134
STUDY PROFILES AND RESULTS COMPARING RETINAL CRYOTHERAPY TO CONTROL OR ALTERNATIVE TREATMENTS IN THE
PREVENTION OF RETINAL DETACHMENT................................................................................................................. 136
PICO CRITERIA FOR RETINAL DETACHMENT ITEMS ................................................................................................... 137
SEARCH TERMS UTILISED FOR RETINAL DETACHMENT ITEMS ....................................................................................... 138
RCTS COMPARING SCLERAL BUCKLING WITH OTHER SURGICAL PROCEDURES TO TREAT RETINAL DETACHMENT ..................... 142
COMPARATIVE STUDIES INCLUDED IN THE REVIEW BY SAW ET AL (2006) COMPARING SCLERAL BUCKLING WITH OTHER SURGICAL
PROCEDURES TO TREAT RETINAL DETACHMENT ....................................................................................................... 146
SEARCH TERMS USED FOR IDENTIFYING RELEVANT LITERATURE IN JOURNAL DATABASES FOR RETINAL DETACHMENT ............ 151
SEARCH TERMS FOR WEBLOGS FOR RETINAL DETACHMENT ........................................................................................ 152
SEARCH TERMS UTILISED FOR PHOTOCOAGULATION ................................................................................................. 162
STUDY PROFILES AND RESULTS OF SYSTEMATIC REVIEWS COMPARING PHOTOCOAGULATION TO CONTROL OR ALTERNATIVE
TREATMENTS IN THE PREVENTION OF RETINAL DETACHMENT ..................................................................................... 165
SEARCH TERMS USED FOR IDENTIFYING RELEVANT LITERATURE IN JOURNAL DATABASES FOR PHOTOCOAGULATION............. 166
WEBLOG SEARCH TERMS FOR PHOTOCOAGULATION................................................................................................. 167
TABLE 55
TABLE 56
TABLE 57
TABLE 58
TABLE 59
TABLE 60
TABLE 61
TABLE 62
TABLE 63
TABLE 64
TABLE 65
TABLE 66
TABLE 67
TABLE 68
TABLE 69
TABLE 70
TABLE 71
TABLE 72
TABLE 73
TABLE 74
TABLE 75
TABLE 76
TABLE 77
TABLE 78
TABLE 79
TABLE 80
TABLE 81
TABLE 82
TABLE 83
TABLE 84
TABLE 85
TABLE 86
TABLE 87
TABLE 88
TABLE 89
TABLE 90
TABLE 91
STUDY PROFILES AND RESULTS OF SYSTEMATIC REVIEWS COMPARING PHOTOCOAGULATION TO CONTROL OR ALTERNATIVE
TREATMENTS FOR THE TREATMENT OF DIABETIC RETINOPATHY .................................................................................. 178
STUDY PROFILES AND RESULTS OF RCTS INCLUDED IN SYSTEMATIC REVIEWS COMPARING PHOTOCOAGULATION TO CONTROL OR
ALTERNATIVE TREATMENTS FOR THE TREATMENT OF DIABETIC RETINOPATHY. ............................................................. 179
STUDY PROFILES AND RESULTS OF RCTS REPORTING ON THE DIFFERENT TECHNIQUES FOR DELIVERING PHOTOCOAGULATION .. 181
STUDY PROFILES AND RESULTS OF RCTS COMPARING PHOTOCOAGULATION TO CONTROL OR ALTERNATIVE TREATMENTS FOR THE
TREATMENT OF DIABETIC RETINOPATHY ................................................................................................................ 187
STUDY PROFILES AND RESULTS OF SYSTEMATIC REVIEWS COMPARING PHOTOCOAGULATION TO CONTROL OR ALTERNATIVE
TREATMENTS FOR CHOROIDAL NEOVASCULARISATION IN PATHOLOGIC MYOPIA ............................................................. 193
STUDY PROFILES AND RESULTS OF RCTS WITHIN SR DESCRIBING PHOTOCOAGULATION VERSUS OBSERVATION FOR THE
TREATMENT OF DIABETIC MACULAR OEDEMA ......................................................................................................... 198
STUDY PROFILES AND RESULTS OF RCTS WITHIN SR DESCRIBING THE COMPARISON OF DIFFERENT LASERS OR TECHNIQUES IN THE
TREATMENT OF DIABETIC MACULAR OEDEMA ......................................................................................................... 199
STUDY PROFILES AND RESULTS OF RCTS WITHIN SR DESCRIBING THE COMPARISON OF PHOTOCOAGULATION VERSUS VITRECTOMY
FOR THE TREATMENT OF DIABETIC MACULAR OEDEMA ............................................................................................. 202
STUDY PROFILES AND RESULTS OF SYSTEMATIC REVIEWS COMPARING PHOTOCOAGULATION VERSUS STEROID INJECTION (WITH
OR WITHOUT PHOTOCOAGULATION) FOR THE TREATMENT OF DIABETIC MACULAR OEDEMA .......................................... 205
STUDY PROFILES AND RESULTS OF SYSTEMATIC REVIEWS COMPARING PHOTOCOAGULATION VERSUS ANTI-VEGF (WITH OR
WITHOUT PHOTOCOAGULATION) FOR THE TREATMENT OF DIABETIC MACULAR OEDEMA ............................................... 206
STUDY PROFILES AND RESULTS OF SYSTEMATIC REVIEWS COMPARING PHOTOCOAGULATION VERSUS INTRAVITREAL ANTIVASCULAR ENDOTHELIAL GROWTH FACTOR INJECTION (WITH OR WITHOUT PHOTOCOAGULATION) FOR THE TREATMENT OF
DIABETIC MACULAR OEDEMA .............................................................................................................................. 206
STUDY PROFILES AND RESULTS OF RANDOMISED CONTROLLED TRIALS COMPARING PHOTOCOAGULATION TO CONTROL OR
ALTERNATIVE TREATMENTS IN THE PREVENTION OF RETINAL DETACHMENT ................................................................... 209
STUDY PROFILES AND RESULTS OF RCTS COMPARING PHOTOCOAGULATION TO INTRAVITREAL INJECTIONS FOR THE TREATMENT
OF CYSTOID MACULAR OEDEMA........................................................................................................................... 212
STUDY PROFILES AND RESULTS OF SYSTEMATIC REVIEWS COMPARING PHOTOCOAGULATION WITH OBSERVATION TO PREVENT
PROGRESSION OF AGE-RELATED MACULAR DEGENERATION ....................................................................................... 216
STUDY PROFILES AND RESULTS OF SYSTEMATIC REVIEWS COMPARING PHOTOCOAGULATION WITH OBSERVATION TO PREVENT
PROGRESSION TO AGE-RELATED MACULAR DEGENERATION ....................................................................................... 217
STUDY PROFILES OF RCTS INCLUDED IN SYSTEMATIC REVIEWS COMPARING PHOTOCOAGULATION WITH OBSERVATION TO
PREVENT PROGRESSION OF AGE-RELATED MACULAR DEGENERATION ........................................................................... 218
STUDY PROFILES OF RCTS INCLUDED IN SYSTEMATIC REVIEWS COMPARING PHOTOCOAGULATION WITH OBSERVATION TO
PREVENT PROGRESSION TO AGE-RELATED MACULAR DEGENERATION ........................................................................... 221
STUDY PROFILE AND RESULTS OF RCTS COMPARING PHOTOCOAGULATION WITH PARS PLANA VITRECTOMY VERSUS PARS PLANA
VITRECTOMY ALONE FOR THE TREATMENT OF MACULAR HOLES .................................................................................. 227
STUDY PROFILE AND RESULTS OF RCTS COMPARING PHOTOCOAGULATION VERSUS OBSERVATION IN THE TREATMENT OF
MACULAR HOLES IN PATIENTS WITH HIGH MYOPIC EYES ............................................................................................ 228
SYSTEMATIC REVIEWS COMPARING PHOTOCOAGULATION WITH EXTERNAL BEAM RADIOTHERAPY FOR THE TREATMENT OF
RETINOBLASTOMA ............................................................................................................................................ 230
PICO CRITERIA FOR VITREOUS SUBSTITUTES ........................................................................................................... 233
SEARCH TERMS UTILISED FOR VITREOUS SUBSTITUTES ............................................................................................... 233
RANDOMISED CONTROLLED TRIALS FOR LIQUID VITREOUS SUBSTITUTES USED IN THE TREATMENT OF COMPLEX RETINAL
DETACHMENT .................................................................................................................................................. 237
COMPARATIVE STUDIES FOR LIQUID VITREOUS SUBSTITUTES USED IN THE TREATMENT OF COMPLEX RETINAL DETACHMENT ... 238
NON-COMPARATIVE STUDIES FOR LIQUID VITREOUS SUBSTITUTES USED IN THE TREATMENT OF COMPLEX RETINAL DETACHMENT
.................................................................................................................................................................... 239
AGE BREAKDOWN OF AUSTRALIAN POPULATION (SOURCE: ABS, JUNE 2009) .............................................................. 268
GENDER BREAKDOWN OF THE AUSTRALIAN POPULATION (SOURCE: ABS JUNE 2009) .................................................... 268
GEOGRAPHIC BREAKDOWN OF AUSTRALIAN POPULATION (SOURCE: ABS DECEMBER 2009) ........................................... 268
RURALITY OF AUSTRALIAN POPULATION (SOURCE: AIHW 2004)1 ............................................................................. 268
DESCRIPTION OF MBS OPHTHALMOLOGICAL ITEMS UNDER REVIEW ........................................................................... 269
MBS ITEM NUMBER 11200 USE (1994 – 2009); BY AGE, GENDER AND STATE............................................................ 276
MBS ITEM NUMBER 11203 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 277
MBS ITEM NUMBER 42746 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 278
MBS ITEM NUMBER 42749 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 279
MBS ITEM NUMBER 42752 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 280
MBS ITEM NUMBER 42770 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 280
MBS ITEM NUMBER 42771 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 281
TABLE 92
TABLE 93
TABLE 94
TABLE 95
TABLE 96
TABLE 97
TABLE 98
TABLE 99
TABLE 100
TABLE 101
TABLE 102
TABLE 103
TABLE 104
TABLE 105
TABLE 106
TABLE 107
TABLE 108
TABLE 109
TABLE 110
TABLE 111
TABLE 112
TABLE 113
TABLE 114
TABLE 115
TABLE 116
TABLE 117
TABLE 118
TABLE 119
TABLE 120
TABLE 121
TABLE 122
TABLE 123
TABLE 124
TABLE 125
TABLE 126
TABLE 127
TABLE 128
TABLE 129
TABLE 130
TABLE 131
TABLE 132
TABLE 133
TABLE 134
TABLE 135
TABLE 136
TABLE 137
TABLE 138
TABLE 139
TABLE 140
TABLE 141
TABLE 142
TABLE 143
TABLE 144
TABLE 145
MBS ITEM NUMBER 11204 USE (2001 – 2009); BY AGE, GENDER AND STATE ............................................................ 282
MBS ITEM NUMBER 11205 USE (2001 – 2009); BY AGE, GENDER AND STATE ............................................................ 283
MBS ITEM NUMBER 11210 USE (2001 – 2009); BY AGE, GENDER AND STATE ............................................................ 284
MBS ITEM NUMBER 11211 USE (2001 – 2009); BY AGE, GENDER AND STATE ............................................................ 284
MBS ITEM NUMBER 11212 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 285
MBS ITEM NUMBER 11215 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 286
MBS ITEM NUMBER 11218 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 287
MBS ITEM NUMBER 11221 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 288
MBS ITEM NUMBER 11222 USE (1997 – 2009); BY AGE, GENDER AND STATE ............................................................ 290
MBS ITEM NUMBER 11224 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 291
MBS ITEM NUMBER 11225 USE (1997 – 2009); BY AGE, GENDER AND STATE ............................................................ 292
MBS ITEM NUMBER 11237 USE (2003 – 2009); BY AGE, GENDER AND STATE ............................................................ 293
MBS ITEM NUMBER 11240 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 294
MBS ITEM NUMBER 11241 USE (2001 – 2009); BY AGE, GENDER AND STATE ............................................................ 295
MBS ITEM NUMBER 11242 USE (2001 – 2009); BY AGE, GENDER AND STATE ............................................................ 296
MBS ITEM NUMBER 11243 USE (2001 – 2009); BY AGE, GENDER AND STATE ............................................................ 297
MBS ITEM NUMBER 42551 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 298
MBS ITEM NUMBER 42554 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 298
MBS ITEM NUMBER 42557 USE (1994 – 2009); BY AGE, GENDER AND STATE............................................................ 299
MBS ITEM NUMBER 42560 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 300
MBS ITEM NUMBER 42563 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 300
MBS ITEM NUMBER 42566 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 301
MBS ITEM NUMBER 42569 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 301
MBS ITEM NUMBER 42644 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 302
MBS ITEM NUMBER 42575 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 303
MBS ITEM NUMBER 42610 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 304
MBS ITEM NUMBER 42611 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 305
MBS ITEM NUMBER 42614 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 306
MBS ITEM NUMBER 42615 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 307
MBS ITEM NUMBER 42698 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 308
MBS ITEM NUMBER 42701 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 309
MBS ITEM NUMBER 42702 USE (1996 – 2009); BY AGE, GENDER AND STATE ............................................................ 310
MBS ITEM NUMBER 42703 USE (1996 – 2009); BY AGE, GENDER AND STATE ............................................................ 311
MBS ITEM NUMBER 42704 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 312
MBS ITEM NUMBER 42707 USE (1994 – 2009); BY AGE, GENDER AND STATE............................................................ 313
MBS ITEM NUMBER 42710 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 313
MBS ITEM NUMBER 42713 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 314
MBS ITEM NUMBER 42716 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 315
MBS ITEM NUMBER 42719 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 316
MBS ITEM NUMBER 42722 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 317
MBS ITEM NUMBER 42731 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 318
MBS ITEM NUMBER 42725 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 319
MBS ITEM NUMBER 42728 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 320
MBS ITEM NUMBER 42773 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 321
MBS ITEM NUMBER 42776 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 322
MBS ITEM NUMBER 42779 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 323
MBS ITEM NUMBER 42812 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 324
MBS ITEM NUMBER 42818 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 325
MBS ITEM NUMBER 42740 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 326
MBS ITEM NUMBER 42782 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 327
MBS ITEM NUMBER 42809 USE (1994 – 2009); BY AGE, GENDER AND STATE............................................................ 329
MBS ITEM NUMBER 42815 USE (1994 – 2009); BY AGE, GENDER AND STATE ............................................................ 330
MBS ITEM NUMBER 51315 USE (1997 – 2009); BY AGE, GENDER AND STATE ............................................................ 331
OPHTHALMOLOGY ITEMS UNDER REVIEW FOR WHICH THERE WAS A COMBINATION OF CLAIMS, 2007-8 TO 2009-10 .......... 332
TABLE OF FIGURES
FIGURE 1
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FIGURE 46
FIGURE 47
FIGURE 48
FIGURE 49
FIGURE 50
FIGURE 51
FIGURE 52
THE ANTERIOR (A) AND POSTERIOR (B) SECTIONS OF THE EYE (BORES 2007) .................................................................. 49
A TRANS PARS PLANA VITRECTOMY DEMONSTRATING THE REMOVAL OF THE VITREOUS (VITREOUS-RETINA-MACULA
CONSULTANTS OF NEW YORK 2009) ..................................................................................................................... 51
ILLUSTRATING THE POSITION AND DEVELOPMENT OF A TARSAL CYST .............................................................................. 62
ILLUSTRATING THE POSITION OF THE NASOLACRIMAL DUCT .......................................................................................... 80
A) A SMALL PROBE IS PASSED THROUGH THE TEAR DUCT SYSTEM TO OPEN UP THE BLOCKAGE AND B) A SILICONE TUBE MAY BE
PLACED IN THE TEAR DUCT SYSTEM TO HOLD THE DUCT OPEN ...................................................................................... 81
(A) ILLUSTRATING THE POSITION OF THE LIMBUS (THE EDGE OF THE CORNEA WHERE IT JOINS THE SCLERA) AND (B) THE PARS
PLANA (PART OF CILIARY BODY LOCATED NEAR THE POINT WHERE THE IRIS AND THE SCLERA MEET) ................................... 115
PROCEDURES BILLED TO MEDICARE PER 100,000 POPULATION FOR MBS ITEM NUMBERS 42818, 42776, 42773,
42728 .......................................................................................................................................................... 129
MBS ITEM NUMBER 11200, NUMBER OF SERVICES (1994 - 2009)........................................................................... 276
MBS ITEM NUMBER 11203, NUMBER OF SERVICES (1994 - 2009)........................................................................... 277
MBS ITEM NUMBER 42746, NUMBER OF SERVICES (1994 - 2009)........................................................................... 278
MBS ITEM NUMBERS 42749, 42752, 42770 AND 42771, NUMBER OF SERVICES (1994 - 2009) ................................ 279
MBS ITEM NUMBERS 11204 AND 11205, NUMBER OF SERVICES (2001 - 2009) ........................................................ 282
MBS ITEM NUMBERS 11210 AND 11211, NUMBER OF SERVICES (2001 - 2009) ........................................................ 283
MBS ITEM NUMBERS 11212, NUMBER OF SERVICES (1994 - 2009) ......................................................................... 285
MBS ITEM NUMBERS 11215, NUMBER OF SERVICES (1994 - 2009) ......................................................................... 286
MBS ITEM NUMBERS 11218, NUMBER OF SERVICES (1994 - 2009) ......................................................................... 287
MBS ITEM NUMBERS 11221, NUMBER OF SERVICES (1994 - 2009) ......................................................................... 288
MBS ITEM NUMBERS 11222 AND 11225, NUMBER OF SERVICES (1997 - 2009) ........................................................ 289
MBS ITEM NUMBER 11224, NUMBER OF SERVICES (1994 - 2009)........................................................................... 291
MBS ITEM NUMBERS 11237, 11242 AND 11243, NUMBER OF SERVICES (2001 - 2009) ............................................ 293
MBS ITEM NUMBER 11240, NUMBER OF SERVICES (1994 - 2009)........................................................................... 294
MBS ITEM NUMBER 11241, NUMBER OF SERVICES (2001 - 2009)........................................................................... 295
MBS ITEM NUMBERS 42551, 42554 AND 42557, NUMBER OF SERVICES (1994 - 2009) ............................................ 297
MBS ITEM NUMBERS 42560, 42563, 42566 AND 42569, NUMBER OF SERVICES (1994 - 2009) ................................ 299
MBS ITEM NUMBER 42644, NUMBER OF SERVICES (1994 - 2009)........................................................................... 302
MBS ITEM NUMBER 42575, NUMBER OF SERVICES (1994 - 2009)........................................................................... 303
MBS ITEM NUMBERS 42610 AND 42611, NUMBER OF SERVICES (1994 - 2009) ........................................................ 304
MBS ITEM NUMBERS 42614 AND 42615, NUMBER OF SERVICES (1994 - 2009) ........................................................ 306
MBS ITEM NUMBER 42698, NUMBER OF SERVICES (1994 - 2009)........................................................................... 308
MBS ITEM NUMBER 42701, NUMBER OF SERVICES (1994 - 2009)........................................................................... 309
MBS ITEM NUMBER 42702, NUMBER OF SERVICES (1996 - 2009)........................................................................... 310
MBS ITEM NUMBER 42703, NUMBER OF SERVICES (1996 - 2009)........................................................................... 311
MBS ITEM NUMBERS 42704, 42707 AND 42710, NUMBER OF SERVICES (1994 - 2009) ............................................ 312
MBS ITEM NUMBER 42713, NUMBER OF SERVICES (1994 - 2009)........................................................................... 314
MBS ITEM NUMBER 42716, NUMBER OF SERVICES (1994 - 2009)........................................................................... 315
MBS ITEM NUMBERS 42719, 42722 AND 42731, NUMBER OF SERVICES (1994 - 2009) ............................................ 316
MBS ITEM NUMBER 42725, NUMBER OF SERVICES (1994 - 2009)........................................................................... 319
MBS ITEM NUMBER 42728, NUMBER OF SERVICES (1994 - 2009)........................................................................... 320
MBS ITEM NUMBER 42773, NUMBER OF SERVICES (1994 - 2009)........................................................................... 321
MBS ITEM NUMBER 42776, NUMBER OF SERVICES (1994 - 2009)........................................................................... 322
MBS ITEM NUMBER 42779, NUMBER OF SERVICES (1994 - 2009)........................................................................... 323
MBS ITEM NUMBER 42812, NUMBER OF SERVICES (1994 - 2009)........................................................................... 324
MBS ITEM NUMBER 42818, NUMBER OF SERVICES (1994 - 2009)........................................................................... 325
MBS ITEM NUMBER 42740, NUMBER OF SERVICES (1994 - 2009)........................................................................... 326
MBS ITEM NUMBER 42782, NUMBER OF SERVICES (1994 - 2009)........................................................................... 327
MBS ITEM NUMBER 42809, NUMBER OF SERVICES (1994 - 2009)........................................................................... 328
MBS ITEM NUMBER 42815, NUMBER OF SERVICES (1994 - 2009)........................................................................... 329
MBS ITEM NUMBER 51315, NUMBER OF SERVICES (1997 - 2009)........................................................................... 331
HOSPITAL SEPARATIONS BY AR-DRG - EYE, SURGICAL, RETINAL PROCEDURES, 1998-99 TO 2007-08 .............................. 334
HOSPITAL SEPARATIONS BY AR-DRG - EYE, SURGICAL, GLAUCOMA AND COMPLEX CATARACT PROCEDURES, 1998-99 ..............
TO 2007-08 ................................................................................................................................................... 335
HOSPITAL SEPARATIONS BY AR-DRG - EYE, SURGICAL, LENS PROCEDURES, 1998-99 TO 2007-08 .................................. 335
HOSPITAL SEPARATIONS BY PRINCIPAL DIAGNOSIS - SELECTED ITEMS, 1998-99 TO 2007-08 .......................................... 336
FIGURE 53
FIGURE 54
FIGURE 55
FIGURE 56
HOSPITAL SEPARATIONS BY PRINCIPAL DIAGNOSIS - LENS DISORDERS, 1998-99 TO 2007-08 .......................................... 336
HOSPITAL PROCEDURES - SELECTED ITEMS, 2002-03 TO 2007-08 ............................................................................ 337
HOSPITAL PROCEDURES - POSTERIOR SEGMENT, RETINA, 2002-03 TO 2007-08 .......................................................... 337
SCRIPTS FOR RANIBIZUMAB (LUCENTIS), BY MONTH, SEPT 2007 TO JUNE 2010 ........................................................... 338
TABLE OF BOXES
BOX 1
BOX 2
BOX 3
BOX 4
BOX 5
BOX 6
BOX 7
BOX 8
BOX 9
BOX 10
BOX 11
BOX 12
BOX 13
BOX 14
BOX 15
BOX 16
BOX 17
BOX 18
BOX 19
BOX 20
BOX 21
BOX 22
BOX 23
BOX 24
BOX 25
BOX 26
BOX 27
EVIDENCE MATRIX FOR OCULAR BIOMETRY AND PARTIAL COHERENCE INTERFEROMETRY ................................................... 44
‘REMOVAL OF FOREIGN BODY’ ITEM DECRIPTOR AMENDMENTS ................................................................................... 48
EVIDENCE MATRIX FOR MAGNETIC REMOVAL OF AN INTRA-OCULAR FOREIGN BODY FROM THE ANTERIOR OR POSTERIOR SEGMENT
OF THE EYE........................................................................................................................................................ 56
EVIDENCE MATRIX FOR TARSAL CYST EXTIRPATION..................................................................................................... 71
BODY OF EVIDENCE MATRIX FOR ESTABLISHING LACRIMAL PASSAGE PATENCY ................................................................. 84
CATARACT SURGERY ITEM DESCRIPTOR AMENDMENTS ............................................................................................. 112
CAPSULECTOMY OR LENSECTOMY DESCRIPTOR ITEM AMENDMENTS............................................................................ 118
VITRECTOMY ITEM DESCRIPTOR AMENDMENTS ...................................................................................................... 119
BODY OF EVIDENCE MATRIX FOR CRYOTHERAPY FOR THE TREATMENT OF RETINOBLASTOMA ............................................ 124
BODY OF EVIDENCE MATRIX FOR CRYOTHERAPY VERSUS OBSERVATION FOR RETINOPATHY OF PREMATURITY ........................ 126
RETINAL CRYOTHERAPY ITEM DESCRIPTOR AMENDMENTS .......................................................................................... 130
BODY OF EVIDENCE MATRIX FOR SCLERAL BUCKLING WITH AND WITHOUT TRANSSCLERAL RETINAL CRYOPEXY FOR RETINAL
REATTACHMENT ............................................................................................................................................... 135
BODY OF EVIDENCE MATRIX FOR SCLERAL BUCKLING................................................................................................. 142
BODY OF EVIDENCE MATRIX FOR PREVENTION OF RETINAL DETACHMENT FOLLOWING SILICONE OIL REMOVAL AFTER VITRECTOMY
.................................................................................................................................................................... 164
BODY OF EVIDENCE MATRIX FOR PHOTOCOAGULATION FOR THE TREATMENT OF DIABETIC RETINOPATHY ............................ 177
BODY OF EVIDENCE MATRIX FOR DIFFERENT METHODS OF DELIVERING PHOTOCOAGULATION ........................................... 183
BODY OF EVIDENCE MATRIX FOR PHOTOCOAGULATION VERSUS INTRAVITREAL OR SUB-TENON’S CORTICOSTEROID OR ANTIVASCULAR ENDOTHELIAL GROWTH FACTOR ............................................................................................................ 186
BODY OF EVIDENCE MATRIX FOR PHOTOCOAGULATION FOR THE TREATMENT OF CHOROIDAL NEOVASCULARISATION ASSOCIATED
WITH PATHOLOGIC MYOPIA ................................................................................................................................ 193
BODY OF EVIDENCE MATRIX FOR PHOTOCOAGULATION FOR THE TREATMENT OF MACULAR OEDEMA.................................. 197
BODY OF EVIDENCE MATRIX FOR PHOTOCOAGULATION VERSUS VITRECTOMY FOR THE TREATMENT OF DIABETIC MACULAR
OEDEMA......................................................................................................................................................... 201
BODY OF EVIDENCE MATRIX FOR PHOTOCOAGULATION VERSUS STEROID OR ANTI-VEGF INJECTIONS WITH OR WITHOUT
PHOTOCOAGULATION FOR THE TREATMENT OF MACULAR OEDEMA ............................................................................ 204
BODY OF EVIDENCE MATRIX FOR THE TREATMENT OF EXUDATIVE RETINAL DETACHMENT SECONDARY TO ISCHAEMIC BRANCH
RETINAL VEIN OCCLUSION................................................................................................................................... 208
BODY OF EVIDENCE MATRIX FOR PHOTOCOAGULATION FOR THE TREATMENT OF CYSTOID MACULAR OEDEMA SECONDARY TO
BRANCH RETINAL VEIN OCCLUSION (BRVO)........................................................................................................... 211
BODY OF EVIDENCE MATRIX FOR PHOTOCOAGULATION FOR THE TREATMENT OF PATIENTS WITH AGE-RELATED MACULAR
DEGENERATION................................................................................................................................................ 215
BODY OF EVIDENCE MATRIX FOR FOR PHOTOCOAGULATION FOR THE TREATMENT OF MACULAR HOLES ............................... 226
BODY OF EVIDENCE MATRIX FOR LIQUID VITREOUS SUBSTITUTES USED IN THE TREATMENT OF COMPLEX RETINAL DETACHMENTS
.................................................................................................................................................................... 237
SURGICAL ASSIST ITEM DESCRIPTOR AMENDMENTS ................................................................................................. 245
EXECUTIVE SUMMARY
Background and purpose of review
Following amendments to the fee for several cataract items listed on the Medicare Benefits
Schedule (MBS), a review of existing MBS ophthalmology was commenced under the MBS Quality
Framework. This review is continuing under the Comprehensive Management Framework for the
MBS. The primary focus of reviews of existing items is to ensure that the MBS supports and
encourages evidence-based, cost-effective clinical practice and to identify and evaluate current
MBS services that present potential safety and quality issues. Given the large number of
ophthalmology MBS items, this review is being undertaken in two stages. Information presented
in this summary and the review report only relates to the first-stage of the review. The secondstage of the review is expected to commence late 2011.
The review of ophthalmology items will inform recommendations aimed at aligning the use of
Medicare-funded ophthalmology services with available evidence. The Royal Australian and New
Zealand College of Ophthalmologists (RANZCO) has played a crucial role in assisting the
Department to develop the approach to reviewing existing items in light of contemporary
evidence regarding their appropriate use in clinical practice. Further to this role, RANZCO also
nominated several specialist ophthalmologists to be part of a small Clinical Working Group (CWG)
to provide expert clinical input to the review to ensure that the research questions are relevant to
current Australian clinical practice, and that valid conclusions are drawn from the evidence. The
Department would like to thank both RANZCO and the CWG members for the vital assistance
provided in undertaking this review.
Scope
The Schedule lists approximately 160 ophthalmology MBS items. Within the specialty, 61 of these
items were included in the first-stage review and were identified through several mechanisms
comprising:




MBS data analysis - highest and lowest utilised items to determine clinical appropriateness of
the most commonly used services, and to identify whether any services are now obsolete;
advice from the Professional Services Review;
items relating to clinical practice guidelines for a concordance exercise; and
items identified by RANZCO as requiring amendment and/or deletion.
An overview of these items and the application of the various methodologies are presented in
Table 2: MBS item reviews and amendments on pages 4 and 5 of this report.
The amendments requested by the College were broadly classified by the Department as minor
non-material amendments to improve clarity and to reflect current terminology; or significant
amendments to existing items with fiscal and health outcome implications, requiring appropriately
targeted health technology assessments and/or a guideline concordance exercise. The
amendments classified as minor have been negotiated between RANZCO and the Department,
whilst significant amendments have undergone more robust assessment, including analysis of
relevant literature. Qualitative analysis of literature on patient and consumer values and
preferences concerning specific ophthalmology services was also undertaken to provide a
snapshot of public opinion with respect to specific ophthalmology services.
Page i
Key conclusions
Adelaide Health Technology Assessment (AHTA), a research group at the University of Adelaide,
undertook the evidence-based analysis for the review. An appraisal of the evidence has been
undertaken and a summary of findings on each of the services under review is at Appendix I on
page 373 of the report. The minor item amendments requested by the College are at Appendix J
on page 377.
Next steps
The outcomes of public consultation will be used to finalise the review report, which will then be
considered by the Medical Services Advisory Committee (MSAC) and its Evaluation SubCommittee. MSAC’s advice regarding any proposed item amendments arising from the review will
then be provided by the Department to the Minister for Health and Ageing.
Page ii
1. INTRODUCTION TO REVIEWS
In the 2009-10 Budget, the Australian Government put in place a new evidence-based framework
for managing the Medicare Benefits Schedule into the future through the measure Medicare
Benefits Schedule – A quality framework for reviewing services (MBS Quality Framework). This
review commenced under the framework and is continuing under the Comprehensive
Management Framework for the MBS.
The primary focus of reviews of existing items is to ensure that the MBS supports and encourages
evidence-based, cost-effective clinical practice and to identify and evaluate current MBS services
that present potential safety and quality issues.
Adelaide Health Technology Assessment (AHTA), School of Population Health and Clinical Practice,
at the University of Adelaide, as part of its contract with the Department of Health and Ageing has
undertaken a review of the evidence relating to specific ophthalmology MBS items (see Table 1).
Table 1
Ophthalmological Services listed on the MBS and under review
SERVICE NAME
MBS ITEM NOS
Glaucoma
Electroretinography
Examination of optic fundi
Retinal photography
Perimetry
Orbital echography/ocular biometry
Removal of foreign body
Extirpation of tarsal cyst
Lacrimal passages
11200, 11203, 42746, 42749, 42752, 42770, 42771
11204, 11205, 11210, 11211
11212
11215, 11218
11221, 11222, 11224, 11225, 10940, 10941
11237, 11240, 11241, 11242, 11243
42551, 42554, 42557, 42560, 42563, 42566, 42569, 42644
42575
42610, 42611, 42614, 42615
42698, 42701, 42702, 42703, 42704, 42707, 42710, 42713,
42716
42719, 42722, 42731
Cataract surgery
Capsulectomy and lensectomy
Vitrectomy
Cryotherapy of retina
Retinal services
Intra-vitreal injection (macular degeneration)
Laser trabeculoplasty
Retinal photocoagulation
Removal of silicone oil
Surgical assist
42725
42728
42773, 42776, 42779, 42812, 42818
42740
42782, 42783
42809
42815
51315
Page 1
1.1 Principles to guide MBS reviews
MBS Quality Framework reviews were underpinned by the following key principles:
•
reviews have a primary focus on improving health outcomes and the financial sustainability
of the MBS, through consideration of areas potentially representing:

patient safety risk;

limited health benefit; and/or

inappropriate use (under or over use).
•
reviews are evidence-based, fit-for-purpose and consider all relevant data sources;
•
reviews are conducted in consultation with key stakeholders including, but not limited to,
the medical profession and consumers;
•
review topics are made public, with identified opportunities for public submission and
outcomes of reviews published;
•
reviews are independent of Government financing decisions and may result in
recommendations representing costs or savings to the MBS, as appropriate, based on the
evidence;
•
secondary investment strategies to facilitate evidence-based changes in clinical practice
are considered; and
•
review activity represents efficient use of Government resources.
1.2 Rationale for the review of ophthalmological items
Following amendments to the Schedule fee for several cataract items, it was agreed that a review
of existing ophthalmology items listed on the MBS would be undertaken as part of the MBS
Quality Framework. The review of ophthalmology items will inform recommendations aimed at
strengthening the evidence-base of Medicare-funded ophthalmology services and their use.
The relevant medical craft groups, the Royal Australian and New Zealand College of
Ophthalmologists (RANZCO) and the Australian Society of Ophthalmologists have been involved in
the development of the review approach, assisting in identifying existing items that may not
appropriately reflect current clinical practice. In addition, RANZCO has nominated several experts
to provide clinical input to the review – Clinical Working Group membership is provided in
Appendix A.
1.3 Objectives of the review
To provide robust, evidence-based analysis to inform recommendations aimed at strengthening
the evidence-base for specific Medicare-funded ophthalmology items and their use.
Page 2
2. REVIEW METHODOLOGY
The draft protocol, outlining the whole approach to this review of MBS ophthalmology items, was
drafted with the assistance of the Clinical Working Group and the Department of Health and
Ageing, and underwent public consultation in October 2010. All feedback was incorporated into
the final protocol for the review.
A mixed-methods approach was used to review the identified ophthalmology services listed on the
MBS. Five methodologies were employed, some of which were applied in combination for some of
the items, and included:
1. analysis of data on usage of ophthalmology services according to MBS item number claims;
2. analysis of the concordance between clinical practice guideline recommendations and the
MBS item descriptors for these services;
3. mini-health technology assessments (HTAs) tailored to be “fit-forpurpose”;
4. a consumer engagement process that involved a qualitative analysis of patient/consumer
literature on values and preferences concerning specific ophthalmology services; and
5. negotiation on minor wording amendments to ophthalmology MBS item descriptors with
stakeholders.
Table 2 provides an overview of the methodology that was used for each of the ophthalmological
items under review. The resulting outputs from each of these methodological approaches have
been synthesised and are addressed in the Review Outcomes section of the report in individual
chapters based on to the service groupings provided in Table 2. A collated summary of the findings
is provided in Appendix I.
Detail on each of the methodologies employed is provided below.
Page 3
Table 2
MBS item reviews and amendments
MBS ITEMS
SERVICE
IDENTIFICATION SOURCE
RANZCO
submission
Guidelines
Highest
utilisation
METHOD †
Other
(Professional
Services
Review)
Mini HTA
review
11200, 11203, 42746, 42749,
42752, 42770, 42771
Glaucoma
11204, 11205, 11210, 11211
Electroretinography
11212
Examination of optic fundi
11215, 11218
11221, 11222, 11224, 11225,
10940*, 10941*
11237, 11240, 11241, 11242,
11243
42551*, 42554*, 42557*,
42560, 42563, 42566, 42569,
42644 *
42575
Retinal photography
Perimetry (*)‡
x
x
Orbital echography/ ocular
biometry ‡
Removal of foreign body (*)
x
x
x
(Item 42644)
x
Extirpation of tarsal cyst ‡
x
x
42610, 42611, 42614, 42615
Lacrimal passages ‡
x
x
42698, 42701, 42702, 42703*,
42704*, 42707*, 42710*,
42713*, 42716
42719, 42722, 42731*
Cataract surgery (*) ‡
x
Capsulectomy and
lensectomy (*)
Vitrectomy (*)
Cryotherapy of retina
Retinal services (*)
x
42725 *
42728
42773, 42776, 42779, 42812,
42818*
Stakeholder
negotiation**
x
x
x
x
x
x
x
x
x
x
Guideline
concordance
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Page 4
x
x
x
x
x
42740
42782, 42783
42809
Intra-vitreal injection ‡
Laser trabeculoplasty
Retinal photocoagulation ‡
x
42815
Removal of silicone oil
x
51315*
Surgical assist (*)
x
x
x
x
x
x
x
x
x
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims data for all of the listed items
‡ Consumer views and preferences, as discussed in qualitative and blog literature, were also reviewed for these specific items.
* These items were flagged for minor amendments and were progressed by the Department having regard to the broader review activity undertaken by the consultant
** The Department of Health and Ageing undertook the stakeholder negotiation
Page 5
x
x
x
2.1 MBS data analysis
Clinical/research questions
1. How frequent are claims for the MBS item numbers under review?
2. Are there any temporal or geographic trends associated with usage of these item numbers?
3. Are the Medicare claims data consistent with trends in the indicence/prevalence of the
conditions/diseases being addressed by the services?
This analysis investigated the usage of 61 items from Category 2 (Diagnostic Procedures and
Investigations) and Category 3 (Therapeutic Procedures) of the Medical Benefits Schedule. In
particular, the ophthalmology items are found in Group D1 (Miscellaneous), Sub-group 2
(Ophthalmology), Group T8 (Surgical Operations), Sub-group 9 (Ophthalmology) and Group T9
(Assistance at Operations). Two perimetry items were included in the review but were not
assessed separately.
Data were sourced from the Medicare Australia website.1 For each of the 20 categories of MBS
ophthalmology services analysed, the following information was extracted for each item related to
that service:




Item number
Description of item
Cost of benefits paid in 2009; and for the first half of 2010.
Graph of number of services over time (calendar years 1994-2009, unless otherwise
indicated) – either for individual items, or for groups of items
 Demographic breakdown – table showing breakdown of services for the total period, by
age, gender and geographic location (state). Reference data for these demographic
distributions were taken from the Australian Bureau of Statistics (see Appendix B).
 Brief comments about its use.
Details of each of the services, represented by an item number, are given in Appendix D.
AIHW National Hospital Morbidity database data2 were investigated, as appropriate, to provide
data on hospital separations related to eye conditions, by diagnosis-related group AR-DRG (Major
Diagnostic Category 02), principal diagnosis in ICD-10-AM (group VII, H00-H59), count of
procedures ACHI (group III, chapters 160-256) and cost.
Confidential Medicare data were provided by the Department of Health and Ageing on item
provision according to rurality of the patient (for the 3 financial years 2007-08 to 2009-10). This
was condensed into Metropolitan (RRMAs 1 and 2) and Rural (RRMAs 3, 4, 5, 6 and 7). Using these
data gave an estimate of the population distribution as Metropolitan 71.3% and Rural 28.7%.
Although the population data for RRMAs is old, it matches closely the average distribution of
claims data provided for the three years. Of a total of 2,257,213 claims, 1,614,594 were for RRMAs
1 and 2, equating to 71.5%. Thus, it was considered a reasonable basis for considering whether the
distribution of services was outside the normal range. A margin of 7 percentage points was
allowed as the range around the point estimate before which a discrepancy from the reference
1
2
https://www.medicareaustralia.gov.au/statistics/mbs_item.shtml, Accessed 2010.
http://www.aihw.gov.au/hospitals/datacubes/datacube_proc.cfm, Accessed 2010.
Page 6
distribution of rural:metropolitan claims was flagged. Analysis was only performed if there was a
minimum of 500 services over the 3 years.
There was no information available on the rurality of the service provider. The data provided by
the Commonwealth was based on rurality of the patient. It is therefore possible that rural patients
were in fact receiving ophthalmological services in metropolitan locations. It was, however, the
best available proxy for determining the rural:metropolitan distribution of services.
2.2 Guideline concordance
Clinical/research question
Is the descriptor for each MBS item number/service under review consistent with evidence-based
(or in the absence of evidence, consensus-based) recommendations provided in relevant clinical
practice guidelines?
Concurrent with the MBS data analysis, an analysis of 10 ophthalmological services (36 items)
identified as requiring a guideline concordance analysis were assessed relative to “best practice”
as recommended in relevant Clinical Practice Guidelines that were relevant to practice in Australia.
Table 3
Ophthalmology items receiving guideline concordance analysis
Service
Glaucoma
Electroretinography
Retinal photography
Perimetry
Cataract surgery
Cryotherapy of retina
Retinal services
Laser trabeculoplasty
Intra-vitreal injection
Retinal photocoagulation
MBS Item Numbers
11200, 11203, 42746, 42749, 42752, 42770, 42771
11204, 11205, 11210, 11211
11215, 11218
11221, 11222, 11224, 11225
42698, 42701, 42702, 42703, 42704, 42707, 42710, 42713, 42716
42728
42773, 42776, 42779, 42812, 42818
42782, 42783
42740
42809
Guidelines used in this concordance exercise are listed in Appendix F, and were also sourced from
the NHMRC Guidelines Portal (http://www.clinicalguidelines.gov.au/) and the National Guidelines
Clearinghouse (http://www.guideline.gov/).
Guideline quality was rated according to the Appraisal of Guidelines for Research and Evaluation
(AGREE) appraisal instrument (http://www.agreecollaboration.org/instrument/) (see Appendix G
for results of the appraisal process). Recommendations regarding the services under review in
those evidence-based Guidelines with a high AGREE score were given more credence than lower
rated Guidelines. When the only available Guidelines were of poor quality, then this was noted
when rating the service’s concordance with the recommendations in the Guideline. The
determination of Guideline concordance was largely descriptive –


the quality of the Guideline being used as the benchmark for the concordance assessment
was indicated;
the Guideline recommendations and relevant information presented in the Guideline text
was described;
Page 7


a judgement was made as to how well the MBS item descriptors reflected the pertinent
recommendations and information in the Guideline; and
suggestions as to whether the MBS item descriptor should be revised or deleted were
made.
MBS item 42740 (intra-vitreal injection) was reviewed specifically with respect to certain
amendments suggested by the RANZCO (see 3.16 in Review Outcomes section). All other MBS
items undergoing the Guideline concordance exercise, however, were reviewed more generally, in
terms of “best practice” in undertaking the relevant service. Appendix H outlines the
recommendations and guideline text that were relevant to each of the services under review,
extracted from the highest quality clinical practice guidelines that were identified.
2.3 Literature review – mini-health technology assessments (mini-HTAs)
Eleven services (28 items) were identified by the Department as requiring an evidence-based
analysis (see Table 4). Those MBS items of high utilisation being considered for this review, but not
prompted by amendments to the item descriptor sought by RANZCO, were appraised generally in
terms of their safety and effectiveness. For other MBS items identified as requiring revision by
RANZCO, a review question was formulated in an attempt to address the issue identified by
RANZCO.
This analysis was undertaken through literature review in the form of mini-health technology
assessment, with processes for literature searching and selection of relevant information using
criteria specified a priori in order to ensure transparency and reduce bias in the selection of
evidence to inform the respective review questions.
Table 4
Ophthalmology items receiving evidence-based analysis
Service
Optic fundi
Retinal photography
Orbital echography/ ocular
biometry
Removal of foreign body
Extirpation of tarsal cyst
Lacrimal passages
Capsulectomy and
lensectomy
Cryotherapy of retina
Retinal services
Retinal photocoagulation
Removal of silicone oil
MBS Item Numbers
11212
11215, 11218
11237, 11240, 11241, 11242, 11243
42560, 42563, 42566, 42569
42575
42610, 42611, 42614, 42615
42719, 42722, 42731
42728
42773, 42776, 42779, 42812, 42818
42809
42815
The PICO (Population, Intervention, Comparator, Outcomes) criteria3 were used to develop welldefined research questions for each mini-HTA. These are provided in ‘section 3. Review
3
Richardson WS, Scott MD, Wilson MC et al. (1995) The well built clinical question: a key to evidence based decisions.
ACP Journal Club, 123, ppA-12.
Page 8
Outcomes’, whenever a mini-HTA is presented, and involves focusing the question on the
following four elements:
• the target population for the intervention;
• the intervention being considered;
• the comparator for the existing MBS service (where relevant); and
• the clinical outcomes that are most relevant to assess safety and effectiveness.
The PICO criteria were determined on the basis of information provided in the literature, as well as
clinical advice. These criteria were used to select literature for the mini-HTAs. Additional criteria
for selecting literature were also pre-specified ie relevant study designs for assessing the safety
and effectiveness of the service, time period within which the literature was sourced, and
language restrictions.
Literature search
Literature searching was tailored according to the type of factors influencing usage of the
procedure described in each item number –

if the service was still in common use then a search for high level literature was
conducted using the Cochrane library – including the Cochrane database of systematic
reviews, Database of abstracts of reviews of effects (DARE) and the HTA database. The
economics database, EconLit, and Embase.com (consisting of both Embase and
Medline) were also canvassed, the latter of which used a ‘systematic reviews’ and
‘meta-analysis’ filter. Literature searches were restricted to the English language only.

if the service was only used infrequently, then a targeted search was undertaken to
determine the current ‘state-of-play’ of the procedure. The most recent narrative
reviews and/or systematic reviews (if any) and Clinical Practice Guidelines were
identified and analysed to determine what international opinion is with respect to the
service and whether there are any subgroups of patients where the technology might
have a use. The literature was sourced from Embase.com (Medline and Embase)
without a filter check but was searched chronologically.
Search strategies generally included a combination of indexing terms (eg MeSH or Emtree
headings) and text word terms. Limits were employed in a hierarchical manner according to the
type of literature being sourced ie Limit 1 (systematic reviews published in English with included
studies conducted in humans, published 2005-2011), and if no relevant literature then Limit 2 (as
with limit 1 but including controlled clinical trials, meta-analyses or randomised controlled trials)
and if no relevant literature, then Limit 3 (any articles published 2005-2011 in English describing
the condition in humans). Search strategies for individual research questions addressed by the
mini-HTAs are outlined in ‘section 3. Review Outcomes’.
Critical appraisal of selected evidence
The literature was categorised according to NHMRC levels of evidence (see Table 5), critically
appraised using checklists relevant for each type of literature, and then synthesised according to
the evidence matrix for NHMRC Grades of recommendation (see
Page 9
Table 6). Relevant checklists included PRISMA for systematic reviews and health technology
assessments (Liberati, Altman et al. 2009); SIGN checklists for appraising randomised and nonrandomised controlled trials and observational studies (SIGN 2008); and the QUADAS checklist for
appraising diagnostic accuracy studies (Whiting 2003).
Table 5
Designations of levels of evidence (Merlin T, Weston A et al. 2009; NHMRC 2009)
Level
Intervention 1
Diagnostic accuracy 2
I4
A systematic review of level II
studies
A systematic review of level
II studies
II
A randomised controlled trial
A study of test accuracy with: an
independent, blinded comparison with a
valid reference standard,5 among
consecutive persons with a defined clinical
presentation6
III-1
A pseudorandomised controlled trial
(i.e. alternate allocation or some other method)
III-2
A comparative study with concurrent
controls:
▪ Non-randomised, experimental trial9
▪ Cohort study
▪ Case-control study
▪ Interrupted time series with a control group
A study of test accuracy with: an
independent, blinded comparison with a
valid reference standard,5 among nonconsecutive persons with a defined clinical
presentation6
A comparison with reference standard that
does not meet the criteria required for
Level II and III-1 evidence
III-3
A comparative study without concurrent
controls:
▪ Historical control study
▪ Two or more single arm study10
▪ Interrupted time series without a parallel control
group
Diagnostic case-control study6
IV
Case series with either post-test or pre-test/posttest outcomes
Study of diagnostic yield (no reference
standard)11
Explanatory notes4
1 Definitions of these study designs are provided on pages 7-8 How to use the evidence: assessment and application of scientific
evidence (NHMRC 2000b) and in the accompanying Glossary.
2 These levels of evidence apply only to studies of assessing the accuracy of diagnostic or screening tests. To assess the overall
effectiveness of a diagnostic test there also needs to be a consideration of the impact of the test on patient management and
health outcomes (Medical Services Advisory Committee 2005, Sackett and Haynes 2002). The evidence hierarchy given in the
‘Intervention’ column should be used when assessing the impact of a diagnostic test on health outcomes relative to an existing
method of diagnosis/comparator test(s). The evidence hierarchy given in the ‘Screening’ column should be used when assessing
the impact of a screening test on health outcomes relative to no screening or opportunistic screening.
4 A systematic review will only be assigned a level of evidence as high as the studies it contains, excepting where those studies
are of level II evidence. Systematic reviews of level II evidence provide more data than the individual studies and any metaanalyses will increase the precision of the overall results, reducing the likelihood that the results are affected by chance.
Systematic reviews of lower level evidence present results of likely poor internal validity and thus are rated on the likelihood that
the results have been affected by bias, rather than whether the systematic review itself is of good quality. Systematic review quality
4
Note - only evidence hierarchies relevant to this review have been reproduced in Table 5, so tablenotes 7 and 8 have
not been reproduced
Page 10
should be assessed separately. A systematic review should consist of at least two studies. In systematic reviews that include
different study designs, the overall level of evidence should relate to each individual outcome/result, as different studies (and study
designs) might contribute to each different outcome.
5 The validity of the reference standard should be determined in the context of the disease under review. Criteria for determining
the validity of the reference standard should be pre-specified. This can include the choice of the reference standard(s) and its
timing in relation to the index test. The validity of the reference standard can be determined through quality appraisal of the study
(Whiting et al 2003).
6 Well-designed population based case-control studies (eg. population based screening studies where test accuracy is assessed
on all cases, with a random sample of controls) do capture a population with a representative spectrum of disease and thus fulfil
the requirements for a valid assembly of patients. However, in some cases the population assembled is not representative of the
use of the test in practice. In diagnostic case-control studies a selected sample of patients already known to have the disease are
compared with a separate group of normal/healthy people known to be free of the disease. In this situation patients with
borderline or mild expressions of the disease, and conditions mimicking the disease are excluded, which can lead to
exaggeration of both sensitivity and specificity. This is called spectrum bias or spectrum effect because the spectrum of study
participants will not be representative of patients seen in practice (Mulherin and Miller 2002).
9 This also includes controlled before-and-after (pre-test/post-test) studies, as well as adjusted indirect comparisons (ie. utilise A
vs B and B vs C, to determine A vs C with statistical adjustment for B).
10 Comparing single arm studies ie. case series from two studies. This would also include unadjusted indirect comparisons (ie.
utilise A vs B and B vs C, to determine A vs C but where there is no statistical adjustment for B).
11 Studies of diagnostic yield provide the yield of diagnosed patients, as determined by an index test, without confirmation of the
accuracy of this diagnosis by a reference standard. These may be the only alternative when there is no reliable reference
standard.
Note A: Assessment of comparative harms/safety should occur according to the hierarchy presented for each of the research
questions, with the proviso that this assessment occurs within the context of the topic being assessed. Some harms (and other
outcomes) are rare and cannot feasibly be captured within randomised controlled trials, in which case lower levels of evidence
may be the only type of evidence that is practically achievable; physical harms and psychological harms may need to be
addressed by different study designs; harms from diagnostic testing include the likelihood of false positive and false negative
results; harms from screening include the likelihood of false alarm and false reassurance results.
Note B: When a level of evidence is attributed in the text of a document, it should also be framed according to its corresponding
research question eg. level II intervention evidence; level IV diagnostic evidence; level III-2 prognostic evidence.
Note C: Each individual study that is attributed a “level of evidence” should be rigorously appraised using validated or commonly
used checklists or appraisal tools to ensure that factors other than study design have not affected the validity of the results.
Source: Hierarchies adapted and modified from: NHMRC 1999; Bandolier 1999; Lijmer et al. 1999; Phillips et al. 2001.
The overall body of research evidence was assessed and synthesised to address each research
question according to
Page 11
Table 6. An evidence rating from A (excellent) to D (poor) was assigned to the evidence,
considering each of the components outlined in the body of evidence matrix. In the absence of
such literature, expert opinion and narratives were synthesised according to the credibility of the
source of such material.
Page 12
Table 6
Body of evidence assessment matrix (adapted from (NHMRC 2009))
Component
A
B
C
D
Excellent
Good
Satisfactory
Poor
Evidence base 1 one or more level I
studies with a low risk
of bias or several
level II studies with a
low risk of bias
one or two level II
studies with a low risk
of bias or a
SR/several level III
studies with a low risk
of bias
one or two level III
studies with a low risk
of bias, or level I or II
studies with a
moderate risk of bias
level IV studies, or
level I to III
studies/SRs with a
high risk of bias
Consistency 2
all studies consistent
most studies
consistent and
inconsistency may be
explained
some inconsistency
reflecting genuine
uncertainty around
clinical question
evidence is
inconsistent
Clinical impact
very large
substantial
moderate
slight or restricted
Generalisability population/s studied in
body of evidence are
the same as the target
population
population/s studied in
the body of evidence
are similar to the
target population
population/s studied in
body of evidence
differ to target
population but it is
clinically sensible to
apply this evidence to
target population 3
population/s studied in
body of evidence
differ to target
population and hard to
judge whether it is
sensible to generalise
to target population
Applicability
applicable to
Australian healthcare
context with few
caveats
probably applicable to not applicable to
Australian healthcare Australian healthcare
context with some
context
caveats
directly applicable to
Australian healthcare
context
SR = systematic review; several = more than two studies
Level of evidence determined from the NHMRC evidence hierarchy – Table 5.
If there is only one study, rank this component as ‘not applicable’.
3 For example, results in adults that are clinically sensible to apply to children OR psychosocial outcomes for one cancer that may be applicable to patients with
another cancer
1
2
2.4 Ascertainment of consumer preferences
Consumers’ “revealed preferences” and experiences concerning the services under review were
analysed qualitatively. Six ophthalmological services5 were selected from those receiving Guideline
concordance analysis and/or a mini-HTA analysis – four of these were to be the most common
services while the remaining two were reserved for potentially problematic services (ie painful
procedures, long hospital stay etc).
Consumer experiences concerning the four most common services occurred through the
canvassing of internet blogs and qualitative literature. Telephone and internet interviewing of
consumers was to be undertaken, but proved too difficult given time constraints and inability to
source potential interviewees. The aim was to determine consumer experiences with the
ophthalmological service under review, their preferences for modifying the service and/or to
identify any consumer concerns or hardship should the service be removed.
The qualitative literature search was undertaken using the Embase.com and Scopus databases.
Blogs (also known as weblogs) are on-line journals documenting views and experiences of a single
author, or in some cases a small group of authors. English language blogs from developed
5
Seven services were eventually investigated, although only six provided relevant data.
Page 13
countries concerning the services under review were identified through a Google advanced
domain search. Commercial blogs were excluded. All literature was imported into NVivo for
thematic coding and analysis.
2.5 Stakeholder negotiation
Several item descriptors for the ophthalmological items under review were discussed and
amended through negotiation between the Department and relevant stakeholders. Most of these
amendments related to corrections of terminology. Items addressed are in Table 7.
Table 7
Ophthalmology items revised through stakeholder negotiation
Service
Removal of foreign body
Cataract surgery
Capsulectomy and
lensectomy
Retinal services
Vitrectomy
Surgical assist
MBS Item Numbers
42551, 42554, 42557, 42644
42703, 42704, 42707, 42710, 42713
42731
42818
42725
51315
The Department will be reviewing the optometry perimetry items 10940 and 10941 separately –
informed by the evidence-based analysis of perimetry items 11221-11225 - and will undertake
stakeholder negotiation with the relevant optometry craft groups.
Page 14
3. REVIEW OUTCOMES
Following an overview of current use of ophthalmological services in Australia, the conclusions
regarding the specific ophthalmological services that have been assessed have been presented in
chapters according to each service being reviewed. The results of the MBS item data analysis,
guideline concordance activity, mini-HTA and consumer engagement have been synthesised for
each service under review. A summary statement and conclusion has been developed for each
“service” chapter. The descriptors for each MBS item are given in Appendix C.
3.1 Summary of current national usage of ophthalmological services
Hospital separations for eye conditions
Information from the Australian Institute of Health and Welfare with regard to Australian hospital
statistics for 2008-09 was analysed6, to give a picture of the importance of eye conditions in
hospital activity, and of the locations where eye services are provided. From this, the following
points emerged:







6
Based on principal diagnosis, eye separations accounted for 243,655 separations out of
a total of 8,148,448 (3.0%). A similar picture was seen using separations based on
either AR-DRG major diagnostic category (MDC) (3.8%) or procedures (3.3%).
While 60% of all separations occurred in public hospitals and 40% in private hospitals,
for the principal diagnosis of the eye, 29.0% were for public hospitals and 71.0%
private. Again, this spread was similar when based either on MDC (32.4% and 67.6%
respectively) or procedure (30.7% and 69.3%).
In public hospitals, eye separations by principal diagnosis constituted 1.4% of all
separations, while for private hospitals the figure was 5.3%. Comparisons according to
MDC were 2.0% vs 6.4%; with 1.7% and 5.8% for procedures.
Based on major diagnostic category, eye separations cost $556,536,000 out of a total
for all separations of $26,162,085,000 (2.1%). These costs represented 1.3% of total
costs in public hospitals and 4.1% of costs in private hospitals.
In terms of cost, 45.2% of costs for the eye MDC were incurred in public hospitals and
54.8% in private hospitals.
Same day separations for lens procedures constituted 2.3% of the top 30 separations,
but only 1.2% within public hospitals (7th highest in the list of number of procedures
performed), and 4.1% (4th highest) for private. Similar to the data above on all eye
procedures/MDC/principal diagnosis, this again represents a split of 30.0% and 70.0%
between the 2 sectors, and compares with the split for 60.4% and 39.6% respectively
for the total top 30 separations.
Geographically, eye separations in total (based on MDC) occurred at a level consistent
with the Australian population. However, there were differences in the split between
the private and public sectors. Within the overall spread of 30% public and 70%
private, Queensland had the highest representation of private hospital eye separations
Available at http://www.aihw.gov.au/publications/hse/84/11173.pdf
Page 15
(81.4% of their total), with New South Wales also slightly higher at 74.4%. The lowest
level of private hospital separations was in Western Australia, at 55.6%, with Victoria
62.6% and South Australia 63.5%.
Summary of MBS item claims for ophthalmology services
The MBS provides information on the year of introduction of each these ophthalmological items,
and the year in which the current description was formulated. Of the 61 items being analysed:

29 commenced in 1991 and have not been amended – relating primarily to glaucoma,
examination of optic fundi, retinal photography, removal of foreign body, extirpation of
tarsal cyst, cataract surgery, cryotherapy of retina, retinal services, laser trabeculoplasty
and removal of silicone oil;

12 items commenced in 1991 and have since been amended – 1 glaucoma item in 1996, 2
perimetry items in 2003, 1 lacrimal passages item in 1998 and 1 in 2001 , 2 cataract surgery
items in 2001 and 1 in 2005, 1 (the sole) retinal photocoagulation item in 2002, 1 pars
plana vitrectomy item and 3 capsulectomy and lensectomy items in 2005;

2 commenced in 1994 and have since been amended – 1 lacrimal passages item in 1998
and 1 in 2001;

2 commenced in 1996 – 1 cataract surgery item which was amended in 2001 and another 1
which has not been amended;

4 commenced in 1997 – 2 of these have not been amended (1 relating to laser
trabeculoplasty, and 1 for surgical assist with cataracts); 2 perimetry items were amended
in 2003;

1 commenced in 1999 and has since been amended – 1 orbital echography/ocular
biometry item in 2004.

5 commenced in 2001 and have not been amended – one relating to glaucoma, and the
other 4 to electroretinography;

3 commenced in 2001 and have since been amended – 3 orbital echography/ocular
biometry items in 2004; and

1 item commenced in 2003 and has not been amended – relating to orbital
echography/ocular biometry.
The most commonly claimed ophthalmology services over a fifteen period from 1994-2009 were
Perimetry, Cataract surgery, and Orbital echography/ocular biometry. The ranking of these three
services has remained relative stable until recently with usage (and thus cost) of Intra-vitreal
injection increasing markedly over the last 18 months, such that it ranked third and replaced
Orbital echography/ocular biometry at the end of the first half of 2010 (see Table 8 and Table 9).
Page 16
Table 8
Summary of number of reimbursements for item numbers during defined periods
Service category
Glaucoma
Electroretinography
Examination of optic
fundi
Retinal photography
Perimetry
Orbital
echography/ocular
biometry
Removal of foreign
body
Removal of foreign
body from cornea or
sclera
Extirpation of tarsal cyst
Lacrimal passages
Cataract surgery
Capsulectomy and
lensectomy
Vitrectomy
Cryotherapy of retina
Retinal services
Intra-vitreal injection
Laser trabeculoplasty
Retinal
photocoagulation
Removal of silicone oil
Surgical assist
TOTALS
Total number of services
Item number
1994 – 2009
11200 – 11203 (2 items)
42746 - 42771 (5 items)
11204 - 11211 (4 items)
2009
Jan – June 2010
85,029
3,469
1,703
76,116
9,431
4,498
562
36
12
11215 - 11218 (2 items)
11221 - 11225 (4 items)
599,457
3,144,852
34,767
258,498
15,749
130,269
11237 - 11243 (5 items)
1,486,979
127,468
61,137
42551 - 42569 (7 items)
1,914
111
57
644,441
28,986
13,362
42575 (1 item)
42610 - 42615 (4 items)
42698 - 42716 (9 items)
301,696
335,022
1,597,710
17,148
21,882
143,440
7,927
10,083
63,139
42719 - 42731 (3 items)
8,256
459
212
42725 (1 item)
42728 (1 item)
42773 - 42818 (5 items)
42740 (1 item)
42782 - 42783 (2 items)
53,093
689
48,510
277,576
205,727
7,286
156
4,566
90,527
24,440
3,629
105
2,165
61,240
11,774
42809 (1 item)
648,476
46.369
21,455
42815 (1 item)
51315 (1 item)
61 items*
3,224
4,856
9,524,185
451
150
773,317
215
39
408,770
11212 (1 item)
42644 (1 item)
* the two optometry perimetry items were not included in the data analysis.
Page 17
Summary of recent MBS expenditure on ophthalmology services
With respect to the ophthalmology items under review, the Commonwealth Government paid
nearly $182 million dollars in Medicare rebates in 2009. The greatest expenditure in 2009 was on
Cataract Surgery, Intra-vitreal injection and Retinal Photocoagulation and this appeared stable into
the first half of 2010 (see Table 9).
Table 9
Summary of overall cost ($) of item numbers during defined periods
Service category
Glaucoma
Electroretinography
Examination of optic fundi
Retinal photography
Perimetry
Orbital echography/ocular biometry
Removal of foreign body
Removal of foreign body from cornea
or sclera
Extirpation of tarsal cyst
Lacrimal passages
Cataract surgery
Capsulectomy and lensectomy
Vitrectomy
Cryotherapy of retina
Retinal services
Intra-vitreal injection
Laser trabeculoplasty
Retinal photocoagulation
Removal of silicone oil
Surgical assist
TOTALS1
Item numbers
11200 – 11203 (2 items)
42746 - 42771 (5 items)
11204 - 11211 (4 items)
11212 (1 item)
11215 - 11218 (2 items)
11221 - 11225 (4 items)
11237 - 11243 (5 items)
42551 - 42569 (7 items)
42644 (1 item)
42575 (1 item)
42610 - 42615 (4 items)
42698 - 42716 (9 items)
42719 - 42731 (3 items)
42725 (1 item)
42728 (1 item)
42773 - 42818 (5 items)
42740 (1 item)
42782 - 42783 (2 items)
42809 (1 item)
42815 (1 item)
51315 (1 item)
61 items*
Total Cost ($)
2009
Jan – June 2010
1,360,261
632,791
819,523
1,932
4,431,261
14,192,071
9,985,460
51,167
394,971
654
1,997,642
7,133,721
4,808,878
22,928
1,646,748
772,523
1,093,123
1,048,077
88,927,213
217,794
6,199,889,
8,502
2,093,575
24,915,656
8,813,409
15,973,258
109,066
28,024
181,916,009
502,507
482,972
32,997,860
104,905
3,164,950
5,247
1,015,677
16,351,953
4,252,058
7,437,331
54,471
7,512
82,141,551
The total cost for the 61 items over a six month period in 2010 was $8.8m less than the cost for the equivalent period in 2009. Of the 61
individual items, 12 showed a greater than 10% increase over the cost for 2009 (pro-rata), while 16 showed a decrease of over 10%.
* the two optometry perimetry items were not included in the data analysis.
1
Page 18
Summary of individual item numbers with highest frequency and highest cost
Consistent with the service groupings given above, Medicare Australia website statistics (item
reports) indicate that the highest frequencies of specific individual ophthalmology services across
the period 1994-2009 were:
Item 11221 Perimetry
Item 42702 Cataract surgery
Item 11240 Orbital echography/ocular biometry
Item 42809 Retinal photocoagulation
Item 42644 Removal foreign body (cornea)
3,024,057
1,262,741
997,874
648,476
644,441
For the 6 months of January to June 2010, the 5 highest frequencies of services were:
Item 11221 Perimetry
Item 42702 Cataract surgery
Item 42740 Intra-vitreal injection
Item 11241 Orbital echography/ocular biometry
Item 42809 Retinal photocoagulation
125,967
62,328
61,240
40,126
21,455
The highest total cost for individual items in 2009 were:
Item 42702 Cataract surgery
Item 42740 Intra-vitreal injection
Item 42809 Retinal photocoagulation
Item 11221 Perimetry
Item 42782 Laser trabeculoplasty
$88,350,739
$24,915,656
$15,973,258
$13,896,053
$8,813,409
In terms of greatest total cost for individual items in the first 6 months of 2010, the order was the
same as for 2009:
Item 42702 Cataract surgery
Item 42740 Intra-vitreal injection
Item 42809 Retinal photocoagulation
Item 11221 Perimetry
Item 42782 Laser trabeculoplasty
Page 19
$32,721,970
$16,351,953
$7,437,331
$6,978,629
$4,252,058
3.2
Glaucoma services
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA review
11200, 11203, 42746, 42749,
42752, 42770, 42771
Glaucoma
Stakeholder
negotiation**
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
Summary of Findings
Item 11200 – The available clinical practice guideline suggests that provocative tests for the management of
patients at risk of angle closure glaucoma are being superseded by gonioscopy. It should be noted that
provocative testing is still recommended for open angle glaucoma. Analysis of the frequency of use of this item
number indicates a low and generally decreasing pattern of use, primarily in metropolitan areas. It is suggested
that the item descriptor be modified to indicate that the provocative test should only be used for the
management of open angle glaucoma.
Item 11203 - Tonography is not mentioned in the available clinical practice guidelines and data analysis
indicates that claims regarding this service are low and decreasing. Tonometry (measurement of intraocular
pressure) is part of a routine ophthalmic examination and does not require an item number. Good quality
guidelines indicate that Goldmann applanation tonometry is the gold standard technique for use in the
diagnosis and monitoring of glaucoma, although other tonometric techniques may be needed for certain patient
groups and good infection control is critical. Given tonometry does not require an item number and tonography
appears to be an outmoded practice, it is suggested that this item is removed from the MBS.
Items 42746 and 42749 - The descriptors for these MBS Items are imprecise. Both 42746 (an initial surgery)
and 42749 (a subsequent surgery) refer broadly to a ‘filtering operation’. There are several types of filtering
operations including penetrating and non-penetrating types. Clinical opinion suggests that these filtering
procedures are sufficiently similar to permit the use of the same MBS item number. Guidelines strongly
recommend the trial of conservative therapies prior to the use of incisional surgery, so the inclusion of
conditional limitations within the MBS descriptor may further clarify the appropriate use of these filtering
procedures. Given that Item 42746 has the highest cost amongst the glaucoma services, it would appear
reasonable to be more precise regarding the patient indications for use of this item. It is suggested that the
descriptor is modified to “Glaucoma filtering operation for, where conservative therapies have failed, are likely
to fail or are contraindicated”.
Item 42752 - The descriptor for this item describes the insertion of a Molteno valve for the treatment of
glaucoma. While current guidelines support the use of tube shunts for the treatment of glaucoma amongst a
restricted population, currently there is no evidence of greater safety or effectiveness of one shunt over another
and several non-Molteno shunts are available on the Australian prostheses list. As such, consensus clinical
opinion suggests that the words “Molteno valve” in the item number descriptor be altered to “Glaucoma,
insertion of device draining to an external plate or extraocular reservoir for, eg Molteno device”. Restricting use
of the service to certain patient subgroups would result in better concordance with evidence based practice. It is
therefore suggested that, in accordance with high quality guidelines, use of this item number is restricted to
patients who are at high risk of failure of trabeculectomy (eg aggressive neovascular glaucoma or extensive
conjunctival scarring), or who have failed trabeculectomy; or who have iridocorneal endothelial syndrome, or
inflammatory (uveitic) glaucoma, or aphakic glaucoma.
Page 20
Summary of Findings (cont.)
Items 42770 and 42771 – The descriptors for these items require the patient to suffer from “intractable”
glaucoma, which accurately describes glaucoma non-responsive to conservative or surgical management and
is consistent with evidence based guidelines on the use of cyclodestructive procedures. Item 42770 limits the
number of cyclodestructive procedures to 2 per two year period, whilst item 42771 allows for subsequent
treatments in situations requiring multiple repeated treatments. Given that the use of item 42771 has virtually
ceased and item 42770 allows the use of multiple (albeit restricted) treatments, deletion of item 42771 could be
considered. In the rare instances where the use of an additional cyclodestructive procedure is necessary (eg for
some paediatric patients), a claim for the additional procedure could be accommodated through the Medicare
Claims Review Panel.
As glaucoma is an age-related disease, the services have been provided primarily to those aged
over 55 years. The 2 glaucoma items that are diagnostic services (11200, 11203) show relatively
low and generally decreasing use and therefore overall cost, with a tendency to be used primarily
in New South Wales. The therapeutic item 42746 shows a similar usage pattern to item 11200
(approximately 1500 services in 2009), but represents the highest cost within this sub-group. The
remaining therapeutic items (42749, 42752, 42770, 42771) have been steady over the last few
years, at between about 100 and 300 services p.a., except for 42771 which has virtually ceased.
Data for the three financial years 2007-08 to 2009-10 shows that item 11200 has been
predominantly provided to patients within metropolitan areas of Australia (94.3%) compared to
rural areas (5.7%) which is not in line with the general spread of the population (see Appendix B,
Table 83). Detailed information on these practice patterns is provided in Appendix D.
The data related to hospital separations shows a steady level of about 3,000 – 4,000 separations
p.a. over the last 10 years, based on principal diagnosis (see Appendix E, Figure 52), in contrast to
the picture provided by the data on separations by AR-DRG (see Appendix E, Figure 50), which
shows significant increases in the last 3-4 years. This inconsistency may be due to the inclusion of
other procedures in the definition for sub-categories C15A and C15B (glaucoma and complex
cataract procedures). There has been a marked increase in the proportion of same day procedures
performed.
Items 11200 and 11203
The Guideline concordance analysis identified one guideline of moderate quality (AAO 2005)
relevant to item 11200 as it addressed the use of provocative tests in the management of
glaucoma. This Guideline reported that provocative testing has been superseded by examination
methods such as gonioscopy for closed angle glaucoma. The Clinical Working Group indicated that
provocative tests are still used for open angle glaucoma.
Item 11203 concerns tonography which is a technique for estimating the outflow of aqueous
humour from the eye on the basis of repeated intra-ocular pressure measurements. These
measurements are most commonly taken with the external application of a Schiötz, or other type
of, tonometer to the eye. No evidence regarding tonography was presented in the identified
guidelines.
Page 21
Three guidelines of good quality addressed the use of tonometry in patients with glaucoma. The
NHMRC (2009) guideline reported high level evidence indicating Goldmann applanation tonometry
(GAT) remains the gold standard for measurement of intra-ocular pressure (IOP), despite inherent
limitations (NHMRC 2009). The evidence also suggests that measuring IOP with applanation
tonometry can increase the risk of eye infections. The NICE (2009) Guidelines reported low level
evidence suggesting the need for regular GAT (slit lamp) in patients with chronic open angle
glaucoma (COAG), presumptively diagnosed with COAG or ocular hypertension (OHT) (NICE 2009).
The Canadian Ophthalmological Guidelines (2009) identified Level 3 evidence that GAT is more
accurate than other techniques for IOP measurement in patients with good corneal health. These
guidelines also recommended via consensus, the use of hand-held devices in children and other
patient groups unsuited to slit lamp GAT (Rafuse P.E., Buys Y.M. et al. 2009).
The Clinical Working Group indicated that tonometry is undertaken as part of a routine ophthalmic
examination and does not require a separate item number.
Concordance conclusions
Tonography is a technique that is no longer routinely utilised, whereas there is good quality
evidence available that Goldmann applanation tonometry is the gold standard measurement
technique for IOP. As tonometry does not require an item number and tonography is rarely
performed, this tonography item number could be removed from the Medicare Benefits Schedule.
Items 42746 and 42749
Items 42746 and 42749 are concerned with filtering operations for the treatment of glaucoma.
Three guidelines of good quality reported on the use of filtering surgery, or trabeculectomy, in
patients with glaucoma. The NHMRC 2009 Guidelines report high level evidence that
trabeculectomy is at least as effective in lowering IOP in patients with open angle glaucoma as
more conservative approaches (medications and laser trabeculoplasty) (NHMRC 2009). This
finding was supported by the NICE 2009 glaucoma guidelines that indicates that trabeculectomy is
superior to laser trabeculoplasty (moderate level evidence) and pharmacological treatment (low
level evidence) (NICE 2009).
The NHMRC 2009 guidelines recommend, based on high level evidence, the use of trabeculectomy
following the failure of pharmaceutical interventions, or where patient compliance is poor, and
after laser trabeculoplasty has failed or is likely to fail (NHMRC 2009). This recommendation is
supported by observations of trabeculectomy use in the COG 2009 guidelines (Rafuse P.E., Buys
Y.M. et al. 2009), as well as the same recommendation in NICE 2009. The NICE and the NHMRC
guidelines both recommend the use of intra-operative and post-operative anti-fibrotic agents;
mitomycin-C (MMC) or 5-fluorouracil (5-FU) for patients undergoing trabeculectomy in order to
reduce the risk of surgical failure (based on moderate quality evidence).
Concordance conclusions
Good quality guidelines support the use of trabeculectomy for the treatment of open angle
glaucoma if intra-ocular pressure lowing medications have failed, and laser treatment has failed or
is likely to fail.
Page 22
While the MBS item descriptors for 42746 and 42749 do not inhibit the practice of trabeculectomy
according to guideline recommendations, the descriptors are imprecise. Both 42746 (an initial
surgery) and 42749 (a subsequent surgery) refer broadly to a ‘filtering operation’. There are
several types of filtration surgery including penetrating surgery, such as trabeculectomy and types
of sclerostomy, and non-penetrating surgery such as viscocanalostomy, canaloplasty and deep
sclerectomy / bleb-forming procedures. Clinical opinion suggests that penetrating and nonpenetrating surgical procedures are similar in terms of complexity, and in the time taken and skill
required to perform the procedure. Although the non-penetrating forms are rarely used in
Australia, the techniques would appear to be sufficiently similar to permit the use of the same
MBS item number. A repeat trabeculectomy (42749) is considered technically much more difficult
due to prior scarring, which is reflected in the higher fee.
Additionally, guidelines strongly recommend the trial of conservative therapies, including
pharmaceutical intervention and laser trabeculoplasty, prior to the use of incisional surgery. The
inclusion of conditional limitations within the MBS descriptor may further clarify the appropriate
use of filtering procedures.
Finally, moderate level evidence supports the use of anti-fibrotic / anti-metabolite agents in
combination with trabeculectomy, such as 5-fluorouracil (5-FU) or mitomycin-C (MMC). While this
appears to be common practice in Australia7, neither 5-FU nor MMC are registered with the
Therapeutic Goods Administration for this indication, nor are they listed in the Australian
Medicines Handbook.
Concordance conclusions
Penetrating and non-penetrating surgical procedures appear to be of similar complexity and
should usually only be peformed after conservative treatment options (eg medication or laser)
have failed, are likely to fail or are contraindicated. Thus, the item could be retained for all filtering
operations but it is suggested that the descriptor is modified to “Glaucoma filtering operation for,
where conservative therapies have failed, are likely to fail or are contraindicated”.
MBS item 42752
MBS item 42752 was addressed in two guidelines of good quality (NHMRC 2009; Rafuse P.E., Buys
Y.M. et al. 2009) that reported on the use of tube shunt surgery for the management of patients
with glaucoma. COG 2009 indicates that tube shunt devices to lower or control IOP are used in
patients with several failed previous trabeculectomies or in patients at very high risk for failure of
trabeculectomy, such as those with aggressive neovascular glaucoma or extensive conjunctival
scarring (Rafuse P.E., Buys Y.M. et al. 2009). Similarly, the NHMRC 2009 guideline reports high
level evidence for the use of tube shunt surgery in patients with glaucoma who:




7
are at a high risk of treatment failure from trabeculectomy;
have previously had an unsuccessful trabeculectomy;
have iridocorneal endothelial syndrome;
have inflammatory (uveitic) glaucoma; or
Liu, L., Siriwardena, D. & Khaw, P. T. (2008). 'Australia and New Zealand survey of antimetabolite and steroid use in
trabeculectomy surgery', J Glaucoma, 17 (6), 423-430.
Page 23

have aphakic glaucoma.
Both guidelines report a lack of evidence to support superiority of one type of implant over
another.
Concordance conclusions
The MBS item descriptor for 42752 describes the insertion of a Molteno valve for the treatment of
glaucoma. While current guidelines support the use of tube shunts for the treatment of glaucoma,
they are not specific regarding the type of prosthesis. Currently, there is no evidence of greater
safety or effectiveness of one shunt over another. Given that several non-Molteno shunts are
available on the Australian prostheses list, the restriction of shunt surgery with a Molteno valve
appears at odds with current guidelines. Consensus clinical opinion suggests that the words
“Molteno valve” in the item number descriptor be altered to “Glaucoma, insertion of device
draining to an external plate or extraocular reservoir for, eg Molteno device”.
While both guidelines support the use of shunt surgery, it is recommended among a restricted
population. This is currently not reflected by the MBS item descriptor and the inclusion of
limitations within the descriptor may better reflect evidence based practice. Thus, use of this item
number could be restricted to patients who are at high risk of failure of trabeculectomy (eg
aggressive neovascular glaucoma or extensive conjunctival scarring), or who have failed
trabeculectomy; or who have iridocorneal endothelial syndrome, or inflammatory (uveitic)
glaucoma, or aphakic glaucoma.
MBS items 42770 and 42771
MBS items 42770 and 42771 were compared to two guidelines of good quality (NHMRC 2009;
Rafuse P.E., Buys Y.M. et al. 2009) that reported on the use of cyclodestructive procedures for the
treatment of glaucoma. The NHMRC 2009 guideline reports high level evidence for the use of
cyclodestructive procedures in patients with advanced open angle glaucoma who are not
candidates for incisional surgery and in whom conservative and laser treatments are ineffectual.
The COG 2009 guidelines support this stance, emphasising that cyclodestructive procedures are
recommended only as a last resort.
Both guidelines indicate that patients may require several treatments with cyclodestructive
procedures, however neither guideline quantified the likely number of procedures that would be
required.
Cyclodestructive procedures may be performed by a number of techniques, including trans-scleral
laser cyclophotocoagulation, endoscopic laser cyclophotocoagulation and cyclocryotherapy.
Guidelines have reported on evidence for trans-scleral cyclophotocoagulation but have not cited
evidence pertaining to the equivalence or superiority of any one technique.
Concordance conclusions
The identified guidelines strongly support the use of cyclodestructive procedures as a treatment
for advanced glaucoma that is non-responsive to medications, laser trabeculoplasty and surgery
(or patients are not fit for surgery). MBS item descriptors 42770 and 42771 require the patient to
suffer from “intractable” glaucoma, which accurately describes glaucoma non-responsive to
Page 24
conservative or surgical management. As such, these MBS item descriptors do not inhibit best
practice of these procedures.
While the descriptor for MBS item 42770 limits the number of cyclodestructive procedures to two
per two-year period, 42771 allows for subsequent treatments in situations requiring multiple
repeated treatments. Cyclodestructive procedures are irreversible and are therefore performed in
a stepwise fashion. Clinical opinion indicates that, in rare cases such as paediatric patients,
cyclodestructive procedures may be required in excess of two occasions over two years as
described in 42770. Should item number 42771 be deleted, the rare request for use of an
additional cyclodestructive procedure could be accommodated through the Medicare Claims
Review Panel.
Page 25
3.3
Electroretinography services
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA
review
11204, 11205, 11210, 11211
Electroretinography
Stakeholder
negotiation**
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
Summary of Findings
Items 11204, 11205, 11210 and 11211 – no evidence-based guidelines provided recommendations
regarding the use of the various forms of electroretinography (ERG), therefore comment on the
appropriateness of MBS item numbers referring to ERG cannot be made. Multifocal
electroretinography (mfERG) is not described in the current MBS item descriptors; however, there
may be some evidence for its effectiveness for various patient indications. Although requiring a more
thorough review, revision of MBS item descriptors to include multifocal electroretinography may be
warranted. The patterns of use of the different forms of ERG suggest that clinical preference for the
different techniques appears to differ between the States.
Three of the four diagnostic items for electroretinography (11204, 11205, 11211) have remained
relatively constant in frequency since their introduction in 2001, whilst 11210 has shown some
increase since 2005. Of the four items, 11205 is the most significant in terms of both frequency
and cost. The services have been provided to a range of ages, with a predominance of female
patients. Geographically, there have been some anomalies in spread, with WA being particularly
high for item 11210, and NSW being high for 11205 and 11211. Detailed information on these
practice patterns is provided in Appendix D.
Analysis of the provision of this sub-group of services in terms of rurality (see Appendix B, Table
83) reveals a higher frequency of electroretinography than expected for patients in metropolitan
areas (80.1%, 82.9% and 84.9% for items 11204, 11205 and 11210 respectively).
The Guideline concordance analysis did not identify any guidelines that provided
recommendations concerning the indications or technical aspects of electroretinography (ERG).
Recommendations for visual system testing8, based largely upon consensus and expert opinion,
have been published that support the use of ERG for a number of indications. In particular, it is
reported that ERG can accurately locate lesions in the visual system which may not be detected by
fundus or ophthalmoscopic examinations. The effectiveness of multi-focal electroretinography
8
Holder, G. E., Celesia, G. G. et al (2010). 'International Federation of Clinical Neurophysiology: recommendations
for visual system testing', Clin Neurophysiol, 121 (9), 1393-1409.
Page 26
(mfERG) for many different indications is further supported by the findings of a large systematic
literature review9.
Concordance conclusions
As no evidence-based guidelines provided recommendations regarding the use of ERG, comment
on the appropriateness of MBS item numbers referring to ERG cannot be made. Multifocal
electroretinography is not described in the current MBS item descriptors; however, there may be
some evidence for its effectiveness for various patient indications. Although requiring a more
thorough review, revision of MBS item descriptors to include multifocal electroretinography may
be warranted.
9
Lai, T. Y., Chan, W. M. et al (2007). 'The clinical applications of multifocal electroretinography: a systematic review',
Surv Ophthalmol, 52 (1), 61-96.
Page 27
3.4
Examination of optic fundi
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA
review
11212
Examination of optic fundi
Stakeholder
negotiation**
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
Summary of Findings
Item 11212 – No evidence was found that compared fluorescein angioscopy to fluorescein
angiography. Given that both procedures involve the introduction of a fluorescent dye into the blood
stream, it is likely that any safety concerns for angioscopy would be shared with angiography. One
advantage of angiography is the ability to create an accurate permanent record of retinal vessels and
retinal pathology. In light of the small number of reimbursements for angioscopy, it is unlikely that the
removal of this item number would impact upon the quality of patient care or their health outcomes.
The diagnostic item for examination of optic fundi (MBS item 11212), which relates to fluorescein
angioscopy, has shown a downward trend in the number of services provided, averaging around
30 p.a., with New South Wales being the predominant location (see Appendix D). The costs, as a
consequence, have been very low. By contrast, retinal photography (item numbers 11215 and
11218), as described at 3.5 below, were reimbursed on 33,092 occasions.
Fluorescein angiography was developed in the 1950s and involves the use of intravenous, and
occasionally oral, fluorescein to allow retinal vasculature to be viewed and photographed (Schatz,
Burton et al. 1978). During fluorescein angiography, the patient is intravenously injected with
sodium fluorescein which spreads throughout the body, staining skin and mucous membranes
within a minute (Schatz, Burton et al. 1978; Dithmar and Holz 2008). Sodium fluorescein leaks
from all vessels in the body with the exception of vessels in the retina and central nervous system.
As a consequence, intravascular concentrations of fluorescein usually reach negligible levels within
minutes and are excreted by the liver and kidneys within 24 hours.
Fluorescein dye is a synthetic fluorophore, emitting a 520 nm to 530 nm green light when excited
by blue light between 465 nm and 490nm.When this blue light, usually generated by using a filter
or a laser, is directed onto the retina, some of the light is absorbed and some is reflected. Those
tissues or vessels containing fluorescein will absorb the blue light and emit a green light. A filter
preventing the passage of reflected blue light into the ophthalmoscope (angioscopy) or camera
(angiography) only allows areas of fluorescence to be viewed or captured.
Normally, retinal vessels do not leak fluorescein due to the tight junctional complexes of
endothelial cells in the vessel. Consequently, images of the retina following fluorescein injection
Page 28
should be of the retinal vessels alone. Leaking vessels or abnormal areas of lingering fluorescence
may point to pathologies, such as choroidal neovascularisation (Dithmar and Holz 2008).
The primary difference between fluorescein angioscopy (item 11212) and angiography (item
11218 and 11215) is that the latter involves the use of a specialised camera to record the retinal
image, whilst the former is usually hand-traced.
An evidence-based analysis using the mini-HTA format was undertaken for this item.
Research question Is there evidence supporting the poor diagnostic performance or safety of fluorescein angioscopy
(item number 11212) relative to fluorescein angiography (items 11218, 11215) that would suggest
removal of the item for fluorescein angioscopy from the MBS is warranted?
Pre-specified criteria for the selection of literature to address this question are provided in Table
10.
Table 10
PICO criteria for examination of optic fundi
Characteristic
Inclusion Criteria
Population
People undergoing eye investigations or evaluations for eye disease
Intervention
Fluorescein angioscopy with intravenous dye injection for examination of the optic fundus
(as described by MBS item number 11212)
Comparator
Fluorescein angiography (as described by MBS item numbers 11215 and 11218)
Outcomes
Latest occurrence (date) of published research on fluorescein angioscopy, preferred usage
of fluorescein angioscopy relative to fluorescein angiography, any safety and/or
effectiveness concerns reported in the literature
Search strategy
A search of the Cochrane library – including the Cochrane database of systematic reviews,
Database of abstracts of reviews of effects (DARE) and the HTA database, the economics database,
EconLit, and Embase.com (consisting of both Embase and Medline) was conducted using the
search terms outlined in Table 11.
Table 11
Search terms utilised for examination of optic fundi
Population
('eye'/exp OR 'eye disease'/exp) AND
Intervention
('angioscopy'/exp OR angioscop* OR 'fluorescein'/exp) AND
Limits
1. [English language]/lim AND [humans]/lim AND [2005-2011]/py AND [systematic review]/lim
2. [humans]/lim AND [2005-2011]/py AND ([systematic review]/lim OR [controlled clinical trial]/lim OR [meta
analysis]/lim OR [randomized controlled trial]/lim)
3. [article]/lim AND [humans]/lim AND [2005-2011]/py
Availability and level of evidence
The Cochrane Library, EconLit, Medline and Embase were searched from January 2005 to
November 2010 according to the pre-specified search strategy. No articles addressing the safety or
diagnostic accuracy of fluorescein angioscopy were found. Successive searches of databases back
to 1990 also did not identify any eligible articles. While a large number of articles - primarily case
Page 29
series or case reports - were retrieved by the search criteria, nearly all were identified due to the
inclusion of fluorescein rather than angioscopy in the search terms. A targeted search of both
Medline and Embase back to the inception of the databases, requiring the article to contain
angioscopy rather than angioscopy or fluorescein, identifed 41 articles. Twelve articles had been
discovered by previous searches leaving 29 non-duplicate articles. After reviewing the abstracts
and full papers of each of these 29 articles it was determined that none reported on the safety or
diagnostic accuracy of fluorescein angioscopy.
Current utilisation
Apart from the data analysis on this item which revealed it is used very infrequently, public
consultation with retinal specialists was also undertaken through the Clinical Working Group.
These retinal specialists confirmed that fluroscein angioscopy is very rarely offered. As such,
RANZCO have suggested that this item is outdated and infrequently used as it is considered is
considered to be inaccurate compared to the more evolved technology of fluorescein angiography
(items 11218 and 11215).
Conclusions
No evidence was found to support the poor diagnostic performance or safety of fluorescein
angioscopy relative to fluorescein angiography. Given that both procedures involve the
introduction of a fluorescent dye into the blood stream, it is likely that any safety concerns for
angioscopy would be shared with angiography. One advantage of angiography is the ability to
create an accurate permanent record of retinal vessels and retinal pathology. This may allow the
serial assessment of disease progression or the assessment of treatment success. While there is no
evidence for this practice, if patients with pathology discovered on angioscopy are then subjected
to angiography to create an image, patients may be needlessly dosed twice with sodium
fluorescein. In light of the small numbers of reimbursements for angioscopy, it is unlikely the
removal of this item number would impact upon the quality of patient care or outcomes.
Page 30
3.5
Retinal photography services
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA review
11215, 11218
Retinal photography
x
Stakeholder
negotiation**
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
Summary of Findings
Item 11215 and 11218 –The descriptors for these items are broad and allow practice that is
consistent with current evidence-based guidelines. Given that fluorescein or indocyanine green (ICG)
angiography may be used for multiple indications, revision of the descriptor to include specific
indications does not appear to be warranted. The current wording of ‘retinal photography’ appears to
adequately serve for both fluorescein and ICG angiography.
Retinal photography (items 11215, 11218) usage has been proportionally higher in NSW, and in
females, but the pattern in numbers of services is different for each item. Item 11215 has shown a
downward trend, especially since 2004, while item 11218 has been relatively constant, peaking in
2005. Of the 2 items, 11218 has been provided at a much higher frequency and hence total cost,
although this is down slightly for the first 6 months of 2010. Detailed information on these
practice patterns is provided in Appendix D.
Fluorescein and indocyanine green angiography are used for different indications and require
different cameras to perform the procedure. Clinical opinion suggests that the majority of
procedures performed using this item number would use fluorescein, with indocyanine green
angiography used infrequently. However, indocyanine green angiography may be performed on
some patients who had previously undergone fluorescein angiography.
The Guideline concordance analysis identified one guideline of moderate quality (AAO 2008) and
one guideline of poor quality (RCO 2009) that reported on the use of fluorescein angiography
(represented by MBS items 11215 and 11218). The AAO 2008 guideline for age-related macular
degeneration (AMD) presents high level evidence for the use of fluorescein angiography in
patients experiencing new metamorphopsia, unexplained blurred vision, or when clinical
examination reveals:





elevation of the retinal pigment ephithelium or retina;
subretinal blood;
hard exudates;
subretinal fibrosis; or
when visual loss is not explained by clinical examination.
Page 31
Fluorescein angiography may be used to create an angiograph to guide treatment and monitor the
effect of treatment.
The AAO 2008 guideline also reports high level evidence for the expeditious use of fluorescein
angiography (performed and interpreted by an individual experienced in AMD) in patients
suspected of having choroidal neovascularisation (CNV).
The RCO 2009 guideline for age-related macular degeneration does not contradict
recommendations made by the AAO 2008 guideline and indicates that fluorescein angiography is
the gold standard for the diagnosis and monitoring of CNV in patients with AMD. The guideline
recommends that fluorescein angiography is performed over a long enough period to adequately
capture arterial or choroidal flow as well as details of fluorescein leakage.
The use of indocyanine green as an alternative to fluorescein provides different information and
may allow better visualisation of the choroidal vessels.
Concordance conclusions
Overall, the descriptors for item numbers 11215 and 11218 are broad and allow practice that is
consistent with current evidence-based guidelines. Given that fluorescein or indocyanine green
angiography may be used for multiple indications, revision of the descriptor to include specific
indications does not appear to be warranted. The current descriptors appear to adequately serve
for both fluorescein and ICG angiography. It was noted by the CWG that the cost per vial of ICG
was substantially greater than that of sodium fluorescein.
An evidence-based analysis using a mini-HTA format was undertaken at 3.4 above, with these
items as comparators to item 11212. No comparative data were identified to add substance to the
suggestion that items 11215 and 11218 are as safe as/safer than, and/or more accurate than,
fluorescein angioscopy – although it appears that this is a common, and seemingly reasonable,
perception amongst ophthalmologists.
Page 32
3.6
Perimetry services
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA
review
11221, 11222, 11224,
11225, 10940*, 10941*
Perimetry (*) ‡
Stakeholder
negotiation**
Guideline
concordance
x
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
‡ Consumer views and preferences, as discussed in qualitative and blog literature, were also reviewed for these
specific items.
Summary of Findings
Items 11221, 11222, 11224 and 11225 – The pattern of use of the ophthalmology perimetry items
appears consistent with an initial diagnostic bilateral use of the procedure and then frequent
monitoring for progression of ocular disease. The 2009 NHMRC Guidelines indicate that 2-3 perimetry
tests per year are commonly required in the first two years to accurately estimate the probable rate of
progression. It would appear, therefore, that the current MBS items and their descriptors – allowing 4
tests in a two year period for non-progressive glaucoma and an additional test per year for
progressive glaucoma - provide sufficient perimetry testing for patients with glaucoma.
Presently, there is no method of billing Medicare for a perimetry procedure that is not automated
threshold perimetry. This is consistent with guideline recommendations. However, it is unclear
whether Medicare can be billed for supra-threshold perimetry which, although not as accurate as
automated threshold perimetry, may have a role in monitoring certain types of patients.
Items 10940 and 10941 – No evidence was available in the identified guidelines regarding the
relative performance of those craft groups who conduct and interpret perimetry testing.
The bilateral perimetry item, number 11221, is the most commonly used service of all 61
ophthalmology items under review, and ranks as the 4th highest in terms of cost. It continues to
increase, with approximately 250,000 services provided in 2009, at a cost of almost $14m. The
other 3 items (11222, 11224, 11225), relating to unilateral perimetry and/or three or more
examinations within a year, are much less frequently used. It should be noted, however, that
perimetry is used for a number of eye conditions and so the frequency of use of item 11221 is not
unexpected. In 2009-10, claims for perimetry item 11221 occurred concurrently with claims for
laser trabeculoplasty in about 1600 cases (see Appendix D, Table 145).
Guideline concordance analysis was undertaken to determine whether the descriptors of the
perimetry items on the MBS were consistent with best practice.
Three guidelines of good quality (NHMRC 2009; NICE 2009; Rafuse P.E., Buys Y.M. et al. 2009)
reported on the use of standard automated perimetry in patients with glaucoma. All three
guidelines, on the basis of low level evidence or consensus, recommended the use of standard
Page 33
automated perimetry for the diagnosis and monitoring of glaucoma. Likewise, all three guidelines,
citing moderate level evidence (NHMRC 2009) or consensus determination (NICE 2009; Rafuse
P.E., Buys Y.M. et al. 2009), emphasised the need for repeated measurements over the first two
years to calculate a reliable baseline and estimate the rate of progression of glaucoma. The 2009
NHMRC guidelines recommend performing visual field (VF) testing with automated perimetry on
multiple occasions at diagnosis, in order to set a reliable baseline. An accurate estimation of the
probable rate of progression will necessitate two to three field tests per year in the first two years.
The Canadian ophthalmology guidelines (Rafuse P.E., Buys Y.M. et al. 2009) reported low level
evidence that current standard automated perimetry may not be as accurate as some emerging
technologies such as short wavelength automated perimetry or frequency doubling technology
perimetry; however, these guidelines also emphasised the need for large scale trials before these
new technologies can be confidently recommended.
The NICE 2009 glaucoma guidelines provided a consensus view that the strategy of visual field
testing with perimetry should be kept the same for each patient to limit inter-test variability and
thereby improve the likelihood of detecting disease progression (NICE 2009).
It was also a consensus position of the NICE 2009 glaucoma guidelines that patients with
established ocular hypertension or chronic open angle glaucoma who achieve normal visual fields,
as measured by standard threshold perimetry, may instead be monitored by supra-threshold
perimetry, a quicker and less demanding testing technique for patients.
Concordance conclusions
The MBS item number descriptors describe automated perimetry for ocular disease (or other
pathology affecting the visual field) for bilateral (10940, 11221) and unilateral (10941, 11224)
testing. These MBS item descriptors limit the number of tests to 2 per year; however, item
numbers 11222 and 11225 allow the use of more perimetry tests where it can be demonstrated
that a further examination is indicated due to the presence of:



Established glaucoma where there has been progression over the past 12 month period
(and surgery may be required);
Neurological disease which may be progressive and where a visual field is necessary for
patient management; or
To monitor for ocular disease that may be caused by systemic drug toxicity.
The 2009 NHMRC guidelines indicate that two to three visual field (perimetry) tests per year are
commonly required in the first two years. The current MBS descriptor for item 11221, which
would allow 4 tests over two years, allow sufficient testing for patients with non-progressive
glaucoma. In cases that are progressing or are likely to require surgery, further tests can be
performed using MBS descriptors 11222 and 11225.
Presently, there is no method of billing Medicare for a perimetry procedure that is not automated
threshold perimetry. Both short wavelength automated perimetry and frequency doubling
technology may offer more accurate results, although further clinical trials are required. Clinical
opinion suggests that short wavelength perimetry is currently already done (and claimed) as an
automatic threshold strategy. In contrast, supra-threshold perimetry may represent a quicker and
less demanding procedure for patients that, while not as accurate as standard threshold
Page 34
perimetry, may be adequate for monitoring patients with glaucoma or ocular hypertension who
have normal findings on threshold perimetry or are non-compliant with automated threshold
perimetry. Despite this consensus clinical opinion given in the NICE 2009 glaucoma guidelines,
Australian clinical opinion suggests that monitoring with supra-threshold perimetry is rarely done.
Presently it is unclear whether supra-threshold perimetry can be billed to Medicare.
Although a consumer preferences analysis was undertaken on perimetry services, no useable data
were identified. As a consequence another ophthalmological service was selected to make up the
six services being reviewed using the consumer preferences qualitative methodology.
Optometry perimetry services
Within the optometry MBS items, there are two items which are currently comparable with the
ones being investigated for ophthalmology. In the area of computerised perimetry, item 10940 is
comparable to item 11221, and item 10941 is comparable to item 11224 (see below).
10940 COMPUTERISED PERIMETRY - Full quantitative computerised perimetry (automated
absolute static threshold) not being a service involving multifocal multichannel objective
perimetry, performed by an optometrist, where indicated by the presence of relevant
ocular disease or suspected pathology of the visual pathways or brain with assessment and
report, bilateral - to a maximum of 2 examinations (including examinations to which item
10941 applies) in any 12 month period, not being a service associated with a service to
which item 10916, 10918, 10931, 10932 or 10933 applies.
10941 - FULL QUANTITATIVE COMPUTERISED PERIMETRY (automated absolute static
threshold) not being a service involving multifocal multichannel objective perimetry,
performed by an optometrist, where indicated by the presence of relevant ocular disease
or suspected pathology of the visual pathways or brain with assessment and report,
unilateral - to a maximum of 2 examinations (including examinations to which item 10940
applies) in any 12 month period, not being a service associated with a service to which item
10916, 10918, 10931, 10932 or 10933 applies.
The comparable ophthalmology items have been included in the concordance exercise with
relevant clinical practice guidelines above. Given the linkages to the optometry items, the
Department will use this opportunity to apply the findings of the guideline concordance to these
optometry items in consultation with the relevant optometry craft group/s.
Concordance conclusions
MBS item numbers 10940 and 10941 describe perimetry performed by an optometrist while
11221 – 11225 describe perimetry performed by or on behalf of an ophthalmologist. No evidence
is reported in the guidelines regarding the merits of who performs or interprets the perimetry
testing.
Page 35
3.7
Ultrasound biometry and PCI services
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA
review
11237, 11240, 11241, 11242,
11243
Orbital echography/ ocular
biometry ‡
Stakeholder
negotiation**
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
‡ Consumer views and preferences, as discussed in qualitative and blog literature, were also reviewed for these
specific items.
Summary of Findings
Items 11237, 11240, 11241, 11242 and 11243 - The apparent high use of the ocular biometry items
and co-occurrence with the cataract surgery items is reasonable, given the role of axial length
measurement in ensuring the placement of the correct intra-ocular lenses in cataract surgery. The use
of orbital echography for the diagnosis, monitoring or measurement of orbital masses was found to be
supported by expert opinion, as empirical evidence could not be identified. The use of ultrasound
biometry and partial coherence interferometry (PCI) to determine intraocular lens power similarly
lacked evidence on comparative safety, and provided very low level evidence on the comparative
accuracy of the two procedures. However, a good quality Australian randomised controlled trial did
find that the ultrasound biometry technique was able to be used on more patients. Ultrasound
biometry has better visual outcomes (post-operative refractive outcomes) in an intention-to-treat
population, although when patients who have failed PCI are excluded it appears that the two
techniques have comparable visual outcomes. It may, therefore, be reasonable to split each of the
lens surgery items (11240, 11241, 11242, 11243) to create separate items for ultrasound biometry
and PCI so that the relevant patient indications (or exclusions) for PCI can be documented in the
descriptor.
Qualitative analysis
None of the three bloggers reported finding ocular biometry to be a painful or distressing procedure
although PCI may be preferred particularly for children because, unlike ocular biometry, it does not
require direct contact with the eye.
Of the ocular biometry items, 11240 and 11241 have been the most frequently used, with 11240
having the 3rd highest number of services of the 61 MBS items analysed across the years (nearly 1
million). Item 11241 has become more prominent in recent years, growing to become the 4th
highest number in terms of usage for the 6 months of January to June 2010. These 2 items have
sometimes been claimed in conjunction with item 42702 (see Appendix D, Table 145). This is
consistent with the demand for cataract surgery, of which ocular biometry or partial coherence
interferometry is a pre-requisite. Items 11237, 11242 and 11243 are used much less often,
although 11237 has increased since 2007. The majority of services have been provided to persons
aged over 65 years, especially females.
Page 36
For this group of items, analysis of the provision of services according to rurality (see Appendix B,
Table 83) shows that item 11240 (orbital echography) had a greater frequency than expected for
rural patients (metropolitan 61.9% compared to rural 38.1%).
Cataract removal becomes necessary due to opacity of the lens which impedes light from reaching
the retina reducing visual acuity. After removal of the cataract, a replacement artificial intraocular
lens (IOL) is placed in situ to allow the eye to focus properly, however it is crucial that the correct
lens is placed accurately in order to attain post-operative refraction. Determination of the correct
IOL is based on pre-operative biometric data including axial eye length (AL), anterior chamber
depth (ACD), lens thickness and refraction of the cornea. Incorrect AL has been found to be a
major deterrent to the predictability of the refractive outcome. Methods of obtaining the
necessary data rely on the use of ultrasound (US) - using either immersion (IUS) or applanation
(AUS), and more recently the use of partial coherence interferometry (PCI). The lens formulae
calculate the correct IOL and where the lens should be positioned, and is named according to the
formulae used in the calculation e.g. a constant, lens factor or anterior chamber (Rajan, Keilhorn
et al. 2002; MSAC 2005).
The curve of the cornea is measured using keratometry. A keratometer measures the anterior
surface to assess the extent and axis of astigmatism. This is assessed using the relationship
between object size, image size, the distance between the reflective surface and the object, and
the radius of the reflective surface (MSAC 2005).
The axial length, when measured using US, uses the echo delay time to measure intra-ocular
distances. Small errors in measuring axial length can lead to post-operative refractive errors. The
applanation method requires contact with the eye and this can lead to corneal indentation during
measurement. As the US transducer makes contact with the surface of the cornea, it requires
application of a topical anaesthetic (Rajan, Keilhorn et al. 2002).
Partial coherence interferometry (PCI), also known as optical, ocular, coherence
biometry/tomography or laser Doppler interferometry, also measures axial length. PCI uses a dual
beam to eliminate any influence of longitudinal eye motions during measurement. The cornea is
used as a reference surface to conduct thickness profile, corneal thickness and AL measurements
and all measurements can be achieved at one sitting without the use of topical anaesthesia. The
use of PCI relies on adequate foveal fixations and therefore is unable to obtain accurate results for
patients with corneal scarring, dense cataracts, posterior capsule plaque and macular
degeneration (Rajan, Keilhorn et al. 2002; MSAC 2005). PCI does not require direct contact with
the eye.
An evidence-based analysis using a mini-HTA format was undertaken to assess the safety, accuracy
and clinical effectiveness of ultrasound biometry and partial coherence interferometry.
Research question
Are ultrasound biometry and partial coherence interferometry safe, accurate and clinically effective
measurement techniques?
Pre-specified criteria for the selection of literature to address this question are provided in Table
12.
Page 37
Table 12
PICO criteria for ultrasound biometry and partial coherence interferometry
Characteristic
Inclusion Criteria
Population
People requiring (1) diagnosis, monitoring or measurement of orbital masses, or (2) orbital
measurement to determine intraocular lens power
Intervention/tests
(1) Uni-dimensional ultrasonic echography
(2) Bi-dimensional ultrasonic echography
Comparator
Laser interferometry (ie partial coherence interferometry)
Outcome
Safety
Adverse physical health outcomes as a consequence of the procedure.
Accuracy
Primary – measures of agreement or concordance (eg kappa), diagnostic accuracy
measures (eg sensitivity, specificity, area under the receiver operator characteristic curve,
and others)
Effectiveness
Primary – improvement or restoration of vision, refractive outcomes
Search strategy
A search of the Cochrane library – including the Cochrane database of systematic reviews,
Database of abstracts of reviews of effects (DARE) and the HTA database, the economics database,
EconLit, and Embase.com (consisting of both Embase and Medline) was conducted using the
search terms outlined in Table 13.
Table 13
Search terms utilised for ultrasound biometry and partial coherence interferometry
Population
('eye'/exp OR 'eye disease'/exp) AND
Intervention
('echography'/exp OR echograph* OR 'interferometry'/exp OR interferomet*) AND
Limits
1. [English language]/lim AND [humans]/lim AND [2005-2011]/py AND [systematic review]/lim
2. [humans]/lim AND [2005-2011]/py AND ([systematic review]/lim OR [controlled clinical trial]/lim OR [meta
analysis]/lim OR [randomized controlled trial]/lim)
3. [article]/lim AND [humans]/lim AND [2005-2011]/py
Availability and level of evidence
The search for evidence on the safety, accuracy and/or effectiveness of ultrasound biometry and
partial coherence interferometry considered two eligible populations:
(1) those requiring diagnosis, monitoring or measurement of orbital masses, or
(2) those undergoing ocular axial length measurement to determine the correct intraocular lens
for cataract surgery.
Given that the level of evidence available for the second eligible population was found to be
considerably higher, the results from these studies are presented first, followed by the results for
the first eligible population.
Page 38
While Limit 2 (see Table 13) was sufficient to identify studies relating to the safety and
effectiveness of ultrasound biometry and PCI for the period 2000-2010, this returned no studies
on diagnosis, monitoring or measurement of orbital masses with these techniques. Limit 3 for the
period 2005-2010 was therefore applied in the search for literature pertaining to this part of the
assessment. Accuracy data for lens/cataract surgery were also sourced using Limit 3 for the period
2005-2010.
Results
Ultrasound biometry and PCI to determine intraocular lens power
A total of 271 papers were identified for the period 2000-201010 and reviewed for data on PCI to
determine intraocular lens power (as per Limit 2 defined in the protocol). Of these, one study was
included for an assessment of accuracy (Nepp, Krepler et al. 2005) and two eligible randomised
controlled trials (RCTs) were included for an analysis of safety and effectiveness (Rajan, Keilhorn et
al. 2002; Raymond, Favilla et al. 2009). Searching at the level of Limit 3 for the period 2005-2010
identified 3,132 potentially eligible studies, of which four were included for the assessment of
accuracy (Madge, Khong et al. 2005; Moeini, Eslami et al. 2008; El-Baha and Hemeida 2009;
Landers and Goggin 2009). Of these, one (Moeini, Eslami et al. 2008) was a cohort study, while in
the remaining studies, PCI and ultrasonographic techniques were each used in case series of
patients, and results were subsequently indirectly compared.
Accuracy
The five eligible studies included for an analysis of accuracy compared partial coherence
interferometry (PCI) with A-scan ultrasound for axial length measurements and estimates of
refractive outcomes. Study profiles and results are summarised in Table 14. Final post-operative
outcomes, as determined at follow-up, were assessed by a third method which was usually poorly
described. In one study this was identified as subjective refraction (Landers and Goggin 2009) and
in two studies, auto-refraction (Moeini, Eslami et al. 2008; El-Baha and Hemeida 2009). Only
Moeini and colleagues identified the exact equipment used to determine post-operative
refraction. One study repeated post-operative follow up measurements with the same techniques
(PCI and A-scan ultrasound) used in their pre-operative calculations (Nepp, Krepler et al. 2005).
Interestingly, the only finding of statistical difference between PCI and ocular biometry for
refraction calculations was in the study that assessed post-operative refraction with unknown
subjective methods (Landers and Goggin 2009). Even if the finding is of clinical significance, it is
not directly comparable with the results of the other studies that used unknown methods of autorefraction. Comparison between the studies that used automated methods of refraction is also
limited because these methods have not been adequately described and it is unknown how they
may differ in regard to measurement reliability.
10
In 2005, an assessment report published for the Medical Services Advisory Committee (MSAC Application 1050)
identified optical biometry using PCI as a new technique in that year. The literature search employed for the report
included articles published between 1966 and 2002 and finally returned six case series for inclusion. Given these
considerations, the evaluator determined that a literature search for this assessment prior to 2000 would not provide
any relevant additional data.
Page 39
Table 14
Study profiles and results for included studies of diagnostic accuracy/measurement
concordance for ultrasound biometry and PCI
Studies reporting on outcomes of ultrasound biometry and partial coherence interferometry
Included studies, population characteristics,
inclusion criteria and quality assessment
Intervention(s)
/tests(s) and
comparator(s)
Outcome(s)
(El-Baha and Hemeida 2009)
N= 21 cataract patients (22 eyes)
Country: Egypt
Age: 47 years
Sex: 16 female
Inclusion: Patients with lenticular opacities requiring
cataract extraction due to silicone oil used in previous
vitrectomy
Follow up: 3 months
Overall quality assessment: Poor quality – indirect
comparison of case series
Intervention/test: PCI
(IOL Master®) to inform
IOL power calculations
for cataract surgery
Comparator: A-scan
ultrasound to inform IOL
power calculations for
cataract surgery
Accuracy: Mean
differences in pre and
post-operative refraction
of the two techniques
Intervention/test: PCI
(IOL Master®) to inform
IOL power calculations
for cataract surgery
Comparator: IUS to
inform IOL power
calculations for cataract
surgery
Accuracy: Mean
differences in pre and
post-operative refraction
of the two techniques
Results
Mean differences in pre and post-operative refraction:
PCI, D
Ultrasound, D
p value
0.59 ± 0.38
0.65 ± 0.46
0.638
(Landers and Goggin 2009)
N= 55 cataract patients (55 eyes)
Country: Australia
Age: 76 years
Sex: 22 female
Inclusion: Patients with previous corneal diseases, IOL
not implanted in-the-bag, no IOL, previous anterior
segment or vitreoretinal surgery patients were excluded
Follow up: 8 weeks
Overall quality assessment: Poor quality – indirect
comparison of case series
Results
Mean differences in pre and post-operative refraction:
PCI, D
Ultrasound, D
p value
+0.01 ± 0.63
-0.25 ± 0.73
<0.001
Note: Plus sign indicates a mean difference that is more hyperopic than the predicted refraction and minus sign
indicates the refraction outcome is more myopic than the predicted value
Page 40
Studies reporting on outcomes of ultrasound biometry and partial coherence interferometry
Included studies, population characteristics,
inclusion criteria and quality assessment
Intervention(s)
/tests(s) and
comparator(s)
Outcome(s)
(Madge, Khong et al. 2005)
N= 20 cataract patients
Country: UK
Age: 18+ years
Sex: NR
Inclusion: Patients with axial length <22 or >26 mm,
preoperative refraction >± 6 D, patients with ocular
comorbidity and preoperative cylinder > 2 D were
excluded
Follow up: 2 weeks
Overall quality assessment: Poor quality – indirect
comparison of case series
Intervention/test: PCI
(IOL Master®) to inform
IOL power calculations
for cataract surgery
Comparator: A-scan
ultrasound to inform IOL
power calculations for
cataract surgery
Accuracy: Mean
differences in pre and
post-operative refraction
of the two techniques
Results
Mean differences in pre and post-operative refraction:
PCI, D (range)
Ultrasound, D (range)
p value
+0.59 (+ 0.37 to +1.02) -0.15 (-1.34 to +0.8)
0.042
Note: Plus sign indicates a mean difference that is more hyperopic than the predicted refraction and minus sign
indicates the refraction outcome is more myopic than the predicted value
(Moeini, Eslami et al. 2008)
N= 132 cataract patients
Country: Iran
Age: Mean 72 years
Sex: 65 female
Inclusion: Patients who underwent uncomplicated
cataract surgery by phacoemulsification in an academic
hospital and ophthalmology clinic
Follow up: 1 week
Overall quality assessment: Moderate quality cohort study
Intervention/test: PCI
(IOL Master®) to inform
IOL power calculations
for cataract surgery (56
patients)
Comparator: AUS to
inform IOL power
calculations for cataract
surgery (76 patients)
Accuracy: Mean
differences in pre and
post-operative refraction
of the two techniques
Intervention/test: PCI for
measurement of AL of
eyes to inform cataract
surgery
Comparator: Standard Ascan echography for
measurement of AL of
eyes to inform cataract
surgery
Accuracy: Between
group comparison of pre
and post-surgery
differences in mean AL
measurements
Results
Mean differences in pre and post-operative refraction:
PCI, D
Ultrasound, D
p value
0.67 ± 0.70
0.79 ± 0.76
0.342
(Nepp, Krepler et al. 2005)
N= 117silicone filled eyes of 107 cataract patients
Country: USA
Age: Mean 56 years
Sex: 46 female
Inclusion: NR
Follow up: 1 year
Overall quality assessment: Poor quality – indirect
comparison of case series
Page 41
Studies reporting on outcomes of ultrasound biometry and partial coherence interferometry
Included studies, population characteristics,
inclusion criteria and quality assessment
Intervention(s)
/tests(s) and
comparator(s)
Outcome(s)
Results
Pre and post-surgery differences in mean AL, mm ± SD (range):
Echography
PCI
p value
0.4 ± 2.6 (0.04-1.7)
0.04 ± 0.46 (0-1.19)
>0.1
PCI = partial coherence interferometry, AL = axial length, IOL = intraocular lens, D= dioptres, IUS = immersion ultrasound
biometry, AUS = applanation ultrasound biometry
Safety and Effectiveness
The two eligible RCTs included for analysis of safety and effectiveness compared partial coherence
interferometry (PCI) with standard applanation ultrasound biometry (AUS) in eyes requiring
cataract surgery (Rajan, Keilhorn et al. 2002; Raymond, Favilla et al. 2009). Study profiles and
results are presented in alphabetical order (Table 15). The poor quality RCT by Rajan et al 2002
randomised a total of 100 patients to either PCI or AUS (50 patients per arm) and compared the
mean post-operative absolute refraction error (MAE11) between the groups. The reported values
of MAE for each group were comparable and the proportion of eyes with post-operative refraction
within ±1 D of the predicted value appeared to favour PCI, although this difference was not
statistically significant. Given these data did not take into account the inability to measure four
(8%) patients allocated to PCI12 (no intention-to-treat analysis was evident), these results are likely
to over-represent the effectiveness of PCI in predicting refractive outcomes. Furthermore,
concealment of allocation to treatment groups from investigators measuring post-operative
refraction was not evident, and this may introduce further bias in the direction of the assessing
clinician’s preference for biometric technique. Conversely, results obtained in the intention-totreat analysis of the good quality RCT by Raymond et al 2009 indicated that 36 (17.6%) patients
failed PCI compared to nil with AUS. Compared to the PCI arm, patients in the AUS arm achieved
higher proportions of post-operative refraction within 0.5, 1.0, 1.5 and 2.0 D of the predicted
values (p<0.01). Raymond and colleagues also ensured blinding of post-operative assessors to the
allocation of patients to treatment groups. These methodological strengths have resulted in a
substantially better quality rating for this study compared to Rajan et al 2002. Neither study
reported on the safety of the investigated biometry techniques.
11
MAE is a measure of the difference between refraction as predicted by PCI or AUS and the actual refractive value as
measured after surgery.
12
Possible reasons for failure with PCI have been recognised. They include inadequate foveal fixation, corneal scarring,
dense cataracts, posterior capsule plaque, macular degeneration and eccentric fixation.
Page 42
Table 15
Study profiles and results for included RCTs reporting on outcomes of ultrasound
biometry and PCI
RCTs reporting on outcomes of ultrasound biometry and partial coherence interferometry
Included studies, population characteristics,
inclusion criteria and quality assessment
Intervention(s)/test(s)
and comparator(s)
Outcome(s)
(Rajan, Keilhorn et al. 2002)
N= 100 patients with cataract: 50 randomised to PCI, 50
to AUS
Country: UK
Age: Mean PCI, 67 years; mean AUS, 71 years
Sex: NR
Exclusion: Patients with complicated cataracts related to
chronic uveitis, trauma, or silicone oil were not included
Follow up: 2 months
Overall quality assessment: Poor quality RCT
Intervention/test: PCIbased (IOLMaster®) AL
measurement of eyes to
inform IOL power
calculations for cataract
surgery
Comparator: AUS-based
AL measurement of eyes
to inform IOL power
calculations for cataract
surgery
Safety: NR
Effectiveness:
Number and proportion of
patients who failed PCI
and AUS
MAE based on difference
between predicted and
attained post-operative
refraction
Proportion of eyes with
post-operative refraction
within ±1 dioptre (D) of the
predicted value.
Results
Patients who failed PCI, n (%): 4/50 (8)
Patients who failed AUS, n: 0/50
MAE ± SD (difference predicted vs attained post-operative refraction):
PCI, D
AUS, D
p value
0.52 ± 0.35
0.62 ± 0.4
0.24
Proportion of eyes with post-operative refraction within ±1 D of the predicted value:
PCI, %
AUS, %
p value
87
80
0.24
(Raymond, Favilla et al. 2009)
N= 205 patients with cataract: 103 randomised to AUS,
102 to PCI
Country: Australia
Age: Means for PCI, AUS, PCI-ITT*, and AUS-ITT*
groups - 73.7, 73.6, 73.3 and 72.5 years, respectively
Sex: % female for PCI, AUS, PCI-ITT and AUS-ITT
groups - 58, 59, 56 and 56%, respectively
Inclusion: All cataract patients booked for cataract
surgery at a day surgery centre between 6 April 2006
and 24 August 2006
Follow up: 5 weeks
Overall quality assessment: Good quality RCT
*ITT, intention-to-treat; both ITT and ‘best possible
outcomes’ analyses were performed to give four groups
for comparison in this study; this illustrates the extent of
bias that would be expected to occur if patients who
failed AL measurement of eye(s) with PCI were to be
omitted from the analysis.
Intervention/test: PCIbased (IOLMaster®) AL
measurement of eyes to
inform IOL power
calculations for cataract
surgery
Comparator: AUS-based
AL measurement of eyes
to inform IOL power
calculations for cataract
surgery
Page 43
Safety: NR
Effectiveness:
Number and proportion of
patients who failed PCI
and AUS
Proportion of eyes with
post-operative refraction
within 0.5, 1.0, 1.5 and 2.0
D of the predicted
spherical equivalent.
RCTs reporting on outcomes of ultrasound biometry and partial coherence interferometry
Included studies, population characteristics,
inclusion criteria and quality assessment
Intervention(s)/test(s)
and comparator(s)
Outcome(s)
Results
Patients who failed PCI, n (%): 36/205† (17.6)
Patients who failed AUS, n: 0/205†
Proportion of eyes achieving a post-operative refraction within 0.5, 1.0, 1.5 and 2.0 D of the predicted spherical
equivalent:
Post-operative MAE (%)
<0.5 D
<1.0 D
1.5 D
< 2.0 D
Group
PCI (n=84)
69.0
91.7
97.6
100
AUS (n=85)
69.4
89.4
95.3
100
PCI-ITT (n=102)
56.9
75.5
80.4
82.4
AUS-ITT (n=103)
68.0
87.4
94.2
99.0
PCI vs AUS, p=0.133
PCI-ITT vs AUS-ITT, p<0.01
†Prior to the randomisation process, all patients underwent AL measurements with both techniques, facilitating
separate analyses, i.e. ‘best possible outcomes’ and ITT
PCI = partial coherence interferometry, AUS = applanation ultrasound biometry, AL = axial length, IOL = intraocular lens, NR =
not reported, MAE = mean absolute post-operative refractive error, RCT = randomised controlled trial
Ultrasound biometry for the diagnosis, monitoring or measurement of orbital masses
Search criteria applied at Limit 2 for the period 2005-2010 failed to identify any eligible
comparative studies concerned with the safety, accuracy or effectiveness of ultrasonography as
applied to the diagnosis, monitoring or measurement of orbital masses. Of the 3,132 results
obtained with search criteria applied at Limit 3, one narrative review (Bakri, Sculley et al. 2006) of
imaging techniques for uveal melanoma was identified and included for this assessment. Given no
primary data are available for extraction, a summary of the relevant information from this review
is provided.
The review acknowledged ultrasonography with A and B scan techniques as the most useful
adjunctive test currently in use for the diagnosis of uveal melanoma. The benefits of A and B scan
ultrasonography for the diagnosis of uveal melanoma include the ability to define the intra-ocular
extent of the tumour and detect extra-ocular involvement. These ultrasonographic techniques can
also be useful in the differential diagnosis of melanoma from a variety of other lesions. However,
there are no distinctive features that differentiate a benign choroidal naevus from a small
choroidal melanoma. Certain extra-macular lesions show higher internal reflectivity of sound
waves than melanoma, whereas some haemorrhagic lesions, retinal harmatoma, tuberculoma,
neurilemmoma and combined choroidal-retinal detachment may closely mimic melanoma on
ultrasound. Another ultrasonographic technique, colour Doppler imaging (CDI), provides colour
encoded Doppler flow information throughout a two-dimensional gray scale image, enabling
selective analysis of spectra in intraocular blood vessels. The demonstration of intrinsic tumour
blood flow makes CDI a helpful ancillary tool for diagnosis of choroidal melanoma. A third
technique, high-frequency ultrasound biomicroscopy has applications in the diagnosis of lesions of
the iris and ciliary body. Distinct from standard ultrasonography, ultrasound biomicroscopy
Page 44
enables quantitative measurements of tumour size and extension within and beyond the iris.
Additionally, the high-frequency technique can differentiate between cystic and solid lesions and
can be used for serial monitoring. Imaging of uveal melanoma generated by ultrasound
biomicroscopy shows high correlation with histopathologic features, but differentiation between
various anterior uveal growths is limited with this method (Bakri, Sculley et al. 2006).
Conclusions
Ultrasound biometry and PCI to determine intraocular lens power
The body of evidence currently available on the comparative accuracy of ultrasound biometry and
PCI to predict refractive outcomes is principally low-level. Given the identified studies in most
cases employed a third (usually undefined) method for the post-refractive outcomes on which
differences between PCI and ultrasound biometry are both dependent, there is uncertainty
regarding the validity of the reported results.
In terms of safety, neither of the two RCTs included in this analysis reported any data. For
effectiveness outcomes, the weight of evidence is provided by Raymond et al 2009. Raymond and
colleagues found that 17 per cent of their subjects could not be measured with PCI, and this result
has been corroborated in an earlier series of patients measured with the IOL Master®(Freeman
and Pesudovs 2005). This was also the finding of the 2003 assessment report prepared for the
Medical Services Advisory Committee (MSAC Application 1050). Therefore, at the present time,
PCI is not well indicated as a technology to supersede ultrasound biometry. It may, therefore, be
reasonable to split each of the lens surgery items (11240, 11241, 11242, 11243) to create separate
items for ultrasound biometry and PCI so that the relevant patient indications (or exclusions) for
PCI can be documented.
The body of evidence for safety, accuracy and effectiveness is summarised in the matrix at Box 1.
Box 1
Evidence matrix for ultrasound biometry and partial coherence interferometry
Component
Rating
Description
Evidence base
B
Consistency
B
2 RCTs, one cohort study and 4 indirect comparisons of case
series
Most studies consistent and any inconsistency can be explained
Clinical impact
D
Slight or restricted
Generalisability
B
Majority of the evidence generalisable to the target population (the
generalisability of results from the 2 studies conducted in
developing countries is uncertain)
Applicability
A
The key RCT evidence was conducted in Australia. The results are
therefore applicable to the Australian health care context.
Ultrasound biometry for diagnosis, monitoring or measurement of orbital masses
The one narrative review included for this part of the assessment was not considered within the
body of evidence matrix shown at Box 1, given no primary data were available. However, orbital
Page 45
echography appears to be of continuing value in the diagnosis, monitoring or measurement of
orbital masses of uveal origin. No studies concerned with other orbital masses were identified.
Qualitative analysis
A consumer preferences analysis was undertaken for this group of ocular biometry services.
Search strategy
A qualitative literature search was undertaken using the Scopus and Embase databases Articles
and weblogs in English were sourced from developed nations13 using the search terms described
in Table 16 and
Table 17.
Full text reading of identified titles revealed that none of the identified peer reviewed papers were
relevant for our purpose. Two relevant blogs were sourced from previous searches for this review
giving a total of eight relevant blogs although four of these gave very little detail about the
procedure. Four blogs from four bloggers provided sufficient information about the procedure to
warrant inclusion in this review.
Table 16
Search terms used for identifying relevant literature in journal databases
Disease/disorder description
Lens surgery
‘Umbrella’ terms describing the activity
(Orbit* OR eye) AND (echography OR "Ultrasonography"[Mesh] AND "ultrasonography "[Subheading]
AND
OR ultrasound OR ‘standardized echography’)
What are we trying to canvass
“patient satisfaction” [MeSH]; attitude to health [MeSH]; patient compliance [MeSH]; public opinion
[MeSH]; health knowledge, attitudes, practice [MeSH]; patient acceptance of health care [MeSH]
Methods that might be employed in canvassing views
“qualitative research” [MeSH]; “focus Groups” [MeSH]; “focus groups”[TW]; interviews[TW]
Table 17
Weblog search terms for ultrasound biometry
Search
Number
1
Domain
Search terms
Initial
scan
62
Relevant sites
‘eye ultrasound’
Number
of results
62
blogspot.com
2
none
‘eye ultrasound’ AND blog
930
200
4 but same as for search 1
3
none
‘orbital echography’ AND blog 14
14
0
4
blogspot.com
‘orbital echography’
1
0
1
6
Results
From the blogs it is apparent that most patients do not find ultrasound biometry testing painful or
distressing. However, it should be noted that two out of the three included blogs related to
13
A developed country was defined to be; European Community, Canada, U.S, Norway, New Zealand, Australia,
Singapore, Switzerland, Hong Kong and Japan
Page 46
paediatric patients, who represent a small proportion of the patient population likely to undergo
this procedure. The two blog postings below describe the experience of eye ultrasound tests:
One American mother described her young daughter’s response to the eye ultrasound:
Madelyn has not had a very glamerous [sic] reputation with "medical procedures" (Just
read last years post about her MRI) I was a little worried that she would be uncooperative
for the procedure as well. I prayed that she would do great and she did. She was a trooper!!
They stuck a miniature [sic] ultrasound wand on her eyes and all around her eyes. I could
not stand that one bit. I can't even put a contact in my eye. Madelyn didn't even flinch
(Kathleen Short July 16, 2008).
However, one Canadian blogger waiting for cataract surgery indicated he was willing to pay for the
more expensive partial coherence interferometry using a laser as this is a non-contact method:
A few weeks prior to surgery I get my eyes measured by the latest computerized laser-using
ophthalmologic device that measure all kinds of parameters about each of my eyes…I have
paid a premium of $280 to get the measurement done by the non-invasive laser machine. It
does not even care if I blink. OHIP covers measurement by a more primitive device that
actually touches the eyes. I buy myself this luxury service. I sit for a few minutes till the laser
has done its readings (Len Micay April 11, 2007).
And another Canadian blogger documents the reluctance of her child to undergo of her child to
undergo ocular biometry. This was their second attempt to complete an eye ultrasound on the
child:
Emilie went in for the eye ultrasound first. This is the test where they freeze the eye, and
then put on a cup that holds open the eye, then they put water in the cup, and then put on
the ultrasound wand. Well Em would not do the test. I don't really blame her. The techs
were pretty clueless when it comes to kids. So instead they put a little balloon full of water
on her eye and did the ultrasound that way. It is not as good of an image but at least Emilie
could keep her eye shut (Celia Preusse October 29, 2007).
Page 47
3.8
Removal of foreign body
MBS ITEMS
42551*, 42554*, 42557*,
42560, 42563, 42566, 42569,
42644 *
SERVICE
REVIEW METHOD †
Removal of foreign body (*)
Mini HTA
review
Stakeholder
negotiation**
x
x
Guideline
concordance
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
Summary of Findings
Items 42551, 42554, 42557- The items concerned with perforating wounds of the eyeball are rarely
claimed (20-30 services each year). Minor wording changes were suggested for these items as part of
stakeholder negotiation and were mutually agreed between the Department and the RANZCO.
Items 42560, 42563, 42566, 42569 - The items concerned with removal of intraocular foreign bodies
(IOFB) are similarly infrequently used (up to 30 services a year), with magnetic removal from either
the anterior or posterior segment being extremely uncommon (~5 services per year). Evidence-based
analysis suggests that no conclusions can be made as to the comparative effectiveness of either the
external (external magnet) or internal approach (intra-ocular magnet or no magnet) for IOFB removal
from the anterior segment due to a lack of evidence. Firm conclusions as to the effectiveness of either
the external or internal approach for IOFB removal from the posterior segment are difficult to make
due to the lack of stratification of results reported in many studies and the confounding inherent in the
study designs. The low numbers of IOFB services required suggests that good quality evidence
comparing the internal and external approaches is unlikely to be produced. Use of either technique
appears related to clinical preference and size of the IOFB. The very low use of magnet for either the
anterior or posterior segment removal of IOFBs on the MBS suggests that item numbers 42560 and
42566 could be removed and the wording of 42563 and 42569 could be modified by removing the
word ‘nonmagnetic’. The increase in cost would be minimal.
Item 42644 – This item is concerned with removal of an embedded foreign body from the cornea or
sclera and is commonly used (30,000 services per year), although slowly declining. The Department
suggested a minor amendment to the item – the inclusion of the term ‘complete’ which was agreed to
by the RANZCO as it was consistent with the explanatory notes for the item.
The three items for perforating wounds of the eyeball (42551, 42554, 42557) have each incurred
around 20-30 services per annum, fluctuating from year to year during the analysis period. The
four items for removal of intraocular foreign bodies (42560, 42563, 42566, 42569) also show low
frequencies, with 42563 being the highest of the four. Unlike most of the other items reviewed
which are associated with age-related disease, these services have been performed on all age
groups, with a high proportion of males requiring the service. The total cost for all seven items in
the group is minimal compared to other procedures.
The item analysed separately (42644 - removal of imbedded foreign body from cornea or sclera) is
the one which has predominantly been used for eye trauma. It has shown a steady decline in
number of claims since the mid 1990’s, being around 30,000 p.a. for the last few years, but still
Page 48
represents the 5th highest number of services across the 16 years analysed. Procedures have been
performed in all states, across all ages, and mainly on males. The cost is much more significant
than for the other seven items, being around $1.6m for 2009.
Hospital separations relating to this item 42644 are shown in Appendix E, Figure 54, but at a level
of around 4,000 to 5,000 procedures p.a., indicating that many are performed in the non-hospital
setting.
Stakeholder negotiation regarding minor wording amendments to the MBS descriptor for the
perforating eyeball items (42551, 42554, 42557) and the commonly used ‘imbedded foreign
object’ item (42644) was undertaken (see Box 2). The RANZCO had suggested modifying items
42551, 42554 and 42557 to replace the term ‘perforating’ with ‘penetrating’, replacement of
‘eyeball’ with ‘eye’ and the addition of the term ‘rupture’. The terminology changes were agreed
by the Department. The Department suggested a small wording change to item 42644 – the
addition of the word ‘complete’. This is consistent with the existing explanatory notes for this item
number. The change was agreed to by RANZCO on the understanding that it does not preclude the
use of the same item number by a different provider within a short time frame. Clinical advice
indicated that it is not uncommon for a non-ophthalmologist (eg GP) to remove a foreign body
macroscopically, and the patient to subsequently require further removal under the slit lamp
biomicroscope.
Box 2 ‘Removal of foreign body’ item decriptor amendments
42551
EYEBALL, PERFORATING PENETRATING WOUND or RUPTURE OF, not involving
intraocular structures repair involving suture of cornea or sclera, or both, not being a
service to which item 42632 applies (Anaes.) (Assist.)
42554
EYEBALL, PERFORATING PENETRATING WOUND or RUPTURE OF, with incarceration
or prolapse of uveal tissue repair (Anaes.) (Assist.)
42557
EYEBALL, PERFORATING PENETRATING WOUND or RUPTURE OF, with incarceration
of lens or vitreous repair (Anaes.) (Assist.)
42644
CORNEA OR SCLERA, complete removal of imbedded foreign body from - not more
than once on the same day by the same practitioner (excluding aftercare) (Anaes.)
An evidence-based analysis using a mini-HTA format was undertaken for the items relating to the
removal of intra-ocular foreign bodies (items 42560, 42563, 42566, 42569).
The removal of intra-ocular foreign bodies (IOFB) with magnetic properties was described as early
as 1942 by Stallard, who reported on the treatment of penetrating wounds of the eye suffered
during the course of the Western Desert battles during World War II (Stallard 1942). Two
approaches may be used to remove magnetic IOFBs: the external approach, which uses an
Page 49
external magnet to draw the foreign body out of the eye in either a direct or indirect manner (see
further detail below) and the internal approach, referred to as vitrectomy, which utilises
microsurgical techniques (Lit and Young 2002). The approach used may differ depending on
whether the IOFB is located in the anterior or posterior segment of the eye. This mini-HTA is
intended to provide an overview of the safety and effectiveness of the magnetic removal of IOFB
from the anterior segment (MBS item number 42560) and the posterior segment (MBS item
number 42566) relative to non-magnetic removal (MBS items 42563 and 42569, respectively).
Background
The anterior section of the eye consists of the structures in front of the vitreous humour,
approximating to the front third of the eye. The main structures of the anterior segment include
the cornea, iris, ciliary body and the lens (Figure 1).
a
Figure 1
b
A
The anterior (a) and posterior (b) sections of the eye (Bores 2007)
Within the anterior segment are two chambers: the anterior chamber, which lies between the
posterior surface of the cornea and the iris; and the posterior chamber which lies between the iris
and the surface of the vitreous. Both chambers are filled with aqueous humour, which maintains
intraocular pressure and transports nutrition to the cornea and lens (Pick T.P. 1977). The posterior
segment of the eye is the remaining five-sixths of the eye including the optical structures: the
retina, choroid and optic nerve as well as the vitreous humour, which maintains the shape of the
eye and cushions the eye from shock (Figure 1) (Pick T.P. 1977).
Ocular trauma associated with IOFBs is one of the major causes of acute and long standing visual
impairment, and may even result in severe visual loss. A significant number of penetrating ocular
trauma cases involving IOFBs occur in young male adults, with the majority of these injuries being
work-related (Lit and Young 2002; Yeh, Colyer et al. 2008). Approximately 75-90 per cent of all
IOFBs are metallic and a large proportion of these (55-80%) are magnetic in nature. Although
injuries involving IOFBs are commonly located in the anterior segment of the eye, the ciliary body,
lens and the intra-retinal, sub-retinal, and retrobulbar spaces, the majority of IOFBs (47-61%) are
finally localised in the vitreous (posterior segment) (Soheilian, Abolhasani et al. 2004; Soheilian,
Feghi et al. 2005).
Page 50
External approach (anterior and posterior segment)
When using the external method, there are potentially two routes that may be utilised, as Stallard
described in 1942: the anterior or posterior route. When using the anterior route, also referred to
as the direct approach, a large electromagnet is placed external to the eye and acts to draw the
IOFB through the suspensory ligament into the posterior chamber. By changing the direction of
the magnetic force the IOFB is drawn between the iris and the lens into the pupil and the anterior
chamber, where it can be extracted from the eye via a keratome section with the aid of a small
magnet guided by the ophthalmologist. The disadvantage of this method lies in the very nature of
the IOFB, which being metallic may have irregular, sharp edges and therefore be capable of
causing damage to the internal structures of the eye, including the ciliary body, iris and lens. For
this reason an indirect ophthalmoscope is used to visualise the path of the IOFB as it moves
towards the external magnet, avoiding any internal structures. The external approach is more
suited to IOFBs that are anterior localised or those that are either intra-retinal, sub-retinal or over
the pars plana14. Only large electromagnets are capable of generating a field strength sufficient to
move metallic IOFBs in this manner (Lit and Young 2002).
When using the posterior route, also referred to as the indirect approach, an incision in the sclera
is made and the IOFB is drawn out from the vitreous through this incision when a small
electromagnet is applied to the edges of the wound. Usually the incision in the sclera is made
opposite or 180 degrees away from the position of the IOFB to prevent the IOFB from “skating”
the retina as it moves out of the posterior chamber, however lens damage can occur with this
approach (Lit and Young 2002). The advantage of the indirect approach is, however, that it also
allows for the extraction of the IOFB using surgical means if the IOFB proves to be non-magnetic in
nature (Stallard 1942).
Internal approach (posterior segment)
The pars plana vitrectomy (PPV) technique was developed in the early 1970s for the removal of
IOFBs from the posterior segment (Mester and Kuhn 1998). Since its development, the PPV
technique has been improved with the use of intra-ocular forceps and intra-ocular magnets (Yeh,
Colyer et al. 2008). A small incision is made in the pars plana to avoid damage to the retina and the
lens. Using a specialised cutting device and a fibre optic light source the vitreous is removed from
around the IOFB (Figure 2). The IOFB can then be removed with either intra-ocular forceps
(relevant to item 42569) or an intra-ocular magnet (relevant to item 42566) (Lit and Young 2002).
PPV is recommended for the removal of posterior located IOFBs and is usually performed under
local anaesthetic as an ambulatory procedure (Yeh, Colyer et al. 2008).
14
The pars plana is part of ciliary body that is about 4 mm long and located near the point where the iris and the
sclera meet.
Page 51
Figure 2
A trans pars plana vitrectomy demonstrating the removal of the vitreous (VitreousRetina-Macula Consultants of New York 2009)
Complications of foreign body extraction include lens trauma, retinal traction, vitreous
haemorrhage, bleeding on the edge of the sclerotomy and retinal detachment (Soheilian, Feghi et
al. 2005).
Research question
Is the magnetic removal of an intra-ocular foreign body, from the anterior or posterior segment of
the eye, a safe and effective procedure?
Pre-specified criteria for the selection of literature to address this question are provided in
Table 18.
Table 18
PICO criteria for intraocular foreign body removal
Characteristic
Inclusion Criteria
Population
People with trauma caused by foreign bodies which have penetrated the eyeball
Interventions
Magnetic removal of intraocular foreign bodies from either the anterior or posterior segment
of the eyeball (items 42560, 42566)
Comparator
Microsurgery to remove intraocular foreign bodies ie non-magnetic removal via forceps,
sclerotomy, scleral tunnel (items 42563, 42569)
Outcome
Safety
Adverse physical health outcomes as a consequence of procedure to remove the intraocular
foreign body, including infection, vitreous loss, or other morbidity associated with the
procedure.
Effectiveness
Primary – improvement or restoration of vision, reduction in pain or discomfort, healing rate
Secondary – length of hospital stay
Page 52
Search strategy
A search of the Cochrane library – including the Cochrane database of systematic reviews,
Database of abstracts of reviews of effects (DARE) and the HTA database, the economics database,
EconLit, and Embase.com (consisting of both Embase and Medline) was conducted using the
search terms outlined in Table 19.
Table 19
Search terms utilised for intra-ocular foreign body removal
Population
('eye'/exp OR 'eye disease'/exp) AND
Intervention
('magnetism'/exp OR 'magnetic separation'/exp OR 'magnetic and electromagnetic equipment'/exp OR
('eye surgery'/exp AND 'foreign body'/exp)) AND
Limits
1. [English language]/lim AND [humans]/lim AND [2005-2011]/py AND [systematic review]/lim
2. [humans]/lim AND [2005-2011]/py AND ([systematic review]/lim OR [controlled clinical trial]/lim OR [meta
analysis]/lim OR [randomized controlled trial]/lim)
3. [article]/lim AND [humans]/lim AND [2005-2011]/py
Availability and level of evidence
No published systematic reviews were identified in the Cochrane Library or EconLit databases.
When Limit 1 was applied, a total of two citations were downloaded from Embase.com, both of
which described pharmacological interventions and were therefore not relevant. When Limit 2
was applied, a total of 29 citations were downloaded from Embase.com, none of which were
relevant to the research question. When Limit 3 was applied, a total of 444 articles were
identified, of which 18 were considered potentially relevant.
As the usage of MBS item numbers 42560 and 42566 is very low a targeted search was also
undertaken to determine the current ‘state-of-play’ of these procedures. A total of 210 narrative
reviews were downloaded from Embase.com (no restriction on year of publication but limited to
English and Human), with 34 being considered potentially relevant. These two searches were
combined (total 52) and the papers were evaluated further. Relevant papers were also pearled for
possible inclusions. Six papers did not report on outcomes, 14 papers were considered irrelevant
to the research question and 18 papers could not be retrieved. A total of 22 papers were
examined in detail for relevant outcomes, with the more recently published papers assessed as a
priority. Seven of these were published post-2005 and seven were published between 2000 and
2005.
Results
No systematic reviews or randomised controlled trials were identified. The narrative review by Yeh
et al (2008) cited the study by Mester and Kuhn (1998), which compared the use of an external
electromagnet for the removal of ferrous IOFBs compared to the use of the internal PPV approach.
Yeh et al indicate that once there is a decision to use the PPV approach, the strategy for IOFB
removal will depend on the size and volume of the fragment, with those <1.0 mm able to be
removed with an intra-ocular magnet, with medium sized (1.0-3.0 mm) fragments requiring intraocular forceps. Most small and medium sized IOFBs can be removed via the sclerotomy site,
however a scleral tunnel may be required for those IOFBs larger than 4 mm3.
Page 53
Removal of IOFBs from the posterior segment of the eye
The narrative review by Lit and Young (2002) stated that studies have "not yet shown definitively
better outcomes" when the internal approach is used for the removal of IOFBs compared to the
external approach, but they clarify this statement with the comment that "because metallic IOFBs
may move quickly and uncontrollably, many surgeons will opt for an internal approach", citing the
papers by Mester and Kuhn (1998) and Chow, Garretson et al. (2000), which are described
below.”
The retrospective cohort study by Chow et al (2000) reviewed patients who had undergone
removal of IOFBs with the external method (n=24) or the internal approach (n=44) (Table 20).
Mean pre- and post-operative visual acuity scores were reported for both groups. Patients in the
internal removal group had poorer visual acuity at baseline (20/300) compared to those in the
external removal group (20/150), however this difference was not statistically significant (p=0.08).
Both groups demonstrated improved visual acuity at follow-up, however only a difference
between groups, rather than an improvement within groups, was tested for and was found to be
non-significant (p=0.19). A number of adverse events were reported and stratified by IOFB
removal method, including retinal detachment, profilerative vitreoretinopthay, enucleation and
phthsis. The rate of post-operative endophthalmitis was significantly higher in those patients in
the external approach group (2/24 patients vs no patients in the internal group, p=0.05).
A similar study by Mester et al (1998) reported on the removal of IOFBs by external magnet (n=30)
or by intra-ocular forceps (n=34). Anatomic and functional results were better for patients in the
internal approach group, with a significantly higher proportion of patients with improved visual
acuity. After adjustment for preoperative visual acuity values, the mean post-operative visual
acuity in the internal group was still significantly higher (p= 0.001) than the mean post-operative
visual acuity in the external group. Approximately 17 per cent of eyes were considered failures
(enucleation, evisceration, or phthisis) in the external removal group, with no eye failures
identified in the internal group. In addition, the rate of advanced proliferative vitreoretinopathy
was almost four times higher in the external group compared to the patients in the internal group.
The retrospective interrupted time series15 by Wickham et al (2006) reported on a small number
of patients who underwent removal of an IOFB with an external magnet (n=8) as well as a larger
group of patients who underwent IOFB using the internal approach (n=106) (Wickham, Xing et al.
2006). Those receiving the internal approach had the IOFBs removed, variously, by forceps,
forceps and intra-ocular magnet, or intra-ocular magnet alone. No information was given as to
whether the site of entry, the position of the IOFB, length of time to IOFB removal or size of the
IOFB in those patients who underwent external removal differed from those patients who
underwent IOFB removal by the internal approach. Only two of the external magnet patients
experienced a good outcome in terms of visual acuity being defined as 6/3616 (20/120) or better,
15
The studies by Wickham et al (2006) and Mester and Kuhn (2006) reported on the results of IOFB removal using the
external method during a discrete period of time, followed by another series of patients where the IOFB was removed
using the internal method. The two methods were not conducted concurrently.
16
A visual acuity of 6/6 means that a person can see detail from 6 m away the same as a person with normal eyesight
would see from 6 m. If a person has a visual acuity of 6/36 they can see detail from 6 m away the same as a person
with normal eyesight would see it from 36 m away.
Page 54
with six patients experiencing a poor outcome with visual acuity of 6/60 (20/200) or worse
(p=0.009). Patients experienced better visual acuity outcomes when the IOFB was removed by an
internal approach including intra-ocular magnet, forceps, forceps combined with intra-ocular
magnet or a cutter. These results differ from those reported in much earlier studies cited in this
paper (Chiquet, Zech et al. 1998; Pavlovic, Schmidt et al. 1998; Chow, Garretson et al. 2000), which
all reported no difference between the internal and external approaches. A number of postoperative complications were reported, however these were not stratified according to method of
IOFB removal and therefore no conclusions may be made in regard to the different techniques.
Interestingly there was a significant improvement in visual acuity for patients who underwent
surgery after 1999 (p=0.043), with 39 per cent of patients having a poor outcome prior to this date
compared to 22 per cent after. Again, there was no indication as to the removal technique used in
these patients.
A retrospective case series reviewed the outcomes of the removal of posterior located magnetic,
metallic IOFBs (< 5.0 mm) in 71 eyes (Soheilian, Abolhasani et al. 2004). Removal of the IOFB was
achieved with an external magnet (n=30) or by intra-ocular forceps (n=41). Improvements in visual
acuity were reported stratified by the removal technique (Table 20), however pre and postoperative visual acuity values were only reported for the patient group as a whole and could
therefore not be included in this assessment. A higher proportion of patients had improved visual
acuity after IOFB removal by the external method compared to removal by the internal approach
(63.4% vs 46.7%), which would appear clinically important but no statistical comparison was
made. Rates of adverse events were similar in both groups. It has been thought that the surgical
management of IOFBs may be associated with a higher rate of retinal break formation due to
multiple passages of instruments through the sclerotomy site. Rates of retinal break formation
were similar in patients receiving either the external and internal approach indicating that the
passage of the IOFB through the vitreous may be a risk factor for retinal break formation rather
than the IOFB extraction method. Although visual loss was reported as an outcome of retinal
detachment, again this outcome was not stratified as to treatment group.
A retrospective cohort reviewed all consecutive patients with metallic IOFB injury reporting to the
emergency department over a 10-year period. Of the 96 patients reporting to emergency with a
metallic IOFB, 64 of these were magnetic (Ehlers, Kunimoto et al. 2008). All patients underwent
ruptured globe repair and attempted IOFB removal using either an external magnet or PPV, with
the removal approach used based on surgeon preference. Although safety and effectiveness
results were reported in terms of visual acuity, infection and globe loss and survival, results were
not stratified according to the method of IOFB removal (external vs internal), site of IOFB, or
whether or not the IOFB was magnetic or non-magnetic, and were therefore not included in this
assessment. Similarly, two other case series reported the visual acuity results only of patients who
had undergone PPV for IOFB removal and therefore results of these studies are not included in this
assessment (Demircan, Soylu et al. 2005; Macedo, Ferreira et al. 2005).
When the search period was extended to studies published earlier than 2005, seven papers were
identified that were potentially relevant to the research question. Of these, one reported on
retained metallic IOFBs (Ho, Wilson et al. 2004), one described anterior abnormalities not anterior
IOFBs (Kuhn and Mester 2002) and one was a narrative review (Mester and Kuhn 2002). These
Page 55
papers were not included for assessment. The largest case series identified described the results
of 767 patients with an IOFB acquired during the Iran-Iraq War (1980-1988). However the
methods of IOFB removal included intra-ocular magnet, vitreoretinal forceps during pars plana
vitrectomy, or an open-sky vitrectomy and not the use of an external magnet, therefore these
results could not be included in this assessment (Nguyen, Kruger et al. 2002).
Removal of IOFBs from the anterior segment of the eye
No systematic literature reviews, randomised controlled trials or comparative studies were
identified that examined the removal of IOFBs from the anterior segment of the eye using either
the internal or external approach.
Conclusions
No conclusions may be made as to the efficacy of either the external or internal approach for IOFB
removal from the anterior segment due to a lack of evidence.
Firm conclusions as to the effectiveness of either the external or internal approach for IOFB
removal from the posterior segment are difficult to make due to the lack of stratification of results
reported in many studies. In addition, unreported differences in the nature, size and location of
the IOFB makes direct comparison of outcomes difficult. Only the small case series by Mester et al
(1998) recommended the internal approach over the external approach, with most other studies
supporting either technique. It would appear from the included studies that surgeon preference
was the deciding factor in determining which method of IOFB removal was employed and that
limited evidence exists to support the use of one method over the other. Soheilian (2004) suggests
that some surgeons may opt for the external approach to reduce the theoretical risk of
inflammation and trauma associated with the use of intra-ocular forceps, and that other surgeons
advocate the use of intra-ocular forceps for improved control during IOFB extraction. Both
methods are associated with complications including retinal break formation posterior to the
sclerotomy, cataract, traction retinal detachment and vitreous inflammation. In addition, as
metallic IOFBs may be unpredictable and rapid in their movement, many surgeons may opt for an
internal approach unless the IOFB is subretinal and can be accessed directly with a sclerotomy,
with minimal movement of the IOFB (Lit and Young 2002).
Intra-ocular foreign bodies remain a rare occurrence even in specialised eye hospitals, with several
case series of 100 patients or less presenting over a time period of 10 years. Good quality evidence
comparing the internal and external approach for either eye segment is therefore unlikely to be
produced. The low rate of usage of the MBS item numbers associated with the magnetic removal
of IOFBs (~5 services per year) would indicate that in Australia most ophthalmologists use the
internal approach. As such, item numbers 42560 and 42566 could be removed and the wording of
42563 and 42569 could be modified by removing the word ‘nonmagnetic’. The increase in cost
would be minimal.
A summary assessment of the body of evidence is provided in Box 3.
Page 56
Box 3
Component
Evidence base
Evidence matrix for magnetic removal of an intra-ocular foreign body from the anterior
or posterior segment of the eye
Rating
D
Consistency
B
Clinical impact
D
Generalisability
A
Applicability
B
Table 20
Description
2 retrospective cohorts, 2 retrospective interrupted time series
without a parallel control group
Most studies consistent with only one 1998 study reporting
conflicting results which may a reflection of the small size of the
study or differences in the technique over time.
Only one study provided a statistical analysis. Most studies did not
stratify results according to intervention.
Evidence is generalisable to the target population.
Evidence from developed countries therefore applicable to the
Australian health context with a few caveats.
Studies of intra-ocular foreign body extraction
Studies reporting the outcomes of the removal of intra-ocular foreign bodies (IOFB) from the posterior
segment
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Chow, Garretson et al. 2000)
Retrospective cohort
N= 68 retrospectively reviewed patients with IOFB injuries,
of which 95 (83%) were metallic. Nature of metal was not
documented.
Country: USA
Age: Mean age 31 year s (range 2-78 years)
Sex: 69/70 (98.6%) male
Inclusion: All patients presenting to hospital with a
posterior segment IOFB between 1973 and 1996.
Follow up: mean follow-up for external approach patients
39.7 months and 23.2 months for internal approach
patients (p=0.17)
Intervention: IOFB
removal by external
approach (n=24)
Comparator: IOFB
removal by internal
approach (n=44)
Effectiveness: visual
acuity.
Safety: post-operative
complications
Page 57
Studies reporting the outcomes of the removal of intra-ocular foreign bodies (IOFB) from the posterior
segment
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
Results
Pre-operative
Post-operative
Mean logMAR visual acuity (Snellen)
External magnet (n=24)
Intra-ocular forceps (n=44)
0.838(20/150)
1.21 (20/300)
p=0.08
0.394 (20/50)
0.619 (20/80)
p=0.19
Safety
External method (n=24)
Retinal detachment
5/24 (20.8%)
Proliferative vitreoretinopathy
3/24 (12.5%)
Endophthalmitis
2/24 (8.3%)
Enucleation
1/24 (4.2%)
Phthsis
0/24 (0%)
Glaucoma
2/24 (8.3%)
Cystoid macular oedema
2/24 (8.3%)
Vitreous haemorrhage
3/24 (12.5%)
Epiretinal membrane
1/24 (4.2%)
Macular impact scars
0/24 (0%)
Average number of
re-operations
0.583
(Soheilian, Abolhasani et al. 2004)
Retrospective cohort
N= 417 retrospectively reviewed patients with IOFB
injuries, of which 110 (26.4%) were located in the
posterior segment. Of these, 74 (67%) were metallic and
magnetic. 3 eyes were excluded (IOFB >5.0mm)
Country: Iran
Age: Mean age 27.6 ± 12.3 year s (range 8-77 years)
Sex: 71 (100%) male
Inclusion: All patients presenting to hospital with a
posterior segment IOFB between 1986 and 2000, IOFB <
5.0 mm.
Follow up: mean follow-up 29.7 ± 20.3 months (range 676 months)
Internal method (n=44)
7/44 (15.9%)
7/44 (15.9%)
0/44 (0%)
2/44 (4.5%)
4/44 (9.1%)
2/44 (4.5%)
4/44 (9.1%)
4/44 (9.1%)
5/44 (11.4%)
4/44 (9.1%)
p=0.61
p=0.7
p=0.05
p=0.96
p=0.12
p=0.53
p=0.91
p=0.66
p=0.32
p=0.17
0.341
p=0.26
Intervention: IOFB
removal by external
approach (n=41)
Comparator: IOFB
removal by internal
approach (n=30)
Page 58
Effectiveness: visual
acuity.
Safety: post-operative
complications
Studies reporting the outcomes of the removal of intra-ocular foreign bodies (IOFB) from the posterior
segment
Included studies, population characteristics, inclusion
criteria and quality assessment
Results
Post-operative visual acuity results
Method of IOFB removal
Intra-ocular forceps (n=30)
(use of intra-ocular magnet NR)
External magnet (n=41)
Safety
Intra-ocular forceps (n=30)
Retinal break
Giant retinal dialysis
Retinal detachment
Endophthalmitis
External magnet (n=41)
Retinal break
Giant retinal dialysis
Retinal detachment
Endophthalmitis
Intervention(s) and
comparator(s)
Outcome(s)
Vision improved
Vision stable
Vision worse
14 (46.7%)
26 (63.4%)
8 (26.7%)
8 (19.5%)
8 (26.7%)
7 (17.1%)
Pre-operative
15/30 (50%)
Post-operative (2 weeks)
3/30 (10%)
3/30 (10%)
2/30 (6.7%)
3/30 (10%)
Pre-operative
15/41 (36%)
Post-operative (2 weeks)
4/41 (10%)
0/41 (0%)
3/41 (7.3%)
4/41 (10%)
(Mester and Kuhn 1998)
Retrospective interrupted time series without a parallel
control group
External method
N= 30 retrospectively reviewed patients with metallic,
magnetic IOFB injuries
Age: Mean age 29.8 year s (range 15-54 years)
Sex: 30 (100%) male
Inclusion: All patients presenting to hospital with a
posterior segment IOFB between 1974 and 1982
Follow up: mean follow-up 22.9 months (range 1-56
months)
Internal method
N= 34 retrospectively reviewed patients with metallic,
magnetic IOFB injuries
Age: Mean age 33.4 year s (range 15-65 years)
Sex: 34 (100%) male
Inclusion: All patients presenting to hospital with a
posterior segment IOFB between 1988 and 1997
Follow up: mean follow-up 17.5 months (range 2-53
months)
Country: USA
Intervention: IOFB
removal by external
approach (n=30)
Comparator: IOFB
removal by internal
approach (n=34)
Page 59
Effectiveness: visual
acuity.
Safety: post-operative
complications
Studies reporting the outcomes of the removal of intra-ocular foreign bodies (IOFB) from the posterior
segment
Included studies, population characteristics, inclusion
criteria and quality assessment
Results
Method of IOFB removal
Intra-ocular forceps (n=34)
External magnet (n=30)
Intra-ocular forceps (n=34)
External magnet (n=30)
Intervention(s) and
comparator(s)
Visual acuity improved
25 (73.5%)
7 (23.3%)
Visual acuity same
6 (17.6%)
7 (23.3%)
Pre-operative visual acuity
5.74 ± 2.34
4.03 ± 2.27
Outcome(s)
Visual acuity worse
3 (8.8%)
16 (53.3%)
Post-operative visual acuity
7.53 ± 3.17
3.8 ± 3.2
Safety
Internal approach (n=34)
0/34 (0%) eyes were anatomical failures (enucleation, evisceration, phthisis)
4/34 (11.7%) developed advanced proliferative vitreoretinopathy
External magnet (n=30)
5/30 (16.7%) eyes were anatomical failures (enucleation, evisceration, phthisis)
12/30 (40%) developed advanced proliferative vitreoretinopathy
12/30 (40%) remained aphakic (lacking the natural lens)
3/30 (10%) developed secondary glaucoma
(Wickham, Xing et al. 2006)
Retrospective interrupted time series without a parallel
control group
N= 114 retrospectively reviewed patients with IOFB
injuries, of which 95 (83%) were metallic. Nature of metal
was not documented.
Country: United Kingdom
Age: Mean age 34.6 ± 12.4 year s
Sex: 114 (100%) male
Inclusion: All patients presenting to hospital with a
posterior segment IOFB between 1987 and 2004.
Follow up: median follow-up from time of injury 15.6
months (interquartile range 6-38 months)
Intervention: IOFB
removal by external
approach (n=8)
Comparator: IOFB
removal by internal
approach (n=106)
Page 60
Effectiveness: visual acuity.
Safety: post-operative
complications
Studies reporting the outcomes of the removal of intra-ocular foreign bodies (IOFB) from the posterior
segment
Included studies, population characteristics, inclusion
criteria and quality assessment
Results
Method of removal of IOFB
External magnet
Intra-ocular magnet
Forceps
Forceps and intra-ocular magnet
Cutter
Not removed
Not documented
Intervention(s) and
comparator(s)
Good visual acuity 6/36 (n)
2 (25%)
10 (66.7%)
35 (77.8%)
11 (91.7%)
12 (85.7%)
2 (40%)
7 (46.7%)
Outcome(s)
Poor visual acuity 6/60 (n)
6 (75%)
5 (33.3%)
10 (22.2%)
1 (8.3%)
2 (14.3%)
3 (60%)
8 (53.3%)
Safety
Overall complications were not stratified according to removal method used but were reported as a whole
Retinal detachment
42/114 (36.8%)
Proliferative vitreoretinopathy
24/114 (21.1%)
Strabismus
13/114 (11.4%)
Epiretinal membrane
6/114 (5.3%)
Glaucoma
6/114 (5.3%)
Endophthalmitis
4/114 (3.5%)
Page 61
3.9
Extirpation of tarsal cyst
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA review
42575
Extirpation of tarsal cyst ‡
Stakeholder
negotiation**
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
‡ Consumer views and preferences, as discussed in qualitative and blog literature, were also reviewed for these
specific items.
Summary of Findings
Item 42575 – Tarsal cysts are a common problem, with treatment being sought mainly from patients
in metropolitan areas. The treatment of tarsal cysts with surgical incision and curettage has been
found to be safe and effective for people who are unresponsive to supportive care (warm compresses
and antibiotics) and/or corticosteroid injection. Incision and curettage was considered to be the
treatment of choice for patients with suppurating granuloma cysts, large tarsal cysts and recurring
tarsal cysts and is essential for confirming cyst pathology. Standard clinical practice in Australia for
the treatment of tarsal cysts would consist of the application of a warm compress, followed by surgery,
with the use of corticoid steroid injections rarely considered as a treatment option. It would therefore
appear that the item is essential and the descriptor can remain unchanged.
Qualitative analysis
Extirpation of tarsal cysts is generally seen as a treatment of last resort but the blogs suggest that
patients may prefer this treatment for aesthetic reasons.
Bloggers and a single study which measured pain levels using a numerical rating scale report that
tarsal cyst extirpation is a very painful experience but an alternative treatment of steroid injections was
also considered painful. The alternative conservative treatment of hot compresses was reported as
painless. Bloggers also reported that the postoperative period could also be painful.
Reported satisfaction levels for all therapeutic options were low. The reasons for this were not
explored in the study but the low success rate for the former treatment and the painful nature of the
latter two treatments may explain these low ratings.
The single item 42575 for this therapeutic procedure has remained steady at around 17,000
services p.a. It is used across all States and in 2009 cost over $1m in benefits. It is a service
provided to patients from metropolitan areas at a greater rate than would be expected for the
population spread (see Appendix B, Table 83) – 81.0% in metropolitan areas compared to 20.7% in
rural areas. Further detail on claims for this item is provided in Appendix D.
This mini-HTA is intended to provide an overview of the safety and effectiveness of tarsal cyst
extirpation (MBS item number 42575).
Page 62
Background
A tarsal cyst, also known as a chalazion, a meibomian cyst or a conjunctival granuloma, is a small
lump which develops on the eyelid and is caused by inflammation of an eyelid gland. Tarsal cysts
are sub-acute, non-tender and usually painless. They may be fluid-filled and soft but when
unresolved can become firmer. Many tarsal cysts are self-limiting and resolve without treatment,
however, those that do require treatment may take many months to fully heal. Tarsal cysts are
benign and are caused by secretions in the blocked meibomian gland resulting in local eye
irritation and inflammation (Figure 3).
Figure 3
Illustrating the position and development of a tarsal cyst
Larger tarsal cysts may cause mechanical ptosis and corneal astigmatism (Ben Simon, Huang et al.
2005). Patients with underlying conditions such as rosacea, seborrheic dermatitis or blepharitis are
more prone to multiple and recurring tarsal cysts (Gilchrist and Lee 2009). Conservative treatment
of tarsal cysts consists of heat and massage to break down and disperse the fatty material (Arbabi,
Kelly et al. 2010). When conservative management fails to resolve the tarsal cyst, second line
treatments consisting of surgical management (incision and curettage) or intra-lesional
triamcinoline acetonide are utilised.
Tarsal cysts need to be differentiated from hordeola or styes, which are painful abscesses caused
by a bacterial infection, usually staphylococcal, and require topical/oral antibiotic treatment. A
hordeolum may be internal or external and is usually on the lid margin (Lindsley, Nichols Jason et
al. 2010). Differential diagnosis of tarsal cysts or hordeola is often difficult (Mueller and McStay
2008).
The treatment of tarsal cysts using incision and curettage has been extended to nurse
practitioners in the United Kingdom, reducing waiting lists and cost to the health care system
(Dunlop 2010). In an audit of the nurse led treatment the service was found to reduce waiting time
from six months to three weeks with high levels of patient satisfaction.
Although a minor surgical procedure, there are risks associated with incision and curettage which
include haemorrhage, infection, globe perforation causing traumatic cataract and canalicular
trauma (Kim, Yang et al. 2006; Gilchrist and Lee 2009), therefore appropriate levels of training and
Page 63
experience are necessary pre-requisites to the use of this treatment option. Patients may not be
amenable to wearing an eye patch and may prefer a single injection of triamcinolone acetonide
especially when this option is cheaper, quicker and may be more aesthetically pleasing than the
surgical option (Unal 2008).
Research question
Is tarsal cyst extirpation a safe and effective procedure?
Pre-specified criteria for the selection of literature to address this question are provided in Table
21.
Table 21
PICO criteria for tarsal cyst extirpation
Characteristic
Inclusion Criteria
Population
People with tarsal (meibomian) cysts/chalazia that are unresponsive to supportive care
(warm compresses and antibiotics) and/or corticosteroid injection
Interventions
Surgical extirpation/removal. Note: Intervention is last line therapy
Comparator
If comparative studies are available – then likely comparator would be extended versions of
previous line of therapy ie supportive care (warm compresses and antibiotics) and/or
corticosteroid injection
Outcome
Safety
Adverse physical health outcomes as a consequence of the procedure.
Effectiveness
Primary – improvement or restoration of vision, reduction in pain or discomfort, resolution of
the cyst
Search strategy
A search of the Cochrane library – including the Cochrane database of systematic reviews,
Database of abstracts of reviews of effects (DARE) and the HTA database, the economics database,
EconLit, and Embase.com (consisting of both Embase and Medline) was conducted using the
search terms outlined in Table 22.
Table 22
Search terms utilised for tarsal cyst extirpation
Population
'chalazion'/exp OR 'chalazi*' OR 'tarsal' NEAR/2 'cyst' OR 'meibomian' NEAR/2 'cyst' AND
Intervention
Not required
Limits
1. [English language]/lim AND [humans]/lim AND [2005-2011]/py AND [systematic review]/lim
2. [humans]/lim AND [2005-2011]/py AND ([systematic review]/lim OR [controlled clinical trial]/lim OR [meta
analysis]/lim OR [randomized controlled trial]/lim)
3. [article]/lim AND [humans]/lim AND [2005-2011]/py
Availability and level of evidence
When Limit 2 was applied (systematic reviews and randomised controlled trials), four articles were
retrieved. Further levels of evidence (Limit 3, pseudo-randomised trials, comparative studies and
case series) were then searched and 170 articles were retrieved. Following a review of the abstract
and full-text (if eligibility was unclear), 18 studies were found to be eligible.
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Results
A moderate quality level III-1 pseudo-randomised controlled trial compared three arms of
treatment for tarsal cysts (
Page 65
Table 23). The first treatment group received conservative management comprising lid massage
and heat, the second group received intra-lesion injections of the corticosteroid triamcinolone
acetonide (TA) (0.2 ml of 10 mg/ml, 2mg total) and the third group had surgical treatment with
incision and curettage. The authors concluded that injecting TA was as effective as incision and
curettage, with less reported pain, bruising and patient inconvenience. Intra-lesion injections were
considered more economical and practical as they require less equipment and time, both for the
health care provider and patient, compared to surgical intervention. Nine patients (16%) received
a second TA injection when the tarsal cyst did not resolve after initial treatment. Treatment by
injection of TA or incision and curettage were both statistically significantly more effective than
conservative treatment with heat and massage alone. Adverse events associated with steroid
injections include loss of pigmentation around the injection site and raised intraocular pressure,
which may occur if the steroid infiltrates the conjunctiva. No adverse events were reported for any
of the treatment options included in this study (Goawalla and Lee 2007).
A moderate quality level II RCT compared conservative treatment of tarsal cyst such as heat and
massage versus invasive treatment consisting of 0.3 ml TA (10 mg/ml) injected to subcutaneous
tissue extra-lesionally via the percutaneous route (
Page 66
Table 23) (Chung, Lai et al. 2006). A statistically significant benefit was identified from the use of
TA injections with success rates of 94 per cent (15/16) compared to the success rate in the
conservative treatment group of 58 per cent (7/12) (p = 0.04).
A moderate quality level III-2 study compared surgical treatment of tarsal cysts consisting of
incision and curettage versus intra-lesion steroid injection of 0.05 to 0.1 ml of TA (40 mg/ml, total
dose 2-4 mg) (Table 24) (Dhaliwal and Bhatia 2005). The underlying pathology of the tarsal cysts
and whether they were either mixed-cell or suppurating granulomas was determined. Older
patients, with larger lesions that had persisted for a greater length of time were more likely to
have a suppurating granuloma, were identified as more responsive to excision and curettage (p =
0.0008). This finding demonstrated that clinical diagnosis of tarsal cysts may be inadequate and
that tissue diagnosis may yield better patient outcomes. Significant differences were identified in
the time taken to heal after surgery and in the cost of surgical treatment compared to a single
injection of TA. Injections were reported as being less painful than surgery and required a shorter
period of antibiotic cover post treatment. The authors concluded that intra-lesion injection of TA
was the preferred treatment option for tarsal cysts unless a suppurating granuloma was
diagnosed.
In a similar study, Khurana et al (1988) compared the treatment of tarsal cysts using either incision
and curettage or 0.02 – 0.20 ml injections with TA (10 mg/ml) and stratified the participants
according to lesion size. Smaller lesions responded better to a single injection of TA whilst larger
lesions required incision and curettage to achieve complete resolution of the cyst (Table 24). Rates
of resolution for the injection group were 70, 50 and 0 per cent respectively for the groups in
relation to size of lesion with the largest group receiving no benefit from injection of TA. The rates
of resolution were 90, 88 and 100 per cent for the corresponding groups in the incision and
curettage group (Khurana 1988). No adverse events were experienced by participants in the
Khurana et al (1988) study. The authors recommend the use of TA injections for small, multiple or
marginal tarsal cysts where surgery may be difficult.
Ben Simon et al (2005) in a retrospective, interventional, consecutive case series study, followed
patients who had treatment with an intra-lesion TA injection (Table 25) (Ben Simon, Huang et al.
2005). Tarsal cyst resolution occurred within 2.5 weeks in 80 per cent of cases after a single intralesion TA injection, with no adverse events reported. Similar results were described by PavicicAstalos et al (2010) when comparing intra-lesion injections of TA compared to control injections of
sodium chloride (Pavicic-Astalos, Ivekovic et al. 2010). Participants in the control group had no
resolution of their tarsal cysts whilst 95 per cent of tarsal cysts in the intervention group were
resolved after one TA injection. Again, no adverse events were reported associated with the use of
intra-lesion injections of TA.
Tarsal cysts are known to affect vision by exerting pressure on the eye which causes hyperopia and
corneal astigmatism. Bagheri et al (2008) compared the impact of tarsal cyst removal on visual
acuity in 195 patients with single or multiple lesions. Astigmatism was significantly reduced as
indicated by a reduction in surface regularity index (SRI), surface asymmetry index (SAI), and
difference of keratometry (DK) (Table 25). After excision of the lesion the potential visual acuity
(PVA) was also improved. It was also noted that single tarsal cysts induced greater astigmatism
Page 67
that multiple ones and a central firm tarsal cyst had the largest effect on topographic indices and
optical properties of the cornea (Bagheri, Hasani et al. 2009).
Several authors highlight the difficulty of diagnosing a tarsal cyst, as other pathologies present in a
similar manner e.g. sebaceous, basal or squamous cell carcinoma, hordeolum (styes), molluscum
contagiosum, tuberculosis, sarcoidosis or epithelial inclusion cysts (Dhaliwal and Bhatia 2005;
Keskinaslan, Pedroli et al. 2008; Dunlop 2010). Goawalla & Lee (2007) further highlighted the
danger of injecting a steroid, such as TA, into an undiagnosed cancer which may mask the growth,
or even cause a missed diagnosis (Goawalla and Lee 2007). Several authors reported case studies
of patients who presented with what had been diagnosed as a tarsal cyst but was in fact a
squamous cell carcinoma (Chen, Chen et al. 2006; Motegi, Tamura et al. 2006; Ishikawa, Watabe et
al. 2009). There were no morphological changes to indicate anything other than a simple tarsal
cyst and if not for the histopathology after incision and curettage they may not have been
diagnosed as cancerous until there was metastatic spread to regional lymph nodes. In one case,
swelling worsened rapidly after steroid injections and after cyst excision a peripheral T-cell
lymphoma was confirmed (Ishikawa, Watabe et al. 2009).
Page 68
Table 23
Randomised controlled trials for tarsal cyst extirpation
Randomised Controlled Trials (RCTs) on tarsal cyst extirpation
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Chung, Lai et al. 2006)
Moderate quality level II RCT
Country: Hong Kong
Patients >18 years presenting with primary tarsal cyst
Gender: male/female ratio:
Group 1: 4:8
Group 2: 7:9
Mean age (SD) years:
Group 1: 38 (17)
Group 2: 39 (17)
Mean duration (SD, weeks) of tarsal cyst:
Group 1: 4.6 (4.3)
Group 2: 8.8 (9.9)
Exclusion criteria: acutely infected tarsal cyst with preseptal cellulitis, recurrent or small tarsal cyst or prior
treatment to tarsal cyst
Follow-up 2 and 4 weeks
Group 1 (n = 12)
Eye lid hygiene, warm
compresses,
chloramphenicol 1%
ointment, 4 x per day
versus
Group 2 (n = 16)
0.3 ml triamcinolone
acetonide (10 mg/ml)
injected into
subcutaneous tissue
extra-lesionally via the
percutaneous route
Size of tarsal cyst,
recurrence of tarsal cyst,
intraocular pressure and
complications such as
skin pigment, change or
atrophy and pyogenic
granuloma
Results
There is a clinically and statistically significant benefit in the treatment of tarsal cyst with 0.3 ml extra-lesional
injection of triamcinolone acetonide versus conservative treatment
Treatment success
Group 1
7/12 (58%)
Group 2
15/16 (94%)
p = 0.04
Prior duration of tarsal cysts versus success and failure of treatment
mean prior duration of tarsal cyst: weeks (SD)
p-value
successes
failures
Group 1
2.3 (2.8)
7.8 (4.3)
0.01
Group 2
9.1 (10.1)
4.0 (0)
0.82
(Goawalla and Lee 2007)
Level III-1 moderate quality pseudo-RCT
N = 136
Country: United Kingdom
Gender: 53 (39%) male
Inclusion criteria: > 18 years of age, palpable single tarsal
cyst on eyelid, normal lid anatomy,
Exclusion criteria: recurring tarsal cyst, abnormal tissue
surrounding cyst, allergy to any treatment agents, < 18
years of age, multiple tarsal cysts on eyelid, unable to give
consent, concurrent eyelid infection.
Follow-up 3 weeks
Page 69
Treatment group 1
(n=35): lid massage
and heat
Treatment group 2
(n=56): intralesional
injection with 0.2 ml of
10 mg/ml
triamcinolone
acetonide
Treatment group 3
(n=45): incision and
curettage
Resolution of tarsal cyst,
pain, satisfaction and
inconvenience
experienced.
Randomised Controlled Trials (RCTs) on tarsal cyst extirpation
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
Results
Group 1
Group 2
Group 3
Conservative trt
Intra-lesion injection
Incision and curettage
Resolved
16/35 (46%)
47/56 (84%)
39/45 (87%)
Scores for pain, inconvenience and satisfaction: Median (inter-quartile range)
Pain
0
6 (5, 7)
7 (5.5, 8)
Inconvenience 4 (3, 4)
2 (1, 2)
3 (2, 4)
Satisfaction
2 (0, 4)
4 (3.3, 5)
4 (3, 4)
Specific comparisons between pairs of groups:
1 vs 2
1 vs 3
2 vs 3
tarsal cyst resolved
p <0.001
p<0.001
p = 1.00
pain
p<0.001
p<0.001
p = 0.003
inconvenience
p<0.001
p = 0.86
p<0.001
satisfaction
p<0.001
p<0.001
p = 0.09
Table 24
p-value
p<0.001
Comparative studies for tarsal cyst extirpation
Comparative studies for tarsal cyst extirpation
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Dhaliwal and Bhatia 2005)
Moderate quality level III-2 comparative, non-randomised
study
N = 62
Country: India
Gender: 29 (46.8%) males
Mean age 25.5 ± 9.51years (range 12 – 45 years)
Lesion duration: 0.5 – 18 months
Lesion pathology: 41 (66.1%) mixed-cell granuloma, 21
(33.9%) suppurating granuloma.
Follow-up: one week and one month
Surgical treatment
group (n = 35):
incision and curettage
versus
Injection group (n =
27): 0.05 to 0.1 ml
triamcinolone
acetonide (40 mg/ml)
Size of residual lesion
Results
35 (56.5%) of patients underwent incision and curettage while 27 (43.5%) were treated with intra-lesion TA
injections.
Patients aged ≥35.1 years, with lesion duration ≥ 8.5 months and lesion size ≥ 11.4 mm were more likely to have
suppurating granulomas. Mixed–cell granulomas responded equally well to both treatments whereas suppurating
granulomas responded significantly better to incision and curettage (p = 0.008)
Cytology results
Mixed-cell granuloma
Suppurating granuloma
p-value
Mean age, years (SD)
23.0 ± 9.25
29.0 ± 8.56
0.02
Lesion duration (months)
4.1 ± 2.84
6.2 ± 3.94
0.02
Lesion size (mm)
7.8 ± 2.75
9.6 ± 2.71
0.02
Overall response to treatment at one week and one month
Intra-lesion injection
Incision and curettage
p-value
Resolved at 1 week
16 (59.2%)
30 (85.7%)
0.02
Resolved at 1 month
18 (66.7%)
34 (97.1%)
0.002
Page 70
Comparative studies for tarsal cyst extirpation
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Khurana 1988)
Level III-3 comparative study
N = 60
Country: India
Patients divided into 3 groups depending on size of lesion:
Group 1 (1-4 mm), Group 2 (5-7 mm) and Group 3 (8-12
mm). Alternate patients in each group assigned to either
treatment A or B.
Exclusion criteria: < 12 years of age, infected or recurrent
tarsal cysts.
Group A: intra-lesion Resolution of lesion,
triamcinolone
recurrence of lesion
acetonide 0.02 – 0.20
ml (10 mg/ml)
injections
versus
Group B: incision and
curettage
Results
Group1 (1 – 4 mm)
A (n = 10) B (n = 10)
Resolution at 2 weeks, n (%) 7 (70%) 9 (90%)
Repeat injection, n (%)
3 (30%) 0 (0%)
No resolution at 3 months,
n (%)
0 (0%)
0 (0%)
Group 2 (5 – 7 mm)
A (n = 8) B (n = 8)
4 (50%) 7 (88%)
4 (50%)
Group 3 (8 -12 mm)
A (n = 7) B (n = 7)
0 (0%)
7 (100%)
1 (13%)
7 (100%)
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1 (13%)
0 (0%)
Table 25
Non-comparative studies tarsal cyst extirpation
Comparative studies for tarsal cyst extirpation
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Ben Simon, Huang et al. 2005)
Level IV, retrospective, interventional, consecutive case
series
N = 147 (155 tarsal cysts)
Country: United States
Gender: 80 (51.9%) male
Mean age 45 ± 17 years (range 11 – 91 years)
Mean duration of tarsal cyst 3.5 ± 3.2 months (range 1 - 24
months)
Mean follow-up 10.8 ± 12.4 months (range 3 - 51 months)
Intra-lesion injection of
0.1 to 0.2 ml of
triamcinolone
acetonide (40 mg/ml)
Size of cyst, resolution
and time to resolution,
recurrence and
complications.
Results
Mean number of injections per lesion 1.8 ± 1.2 (range 1 – 7)
Number of injections required for resolution: tarsal cyst n (%)
1 injection
2 injections
3 injections 4 injections
5 injections
93 (60%)
31 (20%)
19 (12.3%)
6 (3.9%)
3 (1.9%)
Mean decrease in size of cyst (range): 75 ± 33% (0 - 100%)
Mean time to resolution (range): 2.7 ± 2.2 weeks (0.5 – 13.5 weeks)
(Pavicic-Astalos, Ivekovic et al. 2010)
Level IV case series
Country: Croatia
Patients with primary or recurring tarsal cysts
Intervention group Control group
Mean age (yrs) 41.47 ± 17.95
33.33 ± 13.67
Mean duration of lesion (wks)
32.95 ± 11.46
27.08 ± 9.28
Follow-up: 1-2 weeks
6 injections
2 (1.3%)
Intervention group (n =
30, with 37 tarsal
cysts):
Intra-lesion injection of
0.1 to 0.2 ml
triamcinolone
acetonide (40 mg/ml)
versus
Control group (n = 24):
Intra-lesion injection of
0.1 ml to 0.2 ml of NaCl
Results
Complete resolution of tarsal cyst
Intervention Group
n = 35/37 (95%)
Time to resolution
Intervention Group
15.27 ± 6.12 days after one injection
17.71±5.31 days for participants requiring two injections.
Control group:
no resolution of tarsal cysts.
Page 72
7 injections
1 (0.6%)
Regression or
recurrence of lesion
Comparative studies for tarsal cyst extirpation
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
(Bagheri, Hasani et al. 2009)
Level IV case series
N = 195 (253 cysts)
Country: Iran
Patients with single or multiple tarsal cysts: 83 (42%) right
eye, 79 (40%) left eye and 33 (18%) both eyes involved
Gender 110 (56.6%) female
Mean age 31 ± 14 years (range 7 -71 years)
Mean duration of lesion before excision 4 ± 2.8 (range 124) months, ,
Inclusion criteria: > 7 years of age, at least 1 month duration
of cyst with or without medical treatment and improvement
of acute inflammation,
Exclusion criteria: history of any ocular or periocular surgery
and incomplete follow-up.
Follow-up: Day 1, week one, 1, 3, and 6 months
Outcome(s)
Best corrected visual
acuity (BCVA), spherical
equivalent (SE), surface
asymmetry index (SDI),
surface regularity index
(SRI), potential visual
acuity (PVA), and
difference of
keratometry (DK)
Results
Changes in refractive and topographic indices after tarsal cyst excision
Variable
pre-op
post-op
difference
SRI
0.40
0.27
0.13
SAI
0.35
0.26
0.09
DK (diopter)
1.28
0.94
0.34
PVA (logMAR)
0.11
0.05
0.06
BCVA
0.0004
0.000
0.0004
Sphere (diopter)
-0.09
-0.08
-0.01
Cylinder (diopter)
-0.55
-0.37
-0.18
Axis (degree)
67.4º
63.8º
3.6º
SE (diopter)
-0.34
-0.28
-0.06
p-value
<0.0001
<0.0001
<0.0001
<0.0001
0.3
0.9
<0.0001
0.3
0.08
Comparison of two typical groups of tarsal cyst
Variable
pre-op
single firm central
DK
1.21
SE
-1.25
multiple peripheral soft
DK
1.06
SE
-0.13
post-op
0.46
-0.09
0.84
-0.02
difference
0.75
-0.35
0.22
-0.11
p-value
0.001
0.001
<0.0001
0.1
Changes in DK and SE in different size groups of tarsal cysts
Variable
pre-op
post-op
small
DK
0.92
0.49
SE
0.02
-0.02
medium
DK
1.02
0.47
SE
-0.03
-0.08
large
DK
1.11
0.41
SE
-0.21
-0.45
huge
DK
1.21
0.35
SE
-0.41
-0.83
difference
0.43
0.04
0.55
0.05
0.70
0.24
0.86
0.42
p-value
0.05
0.40
0.02
0.21
0.01
0.11
0.003
0.04
Page 73
Conclusion
The treatment of tarsal cysts with surgical incision and curettage has been found to be safe and
effective for people who are unresponsive to supportive care (warm compresses and antibiotics)
and/or corticosteroid injection. Incision and curettage was considered to be the treatment of
choice for patients with suppurating granuloma cysts, large tarsal cysts and recurring tarsal cysts
and to confirm cyst pathology. The body of evidence for safety, accuracy and effectiveness is
summarised in the matrix at Box 4.
Box 4 Evidence matrix for tarsal cyst extirpation
Component
Rating
Description
Evidence base
C
One moderate quality RCTand pseudo randomised RCT and five
comparative studies with moderate risk of bias
Consistency
A
All studies were consistent
Clinical impact
B
Not all studies provided statistical analysis data however those that did
showed significant clinical benefit of surgical intervention for the
treatment of tarsal cysts
Generalisability
A
Evidence directly generalisable to the target population
Applicability
B
Evidence applicable to the Australian health care context with few
caveats
Qualitative analysis
A consumer preferences analysis was undertaken regarding extirpation of tarsal cyst.
Research question
What is the patient experience of and perspective on the ophthalmology service described by MBS
Item 42575?
Search strategy
A qualitative literature search was undertaken using the Scopus and Embase databases Articles in
English were sourced from developed nations17 using the search terms described in Table 26.
Table 26
Search terms used for identifying relevant literature in journal databases for tarsal cyst
extirpation
Disease/disorder description:
“tarsal cyst” OR Meibomian cyst OR chalazion
‘Umbrella’ terms describing the activity
Extirpation OR remov* OR excision OR surgery
What are we trying to canvass
“patient satisfaction” [MeSH]; attitude to health [MeSH]; patient compliance [MeSH]; public opinion
[MeSH]; health knowledge, attitudes, practice [MeSH]; patient acceptance of health care [MeSH]
Methods that might be employed in canvassing views
“qualitative research” [MeSH]; “focus Groups” [MeSH]; “focus groups”[TW]; interviews[TW]
Studies were selected on the basis that they included the patient perspective of the experience of
the removal of a tarsal cyst (often by another name) including the period before and after the
17
A developed country was defined to be; European Community, Canada, U.S, Norway, New Zealand, Australia,
Singapore, Switzerland, Hong Kong and Japan
Page 74
procedure and any side effects which the patient associated with the procedure. From the
searches above, 12 studies were selected based on their titles. Full text articles were then
retrieved for these studies, and based on these, 10 were excluded. The remaining two publications
were analysed and the findings therein reported in this document.
Blogs, or weblogs, are on-line journals documenting views and experiences of a single author, or in
some cases a small group of authors. English language blogs from developed countries which
described the experience of intra-vitreal injection were identified through a Google advanced
domain search. The searches conducted are shown in Table 27. Blogs were selected on the basis
that they presented the perspectives of people who had experienced the surgical removal of a
tarsal cyst as described above. Commercial blogs were excluded. All literature was imported into
NVivo for thematic coding and analysis.
Table 27
Google searches to source relevant blogs for tarsal cyst extirpation
Number
Domain
Search
Number of
results
Viewed
1
blogspot.com
(“tarsal cyst” OR Meibomian cyst OR chalazion OR
cyst) AND (Extirpation OR remov* OR excision OR
surgery)
3
All
2
blogspot.com
130
All
3
No domain
used
(“tarsal cyst” OR Meibomian cyst OR chalazion OR
cyst)
(“tarsal cyst” OR Meibomian cyst OR chalazion OR
cyst) AND (Extirpation OR remov* OR excision OR
surgery) AND blog
37
All
4
First 200
1
All
6
blogspot.com
(“tarsal cyst” OR Meibomian cyst OR chalazion OR
cyst) AND blog
'tarsal cyst' OR "Meibomian cyst" OR chalazion OR
stye
(“tarsal cyst” OR Meibomian cyst OR chalazion OR
stye
4460
5
No domain
used
wordpress.org
188
All
7
blogspot.com
stye OR sty (removal OR surgery OR excision OR
Extirpation)
18600
First 200
8
wordpress.org
stye OR sty (removal OR surgery OR excision OR
Extirpation)
24
All
9
technorati.com
stye OR sty (removal OR surgery OR excision OR
Extirpation)
3
All
10
No domain
used
“tarsal cyst” OR Meibomian cyst OR chalazion OR
stye/blog
18600
First 200
Review of search results in Search 4, 7 and 10 was discontinued after examining the first 200
results, as it became apparent that all of the weblogs identified were repeats of earlier findings.
Twelve blogs from nine bloggers provided sufficient detail of their experience for inclusion in this
review.
Page 75
Results
In looking at the patient experiences and perspectives on this procedure, a very limited amount of
relevant literature and weblogs were located. The identified literature and weblog articles can
provide some understanding of patient experiences and perceptions of the procedure but the
confidence we can place in this data is limited by the small number of sources available.
Pre-operative experience
Reasons for undergoing an extirpation procedure:
Tarsal cysts are generally not a debilitating condition, and therefore surgical removal is a last
resort as one United States blogger suggests:
My doctor said I will have to work hard to avoid surgery. I have to use a Q-tip a rub an
ointment on the eyelid at night, after a warm compress. In the morning, I have to use a
scrub on the eyelid. She told me it could take as long as three months or so to go away and
that if it hasn't in three months, I will need surgery..? (Jackie Meyers September 9, 2009 )
One blogger from New Zealand, Emeline, experienced a doctor’s reaction to her request for cystremoval:
She told me that I should try home remedies (hot compress) because I'll never receive
treatment in New Zealand for something that is asymptomatic and relatively painless
(Emeline November 16, 2008).
The cyst was not mentioned again in the blog and presumably disappeared. Some can be more
persistent however and one of the major reasons for undergoing the procedure is concerns about
personal appearance. Blogger SabilaK, from the United States, lists the reasons for getting it
removed as follows:
So, I'm having the squatter removed tomorrow because: 1) while a chalazion might taste
delicious if it was an Italian pastry, it's actually just an inflamed, ugly, but luckily small and
useless mess at the moment; 2) I'm getting married so, as much as this guy's been a part of
all of the milestones this year, I won't miss it at all next year; 3) and I get to sport a patch
after the procedure, which is pretty cool (SabilaK April 27, 2009).
Anticipatory fear
We have noted from other reviews of MBS items that it is common for patients to experience
anticipatory fear when procedures involve invasive measures on the eye. This was not explored in
the peer-reviewed literature on the extirpation of tarsal cysts, but is a recurrent theme in the
weblogs. The bloggers report fear based on information from different sources. One blogger from
the United States, Sabilak, refers to her fear being based on the information provided by her
doctor:
Page 76
“I'll need to focus on these reasons tomorrow when the doctor injects my eyelid with
anesthesia (he admitted that this would hurt like a [expletive]) and then scoops the
[expletive] out (SabilaK April 27, 2009).
In a following blog entry, SabilaK reported her feelings on the day of the procedure, she notes the
high level of fear experienced:
No untruths here, kittens: I was scared for my eye and my life as I made my way to the
cosmetic opthamologist (SabilaK April 27, 2009).
Furthermore, two blogs from the United States note that fear was brought on by watching videos
of the procedure published on the internet:
Today I was watching videos of chalazion eye surgery and I almost passed out. I had to lie
down for a few minutes... If you're interested in seeing the video that almost made me pass
out, here it is: [video of tarsal cyst extirpation] (Colman Carter November 24, 2008 ).
Why do I NOT want surgery? Check it out [YouTube link to video of tarsal cyst extirpation]
(Jackie Meyers September 9, 2009 ).
Intra-operative experience
Pain and discomfort
Most of the weblogs which describe the procedure suggest it is an unpleasant process. One
blogger from the United States, who has been diagnosed with Ehlers-Danlos syndrome, notes the
unpleasantness of previous extirpation as motivation from avoiding a second procedure:
Styes...One became big and bad enough that I was prompted to see an eye doctor in
Lapeer- not knowing he was going to remove it right there in his office- I was in for a huge
surprise- They froze it- felt like they pulled my eyelid back and tied it to my ponytail- took
the stye out- and left me with a huge bruise and a patch to cover it. That wont [sic] happen
again- I assure you. I have since had styes- but use over the counter stye medication which
seems to be doing a good job (TJ November 13, 2003).
Blogger, SabilaK, from the United States, gives an account of her experience with the extirpation
of her tarsal cyst:
Cosmetic opthamologist flips my lower eyelid inside out with something that might look like
an eyelash curler and I'm horrified but am able to keep my eyes closed so the horribleness
subsides, or so I think. Cosmetic opthamologist instructs me to take deep breaths, that I'm
way too tense but when I proceed to follow his instructions, he tells me not to move my
face, so I try to breathe without moving my face. I hear him snipping (there is no scalpel,
apparently, only scissors) away at the chalazion and I feel pressure on my eyelid and I hope
Page 77
and pray that cosmetic opthamologist doesn't accidently poke me in the eye with the
scissors. Then he says that he's going to cauterize the incision and that I may smell
something burning and I try not to pass out (SabilaK April 27, 2009).
Another blogger from the United Kingdom noted:
She sat me down in a dentist like chair and put a local in my eyelid which stung and pretty
much made my eyelid trickle with blood... she then put some kinda clamp on my eyelid to
turn it inside out which was painfully uncomfortable!!! it felt like it was squeezing my
eyeball (Laura 2010).
Interestingly, the only report of the procedure in which it is not described as unpleasant is from a
mother in the United States who helped her four year old daughter through the procedure, which
was, however carried out under anaesthesia:
All the chalazions were removed from her eye within 10 minutes (Lindsay Lane August 6,
2009 ).
And with a second chalazion removal procedure:
Yesterday morning, Zella had her second surgery done for the removal of her chalazions on
her upper right eye lid. Everything went well and she is back to her happy, wild, silly, and
crazy ways (Lindsay Lane August 21, 2009 ).
The experience described in the weblogs is supported by Goawalla and Lee who report that
extirpation is significantly more painful than the alternate treatments, triamcinolone injections or
hot compresses with massage (Goawalla and Lee 2007).
Administration of local anaesthesia was described by two bloggers as the most painful part of the
procedure. For example SabilaK from the United States notes the extreme and unexpected pain of
the local anaesthetic injection, despite a warning from her ophthalmologist;
...my cosmetic opthamologist gently (sexily) reminds me that it's going to be the most
painful part of the surgery.
"What could possibly be more painful than a scalpel in my eye?" I wonder and brush the
warning aside until, holy Allah in Jannah with all of his angels, the cosmetic opthamologist
sticks me right in the chalazion with a needle. And what I proceed to feel is fiery hot and
spicy damnation spread all across my lower lid until all I want to do is go home with my
chalazion intact and [expletive] cuddle with it at every milestone from here to freakin'
eternity.
But the pain subsides. I stop squirmin. (SabilaK April 27, 2009).
Page 78
A respondent on WikiAnswers reports that the administration of local anaesthesia was the ‘only
part that hurt’ and describes the painless nature of the rest of the procedure:
It took them awhile to numb it. They also gave me frops [sic] to numb my eyeball was well.
The clamp to hold my eye open was uncomfortable. But I didnt [sic] feel anything. Its more
annoying and uncomfortable then anything .
The role of choice of health professional in determining patient satisfaction with the procedure is
explored in a non-randomised study (Jackson and Beun 2000). This study found that patients were
more satisfied with explanations and advice about their diagnosis and treatment when it came
from the nurse, than from a ‘senior house officer’ (SHO) and this in turn led to the patient
reporting higher satisfaction with the treatment overall. In a similar vein, patients also reported
lower pain scores and higher satisfaction ratings when certain aspects of the procedure were
performed by the nurse, rather than the SHO. The authors did not explore why this was the case
but suggested that the nurse who treated much higher numbers of patients than any single SHO
may have become more skilled in communicating, choosing and carrying out the treatment.
Post-operative experience
Patient perspectives and experiences post-operatively were not explored in the peer-reviewed
literature. The two posts from the United States which describe the post-operative period suggest
that the recovery may be painful.
it is very swollen now, he said it will take a week to heal. It hurts more now then[sic] it did
before, and I cant [sic] take any pain med because im pregnant. They also gave me a gel
cream to put INTO my eye 4 times a day for the next 5 days. I sure hope it helps heal asap!
…wait a minute, is that my anesthesia wearing off?
Yes. Yes it is. So, by the time we get home, the upper right quadrant of my face feels like it's
been bashed in by a hammer (even my gums hurt) and, forgetting about the patch, I fall
asleep (SabilaK April 27, 2009).
Although a parent from the United States describing her child’s reaction post-operatively was
more positive:
The swelling should go away within a few days and the bruising should also fade away
within the next few weeks or so. Zella is so happy and told me she wants to go swimming
and play outside already. The doctor said only light play today so I think we will just go for a
walk and plan for a funfilled day tomorrow (Lindsay Lane August 6, 2009 ).
Only one weblog noted that the tarsal cyst returned after the extirpation:
Her eye is swollen shut. A few of the chalazions had returned 5 days after her surgery
(Lindsay Lane August 18, 2009 ).
Page 79
Comparison of extirpation of a tarsal cyst with alternate therapies
A lot of the blogs canvassed in the searching did not report experience of the procedure itself, but
rather talked about the extirpation of the tarsal cyst as the next step or the last resort. A theme in
both the literature and weblogs was the comparison of this procedure with alternative therapies.
The following comment from a United States blogger, Jackie, demonstrates the extensive and
variable types of alternative treatments described by bloggers:
A friend told me that her father was a doctor and he always told her to rub her 14 k gold
ring across it. She said she did and the styes always went away. I tried it. It's still there.
Someone else, who is a physician, told me to heat a sterling silver knife and hold it on the
stye. (What is it with metals??) I tried it. It's still there. I read somewhere to put triple
antibiotic ointment on it. I tried it. It's still there; and not only that, it seems larger than life!
(Jackie Meyers September 9, 2009 ).
A study by Goawalla and Lee compared patient satisfaction, pain level and adverse effects
experienced during extirpation with that of alternate treatments: intralesional triamcinolone
acetonide (TCA) steroid injections and application of hot compresses to the affected area
(Goawalla and Lee 2007). The satisfaction score reported in this study for the extirpation of tarsal
cysts was significantly higher than that for the advice to apply hot compresses to the affected
area. However, the mean satisfaction score for extirpation and TCA injection was only four (on a
scale from 0-10), compared to the group which received advice to apply hot compresses to the
affected area who reported a mean satisfaction of two. Reported pain levels were considerably
higher with extirpation with a mean of 7/10 (range 5.5 - 8) (where 10 is extremely painful)
compared with no pain, 0/10, for hot compress treatment (Goawalla and Lee 2007). Reported pain
levels with TCA injection were similar to extirpation with a mean of six (range 5-7). Extirpation and
TCA injection methods were more successful with 84-87 per cent of chalazions resolved in three
weeks compared with 46 per cent with the conservative treatment. This may explain the lower
satisfaction level with conservative treatment options although the comments of one blogger from
New Zealand, who was unimpressed with the conservative treatment option provided to her, may
also provide some clues:
She gave me approximately the same information that my grandmother might have given
me, if she was still alive. A hot compress fixes almost anything, after all -- or at least does
no harm (Emeline November 16, 2008).
One United States blogger commented on the use of intralesional injection suggesting that it was a
valid option with extirpation as treatment of last resort:
[The doctor] gave me an intralesional steroid injection. In the majority of the cases this will
take care of the problem. However, in some of the cases, if there is too much scare [sic]
tissue, they may need to surgically remove it (Gary January 10, 2008).
Notably the blogger did not find the procedure painful and was very willing to return for similar
treatment.
Page 80
Cost
As described above, a UK based study showed that patients experienced less pain and were more
satisfied when aspects of the procedure were performed by a nurse (Jackson and Beun 2000). This
also reduced the cost of the procedure significantly.
Page 81
3.10
Lacrimal passage services
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA
review
42610, 42611, 42614, 42615
Lacrimal passages ‡
Stakeholder
negotiation**
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
‡ Consumer views and preferences, as discussed in qualitative and blog literature, were also reviewed for these
specific items.
Summary of Findings
Items 42610, 42611, 42614, 42615 - No evidence relating to the safety of lacrimal passage
procedures was reported in the included studies. Lacrimal probing is considered to be a therapeutic
procedure in paediatric patients, whereas lacrimal probing in adults tends to be less invasive and
performed as a diagnostic procedure. The evidence from non-comparative studies reporting on
success rates (usually a combination of surgical and patient relevant outcomes) suggests that high
rates of lacrimal passage patency and reduced epiphora are achievable using probing procedures,
and that younger children may experience better clinical outcomes than older children with congenital
nasolacrimal duct obstruction. No studies concerning probing in adult populations or nasolacrimal
tube removal or replacement were identified, and therefore, an assessment of the safety or
effectiveness of these procedures in adults was not possible.
Qualitative analysis
Understanding of the procedure was high amongst bloggers. Parents were often very anxious prior to
the procedure being carried out on their children. Anxiety could be relieved and the satisfaction of the
parents increased by good preoperative counselling but anxiety about their children undergoing
general anaesthesia may remain. Parents became very distressed if their children were distressed.
This service sub-group consists of four items (42510, 42611, 42614, 42615). Detailed information
regarding each of these items is provided in Appendix D. The first two of these items have
relatively low in frequency, with around 500 services each p.a. since 1998. The main recipients
have been children under four years, with the over-65 age group also undergoing a proportion of
these procedures. In 2009, the total cost for the two items was about $65,000.
In comparison, items 42614 and 42615 have averaged around 10,000 services each p.a., at a more
substantial combined cost of around $1m in 2009. The services have been provided mainly to
those aged over 55 years, and especially to females.
For the 3 financial years 2007-08 to 2009-10, a slightly-higher-than-expected proportion of
services (see Appendix B, Table 83) occurred in metropolitan areas – 79.3 and 79.1 per cent for
items 42510 and 42615, respectively.
Page 82
Hospital data for separations by principal diagnosis, related to lacrimal passages (combined with
disorders of the eyelid and orbit), shows a slight increase over the period of analysis (see Appendix
E, Figure 52).
Background
The lacrimal drainage system commences at the superior and inferior puncta, located at the inner
canthus18 of the eye. Normally tears flow from the punctal openings along superior and inferior
canaliculi into the lacrimal sac, and then drain by way of the nasolacrimal duct to the nasal cavity
where they either evaporate or reabsorb (Kapadia, Freitag et al. 2006; Mills and Meyer 2006).
Obstructions of the nasolacrimal duct, which may be either acquired or congenital, disrupt this
normal drainage system and can lead to excessive tearing, known as epiphora, or dacryocystitis,
an inflammation of the lacrimal sac. Acquired nasolacrimal duct obstruction (NLDO) may also be
further divided into primary and secondary NLDO. The aetiology of primary acquired NLDO,
characterised by varying degrees of inflammation and secondary occlusive fibrosis, is unknown.
Secondary acquired NLDO may be due to a variety of underlying conditions including neoplasms,
infection and inflammation of known cause (Yeatts 2000). Congenital NLDO is frequently caused
by a lack of a patent opening through the Valve of Hasner, a membrane at the lacrimal-nasal
mucosa junction which prevents backflow of nasal material into the lacrimal duct (Figure 4).
Figure 4
Illustrating the position of the nasolacrimal duct
Complete canalisation usually occurs by the sixth month of gestation, but in cases where
incomplete patency extends to or beyond birth and fails to resolve spontaneously, interventions
to establish adequate passage for tears and/or to relieve purulent discharge due to dacryocystitis
may be necessary. Dacryocystocele, which is present in a small proportion of congenital NLDO, is
thought to arise from concurrent proximal and distal obstruction of the lacrimal system, and
presents as a blue or pink coloured mass inferior to the inner canthus due to swelling of the
lacrimal sac. The presence of a dacryocystocele in congenital NLDO does not change the treatment
indications. First line treatments include topical antibiotics and lacrimal sac massage, after which
lacrimal probing and irrigation are usually considered if conservative treatment is unsuccessful
(Figure 5a). Failed probing in turn is often followed by repeat probing combined with silicone
18
The angle formed by the meeting of the upper and lower eyelids.
Page 83
intubation, or alternatively, an infracture of the inferior turbinate or balloon catheter dilation may
be used (Figure 5b) (Cunningham 2006; Kapadia, Freitag et al. 2006).
a
b
Figure 5 a) A small probe is passed through the tear duct system to open up the blockage and b) a
silicone tube may be placed in the tear duct system to hold the duct open
A more invasive surgical procedure, dacryocystorhinostomy (DCR), may be required to create a
bypass fistula between the lacrimal sac and the nose, thus providing an alternative passage for
lacrimal drainage (Cunningham 2006; Kapadia, Freitag et al. 2006). However, only probing and
removal or replacement of silicone tubes are considered within the scope of this mini-HTA.
The probing procedure may be performed in the office in selected patients; however it is usually
performed under general anaesthesia. In instances of uncertain diagnosis, irrigation is performed
prior to probing to confirm obstruction. The procedure begins with dilation of the lower punctum
using a dilator instrument, followed by advancement of a Bowman probe from the punctum,
horizontally through the canaliculi, and into the lacrimal sac. Inferior angling is then used to
advance the probe through the nasolacrimal duct into the nose. A popping sensation may be felt
as the probe passes through the Valve of Hasner into the inferior meatus of the nose. Irrigation
may be repeated to confirm patency has been achieved, or a fluorescein dye disappearance test
(FDDT) may be used. If this initial probing fails, silicone intubation may be considered as the next
treatment option. The reported advantage of this procedure is the prevention of granulation
tissue-related obstruction along the newly patent tract created by the repeat probing procedure.
Intubation, under general anaesthetic, involves a piece of silicone tubing with metal probes
attached at both ends which is cannulated through the upper and lower puncta and advanced into
the nose. Each end is retrieved by a metal hook, the metal probes are snipped off, and the tubing
is tied and allowed to retract into the nasal cavity, or is sutured to the lateral wall of the nose. The
small loop visible between the superior and inferior puncta do not usually cause discomfort.
Removal or replacement of silicone tubes is indicated when complications such as extrusion
through the nose or aspiration occur, or for other complications such as the creation of false
passages, erosion or slitting of the punctum and formation of pyogenic granulomas. Timing of tube
removal after successful intubation is still a matter of controversy, with most investigators
recommending three to six months, while some have found success with tube removal after only
six weeks (Kapadia, Freitag et al. 2006).
Page 84
Clinical opinion observes that lacrimal duct obstruction tends to be congential in children and
acquired in adults. Lacrimal probing is considered to be a therapeutic procedure in paediatric
patients, whereas lacrimal probing in adults tends to be less invasive and performed as a
diagnostic procedure. Lacrimal probing when performed in children is more complex than in adults
and is usually performed under general anaesthetic as the probe must pass from the lower
punctum through to the nose. Adults usually only require probing into the lacrimal sac to identify
the obstruction, and as such this procedure may be performed and billed as part of a general
consultation rather than as a separate procedure.
An evidence-based analysis using a mini-HTA format was undertaken to review these items on
lacrimal passage procedures.
Research question
Are probing techniques to assess lacrimal passage patency or removal of obstructions and/or
removal or replacement of nasolacrimal tube(s) safe and effective procedures? (MBS item numbers
42610, 42611, 42614 or 42615).
Pre-specified criteria for the selection of literature to address this question are provided in Table
28.
Table 28
PICO criteria for lacrimal passage procedures
Characteristic
Inclusion Criteria
Population
1. Adults with epiphora
2. Children with dacryocystocele (Timo cyst)
Interventions
(1) Probing techniques to establish patency of lacrimal passages or remove obstruction
(2) Remove or replace nasoclacrimal tube(s)
Comparator
N/A
Outcome
Safety
Adverse physical health outcomes as a consequence of the procedures.
Effectiveness
Primary – reduction in tear production, quality of life
Secondary - reoperation
Search strategy
A search of the Cochrane library – including the Cochrane database of systematic reviews,
Database of abstracts of reviews of effects (DARE) and the HTA database, the economics database,
EconLit, and Embase.com (consisting of both Embase and Medline) was conducted using the
search terms outlined in Table 29. Lacrimal passage procedures considered eligible for review in
this assessment involve the removal or replacement of nasolacrimal tubes and probing to establish
patency of the nasolacrimal ducts in cases of acquired or congenital obstruction, which may
include lavage (irrigation to assist in clearing of the lacrimal drainage system). A revised search
strategy, representing a protocol amendment, was employed for the purposes of this assessment
because the initial search failed to identify any articles concerned with lacrimal probing. Rather it
was observed that the majority of identified studies dealt with various approaches to
dacryocystorhinostomy (DCR), a surgical procedure that creates a bypass fistula between the
lacrimal sac and the nose, thus providing an alternative passage for lacrimal drainage (Kapadia,
Freitag et al. 2006). The evaluators determined that this resulted from the inclusion of ‘eye
Page 85
surgery’ in the original search terms, accordingly, the term ‘eye surgery’ was replaced with
‘probing’ OR ‘clearing’.
Table 29
Search terms utilised for establishing lacrimal passage patency
Population
'lacrimal apparatus'/exp OR 'nasolacrimal tube' OR 'lacrimal passages' OR 'lacrimal gland disease'/exp
OR dacryocyst* OR 'epiphora' AND
Intervention
'probing'/exp OR 'clearing'
Limits
1. [English language]/lim AND [humans]/lim AND [2005-2011]/py AND [systematic review]/lim
2. [humans]/lim AND [2005-2011]/py AND ([systematic review]/lim OR [controlled clinical trial]/lim OR [meta
analysis]/lim OR [randomized controlled trial]/lim)
3. [article]/lim AND [humans]/lim AND [2005-2011]/py
Availability and level of evidence
When limit 3 of the revised search strategy was applied for the period 2005 to 2010, 105 hits were
identified, of which 13 were relevant articles concerned with the safety and effectiveness of
eligible lacrimal passage procedures. All were concerned with probing procedures for the
treatment of congenital nasolacrimal duct obstruction or dacryocystocele (3 studies19), a condition
reported to occur in 0.1 per cent of congenital NLDO cases (MacEwen and Young 1991). Extending
the search back in time by a 5-year increment did not result in the identification of any literature
concerned with adult epiphora, nor studies of a higher evidence level (i.e. comparative studies)
concerned with probing in the paediatric population. No literature was identified regarding the
removal or replacement of nasolacrimal tubes. Of all the studies identified as relevant for
inclusion, only one was comparative (Cakmak, Yildirim et al. 2010). However, the comparison was
between conventional probing and probing with the aid of nasal endoscopy, and therefore the
patient groups were regarded as two separate case series. The finding by Cakmak and colleagues
that probing of the lacrimal passages with the aid of nasal endoscopy achieved a higher rate of
success in the treatment of congenital NLDO compared to blind probing can be noted, however,
no other studies that confirm or refute this lower level (non-randomised) evidence were found.
Results
The 12 non-comparative studies all reported on success of probing, with some variation in
definitions of success. Commonly included criterion for success involved at least partial resolution
of epiphora and/or discharge following establishment of lacrimal passage patency, usually
confirmed by FDDT. Overall success ranged from 65 to 100 per cent of probed lacrimal passages.
This was often reported as successes per number of eyes, as each eye is associated with its own
lacrimal drainage structure, and clinically significant outcomes such as reduction of epiphora have
a direct impact on the eye. Four studies reported on the proportion of children who underwent
successful probing, which ranged from 80 to 94 per cent (Lee, Fudemberg et al. 2005; Maheshwari
2005; Zilelioglu and Hosal 2007; Cavazza, Laffi et al. 2008). Of the studies that stratified outcomes
19
Given only 3 studies concerned specifically with dacryocystocele were found, and the search results made it clearly
evident that probing techniques are relevant to all congenital NLDO, irrespective of whether or not dacryocystocele is
the underlying cause, the eligibility criteria were expanded to include NLDO due to any cause.
Page 86
by age group, it was noted that successful probing in most instances appeared to be higher among
younger age groups, however, only Maheshwari and co-workers tested for a statistical difference
between age groups. They found no significant differences between a group aged 13 to 24 months
and a group that included only children older than 24 months.
None of the included studies in this assessment reported on safety outcomes, and therefore, no
appraisal of safety issues associated with probing of lacrimal passages could be undertaken.
Study profiles and results are summarised in Table 30. To reflect the original inclusion criteria,
details and results for studies concerned with congenital NLDO due to dacryocystocele appear
first, arranged in descending patient sample size. Profiles and results of studies that are concerned
with congenital NLDO more generally are then presented, also in following patient sample size
from highest to lowest.
Conclusion
No evidence relating to the safety of lacrimal passage procedures was reported in the included
studies. The evidence from non-comparative studies reporting on success rates (usually a
combination of surgical and patient relevant outcomes) suggests that high rates of lacrimal
passage patency and reduced epiphora are achievable using probing procedures, and that younger
children may experience better clinical outcomes than older children with congenital NLDO. The
body of evidence matrix is shown in Box 5. No studies concerning probing in adult populations or
nasolacrimal tube removal or replacement were identified, and therefore, an assessment of the
safety or effectiveness of these procedures was not possible.
Box 5 Body of evidence matrix for establishing lacrimal passage patency
Component
Evidence base
Rating
D
Consistency
C
Clinical impact
C
Generalisability
B
Applicability
B
Description
12 case series and one non-randomised comparative study (this
study compared two probing techniques and patients were therefore
considered as two separate series)
Some inconsistency reflecting genuine uncertainty around clinical
question
Few studies provided statistical analysis data, however the noncomparative data suggest a significant clinical benefit associated
with lacrimal probing for congenital NLDO
Majority of the evidence directly generalisable to the target population
(the generalisability of results from the 5 studies conducted in
developing countries is uncertain)
Evidence from the majority of studies (those in developed countries)
applicable to the Australian health care context with few caveats;
applicability of evidence from studies in developing countries is
questionable
Page 87
Table 30
Study profiles and results for included non-comparative studies for lacrimal passage
procedures
Studies reporting on outcomes of probing techniques to establish patency of lacrimal passages
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Wong and Vander Veen 2008)
N= 42 retrospectively reviewed children with diagnosed
congenital dacryocystocele (46 eyes)
Country: USA
Age: Median 7 days
Sex: 24 female
Inclusion: Children diagnosed with congenital
dacryocystocele between 1997 and 2006 at a children’s
hospital
Follow up: NR
Overall quality assessment: Case series - NA
Intervention: In-office
or operating room
probing of
nasolacrimal system
Comparator: NA;
some children
received
combinations of
massage and
topical/systemic
antibiotics instead of
or in addition to
probing, but no direct
comparisons were
possible from the
data due to
unquantified overlap
of treatments
Effectiveness: Resolution
of dacryocystocele
Safety: NR
Results
Resolution of dacryocystocele (success) with probing
n eyes (%)
Success, n eyes (%)
In-office probing 17/46 (37)
13/17 (76.5)
Operating room
probing
23/46 (50)
15/23 (65.2)
Note: 36/46 (78.2%) of eyes were treated with probing and overlap exists between in-office and operating room
probing, presumably due to failure among initial in-office probing which was not reported; it is apparent that
children who did not undergo any probing received combination treatments (massage and/or topical/systemic
antibiotics) and some children received these treatments in addition to probing (data insufficient to quantify
treatment overlap).
(Becker 2006)
N= 27 children with 29 congenital dacryocystoceles
Country: USA
Age: Children who developed infection (dacryocystitis),
mean 5.9 days; children who did-not develop infection,
mean 17.3 days
Sex: 17 female
Inclusion: Children presenting with congenital
dacryocystocele at an ophthalmology practice between
1987 and 2006
Follow up: NR
Overall quality assessment: Case series - NA
Intervention: Probing
(office/operating
room) was performed
in 26 (89.7%) lacrimal
systems; Bowman
probe size 00
Comparator: NA;
multiple treatments
were assessed but no
direct comparisons
were made
Effectiveness: Patency as
confirmed by recovery of
fluorescein solution from
the nose
Safety: NR
Results
Success of probing among children with/without infection and overall, n lacrimal systems (%)
Infection
No infection
Overall
7/7 (100)
10/19 (53%)
17/26 (65%)
Page 88
Studies reporting on outcomes of probing techniques to establish patency of lacrimal passages
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Cavazza, Laffi et al. 2008)
N= 5 children with unilateral congenital dacryocystocele
Country: Italy
Age: Mean 29 days
Sex: 4 female
Inclusion: Children diagnosed with congenital
dacryocystocele at a hospital between January 2003 and
October 2006
Follow up: Mean 18.2 months
Overall quality assessment: Case series - NA
Intervention:
Nasolacrimal probing
was performed in 4
patients who failed
conservative
treatment (massage
and antibiotics);
Bowman probe size
00
Comparator: NA
Effectiveness: Probing
success (no definition
provided)
Safety: NR
Intervention: Probing
followed by saline
syringe irrigation of
lacrimal passages;
Bowman probe size
000
Comparator: NA
Effectiveness: Success of
probing and syringing
defined as relief of
symptoms and signs
Safety: NR
Results
Overall success of probing
n children (%) 4/5 (80)
(Shrestha, Bajimaya et al. 2009)
N= 106 children (117 eyes) with congenital NLDO
Country: Nepal
Age: Mean 7.7 months
Sex: 40% female
Inclusion: Children aged ≤18 months with congenital NLDO
attending at a paediatric ophthalmology clinic (diagnosis
based on history of watering eye with discharge and
regurgitation of fluid from punctum upon pressure to the
area over the lacrimal sac); children aged >18 months or
with history of birth trauma or congenital adnexal
anomalies were excluded
Follow up: 2-4 weeks
Overall quality assessment: Case series - NA
Results
Success of probing and syringing, by age group
≤6 months
7-12 months
Children, n
40
35
Eyes, n
45
41
Success,
1st attempt, n eyes(%)
43 (95.6)
38 (97.2)
Success,
2nd attempt, n eyes (%) 2 (100)
2 (66.7)
Overall
success, n eyes (%)
45 (100)
40 (97)
(Lee, Fudemberg et al. 2005)
N= 98 children with 138 cases of NLDO
Country: USA
Age: Mean 12.4 months
Sex: 53 female
Inclusion: All children who underwent probing and irrigation
for NLDO at a university eye institute between 2001 and
2002
Follow up: Mean 9.2 months
Overall quality assessment: Case series - NA
13-18 months
31
31
p, between groups
27 (87.1)
0.39
2 (50)
0.47
29 (93.5)
0.21
0.59
Intervention: Probing
and irrigation of
lacrimal passages
Comparator: NA
Page 89
Effectiveness: Relief of
symptoms as indicated by
parent/guardian response
to a standard
questionnaire; failure was
defined as persistence of
symptoms and/or
requirement for further
procedures
Safety: NR
Studies reporting on outcomes of probing techniques to establish patency of lacrimal passages
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
Intervention: Probing
of nasolacrimal
passages; Bowman
probe size 00
Comparator: NA
Effectiveness: Successful
probing defined as
complete resolution of
symptoms and signs
Safety: NR
Results
Probing and irrigation success
n obstructions (%)
119/138 (86.2)
n children (%)
84/98 (85.7)
(Maheshwari 2005)
N= 84 children with diagnosed congenital NLDO (based on
history of tearing and/or discharge and reflux of lacrimal
sac contents upon pressure)
Country: India
Age: Group 1 mean 19.5 months, Group 2 mean 45.7
months; Group 1 (13-24 months) were compared with
Group 2 (>24) months to assess the influence of age on
success of probing
Sex:24 female
Inclusion: Children presenting with congenital NLDO
between January 1999 and February 2003
Follow up: 3 months
Overall quality assessment: Case series - NA
Results
Probing success
Group 1, n children(%)
37/42 (88)
Group 2, n children(%)
34/42 (81)
p
0.66
(Wallace, Cox et al. 2006)
N= 67 consecutive children (87 eyes = 87 lacrimal
systems) with congenital NLDO (based on history of
epiphora and abnormal FDDT)
Country: UK
Age: Median 32.3 months
Sex: NR
Inclusion: Children undergoing probing for congenital
NLDO between 1996 and 2003; children with previous
probing and those with epiphora not due to NLDO were
excluded
Follow up: 9 months
Overall quality assessment: Case series - NA
Intervention:
Endoscopic-assisted
probing of lacrimal
passages
Comparator: NA
Page 90
Effectiveness: Successful
probing defined as
resolution of epiphora
and/or re-establishment of
lacrimal passage patency
Safety: NR
Studies reporting on outcomes of probing techniques to establish patency of lacrimal passages
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
Intervention: Probing
of lacrimal passages
Comparator: NA
Conventional probing
was compared to
probing with the
assistance of
intranasal endoscopy,
but patients were
considered as two
separate case series
for the purpose of this
report given both
underwent probing
which was not
compared with any
other method
(surgical/nonsurgical) for clearing
lacrimal passages
Effectiveness: Successful
probing defined as
complete absence of eye
watering/stickiness with a
normal FDDT
Safety: NR
Results
Success rate of probing
Success rate, n eyes (%)
Age, months
12-23
28/29 (96.4)
24-35
25/28 (89.3)
36-47
14/16 (87.5)
48-59
4/7 (57.1)
60+
6/7 (85.7)
Site/cause of obstruction
Physiological 5/9 (55.6)
Punctal
13/13 (100)
Canalicular
0/4 (0)
Upper NLD
0/3 (0)
Lower NLD
58/58 (100)
Overall
77/87 (88.5)
(Cakmak, Yildirim et al. 2010)
N= 51 children (73 eyes) with congenital NLDO (based on
history of epiphora, with/without discharge from birth and
reduced lacrimal outflow as evidenced by abnormal FDDT)
Country: Turkey
Age: Group 1 (probing alone) mean 26.6 months, Group 1
(probing with endoscopy) mean 33.9 months
Sex: Group 1, 13 female; Group 2, 15 female
Inclusion: Children undergoing probing for congenital
NLDO in a Turkish hospital between June 2007 and April
2009; children who had undergone previous probing were
excluded
Follow up: Mean 6 months
Overall quality assessment: Case series - NA
Results
Probing success
Group 1, n eyes (%)
32/37 (86.5)
Group 2, n eyes (%)
34/36 (94.4)
Page 91
Studies reporting on outcomes of probing techniques to establish patency of lacrimal passages
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Thongthong, Singha et al. 2009)
N= 44 children(59 eyes) with congenital NLDO
Country: Thailand
Age: Mean 2.5 years
Sex: 25 female
Inclusion: All children aged <10 years who underwent
probing and irrigation for congenital NLDO at a Thai
hospital between 1997 and 2007 were reviewed; children
with lid malposition or abnormalities, punctal or canalicular
anomalies, previous lacrimal drainage system surgery
except probing, or history of trauma to the nasolacrimal
system were excluded
Follow up: ≥1 month
Overall quality assessment: Case series - NA
Intervention: Probing
and irrigation of
lacrimal passages
Comparator: NA
Effectiveness: Successful
probing as defined by
absence of tearing and eye
discharge in the affected
eye ≥1 month after
treatment
Safety: Complications
Results
Probing success
Success rate, n eyes (%) 95% CI
Age, years*
<1
8/10 (80)
NR
1-2
18/21 (86)
NR
2-3
12/16 (75)
NR
3-10
9/12 (75)
NR
Overall
47/59 (80)
[67,89]
*NB – age was not stratified by mutually exclusive groups and results are presented here as reported; it is
therefore uncertain where cut-offs between age groups were made
Complications:
No complications due to probing were reported.
(Kouri, Tsakanikos et al. 2008)
N= 40 children (52 eyes) with diagnosed congenital NLDO
(based on history of epiphora/discharge within the first few
weeks of life and abnormal FDDT)
Country: Greece
Age: Mean 32 months
Sex: 28 female
Inclusion: Children undergoing probing and nasal
endoscopy in a Greek hospital between 2005 and 2007;
children with craniofacial anomalies or nasal trauma were
excluded
Follow up: ≥6 months
Overall quality assessment: Case series - NA
Results
Probing success, n eyes (%)
Improved symptoms
Complete resolution of symptoms
Unchanged symptoms
Overall success
Intervention: Probing
of lacrimal passages
with concurrent nasal
endoscopy; Bowman
probe size 00 or 0
Comparator: NA
6/52 (11.4)
38/52 (73.1)
8/52 (15.4)
44/52 (84.6)
Page 92
Effectiveness: Success
defined as complete
resolution of epiphora,
confirmed by normal
FDDT, or near complete
resolution with
improvement of signs and
minimal symptoms in
association with respiratory
tract infection/exposure to
wind or cold
Safety: NR
Studies reporting on outcomes of probing techniques to establish patency of lacrimal passages
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Zilelioglu and Hosal 2007)
N= 38 children (50 eyes) with congenital NLDO
Country: Turkey
Age: Mean 33 months
Sex: 14 females
Inclusion: Children aged >1 year undergoing probing for
congenital NLDO
Follow up: Mean 8 months
Overall quality assessment: Case series - NA
Intervention: Probing
of lacrimal passages;
Bowman probe size
000 to 0
Comparator: NA
Effectiveness: Successful
probing defined as
complete resolution of
symptoms and signs
Safety: NR
Intervention: Probing
of lacrimal passages;
Bowman probe size
000 to 0
Comparator: NA
Effectiveness: Functional
success of probing defined
as restoration of lacrimal
drainage system patency
with no sign of epiphora
Safety: NR
Results
Probing success
n eyes (%)
44/50 (88)
n patients (%)
34/38 (89.5)
(Steindler, Mantovani et al. 2009)
N= 23 children (39 eyes) with persistent congenital NLDO
(based on history of epiphora, with/without discharge and
reduced lacrimal outflow as evidenced by FDDT
Country: Italy
Age: 23.6 months
Sex: 12 female
Inclusion: Children undergoing uneventful probing for
uncomplicated congenital NLDO
Follow up: 3 months
Overall quality assessment: Case series - NA
Results
Functional probing success, n eyes (%)
29/39 (85.3)
(Pediatric Eye Disease Investigator Group 2009)
N= 20 children with persistent NLDO (based on at least
one of the following symptoms prior to 6 months of age –
epiphora, increased tear lake, mucopurulent discharge in
the absence of upper respiratory infection or ocular surface
irritation)
Country: USA
Age: Mean 16 months
Sex:10 female
Inclusion: Children aged between 6 and 48 months
undergoing repeat probing for persistent NLDO following
failed initial probing; children with history of nasolacrimal
intubation, balloon catheter dilation, more than one
previous probing or dacryocystorhinostomy or Down’s
syndrome were excluded
Follow up: 6 months
Overall quality assessment: Case series - NA
Intervention: Probing
of lacrimal passages;
probe size at
investigator discretion
Comparator: NA
Page 93
Effectiveness: Successful
probing defined as the
absence of epiphora,
increased tear lake and
mucous discharge
Safety: NR
Studies reporting on outcomes of probing techniques to establish patency of lacrimal passages
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
Results
n eyes with successful
probing (% [95% CI])
n patients, total (%)
1 month follow-up
6 month follow-up
11/22 (53 [31, 73])
19 (95)
11/21 (56 [33,76])
18 (90)
NLDO = nasolacrimal duct obstruction, NR = not reported, NA = not applicable, FDDT = fluorescein dye disappearance test
Qualitative analysis
A consumer preferences analysis was undertaken regarding probing techniques to establish
patency of lacrimal passages.
Research question
What is the patient experience of and perspective on the ophthalmology service described by MBS
Items 42610, 42611, 42614 or 42615?
Search strategy
A qualitative literature search was undertaken using the Scopus and Embase databases. Articles in
English were sourced from developed nations20 using the search terms described in Table 31.
Table 31
Search terms used for identifying relevant literature in journal databases for lacrimal
passage procedures
Disease/disorder description
(‘lacrimal duct obstruction’[MeSH] OR ((“lacrimal duct” OR “lacrimal passage” OR “nasolacrimal duct” OR
canaliculi) AND (obstruction OR blockage)) OR dacryocystitis OR epiphora OR dacryocystocele OR
“Timo cyst”
‘Umbrella’ terms describing the activity
Probe OR patency OR “tube (remov* OR replace*)” OR surgery OR dacryocystorhinostomy OR
Conjunctivocystorhinostomy OR cystorhinostomy
What are we trying to canvass
“patient satisfaction” [MeSH]; attitude to health [MeSH]; patient compliance [MeSH]; public opinion
[MeSH]; health knowledge, attitudes, practice [MeSH]; patient acceptance of health care [MeSH]
Methods that might be employed in canvassing views
“qualitative research” [MeSH]; “focus Groups” [MeSH]; “focus groups”[TW]; interviews[TW]
Papers were selected on the basis that they included the patient perspective of the experience of
lacrimal passage removal, replacement or probing (including the period before and after the
procedure and any side effects which the patient associated with it). Inclusion and exclusion
criteria have been described previously. Studies deemed relevant based on the title were
identified (n=80) and combined into one EndNote X3 database. The abstracts of these studies
were then read, and 21 studies were excluded based on our original inclusion/ exclusion criteria.
20
A developed country was defined to be; European Community, Canada, U.S, Norway, New Zealand, Australia,
Singapore, Switzerland, Hong Kong and Japan
Page 94
Selected articles (n=27) were subjected to full text reading. With reading full text, all were
excluded because they related to a more complex procedure dacryocystorhinostomy or to lateral
canthal surgery or because they described outcomes rather than patient perspectives. No relevant
peer reviewed literature was found.
General methods and inclusion and exclusion criteria for blog searches have been described
previously. Postings were selected on the basis that they presented the personal views and
perspectives of people who had experienced lacrimal passage surgery as described above. In
search 1, 2, 4 and 5 after searching numbers of blogs shown (Table 32), weblogs identified were
repeats of earlier findings. Searches were therefore discontinued in each case at this point. From
twenty three relevant blogs identified, fourteen weblogs from thirteen bloggers provided
sufficient information for inclusion in this review.
Table 32
Weblog search terms for lacrimal passage procedures
Number
Domain
Search term
Results
Viewed
1
blogspot.com
368
First 200
2
blogspot.com
(Lacrimal duct OR lacrimal passage OR tear duct
OR nasolacrimal duct) AND (dacryocystitis OR
epiphora OR dacryocystocele OR Timo cyst OR
obstruction OR blockage)
Lacrimal duct obstruction AND surgery
2,090
First 150
3
blogspot.com
blocked tear duct AND (surgery or procedure)
87
All
4
blogspot.com
tear duct prob*
13,600
First 100
5
None
blocked tear duct AND (surgery or procedure) and
blogs
58,300
First 50
Results
The large majority of relevant weblogs were written by parents, reporting their experience with
their children (usually under the age of two and often with Down syndrome) receiving treatment
for lacrimal passage obstructions. Causes and treatment of lacrimal passage obstruction in
children is different to that of adults, with the obstruction in children usually congenital and fixed
with the implantation of a stent. This reflects the demographic for items 42510 and 42611 with
approximately 500 services p.a. primarily provided to children under the age of four. In contrast,
we did not find blogs describing the experience of the other population group who primarily
receive items 42614 and 42615, women aged 55 and over. This may be attributed, in part, to age
bias in the blogging population.
Preoperative experience
Patient knowledge and understanding
Descriptions of the techniques posted in the weblogs demonstrate a good level of understanding
of the procedure by the patients or patients’ parents. One blogger from the United States
described probing as an ‘old school’ treatment:
Page 95
This procedure was done fairly "old school," in that it was a small wire that was inserted
down the inside corner of his eyes, clearing whatever blockage was there and opening up
some soft muscle tissue between his tear ducts and his nasal canal (Kireta July 9, 2010 ).
Some bloggers described the insertion of a stent as follows:
To fix it, they probe into my tear duct and insert a tube, which they leave for a while. The
tissue reforms around the tube, clearing the blockage, and then they remove the tube later
(Lisa Mosely 2010 June 19)(USA).
This surgery involved placing and leaving a tube through the duct in hopes of stretching it
out (Terri-Anne March 5, 2008 ) (Canada).
He had one surgery in April but his ducts were too small for the tubes so the procedure
didn't fully fix the problem. We were referred to the next specialist for a more invasive
procedure. This time they probed, irrigated and then ballooned out the ducts. He was then
to have tubes placed in both duct (Wally and Leah Hansen 2010) (USA).
So, Friday, December 3rd, Carleigh is scheduled for a Balloon Catheter Dilation, where they
open her tear drainage passages that are blocked by scar tissue and insert a deflated
baloon via a needle and inflate it to open up the duct. She has to go under general
anesthesia again! (Jessica Tondre October 29, 2010) (USA).
Most bloggers do not describe their source of information although one American blogger
reported relying on information that she gauged from a brochure:
It's kinda beside your nose. At least, that's the impression I got from the picture that came
in the brochure for the oculoplastic surgeon that I have to go see (Kerry August 28, 2007 ).
Fear and anxiety
Anxiety before the procedure was a common theme in weblogs particularly those written by
parents of children undergoing the procedure but was not explored in the literature. One
American mother describes her reaction to her ophthalmologist’s recommendation for a probing
operation:
I'm scared. Like terrified. Gianna has blocked tear ducts. She's had this problem since she
was 2 weeks old (Mrs Foreste February 10, 2010 ).
Several other mothers who comment in response to this blog also describe having been very
fearful before the procedure. Such anxiety might be considered to be a normal response as
another response to the blog notes:
Page 96
My god-daughter had this done and although we were more scared then she was (I think
any parent would have some cautiousness)” Mel in (Mrs Foreste February 10, 2010 ) (USA).
Consistent with other ophthalmology procedures included in this review, a determinant of
satisfaction was the level of explanation provided preoperatively and the care provided by health
professionals, for example one mother from the United States described:
The surgeon and the anesthesiologist were very thorough and made me feel very
comfortable. They were amazing. So, Addison was wonderful and everything went
according to plan (Kireta July 9, 2010 ).
Whereas another American mother reports her anxiety and lack of understanding from the
paediatrician:
My pediatrician seems to think this is no big deal, but I am sick to my stomach over it
(Anonymous February 10, 2010).
The least concerned parents were those whose children had other serious co-morbidities such as
heart abnormalities. For example, one blogger suggested:
All of this sounds a bit scary, and it was, but compared with open-heart, this was a walk in
the park (Kireta July 9, 2010 ) (USA).
Similarly, another mother of a two year old with a congenital heart defect noted her relief at only
having to deal with the blocked lacrimal duct procedure:
I can't believe these are the only things we're dealing with though! It's fabulous. :)
(MonkeyMama August 6, 2009) (USA).
Pain and distress
No papers were sourced which described patient experience of lacrimal duct probing removal or
replacement except for those describing the more invasive procedure, dacryocystorhinostomy.
However, one blogging mother from the United States notes the distress of her child undergoing
probing of the tear duct by the ophthalmologist:
THAT was pure torture. They swaddled Jillien's arms and held her down while trying to poke
a small probe into the tear duct. She was a screaming mess and I don't think I've ever felt so
helpless. I clenched Stephen's hand so tight and cried a river. The worst part was that the
procedure wasn't successful (JillyBeansMommy 2010 November 9).
Post-operative experience
Pain and distress
Although it is difficult to gauge the experience of children too young to communicate, Jo from
Australia, the mother of a two year old girl with Down Syndrome who underwent the procedure,
notes her daughter’s distress straight after the procedure:
Page 97
She was far from thrilled when she woke up after her operation. She was awake 5 minutes
after it was over, and its usually 15 minutes. She howled for the 10 minutes that she should
have still been under - really disorientated from what she was feeling. Although they were
convinced she wasn't in pain, they gave her a big dose of panadol, and that allowed her to
relax (Jo 2008 February 6).
Similarly, Colin’s mother from Canada reports her son being very distressed after the procedure:
the nurse came to get me to be there when Colin awakes. "They can be a little unsure when
they wake up," she said. 'A little unsure' was a complete understatement! I got halfway
down the hall and I could hear him screaming the hospital down! When I entered the
recovery room a nurse was trying to hold him in her arms has he wiggled and squirmed and
screamed. ... I spent the next 15 minutes trying in vain to get him to settle (Terri-Anne
March 5, 2008 )
In contrast, one mother from the United States notes her distress at seeing her daughter ‘groggy
and affected by anaesthesia after the procedure:
She eventually heard my voice and stirred. That was probably the worst part for me... she
was groggy and floppy and loopy and every other word that would indicate she was just
'out of it (JillyBeansMommy 2010 November 9).
Another mother from the United States reports her infant to be comfortable and quiet straight
after the procedure:
The procedure was very quick. I soon saw the assistant and she waved me to come back.
We got back into the room and I just held Levi. He put his head on my shoulder and just
rested. On our way home he fell asleep (Kimberly 2010 April 27).
Anaesthesia
The peer-reviewed literature on ophthalmologic procedures frequently focuses on anaesthesia,
particularly comparison between the general anaesthesia and local or topical anaesthesia.
Replacement or probing of the lacrimal passage is most commonly performed under general
anaesthesia. This comes with its own risks and complications and often can negatively affect the
patient and their perspectives on the procedure. In several of the blogs written by mothers of
children undergoing a procedure to treat lacrimal passage obstruction, general anaesthesia was
noted as one of the reasons why they were particularly concerned about the procedure:
We took her to the ophthalmologist last week & he highly recommended getting this
surgical probe thing done. It's only a 5-10 minute procedure & is very simple, but she has to
go under anesthesia, which scares the poop out of me (Mrs Foreste February 10, 2010 )
(USA).
Page 98
..we'll be going to see a pediatric eye specialist to talk about surgically opening her clogged
tear duct. I'm pretty sure it's a procedure they do under anesthesia, and I'm not crazy about
that (Kayris November 29, 2007) (USA).
Usually they can wait until a year to see if it will fully clear up on it's own but the down side
to that is that if it doesn't by then they would have to use general anesthesia to put Levi
under to do the procedure. Mark and I really didn't want them to have to put Levi under so
we decided to have the procedure done today in the office (Kimberly 2010 April 27) (USA).
Post-operative experience
Patient satisfaction
Parents who had a child undergo lacrimal duct surgery were relatively unconcerned about postoperative bruising and more about other aspects of the procedure such as pain and discomfort
and use of anaesthesia. For example, one Canadian mother reports her son’s relatively problem
free recovery:
Colin's eyes and cheeks were a little puffy, and there was a few tiny drops of blood, but
other than that he recovered completely within that hour following the surgery (Terri-Anne
March 5, 2008 ).
This sentiment is mirrored by one United States blogger who recommended the DCR procedure
based on her perspective of the utility of the procedure:
The short procedure will outweigh what she goes through on a more lengthy basis during
the day, day in and day out, dealing with the goop and the watery eyes. She recovered so
quickly and never even knew what happened! Mel in (Mrs Foreste February 10, 2010 ).
In the only blog which mentions long term outcomes, one mother from the United States notes
her son presents with some redness and teariness in the eye which has the tear duct stent in it, a
couple of months on:
… & his teary, red eye- the same one he has the tear duct stent in (MonkeyMama March 28,
2009).
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3.11
Cataract surgery services
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA
review
42698, 42701, 42702,
42703*, 42704*, 42707*,
42710*, 42713*, 42716
Cataract surgery (*) ‡
Stakeholder
negotiation**
Guideline
concordance
x
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
‡ Consumer views and preferences, as discussed in qualitative and blog literature, were also reviewed for these
specific items.
Summary of Findings
Items 42698, 42701, 42702, 42716 – Item numbers 42698 and 42701 are no longer being used and
have been replaced by claims made for item 42702 (combining claims for extraction and insertion of
lens). Item 42702 is heavily used, the second highest in frequency of all 61 items and approximately
half the total cost of all items analysed. Changes made to item 42702 have impacted on the projected
cost being lower than originally anticipated, although service use has not changed. Hospital
separations are also showing a steady increase in cataract surgery, as expected with an ageing
population, although there is an increasing trend to have the surgery undertaken as a day stay and
primarily in private hospitals.
Items 42702*, 42703*, 42704*, 42707*, 42710*, 42713* - Stakeholder negotiation was undertaken
regarding amendments to wording of the descriptors for these items. The RANZCO suggested
rewording to replace ‘artificial lens’ with ‘intraocular lens’ in the descriptors of 42702, 42703, 42704,
42707 and 4710. This was agreed by the Department. Changes to 42713 were also mutually agreed
to better describe iris suturing for fixation of an intraocular lens.
The current MBS item descriptors allow for separate operations for cataract removal and intraocular
lens insertion to take place. While this is not specifically at odds with guideline recommendations, low
level evidence emphasises that timely treatment may reduce risks due to visual impairment and
separate operations will necessarily lengthen the period of poor visual acuity. There is no specific
evidence to support the deletion of single operation item numbers; however single operations should
be performed only when lens removal and IOL implantation are contraindicated at the same operation
(such as in proliferative diabetic retinopathy or recurrent uveitis). The evidence on MBS item claims
suggests that single operations are not currently being performed.
Several MBS item numbers describe the insertion of an artificial lens into the posterior chamber and
sutured to the iris or sclera. Evidence supports this approach in the absence of capsular support.
Evidence also supports the use of anterior chamber intra-ocular lens (IOL) insertion; however, this is
not clearly stated in the MBS item descriptors. Clarification of the lens insertion technique may be
warranted for all MBS item numbers describing IOL insertion to include, not only anterior chamber IOL
insertion (for 42703 and 42710), but to explicitly specify the IOL placement relevant to 42701, 42702,
42704 and 42707.
No evidence for the use of needling in juvenile cataracts (42716) or the use of a McCannell suture
technique (42713) was found in the Guidelines, thus no comment can be made regarding the
appropriateness of the relevant MBS item descriptors.
Page 100
Summary of Findings (cont)
Qualitative analysis
Patients were anxious prior to cataract surgery with one study reporting very high levels of anxiety in
one-third of patients. Bloggers reasons included: fear of complications, fear of being aware during
surgery and waiting time.
The expectations of patients with respect to the experience of surgery and the outcomes from the
cataract surgery may differ from the actual experience and outcomes and this discrepancy may have
a much greater effect on patient satisfaction than any other factor.
Good pre-operative counselling about the surgical experience and expected outcomes, by a health
care worker with time to engage fully with the patient, alleviates fear, improves patient compliance
during the operation, improves patient satisfaction and may reduce complications post-operatively.
Visual sensations during cataract surgery may be frightening to patients if they are inadequately
prepared for this.
There is conflicting evidence about the effect of anaesthesia choice during cataract surgery on pain
experienced and patient satisfaction. Choice of anaesthesia affects visual sensations during surgery.
Public opinion about changes to public funding for cataract surgery is mixed but there is some anger
about perceived overcharging for the service by ophthalmologists.
Of the specific cataract surgery items, item numbers 42698 and 42701 dropped away completely
in 1997, following the introduction of item 42702, which combined the claims for extraction and
insertion of lens (see Appendix D). This item has seen a consistent increase since that time, such
that it ranks 2nd in frequency of services and first in total cost of benefits amongst all 61 items
reviewed ($88m in 2009 alone, which was almost 50 per cent of the total cost of all items
analysed). A Medicare claim for item 42740 (intra-vitreal injection) has been associated with item
42702 in a small percentage of cases (see Appendix D, Table 145). The remaining items in this subgroup (42703, 42704, 42707, 42710, 42713, 42716) have much lower frequencies of service, and
hence cost – although 42710 increased sharply in January to June 2010.
The cost for item 42702 for the first 6 months of 2010 is actually 26 per cent lower than it would
have been, compared to the data for 2009, representing a cost difference of over $11m. This
appears to be a result of changes made to the item between October 2009 and February 2010,
when the item was withdrawn, then re-instated with a reduced rate, followed by an increase again
in the rate until it represented a 12 per cent cut from the rebate which existed prior to October
2009. On a monthly basis, the total number of services remained similar to those seen for the
corresponding months in the previous year. Given that there had been an 8 per cent increase in
2008 and 10 per cent increase in 2009, the stable figures from 2009 to 2010 represent a drop from
what would perhaps otherwise have occurred. Coupled with this was the fact that the lower
rebates were applicable for a 3-month period, which primarily led to the decrease in overall cost
for item 42702.
The hospital data are consistent with the increase in cataract surgery noted above. The graph of
hospital separations by principal diagnosis (see
Page 101
Appendix E, Figure 53) confirms the steady increase in separations related to lens disorders, while
the data shown in the graph of separations by AR-DRG (eye, surgical, lens procedures – see
Page 102
Appendix E, Figure 51) reflects the trend towards same-day procedures. Additional hospital data
show that about 30% of this surgery is performed in public hospitals and 70% in private hospitals,
with some variations between states.
For each of items 42698, 42701, 42702, 42707, 42703, 42710, 42704, 42713 and 42716, a
concordance exercise was undertaken between the item descriptor and best practice as
recommended by good quality evidence-based clinical practice guidelines.
One guideline of good quality (COG cataract 2008) reported on the use of lensectomy and intraocular lens implantation in patients with glaucoma. Low level evidence supports the use of
cataract surgery for the correction of visual impairment due to lens opacity which is not amenable
to non-surgical measures. COG 2009 reported low level evidence for ensuring cataract surgery is
promptly undertaken (within 4 to 6 months of diagnostic consultation) in order to correct visual
impairment and to minimise the risks of falls, fractures, and motor vehicle accidents.
Based on expert opinion, it was also recommended that a posterior chamber IOL (PCIOL) should be
placed within the capsular bag, or placed in the cilliary sulcus in the event of inadequate capsular
support posteriorly. Moderate level evidence supports the use of anterior chamber IOL (ACIOL),
iris-fixated or sclera-fixated PCIOL when there is no capsular support.
COG 2008 reported high level evidence supporting the use of small-incision phacoemulsification as
a method of cataract extraction over the extracapsular cataract extraction (ECCE) due to better
visual outcomes and reduced surgical complications. However, a recommendation based on
consensus suggested that ECCE may have a role in removing extremely advanced cataracts or hard
lenses.
Concordance conclusions
Current MBS item descriptors allow for separate operations for cataract removal and intraocular
lens insertion to take place. While this is not specifically at odds with guideline recommendations,
low level evidence emphasises that timely treatment may reduce risks due to visual impairment
and separate operations will necessarily lengthen the period of poor visual acuity. There is no
specific evidence to support the deletion of single operation item numbers; however single
operations should be performed only when lens removal and IOL implantation are contraindicated
at the same operation (such as in proliferative diabetic retinopathy or recurrent uveitis).
MBS item descriptors allow for separate billing for crystalline lens extraction (42698 and 42702)
and artificial lens extraction (42704, 42707 and 42710). If no distinction is required, several of
these MBS item numbers would be redundant and a coalescing of numbers may simplify billing.
Several MBS item numbers describe the insertion of an artificial lens into the posterior chamber
and sutured to the iris or sclera. Evidence supports this approach in the absence of capsular
support. Evidence also supports the use of anterior chamber intra-ocular lens insertion; however,
this is not clearly supported by the MBS item descriptors. Clarification of the lens insertion
technique may be warranted for all MBS item numbers describing IOL insertion to include, not
only anterior chamber IOL insertion (for 42703 and 42710), but to explicitly specify the IOL
placement relevant to 42701, 42702, 42704 and 42707.
Page 103
No evidence for the use of needling in juvenile cataracts could be found in the guidelines;
however, a standard ophthalmology text book reports that the practice is almost obsolete21. No
evidence was found to guide the treatment of cataracts in juveniles. Similarly the data analysis
that was undertaken indicated it is an uncommon procedure, of approximately 50 procedures per
year. Given the lack of available information, conclusions regarding the appropriateness of MBS
item descriptor for 42716 cannot be made.
No evidence regarding the use of a McCannell suture technique (item number 42713) was
reported in the guidelines. This technique appears to be used for fixing subluxated intraocular
lenses and for fixing lenses with inadequate capsular support. Comment regarding the adequacy
of the MBS item descriptor cannot be made.
Qualitative analysis
A consumer preferences analysis was undertaken regarding cataract surgery.
Research question
What is the patient experience of and perspective on the ophthalmology service described by MBS
Item 42702?
Search strategy
A qualitative literature search was undertaken using the Scopus and Embase databases. Articles in
English were sourced from developed nations (previously defined) using the search terms
described in Table 33.
Table 33
Search terms used for identifying relevant literature in journal databases for cataract
surgery
Disease/disorder description:
Cataract* OR opacification of lens OR cloudy lens OR loss of lens transparency
Who are the interested parties?
Patients [TW] OR patients [Mesh]
‘Umbrella’ terms describing the activity
cataract surgery OR phacoemulsification OR extracapsular cataract extraction OR intracapsular
cataract extraction OR cataract extraction
What are we trying to canvass
“patient satisfaction” [MeSH]; attitude to health [MeSH]; patient compliance [MeSH]; public opinion
[MeSH]; health knowledge, attitudes, practice [MeSH]; patient acceptance of health care [MeSH]
Methods that might be employed in canvassing views
“qualitative research” [MeSH]; “focus Groups” [MeSH]; “focus groups”[TW]; interviews[TW]
Papers were selected on the basis that they included the patient perspective of the experience of
cataract surgery (including the period before and after cataract surgery and any side effects which
the patient associated with the cataract surgery). They were excluded on the basis that they were
written in a language other than English, written by a commercial entity, and not from a
21
A.K Khurana (2007), ‘Comprehensive ophthalmology’, 4th Edition, New Age International Publishers. New Delhi: pg
174, 193.
Page 104
developed country22. Studies deemed be relevant based on the title were identified (n=162) and
combined into one EndNote X3 database. The abstracts of these studies were then read, and 30
studies excluded based on inclusion/ exclusion criteria. Selected articles (n=132) were subjected to
full text reading and 71 excluded. The reference list of relevant reviews sourced from the database
were scrutinised and 1 additional relevant article was found. The key findings of the final 62
publications were tabulated and analysed for the purpose of the following report. Forty seven
publications provided relevant information included in this review.
Blogs from developed countries which described the experience of cataract surgery were
identified through a Google advanced domain search of blogspot.com. A general search was also
conducted using Google (basic search) to capture other relevant weblogs that were published in
other domains (Table 34). Searches were restricted to English Language and the period January
2000 to August 2010. Postings were selected on the basis that they presented the personal views
and perspectives of people who had experienced cataract surgery as described above. Commercial
blogs were excluded. All relevant material was imported into NVivo for thematic coding and
analysis.
Table 34
Weblogs search terms for cataract surgery
Number
Domain
Search
Number of
results
Viewed
1
blogspot.com
‘cataract surgery’
13, 200
First 500
Relevant
sites
/bloggers
32/16
2
No domain used
‘Cataracts and
blogs’
18,700
First 200
3/2
In search 1, after searching the first 500 it became apparent that all of the weblogs identified were
repeats of earlier findings. This was also the case in the second search after the first 200.
Therefore the search was discontinued at this point.
Some bloggers simply recorded that they had undergone or were expecting to undergo cataract
surgery. In total, 16 blogs from 12 bloggers provided sufficient detail for inclusion in this review.
In 2009, proposed reductions in the Medicare rebate for cataract surgery gained considerable
media attention and associated comment in discussion forums. We accessed these forums in the
hope that patient perspectives could be gauged from this source. However, it was too difficult to
ascertain which comments were posted by patients, and which by citizens who were not patients,
and therefore the material was analysed and included as a demonstration of community
perspectives on the issue.
A Google advanced domain search was conducted to collect community perspectives posted in
response to media articles (Table 35). Domains were selected in order to include the principal
Australian mainstream newspaper sources.
22
A developed country was defined to be; European Community, Canada, U.S, Norway, New Zealand, Australia,
Singapore, Switzerland, Hong Kong and Japan
Page 105
Table 35
Media search terms for cataract surgery
No.
Domain
1
www.theage.com
2
www.news.com.au
3
www.news.com.au
4
www.crikey.com.au
Newspapers
captured
The Age
(Melbourne)
Search
Results
Selected
‘cataract AND
medicare’
3440
(First 200)
1
The Australian
Adelaide Now (The
Advertiser &
Messenger SA)
Perth Now (WA)
Courier Mail (QLD)
Herald Sun (VIC)
The Daily
Telegraph (NSW)
As above
‘cataract AND
medicare’
9
1
‘cataract’
51
2
Crikey news
website
‘cataract’
33
6
Results
Preoperative experience
Anxiety
Several bloggers refer to the anxiety experienced prior to surgery. This may be associated with a
general fear of allowing someone to ‘cut into my eyes’ (Oldnovice March 16, 2010; Graham
Clements November 12, 2009) (USA and Australia) because of fear of complications (Oldnovice
March 16, 2010; JMB March 17, 2008) (USA and Canada), fear of being aware during the
procedure (Oldnovice March 16, 2010) (USA) or waiting time (Andrea J March 23, 2009) (USA).
Similarly, a Canadian study of anxiety in older people reported that one-third of patients waiting
for cataract surgery demonstrated anxiety levels in the range of panic disorder patients and using
a Beck Anxiety Inventory score were well above the reported norms for seniors
(Hadjistavropoulos, Snider et al. 2001).
Waiting times
Surgery waiting lists and waiting time to cataract surgery represent a significant patient
experience in other countries but may also have relevance in Australia particularly in differences
between private and public services. Studies have shown that waiting longer than six months is
associated (pre-operatively) with more cataract symptoms, more visual difficulty and more
reported accidents (e.g. falls, burns and vehicle accidents), as well as adverse effects on patients’
mental health and anxiety levels (Hadjistavropoulos, Snider et al. 2001; Hodge, Horsley et al. 2007;
Boisjoly, Freeman et al. 2010). In addition to adverse events, there is some evidence that longer
waiting times are associated with less satisfaction with the procedure (Hadjistavropoulos, Snider
et al. 2001; Conner-Spady, Sanmugasunderam et al. 2004; Hodge, Horsley et al. 2007; Chan, Fan et
al. 2009; Boisjoly, Freeman et al. 2010). In a UK study, which examined patient expectations with
respect to cataract surgery, ‘waiting times’ were the second-most pressing concern of older
Page 106
patients selected from a general practice register after ‘risk of complications’ (Ross, Avery et al.
2003). Conner-Spady et al examined the discrepancies between physician- and patient- rated
‘maximum acceptable waiting times’. They found that physicians rated maximum times
significantly higher (15.05 weeks) than patients (9.87 weeks) but also that patients may be willing
to wait longer for the procedure if it is in accordance with the amount of time they were initially
told (Conner-Spady, Sanmugasunderam et al. 2005). Kirkwood and colleagues found that adopting
a nurse-led practice model could significantly reduce waiting times (Kirkwood, Pesudovs et al.
2006). Other work has researched patients’ ‘willingness to pay’ and found that it was affected by
several factors including willingness to wait, knowing someone who had undergone cataract
surgery, visual function and impairment of work (Chan, Fan et al. 2009).
Waiting is explored in a different way in the blogs: one of the most commonly expressed feelings
was the fear and anxiety surrounding cataract surgery and the role that waiting on the day of the
procedure played in the degree of fear experienced. Graham Clements from Australia commented
that while already being fearful, the doctor “added to my tension by keeping me waiting for an
nearly an hour” (Graham Clements November 12, 2009), while JMB from Canada claimed that
waiting left them like a ‘cat on a hot tin roof’ (JMB April 17, 2008) and David from the United
Kingdom saw his waiting time as providing ‘plenty of time to stew and imagine the worst’ (David
April 4, 2007).
Informed consent
Provision of information
Four papers described the information needed prior to cataract surgery. The majority of patients
indicated that pre-operative education and information reduced anxiety and fear about the
procedure (Nijkamp, Ruiter et al. 2002; Vallance, Ahmed et al. 2004; Lockey 2009). Responses to a
questionnaire asking patients about their experience with preoperative counselling included the
following from the United Kingdom:
After discussing the surgery with the preoperative assessment nurse, I felt more relaxed and
felt able to get on with life (78-year-old male). Information very informative. I was made to
feel at ease from the start. On leaving preoperative assessment, [I] felt very calm about the
operation (79-yearold female) (Lockey 2009).
The study by Vallance et al (2004) found that patients did not believe that the consent procedure
and information about potential complications affected their anxiety levels. A small study assessed
different techniques for obtaining informed consent and found low levels of understanding in
most patients even when risks were explicitly explained but also found that those patients given
detailed risk counselling were more anxious than patients informed with a more paternalistic
communication approach (Cheung and Sandramouli 2005). Vallance et al (2004) showed that,
although most patients could not recall details of the pre-operative education, they believed that
they were given adequate information. Similar results were reported in other studies: most
patients reported having ‘enough information’ prior to the procedure (Wasfi, Pai et al. 2008; Colin,
El Kebir et al. 2010).
Page 107
Information delivery
The way in which information was delivered to the patient was examined in two studies, both
finding that patients preferred verbal or multi-media information, rather than written material
(Nijkamp, Ruiter et al. 2002; Lockey 2009). Lockey’s work suggests that patients were more
satisfied with information delivered by the pre-operative nurse, rather than the doctor. Both
studies also found that provision of information prior to surgery was associated with higher levels
of patient compliance with post-operation care regimens.
The weblogs present a slightly different perspective: here, the list of potential complications
presented by the health professional was viewed with caution (Dan Cooksey and Betty Cooksey
November 25, 2009) and in some cases alarm (JMB April 17, 2008; Graham Clements November
12, 2009):
I'm told that it is a relatively safe surgery that is done all the time. Let's hope they're correct
(Dan Cooksey and Betty Cooksey November 25, 2009) (USA).
Doing his due diligence, he also told me that some people find no improvement after the
surgery, some are worse and 1 in 1700 lose the sight in the eye. Now shall we schedule the
procedure? he asked. I looked at him. You must be joking (JMB April 17, 2008) (Canada)
One United States blogger complains of inadequate information which would have allowed him to
judge the risks of cataract surgery:
I understood that there was a risk of detachment with cataract surgery, but was not told
that the risk increased with age and degree of myopia. What is the detachment rate for 67
year-olds who are as myopic and physically active as I was? I still don't know (Press August
12, 2007).
Alternate sources of information, apart from a health professional, discussed in weblog posts
include the internet, multimedia, books and other people, including people known to the patients
or encountered at the treatment facility. There is insufficient information on the blogs to judge the
effect of these sources overall but it is clear that such sources can increase anxiety and confusion.
For example, David from the United Kingdom who is recovering from his operation comments that
his:
initial euphoria at getting past the operation soon gives way to the jitters. This is mostly
fuelled by a combination of:
Too much time on my hands as I am off work recuperating.
Access to medical sites on the Internet.
Sometimes conflicting information on these sites.
A little knowledge but not enough (David April 5, 2007 ).
Page 108
Obviously the information provided at his operation did not serve to reassure him. Information
gained from others who have gone through the procedure may also increase anxiety or reassure:
a few weeks ago I spoke to an acquaintance whose father had had cataract surgery done,
not at the same clinic as I did, and by a different surgeon. The result of his first surgery was
corneal damage that left him with permanent blurred vision in the eye (Len Micay April 11,
2007) (Canada).
All my friends who have had it done say, don't worry, it's nothing. All my friends who have
not say, I would be worried too if I were you (JMB April 17, 2008) (Canada).
There I met eighty year old Sheila a lovely up beat ex-publican who had one eye done six
weeks ago and assured us all that it was:
A doddle
Painless
Had excellent results which made any minor discomfort more than worth it.
Most important it was excellent value for money as it would cost £4000 to have two eyes
done privately (I suspect from her other attitudes that she was a life long Tory which
probably goes to show that people don't let ideology get in the way of a bargain).
Anyway Sheila was a support to the other five non-veterans for the rest of the day. (David
April 4, 2007) (United Kingdom).
Intra-operative experience
Anaesthesia and sedation
Experience with anaesthesia during cataract surgery dominates the relevant findings in the peer
reviewed literature. This may be due to recent advances in anaesthesia techniques and methods
of administration in ophthalmologic procedures. Several papers examined the differences
between retrobulbar, peribulbar and topical methods of administration and how this affects
various aspects of the cataract surgery procedure. Several studies showed that patients preferred
peribulbar block administration rather than topical anaesthesia, and that topical anaesthesia was
associated with more intra-operative pain (Boezaart, Berry et al. 2000; Friedman, Reeves et al.
2004; Bertrand, Garcia et al. 2008). Contradictory results were found by two studies where
patients were generally very satisfied with topical anaesthesia and requested this for second
surgeries (Spiritus, Huygens et al. 2000; Fung, Cohen et al. 2005) while a third study found no
significant differences in patient preferences (Ezra and Allan 2007). There is no discussion about
anaesthesia choice in the weblogs, possibly because patients would be unaware of the choice.
Canadian blogger, Len Micay, demonstrates the extent of the knowledge that patients may have
about anaesthesia in his comment:
Page 109
.. .An injection was then made into some part of my eye, or behind it.
I’m later told that my optic nerve had been froze (Len Micay April 11, 2007).
Studies exploring the use of sedation during cataract surgery found that sedation with
dexmedetomidine decreased pain on injection and increased patient satisfaction (Ayoglu,
Altunkaya et al. 2007; Erdurmus, Aydin et al. 2008).
Other studies found that patients reported preferring oral to intravenous sedation (Friedman,
Reeves et al. 2004; Rüschen, Celaschi et al. 2005; Rodrigues, Vale et al. 2008). Bloggers do not
provide detail about the type of anaesthesia used but do document both positive and adverse
experiences with anaesthesia. For example, Australian blogger Graham Clements describes the
surgery as follows:
The sedating drug going into my hand was doing a great job because the anaesthetist then
inserted a needle into the corner of my eye. Just a slight sting. The weight was removed. I
was then pushed into the operating theatre and told to close my eyes. Some sort of glue
was brushed over my face and then white plastic wrap applied. I watched as something
pushed against the plastic and then cut though it, but not into my eye. A light was shone
through the gap and into my eye, making it impossible to see anything. Something was
then attached to the eye lids to keep them open. The ophthalmologist then told me to
watch a light, which I dutifully did as he moved the laser around. I felt nothing. After about
ten minutes he stopped and inserted something, the plastic lens I guess. He then removed
the device holding my eye lids apart and the plastic from my face and taped a plastic shield
over my eye. He told me everything had gone well (Graham Clements November 12, 2009).
And American blogger ‘Oldnovice’ talks about her husband’s surgery:
I assure you he wasn't aware of much that day. They gave him some GOOD drugs and while
he could walk and talk, the day of surgery is pretty much a missed day in his life (Oldnovice
March 16, 2010).
Whereas, Canadian blogger Rositta describes the failure of her anaesthesia to relieve pain:
...the anaesthesiologist said he'd make me comfortable. He lied big time because I felt every
little thing and it hurt like hell. I asked the doc about that this morning at my checkup
appointment and told me that the Ontario government has asked hospitals to use the
absolute minimum anesthetic thereby shortening the recovery time needed for the patient.
I guess that's how they can do so many surgeries, in and out like a factory line (Rositta
January 26, 2010).
Similarly an American blogger, Curt Miller, complains:
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I had the unfortunate experience of being the victim of an incompetent anesthesiologist this
morning, who failed to anesthetise me for surgery. During my cataract surgery, I was
totally awake, aware and sensitive to all activity and touch. I let the team know this. I let
the team know that my eye was sensitive and that I could feel all activity when they
touched it. I could feel all action during the procedure (Curt Miller February 11, 2010).
Role of the nurse and nurse practitioner
Cataract surgery is now one of the most frequently performed surgeries in developed countries
and significant waiting lists for the procedure have led some overseas locations to employ nursepractitioners to administer anaesthetic. Studies gauging patient perspectives on who delivers
anaesthesia found that patients are satisfied with delivery by any member of the health care team
and there is some evidence to suggest that nurses are preferred as they have more time to help
the patient relax (Waterman, Mayer et al. 2002; Modi, Shaw et al. 2008; Lockey 2009).
Discussion about the roles of nurses and nurse-practitioners included their role in providing
information to patients, in alleviating fear (both pre-operatively and intra-operatively) and in intraoperation patient-surgeon communication, via such methods as hand-holding. The presence of a
hand-holder intra-operation was associated with significantly lower patient-reported pain and
anxiety levels as well as higher levels of patient-reported satisfaction (Waterman, Mayer et al.
2002; Modi, Shaw et al. 2008). A similar phenomenon was also reported, in that nurse-hand
holding reassured 85.2 per cent of patients (Wasfi, Pai et al. 2008). The notion of hand-holding
was mentioned in Len Micay’s Canadian weblog: “Dr. Leary might be there to hold my hand. That
would temper it [fear]” (Len Micay April 11, 2007).
Visual sensations
Intra-operative visual sensations were reported in five studies. All studies reported that the
majority, if not all, of study patients reported seeing light during the procedure (Newman 2000;
Prasad, Kumar et al. 2003; Bassett, Smith et al. 2007; Biro and Schvoller 2008) with the study by
(Jain, Ragoussi et al. 2007) finding the lowest reported intra-operative visual perception of light
(52%). In a prospective non-randomised cohort post-operative questionnaire study, 10 per cent of
patients reported finding this painful (Wickremasinghe, Tranos et al. 2003). Light was also the
main, and often the only, visual sensation experienced by the bloggers. For example, Australian
blogger Graham Clements (2009) states that ‘A light was shone through the gap and into my eye,
making it impossible to see anything.’
Patients also reported a variety of other visual sensations: the most common being the perception
of colours, although some patients reported seeing movement and a minority, across all papers,
surgical instruments and the surgeon’s hands (Newman 2000; Prasad, Kumar et al. 2003; Tranos,
Wickremasinghe et al. 2003; Wickremasinghe, Tranos et al. 2003; Ang, Au Eong et al. 2007; Jain,
Ragoussi et al. 2007; Biro and Schvoller 2008). Several of the studies explored patients’
perceptions of these visual sensations and how they reacted to them. Ang et al (2007) found that
nearly one in five of the patients were frightened by the visual experiences (19%) whereas Prasad
et al (2003) found a much lower percentage (3%) and in Newman’s (2000) study no patients were
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frightened. One United States blogger talking about her anticipation of visual sensations during
the procedure commented:
Surgery itself was a breeze - I have no memory of anything coming at my eye, which is what
I was dreading (Jan J February 28, 2009).
Several articles commented on the relationship between high pre-operative anxiety and
frightening intra-operative visual sensations as well as the possible link between such experiences
and reduced patient compliance and increased morbidity (Conner-Spady, Sanmugasunderam et al.
2004; Mozaffarieh, Krepler et al. 2004; Pesudovs and Coster 2005).
The type of anaesthesia used has been reported to affect intra-operative visual experience:
patients who received topical anaesthesia reported significantly higher incidence of visual
sensations and in some cases more frightening experiences (Tranos and Peter 2006; Jain, Ragoussi
et al. 2007). While Prasad and colleagues (2003) found that patients administered retrobulbar
anaesthetic were more likely to report frightening experiences (7%) than those administered subTenon’s block (3%).
Pre-operative information provision and intra-operative experience
Several journal articles provide survey evidence to support the importance of good quality preoperative counselling and information in adequately preparing the patient and reducing fear
during the procedure (Newman 2000; Wickremasinghe, Tranos et al. 2003; Tranos and Peter 2006;
Ang, Au Eong et al. 2007; Colin, El Kebir et al. 2010). Adequate preparation of patients may also
increase intra-operative compliance and reduce the occurrence of adverse events during surgery.
A qualitative study regarding fear and cataract surgery identified five stages (before, during and
after procedure) at which patients experience fear and then used these stages to assess what the
patients fear (Nijkamp, Ruiter et al. 2002). The results showed that the patients were most fearful
about the possible deterioration of their vision and the pre-operation injection and pain
associated with this; as well as this they were fearful of surgical complications and outcomes.
These findings were interesting as there was no common suggestion of fear surrounding the
surgery itself – more around the injection and possible effects on vision. Nijkamp’s study also
outlined important situational factors in patients’ ratings of fear, these included, doctor-patient
relationship, information supply, hospital organisation and waiting. This built on a previous
quantitative survey study, also by Nijkamp et al, which used multiple linear regression analysis to
show that, compared with medical outcomes, patient counselling had a greater impact on patient
satisfaction (Nijkamp, Nuijts et al. 2000).
Post operative experience
Several studies aimed to gauge improvements in quality of life after cataract surgery: quality of life
can be seen as a proxy measure for the value placed on the procedure by the patient. However,
within the peer-reviewed literature, this analogy is contentious and certainly cataract surgery may
not correlate well with increased quality of life (Pesudovs, Weisinger et al. 2003; Pesudovs and
Coster 2005). For example, three months post-operation, patients showed no significant
improvement in quality of life from pre-operative levels (Pager, McCluskey et al. 2004) and a
comparative study, exploring outcomes from five different ophthalmologic procedures, found
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that, post-surgery, cataract surgery groups reported the lowest quality of life measures
(Mozaffarieh, Krepler et al. 2004). Similarly visual acuity post-surgery may not correlate well with
improved quality of life, with one study reporting only a moderate correlation between visual
acuity post-surgery and quality of life (Chan, Wong et al. 2003).
Patient Satisfaction
A major factor contributing to high patient satisfaction is patient expectations pre-procedure.
Although Conner-Spady et al (2004) found that visual acuity significantly predicted patient
satisfaction with surgery, an Australian study by Pager found that visual acuity after surgery is not
predictive of patient satisfaction (Pager 2004). Instead it is dependent on the closeness between
patient pre-operative expectations and patient outcomes. Discrepancies between expectations
and outcome are predictive of reduced patient satisfaction. Other studies support this and suggest
that patients may over-estimate their visual outcomes pre-surgery (Wasfi, Pai et al. 2008; Pager
2004). These studies and others emphasise the importance of managing patient expectation prior
to the procedure and providing accurate information as a means of improving patient satisfaction
(Wasfi, Pai et al. 2008; Pager 2004; Pager and McCluskey 2004; Tan, Eong et al. 2005; Ang, Au Eong
et al. 2007; Colin, El Kebir et al. 2010). One study reporting high satisfaction rates, also reported
high percentages of patients who believed that they had ‘enough information’ and that surgery
met expectations (Colin, El Kebir et al. 2010). Other determinants of satisfaction which have
already been discussed are type of anaesthesia, grade of anaesthesia, personnel involved in
treatment and information delivery and the presence of a hand-holder during the operation.
Patient satisfaction is discussed in the weblogs from the simple “I'm happy with it!” (Sandra
August 18, 2010) to Len Micay’s reflections upon his use of spectacles: “I am very happy not to
have to wear glasses any more” and the alternative to surgery - irreversible blindness: “What has
been gained however outweighs by far what has been lost” (Len Micay April 11, 2007). However,
not all ‘bloggers’, were satisfied with the procedure and similar to the literature, this resulted from
gaps between expectations and visual acuity outcomes, for example, Canadian Rossita comments:
Tomorrow I have my one week check up with the Ophthalmologist and intend to tell him
that no, I am not as happy as he said I would be. when I can't knit, read or browse the net I
am unhappy. Hopefully it will get better from here (Rositta January 26, 2010).
Cataract surgery is commonly performed on both eyes, on separate occasions, providing the
opportunity to compare pre- and post-operative experience for the same patient and often with
same technique and same surgeon but obviously with the second procedure, prior experience and
knowledge of cataract surgery. Prior cataract surgery experience may help alleviate fear going into
the second surgery (Tranos and Peter 2006) and improve the overall patient experience: for
example a higher proportion of second eye patients reported a 'very good benefit' of surgery and
were 'very satisfied' with vision after surgery than comparable groups undergoing surgery for the
first time (Lundström, Stenevi et al. 2001). Similarly one Canadian ‘blogger’ stated that he felt
“much more relaxed for the second surgery” (Len Micay April 11, 2007).
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These findings suggest that, at least in the case of cataract surgery, a patient’s frame of mine and
prior knowledge and understanding about the procedure are important predictors of patient
experience and patient satisfaction.
Cost
Patient views on the cost of cataract surgery is an issue that is not well explored in the peerreviewed literature, other than a willingness to pay trade off study (Chan, Wong et al. 2003).
This issue is particularly relevant in Australia, with considerable public debate in 2009 surrounding
a proposed 51% Schedule fee cut for the most commonly claimed item 42702. The
Commonwealth Government engaged in public debate over this issue with The Royal Australian
and New Zealand College of Ophthalmologists (RANZCO) and the Australian Society of
Ophthalmologists (ASO). There was much media attention surrounding this debate and a variety of
community views presented. Although the views were often not those of patients, they do present
another dimension to the cataract surgery experience.
Only two blogs directly mention the cost of the cataract surgical procedure: American ‘blogger’
Andrea J makes comment about the proportion not covered by insurance:
Well, since it's an outpatient procedure, the insurance will cover 90% of the amount over
the $300 deductible. Ouch. Well, I spent 3 times that on the cats' health in January, so it's
more than reasonable that I spend this on my own health (Andrea J March 20, 2009).
And Australian blogger Graham Clements recounts the effect of reduced rebates at the same time
as rising charges:
I got all this mail yesterday including: the hospital bill of $245, artificial lens bill of $310,
ophthalmologist bill of $1100. I had been quoted $950, but upon ringing his clinic I was told
his charges went up at the beginning of November, at the same time as the Federal
government cut back the medicare rebate from $626 to $416, so I am out of pocket
considerably more then I had hoped (Graham Clements November 12, 2009).
A common theme in the small number of media articles and the public response through
associated discussion forums was that ophthalmologists were being greedy and self-interested in
opposing the cuts, and should not be charging more than the schedule fee (Bennett August 26,
2009; Dunlevy November 18, 2009 ). For example, Jenny writes in response to an article:
Someone might like to remind them that The Fred Hollows Foundation does the procedure
for a lot less cost (Jenny in Bennett (2009)) (Australia).
However it should be noted that the surgery performed by the Fred Hollows Foundation in
developing countries is a different method of cataract surgery and is not directly comparable to
modern phacoemulsification surgery as performed in Australia.23
23
Brian Doolan, Chief Executive Officer of the Fred Hollows’ Foundation, has responded to the inappropriateness of
this misconception in a letter to the editor to "The Australian", 26 August 2009.
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And several participants commented how brief the procedure in comparison to the charges:
What used to take 3-4 hours now can be done in about 12 minutes24. The post op care is
minimal and I don’t think you will find many other specialists standing up and supporting
this group. They have not done themselves any favours with their peers by only being able
to perform 4 cataracts in a public hospital session and then trotting off to do 3 to 4 times as
many in private sessions (Jack in Bennett (2009), Australia)
Despite this, some discussion forum responses demonstrated the high level of importance placed
on the clinical outcomes of such a procedure by the community. One commentator referred to it
as a ‘vision-saving operation’ (Woodruff November 3, 2009 ) and a community member responds
to criticism about the cost in saying:
I'd pay $28000 to keep my eyesight (remlableinad in Dunlevy (2009), Australia)
Similarly, an article presenting patient perspectives on the issue quotes participant Nancy Lee as
follows:
Please do not say cataract operations are overpriced. Due to failing eyesight I had both
eyes operated on in the past twelve months under the auspices of Vet Affairs. The
difference is amazing. I can see to read. and enjoy reading Crikey even if I am a woman and
85 years old (Lee N in (August 27, 2009 ), Australia).
In contrast, one participant suggested that because the surgery is not lifesaving, it was less
valuable and therefore should be publicly funded at a lower rate:
Eye surgery is pretty important and makes a massive difference to quality of life. But put it
in perspective. It isn't generally life-threatening. How much do surgeons performing actual
life-saving operations earn in comparison to opthamologists?[sic] Do other surgeons need 4
secretaries, 2 assistants and a practice manager? (David in Dunlevy (2009), Australia).
Stakeholder negotiation regarding minor wording amendments to the MBS descriptor for the
cataract surgery items was undertaken. Changes to items 42703, 42704, 42707 and 42710 were
suggested by the RANZCO, primarily related to replacement of the term ‘artificial lens’ with
‘intraocular lens’ (see Box 6). These changes were agreed by the Department. Similarly, the
modifications to item 42713 (see
24
The Clinical Working Group advise that in Australia cataract surgery takes approximately 30-45 minutes to perform.
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Box 6) were agreed by the Department at the request of the RANZCO.
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Box 6
Cataract surgery item descriptor amendments
42703
ARTIFICIAL INTRAOCULAR LENS or IRIS PROSTHESIS, insertion of, into the posterior
chamber and suture with fixation to the iris and or sclera (Anaes.) (Assist.)
42704
ARTIFICIAL INTRAOCULAR LENS, REMOVAL or REPOSITIONING of by open operation,
not being a service associated with a service to which item 42701 applies (Anaes.)
42707
ARTIFICIAL INTRAOCULAR LENS, REMOVAL of and REPLACEMENT with a different
lens, excluding surgery performed for the correction of refractive error except for
anisometropia greater than 3 dioptres following the removal of cataract in the first
eye (Anaes.)
42710
ARTIFICIAL INTRAOCULAR LENS, removal of, and replacement with a lens inserted
into the posterior chamber and sutured fixated to the iris or sclera (Anaes.) (Assist.)
42713
INTRAOCULAR LENSES , repositioning of, by the use of a McCannell suture or similar
(Anaes.) (Assist.)
IRIS SUTURING, McCannell technique or similar, for fixation of intraocular
lens or repair of iris defect (Anaes.) (Assist)
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3.12
Capsulectomy and lensectomy services
MBS ITEMS
42719, 42722, 42731*
SERVICE
REVIEW METHOD †
Capsulectomy and lensectomy (*)
Mini HTA
review
Stakeholder
negotiation**
x
x
Guideline
concordance
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
Summary of Findings
Items 42719, 42722 - There is a paucity of evidence describing the types of procedures used to
remove part of the lens capsule when not associated with the removal of cataracts. Choice of
technique appears to be by surgeon preference, with either the limbal or pars plana approach
favoured depending on the population in question (paediatric versus adult). It is therefore suggested
that any changes to the wording of MBS item numbers 42719 and 42731 reflect the current
terminology regarding ‘limbal lensectomy’ or ‘pars plana lensectomy’ and should be informed by
clinical consensus as to the most accurate wording – as has been done with item 42731.
Item 42731* - Stakeholder negotiation regarding minor wording amendments to the MBS descriptor
for item 42731 was undertaken. The suggested changes by the RANZCO were accepted by the
Department. The rewording of item 42731 would appear to make the use of item 42722, as currently
worded, redundant.
Item 42731 has a considerably higher cost than the other capsulectomy/lensectomy items. It has been
argued by the RANZCO that the cost should be higher because, due to deficiencies with the previous
descriptor wording, ophthalmologists will have been charging a combination of items to cover the pars
plana lensectomy plus vitrectomy service. There are however less than 500 combination claims
occurring per year.
The items for capsulectomy and lensectomy (42719, 42722, and 42731) are relatively minor in
terms of number of services and costs, although 42722 has shown a higher rate of increase since
about 2004, and is used primarily in New South Wales (see Appendix D). These three items are not
exclusive to cataract or lens disorders – they are also included in the AR-DRG category for retinal
procedures.
For this group of items, analysis of the provision of services according to rurality (see Appendix B,
Table 83) indicates that item 42722 (capsulectomy) had a higher occurrence in metropolitan areas
over the last 3 financial years – 79.8% vs 20.2% - than expected.
This mini-HTA is intended to provide an overview of the evidence pertaining to procedures
currently used to perform capsulectomy, or removal of part of the lens capsule, usually
subsequent to cataract surgery. This procedure is distinct from routine anterior capsulectomy
performed during cataract extraction (MBS item numbers and 42698, 42702, 42716) and
vitrectomy by posterior chamber sclerotomy (MBS item number 42725). The MBS item numbers
currently used for capsulectomy are:
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42719: CAPSULECTOMY OR REMOVAL OF VITREOUS, or both, via the anterior chamber by
any method, not being a service associated with a service to which item 42698, 42702 or
42716 applies;
42722: CAPSULECTOMY by posterior chamber sclerotomy OR REMOVAL OF VITREOUS or
VITREOUS BANDS, or both, from the anterior chamber by posterior chamber sclerotomy,
by cutting and suction and infusion, not being a service associated with a service to which
item 42698, 42702 or 42716 applies - 1 or both procedures; and
42731: CAPSULECTOMY or LENSECTOMY, or both, by posterior chamber sclerotomy in
conjunction with the removal of vitreous or division of vitreous bands or removal of
preretinal membrane from the posterior chamber by cutting and suction and infusion, not
being a service associated with any other intraocular operation.
Background
In 2004, in the region of 0.5 million Australians aged over 55 years were reported as being visually
impaired, with approximately one third of these cases being due to the development of cataracts
(Biotext Pty Ltd 2008). The lens of the eye is made up primarily of protein and water and its role is
to focus light onto the retina at the back of the eye. The protein structure of the lens may break
down, forming clumps over the lens, giving it a cloudy appearance and preventing light from
passing through the lens. This opaque formation is referred to as a cataract and it occurs as a
result of the natural aging process, exposure to x-rays, heat from infrared exposure, systemic
disease (eg diabetes), uveitism systemic medications, or chronic ultraviolet exposure (Beers and
Berkow 1999).
Surgical treatment of cataracts involves performing a capsulectomy to remove a segment of the
anterior capsule followed by the removal of the cataract, producing a lens capsular bag comprising
the entire posterior capsule and the remaining portion of the anterior capsule. The lens is replaced
with a permanent intra-ocular lens implant (IOL), which is housed in this capsular bag
(Wormstone, Wang et al. 2009). By leaving the posterior lens capsule intact an anatomical barrier
between the anterior and posterior segments of the eye is formed, which reduces complications
compared to intracapsular cataract extraction, in which the whole lens with intact capsule is
removed from the eye (Findl, Buehl et al. 2010).
Complications of cataract surgery include endophthalmitis, retinal detachment and one of the
most frequent complications, posterior capsular opacification (PCO), often called “secondary
cataract”, which is thought to result from the presence of the intact capsule post extracapsular
cataract extraction (Do, Hawkins et al. 2008). Decreased visual acuity due to PCO is reported to
occur in approximately 20-40 per cent of patients, two to five years after cataract surgery (Do,
Hawkins et al. 2008; Awasthi, Guo et al. 2009). Of particular concern is that the development of
PCO appears to be age dependent, with a lower incidence in older patients but higher rates in
paediatric or young adult patients (Awasthi, Guo et al. 2009; Wormstone, Wang et al. 2009).
Two methods of lensectomy have been described: pars plana lensectomy and limbal lensectomy,
the latter of which is used for paediatric cataract procedures and is not usually conducted in
conjunction with pars plana vitrectomy. Figure 6 demonstrates the position of the pars plana,
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which is part of the ciliary body located near the point where the iris and the sclera meet, and the
limbus, the marginal region of the cornea, where it is continuous with the sclera.
a
Figure 6
b
(a) Illustrating the position of the limbus (the edge of the cornea where it joins the
sclera) and (b) the pars plana (part of ciliary body located near the point where the iris
and the sclera meet)
In paediatric patients, the pars plana approach combines a lensectomy with an anterior
vitrectomy. Two scleral incisions are made at the pars plana level, one for the vitrectomy probe
and one for the infusion cannula. Once the lensectomy and anterior vitrectomy are complete, the
peripheral rim of the capsule is intact for placement of the IOL. This approach minimises trauma to
the iris and the corneal endothelium, however the major disadvantage of this technique is that
insufficient capsular material may be left behind to support the placement of an IOL. The limbal
approach requires two incisions at the limbus on opposing sides of the eye (the 10 o’clock and 2
o’clock position) and a lensectomy and an anterior vitrectomy are performed. Whilst this
technique is more likely to leave an adequate capsular rim for the support of an IOL there is a
greater risk of damaging the iris (Wilson and Pandey 2005; Dahan 2008). The two methods of lens
removal in adults are the anterior approach (phacoemulsification or extracapsular) or the
posterior (pars plana) approach, often referred to as a pars plana lensectomy.
Research question
What types of procedure or combination of procedures are currently used to remove part of the
lens capsule?
Pre-specified criteria for the selection of literature to address this question are provided in
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Table 36.
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Table 36
PICO criteria for capsulectomy and lensectomy
Characteristic
Inclusion Criteria
Population
Patients requiring removal of vitreous or lens (usually subsequent to cataract surgery)
Intervention
Limbal (anterior) vitrectomy, pars plana lensectomy/vitrectomy
Comparator
NA
Outcome
Latest occurrence (date) of published research on limbal or pars plana
lensectomy/vitrectomy, circumstances where these vitrectomy/lensectomy
procedures might be used, any safety and/or effectiveness concerns reported in the
literature regarding these procedures
Search strategy
A search of the Cochrane library – including the Cochrane database of systematic reviews,
Database of abstracts of reviews of effects (DARE) and the HTA database, the economics database,
EconLit, and Embase.com (consisting of both Embase and Medline) was conducted using the
search terms outlined in Table 37.
Table 37
Search terms utilised for capsulectomy and lensectomy
Population
('eye'/exp OR 'eye disease'/exp) AND
Intervention
('capsulotomy'/exp OR 'lensectomy'/exp OR 'vitrectomy'/exp)AND
Limits
1. [English language]/lim AND [humans]/lim AND [2005-2011]/py AND [systematic review]/lim
2. [humans]/lim AND [2005-2011]/py AND ([systematic review]/lim OR [controlled clinical trial]/lim OR [meta
analysis]/lim OR [randomized controlled trial]/lim)
3. [article]/lim AND [humans]/lim AND [2005-2011]/py
Availability and level of evidence
There is a paucity of data pertaining to the types of technique used for the removal of the lens of
the eye. Two Cochrane Reviews were identified: one that assessed surgery for post-vitrectomy
cataracts (Do, Hawkins et al. 2008) and one that assessed interventions for preventing posterior
capsule opacification (Findl, Buehl et al. 2010). Two narrative reviews discussed the management
and prevention of PCO (Awasthi, Guo et al. 2009; Wormstone, Wang et al. 2009) and two
ophthalmology text books that discussed surgical approaches for the removal of paediatric
cataracts were also identified (Wilson and Pandey 2005; Dahan 2008).
Results
The Cochrane Review by Findl et al (2010) included only prospective, randomised controlled trials
with a follow-up time of at least-12 months. Interventions included modifications in surgical
technique explicitly to inhibit PCO, as well as modifications in IOL design, implantation of other
devices and pharmacological therapies. The surgical techniques assessed in this review discussed
modifications to the cataract surgical technique to prevent post-procedure complications. These
modifications included polishing the capsule to reduce the number of lens epithelial cells
remaining in the capsule bag after cataract removal, which may act to delay or reduce PCO
formation, and to reduce the size of the opening in the anterior capsule, which would have the
effect of overlapping the anterior capsule and IOL, inhibiting PCO. As neither of these techniques
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addressed methods of lens removal, results from this review have not been included in this
assessment.
The Cochrane Review by Do et al (2008) assessed surgery for patients who have developed nuclear
sclerotic cataracts after undergoing vitrectomy for posterior segment disorders. Cataract removal
in these patients is generally considered to be more complicated compared to the removal of agerelated cataracts. Capsular rupture may occur more frequently as a result of the increased mobility
of the posterior capsule due to the absence of the vitreous and the nucleus tends to be harder in
these patients, requiring extended phacoemulsification time. This review failed to identify any
randomised or quasi-randomised controlled trials that evaluated the benefits or outcomes of
surgery for post-vitrectomy cataracts. Published literature describing surgery in this patient group
was, in the main, retrospective case reports or prospective case series.
The reviews by Wormstone et al (2009) and Awasthi et al (2009) discussed a number of surgical
modifications to prevent the development of PCO, including aspiration of the anterior capsule
using an irrigation system, pharmacological dispersion and aspiration of the anterior capsule and
manual polishing of the anterior and/or posterior capsule. However, as these modifications are
aimed at removing residual lens epithelial cells left behind in the capsular bag during cataract
surgery, rather than capsulectomy itself, further discussion of these adaptations is not warranted.
The two text books identified described the two surgical approaches used for the removal of
cataracts in paediatric patients: a limbal lensectomy or pars plana lensectomy, as summarised in
the background section above. The pars plana approach is not commonly used for the primary
removal of congenital cataracts, with the majority of surgeons preferring the limbal approach,
which results in superior preservation of the capsular bag for in-the-bag IOL placement. However,
when a lensectomy is combined with a posterior vitrectomy and retinal repair in an infant, the
pars plana approach is preferred (Wilson and Pandey 2005; Dahan 2008). The pars plana approach
is favoured in neonates and infants under two years of age in whom IOL implantation is not
immediately required (Dahan 2008). Surgical techniques for the removal of the lens or capsule,
when not associated with cataract surgery, was not discussed in either of these text books.
Conclusions
In conclusion, there is a dearth of evidence describing the types of procedure(s) used to remove
part of the lens capsule when not associated with the removal of cataracts. Choice of technique
appears to be by surgeon preference, with either the limbal or pars plana approach favoured
depending on the population in question (paediatric versus adult). It is therefore suggested that
any changes to the wording of MBS item numbers 42719 and 42731 reflect the current
terminology regarding ‘limbal lensectomy’ or ‘pars plana lensectomy’ and should be informed by
clinical consensus as to the most accurate wording – as has been done with item 42731 below.
Stakeholder negotiation regarding minor wording amendments to the MBS descriptor for item
42731 was undertaken. The suggested changes by the RANZCO have been accepted by the
Department (see Box 7).
The suggested rewording of item 42731 by the RANZCO would appear to make the use of item
42722, as currently worded, redundant. It should also be noted that item 42731 has a considerably
higher cost than the other capsulectomy/lensectomy items. It has been argued by the RANZCO
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that the cost should be higher because, given deficiencies with the previous descriptor wording,
ophthalmologists will have been charging a combination of items to cover the pars plana
lensectomy plus vitrectomy service (ie through using vitrectomy item 42725 and lens extraction
item 42698). There are however less than 500 combination claims occurring per year (Appendix D,
Table 145).
Box 7 Capsulectomy or lensectomy descriptor item amendments
42731
CAPSULECTOMY or LENSECTOMY, or both, by posterior chamber sclerotomy in
conjunction with the removal of vitreous or division of vitreous bands or removal of
preretinal membrane from the posterior chamber by cutting and suction and infusion, not
being a service associated with any other intraocular operation (Anaes.) (Assist.)
PARS PLANA LENSECTOMY combined with vitrectomy, not being a service associated with
items 42698, 42702, 42719, 42722, or 42725 (Anaes.) (Assist.)
Page 124
3.13
Vitrectomy services
MBS ITEM
SERVICE
REVIEW METHOD †
Mini HTA review
42725 *
Vitrectomy (*)
Stakeholder
negotiation**
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
Summary of Findings
Item 42725* – Vitrectomy is a commonly used item, either singly or in combination with other items,
and usage has steadily increased over the years. The RANZCO suggested some wording changes to
the item descriptor to assist with clarification of the technique. These were accepted by the
Department.
Vitrectomy (item 42725) has grown steadily in the number of services over the period reviewed,
and represents a fairly significant total cost (over $6m in 2009). This item is used for retinal
procedures to treat retinal detachment, macular pucker, macular holes, diabetic retinopathy,
vitreous haemorrhage or severe cases of vitreous floaters which are obstructing vision (Do,
Hawkins et al. 2008). This is supported by analysis of combination Medicare claims, most
commonly the combination of vitrectomy and intra-vitreal injection (see Appendix D, Table 145).
The steady growth in vitrectomy is illustrated in the graph of separations according to hospital
procedures (selected items – see
Page 125
Appendix E, Figure 54). The results in 2007-2008 may suggest that it is stabilising. Data from 20082009 are not yet available.
Stakeholder negotiation regarding minor wording amendments to the MBS descriptor for this item
was undertaken. The changes in Box 8 were proposed by the RANZCO and agreed by the
Department.
Box 8
42725
Vitrectomy item descriptor amendments
VITRECTOMY by via pars plana posterior chamber sclerotomiesy including the
removal of vitreous, division of bands or removal of preretinal epiretinal membranes
where performed, by cutting and suction and infusion (Anaes.) (Assist.)
Page 126
3.14
Cryotherapy of retina
MBS ITEM
SERVICE
REVIEW METHOD †
Mini HTA review
42728
Cryotherapy of retina
x
42818*
Stakeholder
negotiation**
x
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
Summary of Findings
Items 42728 and 42818 - The MBS item descriptor for cryotherapy with external probe (item 42818)
does not contradict current guideline recommendations. There are no available guideline
recommendations with which to assess the accuracy of the descriptor for endocryotherapy (with
internal probe, item 42728). Both procedures are uncommon and appear to have been largely
superseded by other procedures including laser photocoagulation. There is considerable regional
variation in the usage of item 42728, despite the fact that clinical sources and literature indicates that
the procedure is infrequently performed.
Most of the available literature on cryotherapy did not state whether an internal or external probe
approach was used but clinical advice suggests that most of the reported procedures would have
been performed using cryotherapy with an external probe. There is insufficient good quality evidence
to evaluate the effectiveness or safety of cryotherapy for the treatment of retinoblastoma, although the
use of local therapies, such as cryotherapy, may be appropriate first line treatment for small, nonseeded tumours. Cryotherapy (with external probe) for pre-term infants with threshold retinopathy of
prematurity improves long term visual acuity compared with observation, although there was no high
level evidence available comparing cryotherapy with other active treatments such as photocoagulation
or in combination with pharmaceuticals. In addition, side effects attributed to cryotherapy were not
reported. Cryotherapy with an external probe, therefore, may be effective for certain patient
indications but comparative effectiveness and safety against existing therapies cannot be established.
The key issue with potential deletion of item 42728 appears to be that this item may be used in
conjunction with vitrectomy (item 42725) whereas item 42818 is to be used as a procedure not
associated with vitrectomy, for example cryotherapy for retinal tears, proliferative retinopathies, and
some tumours. The RANZCO initially suggested removing "as an independent procedure" from the
item descriptor, to allow for situations where additional treatment such as laser photocoagulation is
required, but where the procedure is still not done in association with vitrectomy. However, the
treatment of retinal tears or holes with cryotherapy during scleral buckling surgery, given the
preparation already done for the surgery, would be far simpler and thus may not require
reimbursement at the same rate as delivering cryotherapy for retinal tears not in conjunction with the
surgery.
As a consequence, the descriptor for item 42818 was agreed to be re-worded so that it does not
specify the type of cryotherapy probe and, rather than removing “as an independent procedure” from
the descriptor, a list of items was formulated that can be "co-billed" with item 42818 (items 42809,
42770 and 42771). It was suggested that item 42728 could be made redundant.
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The first of the therapeutic procedures, cryotherapy of retina (42728) has generally been provided
to a small number of people. Although these numbers are small, an eight-fold increase has been
observed between 2006 and 2009 (see Appendix D, Figure 38). The cost of the benefits paid is
minimal compared to other items.
Analysis of the provision of this sub-group of services in terms of rurality reveals a higher
frequency of item 42728 than expected (see Appendix B, Table 83) for patients in metropolitan
areas (79.0%). Similar findings were observed for the provision of item 42818 in terms of rurality,
with a higher frequency of the external probe cryotherapy item (42818) than expected (see
Appendix B, Table 83) for patients in metropolitan areas (81.4%).
Retinal cryotherapy or cryopexy is a surgical procedure used to form a chorioretinal scar by means
of freezing choroidal or retinal tissue. Cryosurgery in ophthalmology was pioneered in the 1960s
and was first used to remove cataracts and to repair retinal detachments. Like laser
photocoagulation, it may be used for several indications, such as: retinal breaks or detachments,
retinal ischaemia, choroidal neovascularisation and intraocular tumours. While the mechanism of
treatment for different indications is often similar, differences in the location of treatment within
the eye, as well as differences in available treatment alternatives, will make the safety and
effectiveness of retinal cryotherapy indication specific.
Cryotherapy can be delivered by an external probe which freezes tissue trans-sclerally or transconjunctivally, or by an internal probe which requires a vitrectomy to be performed.
Guideline concordance analysis was undertaken for item 42728 and 42818. One guideline of
moderate quality (AAO 2008) reported on the use of cryotherapy for the treatment of retinal
tears. Clinical advice suggests that treatment of retinal tears (in the absence of retinal
detachment) with cryotherapy is always done with an external probe. The AAO 2008 reported
moderate level evidence to support the use of cryotherapy in the treatment of acute symptomatic
horseshoe tears. However, no evidence of quality exceeding consensus was reported for
treatment of other retinal tears, breaks or lattice degeneration, as listed below:

Traumatic retinal breaks are usually treated.

Asymptomatic horseshoe tears usually do not require treatment.

Asymptomatic lattice degeneration with or without holes usually does not require
treatment.

Acute symptomatic operculated tears may not require treatment.

Treatment is rarely recommended for asymptomatic operculated tears or atrophic round
holes.
Concordance conclusions
The MBS item descriptor for cryotherapy with external probe does not contradict current
guideline recommendations. No guideline recommendations were identified concerning
cryotherapy with an internal probe. It is unclear whether greater precision is required in the MBS
item descriptor to capture the nature of the indication for which cryotherapy is being applied.
Page 128
Research question
Are item numbers 42728 “Cryotherapy of retina or other intraocular structures with an internal
probe” and 42818 “Retina, cryotherapy to, as an independent procedure, with external probe”,
safe and effective procedures?
Pre-specified criteria for the selection of literature to address this question are provided in Table
38.
Table 38
PICO criteria for retinal cryotherapy
Characteristic
Inclusion Criteria
Population
Eye disease
Interventions
Retinal cryotherapy using an external probe, Retinal cryotherapy using an internal probe
(endocryotherapy)
Comparator
NA
Outcome
Latest occurrence (date) of published research on both procedures, circumstances where
these procedures might be used, any safety and/or effectiveness concerns reported in the
literature regarding both procedures
Search strategy
A search of the Cochrane library – including the Cochrane database of systematic reviews,
Database of abstracts of reviews of effects (DARE) and the HTA database, the economics database,
EconLit, and Embase.com (consisting of both Embase and Medline) was conducted using the
search terms outlined in Table 39.
Table 39
Search terms utilised for retinal cryotherapy
Population
('eye'/exp OR 'eye disease'/exp) AND
Intervention
('cryotherapy'/exp OR retin* near/2 cryo*) AND
Limits
1. [English language]/lim AND [humans]/lim AND [2005-2011]/py AND [systematic review]/lim
2. [humans]/lim AND [2005-2011]/py AND ([systematic review]/lim OR [controlled clinical trial]/lim OR [meta
analysis]/lim OR [randomized controlled trial]/lim)
3. [article]/lim AND [humans]/lim AND [2005-2011]/py
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Availability and level of evidence
The Cochrane Library, EconLit, Medline and Embase were searched from January 2005 to
November 2010 according to pre-specified search. Limited to systematic reviews and randomised
controlled trials (Limit 2 of the Medline and Embase search), 407 articles were retrieved. Following
a review of the abstract and full-text (if eligibility was unclear) three studies were found to be
eligible. One study addressed the use of cryotherapy for the treatment of retinoblastoma and two
studies with overlapping populations reported on the use of cryotherapy for the treatment of
retinopathy of prematurity. The complete article was retrieved and assessed for quality using the
PRISMA checklist for systematic reviews and the SIGN checklist for randomised controlled trials.
Cryotherapy for the treatment of childhood retinoblastoma
Background
Retinoblastoma, a malignant tumour of the retina, is a rare cancer affecting approximately 1 in
16,000 to 18,000 births and typically occurs in children under 2 years of age. Retinoblastoma may
arise from a heritable genetic mutation of the RB1 gene or may arise from a sporadic, noninherited mutation (Kivela 2009; Houston, Murray et al. 2011). Treatment for retinoblastoma is
complex, and can range from enucleation to local, vision preserving treatments including
photocoagulation, cryotherapy, transpupillary thermotherapy or brachytherapy. Local therapy
may be accompanied by chemotherapy (Houston, Murray et al. 2011).
As cryotherapy works by directly destroying the tumour it is considered a local or focussed
treatment for retinoblastoma. While tumours may be removed by cryotherapy, if they have
seeded or metastasised, there is an increased chance of distant recurrence and a reduced
likelihood of successful treatment. For this reason, cryotherapy is only indicated for smaller
tumours (< 3.5mm) and tumours that have not seeded (McDaid, Hartley et al. 2005).
Research question
Is cryotherapy a safe and effective procedure for the treatment of patients with retinoblastoma?
Results
One systematic review of good quality (McDaid, Hartley et al. 2005) reported on 31 comparative
studies (no randomised controlled trials) for treatments of retinoblastoma (table 40). Two
retrospective studies involved local treatments such as cryotherapy, photocoagulation or
brachytherapy compared with external beam radiotherapy (EBRT). In one retrospective study, it
was noted that the number of recurrences following photocoagulation or cryotherapy was
approximately equal (28% vs 33%), though an average of 2.6 sessions were required to sterilise a
primary tumour with photocoagulation compared with only 1.6 cryotherapy sessions (p=0.0039)
(Messmer, Sauerwein et al. 1990). Treatment allocation was not randomised and little is known
regarding the comparability of the two groups prior to treatment. In most cases, cryotherapy and
photocoagulation have been assumed to be of similar efficacy and combined; therefore additional
results cannot be extracted. One important comment by the authors is that local therapy may be
less destructive than EBRT and primary local therapy does not exclude future therapeutic options,
unlike EBRT. This is particularly important given the high risk of secondary tumours following EBRT
in patients with the retinoblastoma gene defect.
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In a second retrospective study, patients receiving cryotherapy (n= 7) were not separated from
patients receiving photocoagulation (n= 1) or brachytherapy (n= 1), however the majority received
cryotherapy (Merrill, Buckley et al. 1996). No difference in the rate of new or recurrent tumours
was reported in patients who received external beam radiotherapy and those who received local
therapy. As the treatment allocation was not randomised and the study is very small, the
possibility of bias and confounding is high.
Neither of the studies reported on by McDaid et al 2005 described whether trans-scleral (external
probe) or endocryotherapy (internal probe) was used, however it is presumed that the method
used was an external probe.
Meaningful conclusions from the two studies of local therapy versus external beam radiotherapy
are difficult to make due to their non-randomised nature. Although it was not explicitly stated, the
different treatments were most likely selected according to disease severity; therefore patients
who are treated with local treatment may have less severe disease than those treated with
external beam radiotherapy.
Conclusion
There is insufficient good quality evidence to evaluate the effectiveness or safety of cryotherapy
for the treatment of retinoblastoma. The use of local therapies, such as cryotherapy, may be
appropriate first line treatments for small, non-seeded tumours. The body of evidence for safety,
accuracy and effectiveness is summarised in the matrix at Box 9.
Box 9
Body of evidence matrix for cryotherapy for the treatment of retinoblastoma
Component
Rating
D
Evidence base
Description
Consistency
NA
Systematic review with only uncontrolled, retrospective studies.
High level of bias is possible.
Outcomes from studies difficult to interpret.
Clinical impact
NA
Outcomes from studies difficult to interpret.
Generalisability
NA
Not applicable.
Applicability
NA
Not applicable.
Table 40
Study profiles for systematic reviews for the treatment of retinoblastoma
Systematic Reviews (SRs) comparing cryotherapy to external beam radiotherapy for the treatment of
retinoblastoma.
Study, review period and quality
appraisal
Population characteristics, inclusion criteria
(McDaid, Hartley et al. 2005)
Level of evidence: I
Assessment of quality: Good
Cochrane Library, Medline,
Embase, Science Citation Index,
BIOSIS, Pascal, LILACS.
Searched from database inception
to April 2004
Systematic review based on 2 non randomised studies with a total of 253
eyes
Population:
Children aged 18 years or under
Intervention:
Any intervention or combination of interventions given for the treatment of
retinoblastoma (two studies involved cryotherapy versus external beam
radiotherapy, but no study was able to directly compare the two modalities).
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Systematic Reviews (SRs) comparing cryotherapy to external beam radiotherapy for the treatment of
retinoblastoma.
Included studies, population characteristics and inclusion
criteria
Intervention(s) and
comparator(s)
Outcome(s)
(Messmer, Sauerwein et al. 1990)
N=200 (229 eyes)
Country: Germany
Mean age: NR
Inclusion: All retinoblastoma patients treated either local
therapy or external beam radiotherapy (both without
chemotherapy) since 1960.
External beam
radiotherapy (127
eyes)
Versus
Local therapy (102
eyes)
Occurrence of new or
recurrent tumours,
number of treatments
required to sterilise
tumours, latency period to
tumour recurrence
(Merrill, Buckley et al. 1996)
N= 24
Country: USA
Mean age: NR
Inclusion: All retinoblastoma patients treated at one
institution since 1983 with at least 2 years follow up.
Reese-Ellsworth group V disease was excluded. Treated
with either EBRT or local therapy.
Follow up: min 2 years
External beam
radiotherapy (n=15)
Versus
Local therapy (n=9) –
cryotherapy (n=7) or
photocoagulation
(n=1) or
brachytherapy (n=1)
Occurrence of new or
recurrent tumours
Cryotherapy for retinopathy of prematurity
Background
Retinopathy of prematurity (ROP) is a disease affecting pre-term infants. Normally, the retina is
fully vascularised at term however the retina in pre-term infants may not be fully vascularised.
While the precise mechanism for ROP is not fully understood, it likely involves the exposure of
immature retinal vasculature to hyperoxic conditions, directly triggering a neovascular response
(Kretzer and Hittner 1988) or resulting in the destruction of capillaries and the upregulation of
vascular endothelial growth factor (VEGF), resulting in neovascularisation (Ashton 1980). The
incidence of ROP increases as the birth weight of preterm infants decreases (Fielder, Shaw et al.
1992) and is more common in male than female infants. ROP is a leading cause of visual loss in
children (Fleck and Dangata 1994; Hussain, Clive et al. 1999). Treatment for the condition has been
limited to the destruction of peripheral retina by cryotherapy with an external probe or
photocoagulation in an attempt to decrease the hypoxic tissues and neo-vascularisation of the
retina.
Research question
Is cryotherapy a safe and effective procedure for the treatment of infants with retinopathy of
prematurity?
Results
Two articles of good quality reported on the results of the same randomised controlled trial, which
compared cryotherapy with observation in the treatment of retinopathy of prematurity (
Page 132
Table 41). Dobson et al (2006) reported the 10 year outcomes of the study but did not provide a
statistical comparison. Palmer et al (2005) reported on visual acuity and structural outcomes at 15
years and provided adequate comparison between groups. Adjusting for a loss to follow up, 55 per
cent of eyes that underwent cryotherapy had a favourable visual outcome compared with 36 per
cent of control eyes (p<0.001). Eyes treated with cryotherapy had approximately a 50 per cent
greater chance of a favourable visual outcome than those eyes that were observed [RR 1.55, 95%
CI 1.23, 1.95]. This outcome was mirrored by the structural outcomes, measured as favourable or
not favourable by eye examination and ultrasonography. A favourable outcome ranged from a
normal posterior pole to a partial retinal detachment not involving the fovea. An unfavourable
outcome ranged from a partial retinal detachment involving the fovea to cataract, corneal opacity,
full retinal detachment or enucleation. Eyes treated with cryotherapy were 46 per cent more likely
to have a favourable structural outcome at 15 years compared with eyes that were observed [RR
1.46, 95% CI 1.22, 1.74] (p<0.0001).
Conclusion
Cryotherapy (with external probe) for pre-term infants with threshold retinopathy of prematurity
improves long term visual acuity compared with observation. No evidence was available
comparing cryotherapy with other active treatments such as photocoagulation or in combination
with pharmaceuticals. In addition, side effects attributed to cryotherapy were not reported.
Cryotherapy is an effective treatment for retinopathy of prematurity although further research in
this area is warranted. The body of evidence for safety, accuracy and effectiveness is summarised
in the matrix at Box 10.
Box 10
Body of evidence matrix for cryotherapy versus observation for retinopathy of prematurity
Component
Evidence base
Rating
B
Consistency
NA
Clinical impact
A
Generalisability
B
Applicability
B
Description
One RCT (level II evidence) of good quality with low risk of bias
Only one study.
The clinical impact is substantial given the effect size and the
importance of visual acuity as an outcome.
The study was undertaken in the US and it is likely that the results
are generalisable to the Australian population.
The healthcare system in the US is different to that in Australia,
however, as the trial was multicentre, it is likely that patients were
treated by a mixture of highly specialised paediatrician oncologists
and doctors who are not so highly trained.
Page 133
Table 41
Profiles and results of studies comparing cryotherapy versus observation for
retinopathy of prematurity
Randomised controlled trials (RCTs) comparing cryotherapy to observation for the treatment of
retinopathy of prematurity
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Palmer, Hardy et al. 2005)
Level II evidence RCT of good quality
N= 254
Country : USA (multicentre)
Mean age : not reported – the paper is examining visual
acuity at 15 years (therefore patients are 15 years old).
Sex : Not reported (referred to previous paper)
Inclusion: Premature infants of less than 1251 g in weight
that developed developed threshold ROP
Follow up: 15 years
Randomised to:
Cryotherapy (if
bilateral ROP, one
eye randomised to
cryotherapy and the
other automatically
was an observed eye,
if unilateral,
randomised to either
cryotherapy or
control).
Versus
Control
Effectiveness: visual acuity
at 15 years, structural
outcome at 15 years
Results
Results at 15 years
Cryotherapy
Observation
% (n/N)
% (n/N)
p value
Favourable visual outcome†
55.3 (105/190) 35.7 (66/185)
<0.001
Favourable structural outcome¥
70 (126/180)
48.1 (87/181)
*<0.0001
†defined as better than 20/200 best corrected vision, unfavourable is vision worse than this or blindness
¥defined using pre-determined criteria, see (Palmer, Hardy et al. 2005)
*comparison not reported by authors, estimated using aggregated data
(Dobson, Quinn et al. 2006)
Level II evidence RCT of good quality
N= 255
As above (population included in Palmer et al (2005) 15
year analysis
Follow up: 10 years
As above
Effectiveness: visual acuity
at 10 years (comparative
stats not provided).
An additional analysis was undertaken to determine whether item number 42728 could be
removed from the Schedule and whether 42818 could have a revised descriptor to reflect its use
with selected other procedures.
Research question
Is it reasonable that item number 42728 could be removed and 42818 could be utilised under a
revised MBS item descriptor?
The current status of MBS item numbers
42728: Cryotherapy of retina or other intraocular structures with an internal probe, being a
service associated with a service to which item 42725 applies.
This item number describes endocryotherapy and must be billed with vitrectomy.
Page 134
42773: Detached retina, diathermy or cryotherapy for, not being a service associated with
a service to which item 42776 applies.
This item number describes cryotherapy used for retinal detachment, but cannot be claimed if
scleral buckling or resection is performed.
42818: Retina, cryotherapy to, as an independent procedure, with external probe not being
a service to which item 42773 applies.
This item number describes cryotherapy of the retina, although not for the treatment of retinal
detachment.
Background
The Medicare Benefits Schedule item number 42818 currently reads as: “RETINA, CRYOTHERAPY
TO, as an independent procedure, with external probe not being a service to which item 42773
applies”.
The RANZCO suggested that this item number could be amended to read “RETINA, CRYOTHERAPY
TO, not being a service to which item 42773 applies”.
The rationale behind this proposed amendment was that the current restriction “as an
independent procedure” in the descriptor of item 42818 may have had the unintended
consequence of driving an increased use of item MBS 42773, which has a significantly higher fee
and is for retinal detachment, rather than retinal tear.
There appears to be little regional variation in the use of 42818 (WA, Tas and NT do not use it and
the remaining States bill a similar small proportion of services), therefore if the more costly 42773
item number is being wrongly claimed, it must be occurring across most States (Figure 7).
However, there is substantial regional variation concerning the use of item number 42728
(endocryotherapy) and 42773 (diathermy or cryotherapy for a detached retina). Due to the
current MBS item number descriptions, it is possible that 42773 may be billed instead of 42728,
which would result in a substantially higher reimbursement. In South Australia, where the rate of
procedures per 100,000 people for item number 42773 is substantially lower (2.2 per 100,000)
than the Australian average (14.0 per 100,000), the rate of reimbursement for endocryotherapy is
far higher than the national average without the SA contribution (7.2 versus 0.4 per 100,000
people). If there is indeed a substitution of 42728 with 42773, then the average additional fee per
substituted procedure is in the order of $650.
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Figure 7
Procedures billed to Medicare per 100,000 population for MBS item numbers 42818,
42776, 42773, 42728
The RANZCO indicated that endocryotherapy is very infrequently performed and that as a
consequence item 42728 could be made redundant – thus, the available MBS usage data,
suggesting apparent geographic variations in practice, might instead reflect incorrect billing
practices. The RANZCO suggested that the reference to an ‘external probe’ could be removed in
the revised descriptor for MBS item 42818 as endocryotherapy (with an internal probe) would still
not be able to performed because the descriptor also specifies its occurrence “as an independent
procedure” (ie endocryotherapy is required to be performed in association with vitrectomy, and
so would not qualify).
However, the RANZCO also suggested removing the requirement for item 42818 to be an
independent procedure in order to allow the procedure to be given at the time of other retinal
procedures, such as scleral buckling or resection. Such an amendment would have the
consequence of allowing endocryotherapy to be performed. Item number 42728 for
endocryotherapy currently attracts a full fee of $217.15, while the MBS item number 42818 for
cryotherapy currently has a full fee of $564.25. It is likely that, while endocryotherapy may not be
a less complex procedure than cryotherapy with an external probe, much of the preparation
involved with endocryotherapy is performed during vitrectomy (Item number 42725, full fee
$1,287.75), a procedure required to occur in parallel with endocryotherapy. It is logical that a
procedure that is described as an “independent” procedure will require greater preparation than
one that is coupled with another procedure, and therefore should be reimbursed at a higher rate.
By effectively combining these two numbers, removing “independent” procedure and keeping the
same fee for item 42818, current endocryotherapy procedures - just fewer than 160 a year but
increasing exponentially (see Appendix D, Figure 38) - would be reimbursed at a higher rate.
Further, by removing “as an independent procedure” MBS item number 42818 could also be billed
during a detached retina operation (MBS item number 42776). It is currently not possible to bill for
the combination of a buckling or resection operation for a detached retina and concurrent
cryotherapy. It is possible that much of the preparation required for cryotherapy is completed
Page 136
during a detached retina operation and the procedure would therefore be far shorter than if it
were performed in the absence of scleral buckling or resection. Given that the duration of
administering cryotherapy is likely to be short, the question was posed whether the use of
cryotherapy was assumed to be encompassed by the detached retina, buckling or resection
operation (item number 42776), if required; or, if cryotherapy does significantly extend the
operating time, it was suggested that an additional fee may be warranted. Any fee should reflect
the complexity and duration of the procedure.
As a consequence of the above issues, the RANZCO agreed that rather than removing “as an
independent procedure” from the descriptor of MBS item number 42818, a list of items that can
be “co-billed” with item 42818 will be developed for incorporation into the descriptor (see Box
11).
Box 11
42818
Retinal cryotherapy item descriptor amendments
RETINA, CRYOTHERAPY TO, as an independent procedure, with external probe or
when performed in conjunction with item 42809, 42770 or 42771 (Anaes.)
Conclusion
Although only small numbers of 42728 and 42818 occur each year, they describe different
procedures, one of which (endocryotherapy) is infrequently performed according to clinical
sources. Perhaps the primary difference between the item numbers should not be the emphasis
on the type of cryotherapy (external or internal) but rather that item number 42728 may be used
in conjunction with vitreoretinal surgery (to assist in the closure of retinal tears or to encourage
retinal reattachment) whereas it is expected that 42818 is to be used as a procedure on patients
with retinal tears not associated with concurrent surgery. A revised descriptor for item 42818 was
developed that retains the wording "as an independent procedure" but lists a limited number of
items which may be co-billed, not including items 42776, 42773 or 42725. It was suggested that
item 42728 could be made redundant.
Page 137
3.15
Retinal services
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA
review
42773, 42776, 42779, 42812
Retinal services
Stakeholder
negotiation**
Guideline
concordance
x
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
Summary of Findings
Item 42773 (cryotherapy) – The use of this procedure in Australia is common and increasing. Although there
appears to be some overlap between 42773 (the use of cryotherapy for retinal detachment) and 42818 (the
application of cryotherapy to the retina), item number 42773 was intended to be used for the pneumatic
retinopexy procedure and 42818 was to be used for sealing retinal breaks and horseshoe tears. Item 42773
appears to be often used in conjunction with vitrectomy and intra-vitreal injection. Clarification of the descriptor
for 42773 may be warranted to indicate that it is meant to describe pneumatic retinopexy.
Item 42773 (diathermy) - No guideline recommendations were found to support or oppose the use of
diathermy. Clinical advice suggests that diathermy is now rarely, if ever, used as a form of retinopexy.
Item 42776 - No guideline recommendations were found to support or oppose the use of scleral buckling or
resection. In the mini-HTA, three randomised controlled trials (RCTs) and two comparative studies reported
that pars plana vitrectomy (PPV) (item 42725) had comparable primary reattachment rates to scleral buckling,
with only one RCT reporting significantly better reattachment rates for PPV. Use of scleral buckling for primary
re-attachment has, however, been steadily decreasing while PPV usage has been steadily increasing
(although at a faster rate than the decline in scleral buckling). The evidence comparing scleral buckling with
pneumatic retinopexy appears to favour scleral buckling in terms of the single operation rate, although the
difference was not statistically significant.
Item 42779 – None of the available guidelines provided recommendations regarding revision operations for a
detached retina. In the mini-HTA, although there was no significant difference in the final reattachment rates
between the PPV and scleral buckling (SB) techniques, less intra-operative and post-operative complications
were reported in patients in the PPV group. The degree of improvement in final visual acuity also appeared to
be better after reattachment with PPV. The literature suggests that PPV is the preferred mode of surgery for
repairing failed cases of retinal detachment irrespective of the technique used for the primary surgery, although
in some failed cases of scleral buckling, laser photocoagulation and or gas tamponade were used in addition to
secondary SB. The final reattachment rate and visual acuity when comparing scleral buckling with pneumatic
retinopexy did not differ.
Pars plana vitrectomy is generally the preferred method of revision for retinal re-detachment, and can be billed
using item 42725. Clinical advice suggests that revision of scleral buckling, rather than vitrectomy, is preferred
in a small number of cases. The adoption of RANZCO's recommendation that the wording of 42779 be
amended to:
"DETACHED RETINA, revision of scleral buckling operation for (Anaes.) (Assist.)"
would clarify the original intent of 42779, which is that it should be used only for a buckle revision.
Item 42812 - No evidence was found with respect to removal of a silicone band in patients who have had a
detached retina. The procedure appears to be uncommon.
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Clinical advice indicates that the three basic treatment options for retinal detachment in
contemporary practice are:
1. scleral buckling (SB) (item 42776)
2. vitrectomy (pars plana vitrectomy, PPV) (item 42725), and
3. pneumatic retinopexy (PR) (item 42773)
Pneumatic retinopexy can be performed using either cryotherapy or laser photocoagulation
(diathermy) as the form of retinopexy, depending on surgical factors and clinician preference.
Diathermy is now rarely, if ever, used as a form of retinopexy. It serves a useful function in both
internal and external methods of retinal detachment repair, but its use is “included” in the
relevant item numbers (eg if used when doing SB, it is included as part of 42776).
The four retinal services items (42773, 42776, 42779, 42812) relate to retinal detachment, with
the latter two relating to revision of a re-attached retina. Of these items, 42773 and 42779 have
increased considerably, especially since 2006, with 42773 being the highest of the group, in
numbers and cost (see Appendix D for further detail).
Analysis of data relating to claims for multiple services in the past three years, shows that 42773 is
often combined with claims for intra-vitreal injection and vitrectomy (refer to Appendix D, Table
145).
The graphs produced from hospital data reflect the general increase in retinal procedures,
especially since 2006, whether looking at hospital separations by AR-DRG (see
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Appendix E, Figure 49), by principal diagnosis (disorders of choroid and retina – see Appendix E,
Figure 52), or by procedure (posterior segment, retina, and retinal photocoagulation – see Appedix
E, Figure 55).
Guideline concordance analysis was undertaken for the detached retina items. One guideline of
moderate quality (AAO 2008) reported on the use of laser photocoagulation and cryotherapy for
the treatment of retinal tears and vitreous detachment. The AAO 2008 reported moderate level
evidence to support the use of laser photocoagulation or cryotherapy in the treatment of acute
symptomatic horseshoe tears (as discussed for item 42818 above) to prevent retinal detachment.
Cryotherapy was mentioned as having a key role in sealing retinal breaks to prevent retinal
detachment, although no randomised controlled trials were available to provide guidance.
Treatment of retinal detachment with cryotherapy ie to maintain chorioretinal apposition, is
invariably done with pneumatic retinopexy – an outpatient procedure that involves closure of the
breaks with cryopexy and then administering an expanding balloon in the vitreous.
Concordance conclusions
Although there appears to be some overlap between 42773 (the use of cryotherapy for retinal
detachment) and 42818 (the application of cryotherapy to the retina), the wording of the item
descriptor for 42773 is sufficiently clear that there must be a retinal detachment, thus treatment
of a horseshoe retinal tear with cryotherapy should be billed as 42818 (retinal cryotherapy with an
external probe) and treatment using pneumatic retinopexy should be done using 42773.
While alteration of these MBS item descriptors is not required for evidence based practice,
clarification of these MBS item numbers may be warranted.
No guideline recommendations were found to support or oppose the use of diathermy (MBS item
42773), scleral buckling or resection (item 42776), a revision operation for a detached retina (item
42779) or the removal of a silicone band in patients who have had their retina re-attached (item
42812). Item 42812 is for removal of a scleral buckle. Clinical advice suggests that it occurs in
around 1-2% of cases following scleral buckling (item 42776) and is done because of exposure or
infection of the explant, or occasionally other complications such as diplopia induced by the
buckle.
Cryotherapy for the treatment or prevention of retinal detachment
Background
The retina is the layer of specialised tissue capable of sensing light and transmitting information,
via the optic nerve, to the brain. Retinal detachment (RD) occurs when the neurosensory retina
and the inner tissue layers separate from the underlying retinal pigment epithelium (RPE). This
occurs when one or more retinal breaks leads to an accumulation of sub-retinal fluid (SRF). There
are three main types of RD categorised on a clinical and aetiological basis. Primary or
rhegmatogenous RD is the most common, and involves the full thickness of the retina. Secondary
RDs include tractional and exudative (serous) types.
Rhegmatogenous retinal detachment occurs when there is a break in the retina, such as a hole or
a tear, which allows fluid from the vitreous space to accumulate underneath the retina. Retinal
detachment occurs when the accumulated fluid slowly lifts the retina from the underlying
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epithelium. Exudative retinal detachment occurs due to the accumulation of fluid underneath the
retina in the absence of a hole and is due to inflammation or vascular abnormalities, or rarely
cancer, developing in the tissue beneath the retina. Tractional retinal detachment occurs when the
retina is pulled from the underlying epithelium and occurs when fibrous tissue becomes attached
to the retina, often following inflammation or neovascularisation. The same process may
introduce tears in the retina which may then lead to rhegmatogenous retinal detachment.
However, asymptomatic retinal holes (with or without associated lattice degeneration) rarely
result in retinal detachment. In a study involving patients with retinal breaks, asymptomatic retinal
breaks (in patients with no previous retinal detachment in either eye) resulted in retinal
detachment in only 0.5 per cent over an average of 11 years follow up (Byer 1998). Given that
tears and holes are readily visible to ophthalmologists during routine evaluations, asymptomatic
tears are easily diagnosed. Treatment of RD primarily relies on the identification and plugging of
the retinal breaks to uphold the chorio-retinal apposition, which aims to prevent further influx of
SRF, the external or internal drainage of SRF, and to alleviate vitreo-retinal traction. The main
surgical procedures employed to achieve these goals are scleral buckling (SB), pars plana
vitrectomy (PPV), and pneumatic retinopexy (using cryotherapy or laser, or more rarely diathermy,
for the retinopexy).
An evidence-based analysis using a mini-HTA format was undertaken for the retinal detachment
items.
Research question
Is cryotherapy a safe and effective procedure for the prevention or treatment of retinal
detachment?
Cryotherapy, applied trans-sclerally or trans-conjunctivally, is able to destroy choroidal and retinal
tissues and form a chorioretinal scar, increasing adhesion of the retina to the retinal pigment
epithelium.
Pre-specified criteria for the selection of literature to address the research question are provided
in Table 42.
Table 42
PICO criteria for retinal cryotherapy
Characteristic
Inclusion Criteria
Population
Eye disease
Interventions
Retinal cryotherapy using an external probe, Retinal cryotherapy using an internal probe
(endocryotherapy)
Comparator
NA
Outcome
Latest occurrence (date) of published research on both procedures, circumstances where
these procedures might be used, any safety and/or effectiveness concerns reported in the
literature regarding both procedures
Search strategy
A search of the Cochrane library – including the Cochrane database of systematic reviews,
Database of abstracts of reviews of effects (DARE) and the HTA database, the economics database,
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EconLit, and Embase.com (consisting of both Embase and Medline) was conducted using the
search terms outlined in Table 43.
Table 43
Search terms utilised for retinal cryotherapy
Population
('eye'/exp OR 'eye disease'/exp) AND
Intervention
('cryotherapy'/exp OR retin* near/2 cryo*) AND
Limits
1. [English language]/lim AND [humans]/lim AND [2005-2011]/py AND [systematic review]/lim
2. [humans]/lim AND [2005-2011]/py AND ([systematic review]/lim OR [controlled clinical trial]/lim OR [meta
analysis]/lim OR [randomized controlled trial]/lim)
3. [article]/lim AND [humans]/lim AND [2005-2011]/py
Availability and level of evidence
The Cochrane Library, EconLit, Medline and Embase were searched from January 2005 to
November 2010 according to pre-specified search. Limited to systematic reviews and randomised
controlled trials (Limit 2 of the Medline and Embase search), 407 articles were retrieved. Following
a review of the abstract and full-text (if eligibility was unclear), three studies addressed the use of
cryotherapy in the management of retinal detachment. The complete article was retrieved and
assessed for quality using the PRISMA checklist for systematic reviews and the SIGN checklist for
randomised controlled trials.
Results
Two systematic reviews were identified that addressed the prevention of retinal detachment in
patients with asymptomatic retinal breaks or lattice degeneration (Wilkinson Charles 2005) and
prevention of a giant retinal tear (GRT) in the fellow eye of patients with a GRT (Ang Ghee,
Townend et al. 2009). Neither systematic review identified any randomised controlled trials,
therefore conclusions regarding the effectiveness of cryotherapy for these indications were not
possible.
One randomised controlled trial (RCT) of moderate quality compared the effectiveness of retinal
reattachment after scleral buckling with and without trans-scleral retinal cryopexy (Mahdizadeh,
Masoumpour et al. 2008). No difference in the success of scleral buckling with or without retinal
cryopexy over a minimum follow up period of 34 months was reported (Table 44). The authors
conclude that scleral buckling without cryopexy is a simpler procedure and may decrease the
possible adverse effect of cryotherapy on the progression of proliferative vitreoretinopathy. This
study is limited by the small number of patients (n=55) and may also not have sufficient follow up
to detect late detachments.
Conclusion
There is insufficient evidence to recommend the use of trans-scleral retinal cryotherapy for the
treatment or prevention of retinal detachments or giant retinal tears. One RCT of moderate
quality reported no difference in the success of retinal reattachment using scleral buckling with
and without cryopexy. Further research on cryotherapy for retinal reattachment, either in
combination with other techniques (such as scleral buckling) or by itself, is required before the
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safety and effectiveness of this procedure can be determined. The body of evidence for safety,
accuracy and effectiveness is summarised in the matrix at Box 12.
Box 12
Body of evidence matrix for scleral buckling with and without transscleral retinal cryopexy
for retinal reattachment
Component
Evidence base
Rating
C
Consistency
NA
Clinical impact
B
Generalisability
C
Applicability
C
Table 44
Description
One RCT (level II evidence) of moderate quality and moderate
risk of bias.
Only one study.
The clinical impact is potentially substantial if cryopexy is not
required in combination with scleral buckling. Patients may avoid
potential complications associated with cryopexy and there may
be reduced cost of the procedure.
The study was undertaken in Iran, and it is unclear whether the
population will be similar to that in Australia. There may be
differences in mean age, levels of comorbidities and extent of
disease when diagnosed. However, this finding is probably
largely generalisable to the Australian population.
The healthcare system in the country in which the RCT was
performed may differ substantially to that in Australia. It is unclear
whether differences in ophthalmological practice, follow up,
alternative or auxillary treatments and patient selection will impact
upon the applicability of the study’s findings to the Australian
healthcare context.
Study profiles and results comparing retinal cryotherapy to control or alternative
treatments in the prevention of retinal detachment
Randomised controlled trials (RCTs) comparing retinal cryotherapy to control or alternative treatments in
the prevention of retinal detachment
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Mahdizadeh, Masoumpour et al. 2008)
Level II evidence RCT of moderate quality
N= 55
Country: Iran
Mean age: 54.36 years (scleral buckling alone), 53.45 years
(scleral buckling with retinal cryopexy)
Sex: 38.2% female
Inclusion: Consecutive patients with rhegmatogenous retinal
detachment with proliferative vitreoretinopathy (grades A or
B).
Exclusion: mono-ocular patients, patients with previous
retinal detachment surgery or previous pars plana
vitrectomy, PVR > grade B aand vitreous haemorrhage.
Follow up: 34-56 months
Randomised to:
Scleral buckling
surgery
Versus
Scleral buckling
surgery plus
transscleral retinal
cryopexy (to retinal
breaks or holes or
peripheral part of
detached retina when
no holes were
located).
Safety: progression of
proliferative
vitreoretinopathy
Results
Retinal reattachment
Cryopexy
% (n/N)
84.8 (28)
No cryopexy
% (n/N)
90.9 (20)
p value1
0.68
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Effectiveness: proportion
of successful retinal
reattachments at final
follow up
Systematic Reviews (SRs) comparing retinal cryotherapy to control or alternative treatments in the
prevention of retinal detachment
1
Study, review period and quality
appraisal
Population characteristics, inclusion criteria
(Wilkinson Charles 2005)
Level of evidence: NA
Assessment of quality: NA
Cochrane review
Cochrane Library to Issue 4, 2008
Medline: Jan 1966 to Nov 2008
Embase: Jan 1980 to Nov 2008
Systematic review – no publications found relevant to this mini-HTA.
Population:
Studies of patients with asymptomatic retinal break and / or lattice
degeneration.
Intervention:
Studies of patients receiving any type of treatment (including
photocoagulation and trans-conjunctival cryotherapy)
Included studies, population characteristics and
inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
No randomised controlled trials found relevant to this
review.
NA
NA
Study, review period and quality
appraisal
Population characteristics, inclusion criteria
(Ang Ghee, Townend et al. 2009)
Level of evidence: NA
Assessment of quality: NA
Cochrane review
Cochrane Library to Issue 4, 2009
Medline: Jan 1950 to Oct 2009
Embase: Jan 1980 to Oct 2009
Lilacs: Jan 1982 to Oct 2009
Systematic review – no comparative studies were found relevant to this
review.
Population:
Randomised controlled trials involving patients with unilateral giant retinal
tear (GRT).
Intervention:
Randomised controlled trials of 360-degree laser photocoagulation or 360degree transscleral cryotherapy or 360-degree encircling sclera buckling in
the unaffected eye as prophylactic treatment for GRT or retinal detachment.
Included studies, population characteristics and
inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
No randomised controlled trials found relevant to this
review.
NA
NA
Fisher exact test
Research questions
What is the revision rate for primary scleral buckling retina reattachment surgery (item 42776),
relative to other retinal re-attachment procedures ie diathermy, cryotherapy (item 42773) or
vitrectomy (42725)?
For scleral buckling, for what reason does reoperation occur, other than for failure of retina
reattachment?
Are some of these revision operations more complex than others?
Pre-specified criteria for the selection of literature to address this question are provided in Table
45.
Table 45
PICO criteria for retinal detachment items
Page 144
Characteristic
Population
(1) People with retinal detachment
(2) People having undergone a previous retinal attachment procedure
Interventionsa
(1) Primary retinal attachment procedures
(2) Revision of retinal attachment procedures
Comparatorsa
(1) Primary retinal attachment procedures will be compared with each other
(2) Revision procedures will be compared with each other
Outcomea
a
Inclusion Criteria
Safety
(2) Complications associated with the revision procedure
Effectiveness
(1) Revision rate (failure of primary retinal reattachment), reoperation rate for
reasons other than revision (eg removal of scleral buckling material, silicone
band)
(2) Procedure duration, procedure complexity/need for assistance
Numbering relates to the population of interest ie population (1) or population (2)
Search strategy
A search of the Cochrane library – including the Cochrane database of systematic reviews,
Database of abstracts of reviews of effects (DARE) and the HTA database, the economics database,
EconLit, and Embase.com (consisting of both Embase and Medline) was conducted using the
search terms outlined in Table 46.
Page 145
Table 46
Search terms utilised for retinal detachment items
Population
'vitreous'/exp OR 'retina detachment'/exp OR detach* OR 'vitreous body detachment'/exp OR
'vitrectomy'/exp AND
Intervention
(intraocular NEAR/2 tamponade OR 'vitreous' NEAR/10 substitut* OR 'silicone gel'/exp OR
'organofluorine derivative'/exp OR 'glycosaminoglycan'/exp) AND
Limits
1. [English language]/lim AND [humans]/lim AND [2005-2011]/py AND [systematic review]/lim
2. [humans]/lim AND [2005-2011]/py AND ([systematic review]/lim OR [controlled clinical trial]/lim OR [meta
analysis]/lim OR [randomized controlled trial]/lim)
3. [article]/lim AND [humans]/lim AND [2005-2011]/py
Availability and level of evidence
The Cochrane Library, EconLit, Medline and Embase were searched from January 2005 to
November 2010 according the search specified in the review protocol. Limited to systematic
reviews and randomised controlled trials (Limit 2 of the Medline and Embase search), 12 relevant
studies were identified from the title and abstract, however, the full text for eight of these could
not be retrieved. The remaining four studies included for analysis compared SB with PPV. Further
levels of evidence (Limit 3, pseudorandomised trials, comparative studies and case series) were
then searched only for studies comparing SB with diathermy or cryotherapy
(cryophotocoagulation or pneumatic retinopexy) without success. One literature review
(evidence-based analysis) comparing SB with pneumatic retinopexy (PR) and PPV was included in
this assessment (Saw, Gazzard et al. 2006).
Results
A moderate quality randomised controlled trial (RCT) by Koriyama et al (2007) assigned 46 eyes of
46 patients with rhegmatogenous retinal detachment (RRD) to receive either SB or PPV. The rate
of retinal reattachment after the primary operation was similar in both groups and two eyes in
each group required reoperation. In the SB group, the retina of one eye was reattached by gastamponade and laser photocoagulation, however, successful reattachment in the remaining retina
was only achieved after four additional PPVs. In the PPV group, both eyes were successfully
treated by an additional PPV. The failure to reattach after a single operation was due to
proliferative vitreoretinopathy (PVR) and a fish-mouth retinal tear. A higher proportion of patients
in the PPV group achieved a best corrected visual acuity (BCVA) ≥ 0.8 (Snellen chart) compared to
patients in the SB group. This difference was statistically significant at 3, 6 and 12 months after the
primary operation but not at the 24 and 36 month follow-up time points.
Koriyama et al (2007) reported that none of the postoperative complications that occurred during
these procedures influenced final visual outcomes. The subjective assessment of pain and surgical
discomfort demonstrated that more patients in SB group experienced intermediate or strong
ocular pain, and were dissatisfied with their final levels of vision, compared to those patients in
the PPV group. However, a substantial number of patients who underwent PPV complained about
discomfort in the prone posture required for the procedure (Table 47).
Page 146
The RCT conducted by Azad et al (2007) evaluated the results of phakic RRD patients (n=61)
randomised to treatment with SB or PPV. The reported primary success rates for retinal
reattachment were comparable in both groups (80.6% and 80% for the SB and PPV groups,
respectively, p = 0.21) and the final success rate at the six months was 100 per cent in both
groups. The majority of initial treatment failures were due to an open break, which accounted for
four and three cases of treatment failure in the SB and PPV groups, respectively. Other causes of
treatment failure included PVR in the PPV group and improper buckling in the SB group. The
median BCVA at one week and one month post surgery was significantly better for patients in the
SB group compared to patients in the PPV group, however, the final median BCVA in both groups
was not statistically different (p=0.37) (Table 47). Follow-up in this study was 6 months so
formation of cataract, or requirement for subsequent cataract surgery (clinical advice suggests this
is invariably a consequence of PPV in phakic patients), appears not to have been reported.
A moderate quality study by Sharma et al (2005) randomly assigned 50 eyes of 50 consecutive
patients with uncomplicated pseudophakic RRD to either SB or PPV. The primary reattachment
rate attained in both groups was comparable with no statistically significant difference observed
(p=0.48). A total of six eyes required reoperation in the SB group, while four eyes in the PPV group
required repeated surgery. The main cause of treatment failure was PVR which occurred in five
eyes amongst the SB group and one eye in the PPV group. Open breaks led to the failure of one
eye in the SB group and three eyes in the PPV group. The failed cases from both the groups
underwent PPV for secondary reattachment. Mean pre-operative and mean post-operative BCVAs
showed statistically significant improvement at six months following treatment with PPV
compared to SB (p=0.034). There were few intra-operative and post-operative complications in
both the groups, with none of the complications requiring surgical intervention, except redetachment with PVR. There was a transient rise in intraocular pressure (IOP) in the PPV group
and intractable secondary glaucoma occurred in one eye, which required a cyclo-destructive
procedure (Table 47).
The moderate quality study by Brazitikos et al (2005) included 150 eyes of 150 patients with
pseudophakic RRD, equally randomised to either SB or PPV and followed up at one year postoperatively to assess primary retinal reattachment. The primary reattachment rate was
significantly better in the PPV group compared to the SB group (94 vs 83%, respectively, p=0.037).
The causes of treatment failure in both groups were open breaks and PVR. Inadequate buckling
caused treatment failure only in patients in the SB group. The rate of reoperation was high in the
SB group in comparison to the PPV group (17 vs 8%, respectively), however after reoperation,
retinal reattachment was successful in 94.7 and 98.7 per cent of cases in the SB and PPV groups,
respectively. Compared to patients undergoing SB, patients who underwent PPV experienced
shorter operative times, more intra-operative diagnoses of unidentified retinal breaks, minimal
axial length change, and less reoccurrence of post-operative RD. Brazitikos et al (2005) also
reported intra-operative complications during both procedures and noted that iatrogenic retinal
breaks were the most common complication in the PPV group while drainage complications were
the most common occurrences in the SB group. The final BCVA at one year was not significantly
different between groups (p=0.26).
Page 147
A recent review (2006)25 compared three different surgical procedures i.e. SB, PPV and PR for
uncomplicated RRD (Saw, Gazzard et al. 2006). Rates of single-operation retinal reattachment at
six months, overall retinal reattachment with reoperations, and final visual acuity were reported.
The analysis included only RCTs and controlled trials without randomisation (non-RCTs). This
review summarised the results of two RCTs (Mulvihill et al 1996; Tomambe et al 1991) and three
non-RCTs (Han et al 1998; Kreissig et al 1989; McAllister et al 1988) evaluating the efficacy of SB
with PR for the treatment of uncomplicated RRD (Table 48Table 48).
Tornambe et al (1991) demonstrated that the single operation reattachment rates at six months
were 82 and 73 per cent in the SB and PR groups, respectively (p > 0.05), while overall
reattachment with reoperations after two years of follow-up were 98 and 99 per cent in the SB
and PR groups, respectively. The final visual acuity ≥20/50 in eyes with macular detachment for
≤14 days was reported to be significantly improved in more patients among the PR group
compared to the SB group (89 vs 67%, respectively, p<0.05). Mulvihill et al (1996) reported no
significant differences in rates of single-operation reattachment among the PR and SB groups, (70
vs 80%, respectively, p=0.5) or overall reattachment with reoperations (90 vs 100%, respectively,
p=0.5). Final visual acuity was not reported.
In general, the results for the single-operation reattachment in both RCTs appeared to favour SB;
although these differences did not achieve statistical significance. There were no significant
differences reported for overall reattachment rates in both groups. Similar results were reported
by two of the comparative studies (Kreissig et al PR = 79.6%, SB = 91%, and Han et al PR = 62%, SB
± postoperative laser = 84%, p 0.01). For overall reattachment rates SB was either comparable or
better than PR. Only Han et al reported on final visual acuity, finding no significant differences
between both groups.
Saw et al (2006) also summarised the results of one RCT (Ahmadieh et al 2005) and two non-RCTs
(Miki et al 2001; Oshima et al 2000) where SB was compared with PPV26. Ahmadieh et al (2005)
randomly assigned 225 patients with pseudophakic or aphakic RRD to SB or PPV without any
buckle and found no statistically significant difference in single-operation retinal reattachment
rates and postoperative visual acuity at 1, 2, 4 and 6-months. Both of the comparative studies
observed similar single-operation reattachment rates in both treatment groups. Oshima and
colleagues observed a rate of 91 per cent for both groups (p=0.72), while Miki and others reported
a rate of 92 per cent for both groups, with a final reattachment rate of 100 per cent for both
groups. Oshima et al (2000) reported that the final visual acuity was significantly better in patients
in the PPV group compared to the SB group, with mean values of 0.95 and 0.54 (logMAR unit),
respectively (p=0.03). Also, patients with poor pre-operative visual acuity, ocular hypotony or
macular detachment (>7 days) made a better visual recovery after PPV compared to patients who
underwent SB.
No evidence was identified in respect to the complexity of revision operations for retinal
detachment after failure of primary reattachment surgery.
25
This review was not a systematic review, but did, however, describe a number of RCTs and comparative, nonrandomised studies. The full text of these individual studies included in this review could not be obtained therefore
the complete study profiles have not been provided in the data tables.
26
No details of these studies were provided by Saw et al
Page 148
Diathermy is used to seal the retinal breaks by producing chorioretinal adhesion due to thermal
injury. No literature was identified that compared SB with diathermy, presumably because
historically diathermy was itself part of the SB procedure.
Conclusions
Three RCTs and two comparative studies reported that pars plana vitrectomy had comparable
primary reattachment rates to scleral buckling, with only one RCT reporting significantly better
reattachment rates for PPV. Although there was no significant difference in the final reattachment
rates between the PPV and scleral buckling techniques, less intra-operative and post-operative
complications were reported in patients in the PPV group. The degree of improvement in final
visual acuity appeared to be better after reattachment with PPV. Open breaks, PVR or inadequate
buckling were the main reasons for reoperation. The literature suggests that PPV is the preferred
mode of surgery for repairing failed cases of retinal detachment irrespective of the technique used
for the primary surgery. The evidence comparing scleral buckling with pneumatic retinopexy
appears to favour scleral buckling in terms of the single operation rate, although this difference
was not significant. The final reattachment rate and visual acuity also did not differ between these
groups.
Ordinarily, it would be recommended that - on the basis of the evidence - the descriptor of 42779
should restrict revision of a primary reattachment procedure to PPV only. However, the literature
also suggests that in some failed cases of scleral buckling, laser photocoagulation and or gas
tamponade are used in addition to a secondary SB. This is supported by clinical advice indicating
that there are a small number of patients in whom a secondary scleral buckle is necessary, in
preference to PPV.
As such, an explanatory note could be added to item 42725 (pars plana vitrectomy) to indicate
that it can be used for PPV either for primary retinal re-attachment or revision of a retinal reattachment. Further, to avoid those cases where both items 42779 and 42725 are being claimed
for revision of a retinal detachment repair, it is suggested that the descriptor for item 42725 state
“not being a service associated with a service to which item 42779 applies”.
Alternatively, adoption of RANZCO’s recommendation that the wording of 42779 be amended to:
"DETACHED RETINA, revision of scleral buckling operation for (Anaes.) (Assist.)"
would clarify the original intent of 42779, which is that it should be used only for a buckle revision
– suggested as being a more complex operation (although this could not be confirmed in the
evidence-base) than a revision of a reattachment via pars plana vitrectomy, and thus warranting
the higher fee.
The body of evidence for safety, accuracy and effectiveness is summarised in the matrix at Box 13.
Page 149
Box 13
Body of evidence matrix for scleral buckling
Component
Evidence base
Rating
B
Consistency
B
Clinical impact
C
Generalisability
A
Applicability
C
Table 47
Description
4 RCTs and one non-systematic review – risk of bias in the majority
of the studies was identified to be minimum except in Han et al
where population and treatment biases may have influenced the
results to fall in favour of SB.
Most of the studies included in this review are consistent and
inconsistency if present can be explained.
Moderate clinical impact as SB seemed to be comparable to PPV, if
not better, in terms of final reattachment rate; however, visual acuity
seemed to better with PPV. As compared to PR, the treatment with
SB showed favourable results; however, not statistically significant.
Population studied in these trials was phakic or non-phakic patients
with retinal detachments which is similar to the target population.
Majority of the trials included in this review were done in developed
countries therefore, the results can be extrapolated to Australian
healthcare context but with few caveats.
RCTs comparing scleral buckling with other surgical procedures to treat retinal
detachment
RCTs comparing scleral buckling with other surgical procedures to treat retinal detachment
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Koriyama, Nishimura et al. 2007)
N= 46 patients (46 eyes) with RRD with a glial ring and
with macular detachment
Country: Japan
Mean age: Group 1: 59.4 ± 6.6 years; Group 2: 61.1 ± 7.2
years
Sex: Group 1: 12 male (52.2%); Group 2: 13 male (56.5%)
Inclusion: Patients were excluded if they had a cataract
that affected visual acuity, a giant retinal tear, multiple
tears at different depths, PVR higher than grade C1,
vitreous haemorrhages, a macular hole, or a history of
trauma
Follow up: Group 1 mean (months), 29.3 ± 14.9; Group 2
mean (months), 31.4 ± 11.7
Overall quality assessment: Moderate
Group 1: 23 eyes
underwent SB (5
segmental and 18
encircling buckling)
Group 2: 23 eyes
underwent PPV (also
included
phacoemulcification
and aspiration with
intraocular lens
implantation in all
cases regardless of
the degree of lens
opacity)
Retinal reattachment
Postoperative visual acuity
Postoperative
complications (subjective
assessments):
Intermediate or strong
ocular pain, discomfort in
prone position, satisfaction
with vision
Results
Outcome
Group I, n eyes (%)
Retinal reattachment:
Single operation
21 (91)
Final
23 (100)
Postoperative complications:
Early period
Choroidal detachment
8/23 (35)
Elevation of IOP (>30 mmHg)
3/23 (13)
Fibrin reaction
0
Group 2, n eyes (%)
p value
21 (91)
23 (100)
NR
NR
0
4/23 (17)
3/23 (13)
NR
NR
NR
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RCTs comparing scleral buckling with other surgical procedures to treat retinal detachment
Included studies, population characteristics, inclusion
criteria and quality assessment
Hyphema
0
Iris capture of IOL
0
Late period
Macular pucker
4/23 (17)
PVR
1/23 (4)
Subjective assessments
Intermediate or strong ocular pain 12/21 (57)
Discomfort in prone position
NA
Satisfaction with vision (6 months) 1/14 (7)
Cause of dissatisfaction with vision
Blurred vision
12/13 (92)
Metamorphopsia
9/13 (69)
Diplopia
3/13 (23)
Intervention(s) and
comparator(s)
2/23 (9)
3/23 (13)
(Azad, Chanana et al. 2007)
N= 61 phakic eyes with primary RRD with no lens opacity
and PVR < grade C were included in this study.
Country: India
Mean age: Group 1: 36 ± 16 years; Group 2: 41 ± 15
years
Sex: Group 1: 23 male (73%); Group 2: 17 male (57%)
Inclusion: Patients with eyes having following criteria were
excluded - significant media opacities such as vitreous
haemorrhage which made scleral buckling (SB)
impossible, PVR ≥ grade C, no-break retinal detachment,
aphakia or pseudophakia, intraocular surgery previously,
traumatic retinal detachment, and any retinal detachment
appeared to be unmanageable by conventional SB
surgery.
Follow up: 6 months
Overall quality assessment: Moderate
Group 1: 31 eyes had
SB
Group 2: 30 eyes had
PPV
Results
Outcomes
% primary surgical
success, n eyes (%)
Cause of failure
Group 1
Outcome(s)
NR
NR
0
2/23 (9)
NR
NR
2/20 (10)
18/20 (90)
8/18 (54)
0.003
NA
0.04
3/10 (30)
6/10 (60)
2/10 (20)
0.006
0.99
1.0
Group 2
Percentage of primary
surgical success
Cause of surgical failure
Final visual acuity
p value
25/31 (80.6)
24/30 (80)
0.21
4 cases: open breaks
3 cases: open breaks
NR
2 cases: improper buckle position 2 cases: PVR
1 case: open break + PVR
Median BCVA (logMAR units)
One week
0.78 (range 0.18 – 1.78)
2 (range 0.78 – 3)
0.000
One month
0.78 (range 0.0 – 1.78)
1 (range 0.3 – 3)
0.006
Final
0.6 (range 0.18 - 1.48)
0.6 range (0.0 - 1.78)
0.37
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RCTs comparing scleral buckling with other surgical procedures to treat retinal detachment
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Sharma, Karunanithi et al. 2005)
N= 50 eyes of 50 consecutive patients with uncomplicated
PPRD
Country: India
Mean age: Group 1: 56.8 ± 12; Group 2: 56.3 ± 9.14
Sex: Group 1: 20 male (80%); Group 2: 20 (80%)
Inclusion: Patients with eyes having following criteria were
excluded - age < 16 years, proliferative vitreoretinopathy
(PVR) ≥ grade C, huge tear, multiple tears if located more
than three clock hours apart, RDs with unseen breaks,
macula on PPRDs, traumatic eye, proliferative diabetic
retinopathy, unsustainable postoperative positioning and
previous intraocular surgery
Follow-up: 6 months
Overall quality assessment: Moderate
Group 1: 25 eyes had
SB
Group 2: 25 eyes had
PPV
Primary reattachment rate
BCVA
Causes of failure
Procedural complications
Results
Outcomes
Primary reattachment
rate, n eyes (%)
Cause of failure
Group 1
Group 2
19/25 (76)
1 cases: open breaks
5 cases: PVR
21/25 (84)
3 cases: open breaks
1 cases: PVR
Mean BCVA at 6 months (logMAR unit) 0.19 ± 0.15
Complications associated with procedures
Scleral buckling group (%)
Intra-operative
Needle perforation = 1 (4)
Hypotony = 10 (40)
Retinal haemorrhage = 2 (8)
Residual RD = 6 (24)
Early post-operative
Choroidal detachment = 2 (8)
Raised IOP = 1 (4)
Epithelial defect = 1 (4)
Late post-operative
Cellophane maculopathy = 4 (16)
Cystoid macular oedema = 1 (4)
Buckle infection = 1 (4)
Diplopia = 1 (4)
PVR = 5 (20)
0.28 ± 0.12
p value
0.48
NR
0.034
Pars plana vitrectomy group (%)
Iatrogenic breaks = 6 (24)
Optic capture = 1 (4)
Retinal haemorrhage = 1 (4)
Hazy media = 5 (20)
Raised IOP = 8 (32)
Epithelial defect = 2 (8)
Cellophane maculopathy = 3 (12)
Cystoid macular oedema = 1 (4)
PVR = 1 (4)
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RCTs comparing scleral buckling with other surgical procedures to treat retinal detachment
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Brazitikos, Androudi et al. 2005)
N= 150 eyes of 150 participants with PPRD and PVR ≤
stage
Country: Greece
Age: Group 1 mean, 71 ± 8.1; Group 2 mean, 73 ± 8.6
Sex: Group 1, 42 male (56%); Group 2, 45 (60%)
Inclusion: Excluded patients were those who had history of
severe eye trauma; history of intraocular eye surgery other
than cataract surgery; giant tear, macular hole, or macular
pucker preoperatively; posterior retinal breaks difficult to
support with a buckle; bullous keratopathy; clinically
apparent vitreous hemorrhage; intraocular lens dislocation
in the vitreous; presence of lens material in the vitreous
cavity; and inadequate pupil dilation (< 4 mm)
Follow-up: 12 months
Overall quality assessment: Moderate
Group 1: 75 eyes had
SB which involved
break localisation,
cryotherapy,
placement of a
circumferential 240
style 2.5-mm solid
silicone band,
combined with a local
buckle when
indicated, and
transscleral drainage
of subretinal fluid
Group 2: 75 eyes had
Pars plana vitrectomy
which included
extensive vitreous
removal, perfluoro-noctane injection or
endodrainage of
subretinal fluid to
flatten the retina,
cryopexy treatment of
breaks, and fluid/air
exchange with
injection of 20% SF6
Reattachment with a single
operation
Recurrence of RD
Inadequate buckle
Missed/new break
PVR
Reoperations
Final reattachment
Pupillary block
Macular pucker
Axial length changes
Transient diplopia
Mean operating time
Results
Outcomes
Group 1 (%)
Intra-operative findings and complication data:
Local anesthesia
55 (73.3)
Undiagnosed breaks after surgery
7 (9.3)
New intraoperatively diagnosed breaks
8 (10.7)
IOL posterior luxation
0
Iatrogenic breaks
NA
Drainage complication
8 (11.2)
Choroidal
4 (5.6)
Hemorrhage
4 (5.6)
Mean operating time (min)
65.8 ± 9.34
Post-operative findings:
Reattachment with a single operation
62 (82.7)
Recurrence of RD,
13
Inadequate buckle,
4
Missed/new break
5
PVR
4
Reoperations, total no. (no. of patients)
17 (13)
Final reattachment
71 (94.7)
Pupillary block
0
Macular pucker
3 (4)
Axial length changes (mm)
0.95
Group 2 (%)
p value
73 (97.3)
0
22 (29.3)
1 (1.3)
9 (12)
NA
NA
NA
54.7 ± 8.3
< 0.0001*
0.01*
0.004**
0.99*
NA
NA
NA
NA
0.0001***
71 (94.7)
4
NA
1
3
8 (4)
74 (98.7)
1 (1.3)
2 (2.7)
0.1
0.037*
Page 153
NA
0.38 §
0.37*
0.99*
0.99*
0.0001***
RCTs comparing scleral buckling with other surgical procedures to treat retinal detachment
Included studies, population characteristics, inclusion
criteria and quality assessment
Transient diplopia
3 (4)
Final BCVA at one year (mean ± SD)
0.40 ± 0.48
Intervention(s) and
comparator(s)
0
0.33 ± 0.32
Outcome(s)
0.25*
0.26 ***
RRD, rhegmatogenous retinal detachment; RD, retinal detachment; PVR, proliferative vitreoretinopathy; SB, scleral buckling;
PPV, pars plana vitrectomy; BCVA, best corrected visual acuity; PPRD, pseudophakic primary retinal detachment; IOP,
intraocular pressure; IOL, intraocular lens; NA, not applicable; NR, not reported; RD, retinal detachment
* Fisher exact test, ** est, *** t-test, § Wilcoxon rank sum test
Table 48
Comparative studies included in the review by Saw et al (2006) comparing scleral
buckling with other surgical procedures to treat retinal detachment
Narrative review comparing scleral buckling with other surgical procedures to treat retinal detachment a
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Tornambe, Hilton et al. 1991)
N= 179 patients with uncomplicated RRD undergoing PR
or SB
Country: USA
Age: NR
Sex: NR
Inclusion: Single retinal break or group of breaks ≤ 1 clock
hour of retina in size, located in superior 8 clock hours of
the fundus, with macula on or off
Follow up: 24 months
Overall quality assessment: NA
Group 1: 93 patients
undergoing PR
Group 2: 86 patients
undergoing SB
Single-operation
reattachment at 6 months
Overall reattachment with
reoperations
24-month VA ≥20/50 in
eyes with macular
detachment for ≤14 days
Results
Single-operation reattachment at 6 months
Overall reattachment with reoperations
24-month VA ≥20/50 in eyes with
macular detachment for ≤14 days
Group 1
% patients
73
99
Group 2
% patients
82
98
p-value
89
67
<0.05
(Mulvihill, Fulcher et al. 1996)
N=20 patients with uncomplicated RRD undergoing PR or
SB
Age: NR
Sex: NR
Inclusion: Single retinal break or group of breaks ≤ 1 clock
hour of retina in size, located within the superior 8 clock
hours of the retina
Follow-up: PR mean 16.7 months; SB mean 16.0 months
Overall quality assessment: NA
Group 1: 10 patients
undergoing PR
Group 2: 10 patients
undergoing SB
NS
NS
Single-operation
reattachment
Overall reattachment with
reoperations
Results
Single-operation reattachment
Overall reattachment with reoperations
Group 1
% patients
70
90
Page 154
Group 2
% patients
80
100
p-value
0.5
0.5
Narrative review comparing scleral buckling with other surgical procedures to treat retinal detachment a
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(McAllister, Meyers et al. 1988)
N= 134 patients with uncomplicated RRD undergoing PR
or SB
Age: NR
Sex: NR
Inclusion: Uncomplicated RRD
Follow-up: >6 months
Overall quality assessment: NA
Group 1: 56 patients
undergoing PR
Group 2: 78 patients
undergoing SB
Overall reattachment at ≥6
months
Results
Overall reattachment at ≥6 months
Group 1
% patients
71
(Kreissig, Failer et al. 1989)
N=1000 patients with uncomplicated RRD undergoing PR
or SB
Age: NR
Sex: NR
Inclusion: Single break or group of breaks close together
not subtending > 6–8 mm for about 1 clock hour at the
equator (majority uncomplicated RRD)
Follow-up: PR mean NR; SB mean 25 months
Overall quality assessment: NA
Group 2
% patients
96
Group 1: 500 patients
undergoing PR
Group 2: 500 patients
undergoing SB
p-value
<0.001
Single-operation
reattachment
Overall reattachment with
reoperations
Results
Single-operation reattachment
Overall reattachment with reoperations
Group 1
% patients
79.6
99
(Han, Mohsin et al. 1998)
N=50 patients with uncomplicated RRD undergoing PR or
SB
Age: NR
Sex: NR
Inclusion: NR
Follow-up:6 months
Overall quality assessment:NA
Group 2
% patients
91
99
Group 1: 50 patients
undergoing PR
Group 2: 50 patients
undergoing SB
p-value
NR
NR
Single-operation
reattachment
Overall reattachment with
reoperations
Final VA
Results
Single-operation reattachment
Overall reattachment with reoperations
Final VA
* ± post-operative laser
Group 1
% patients
62
98
NR
a Studies
Group 2
% patients
84*
98
NR
p-value
0.01
NS
NS
included in the narrative review were not retrieved independently so details provided were extracted from the secondary
source (narrative review).
RRD, rhegmatogenous retinal detachment; PR, pneumatic retinopexy; SB, scleral buckling; VA, visual acuity; NS, not significant;
NA, non-applicable; NR, not reported
Page 155
3.16
Intra-vitreal injection services
MBS ITEM
SERVICE
REVIEW METHOD †
Mini HTA review
42740
Intra-vitreal injection ‡
Stakeholder
negotiation**
Guideline
concordance
x
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
‡ Consumer views and preferences, as discussed in qualitative and blog literature, were also reviewed for these
specific items.
Summary of Findings
Item 42740 – This item is a high utilisation service and thus of high overall cost to the MBS. The
current descriptor mentions paracentesis ie removal of fluid from the anterior or posterior segment of
the eye (including the vitreous) for diagnostic purposes, and/ or the introduction of therapeutic
substances. While guidelines support intravitreal injection of anti-VEGF, paracentesis during this
procedure is not discussed.
It is not clear from the current item descriptor whether 42740 is intended to be used for intravitreal
injections (of anti-VEGF, steroids, antibiotics or other pharmaceuticals), or whether it is intended for
the introduction of air, silicone oil or perfluorocarbons for the treatment of retinal detachment. Injection
of pharmaceutical agents, tamponade agents and removal of fluid from the eye are likely to be
undertaken for vastly different indications, as well as require different time and material commitments.
Separation of these procedures into distinct MBS item numbers appears warranted.
Intravitreal injections would only require paracentesis if a large volume of an agent is being injected
and so is seldom required. Similarly, gas, silicone oil or perfluorocarbons are commonly injected in
conjunction with a vitrectomy procedure and thus the paracentesis component of 42740 is usually not
required.
As the complexity of the intravitreal injection procedure is likely reduced when associated with other
ocular procedures (ie vitrectomy), it may be reasonable to have two intravitreal injection items, one
with and one without associated ocular procedures, reflecting the difference in procedure complexity.
It may also be appropriate to have a distinct item for the injection of tamponade substances such as
gas, silicone oil and perfluorocarbons, which would be used in association with the vitrectomy item
(42725).
Qualitative analysis
Anticipation of the eye injection caused more distress than the injection itself. Eye injection is not
considered by patients to be a painful experience (mean pain score 1.5-2.2 where 0 is no pain and 10
is worst possible pain). Good information from the health care provider before the injection reduces
anxiety. Blogs described a number of side effects: floaters, weeping eye, dry red eyes, and
discomfort. Patient perceptions of side effects were not discussed in the evidence base.
Page 156
The single item 42740 has shown dramatic growth since 2005, subsequent to amendment of the
item description in 2006 (see Appendix D, Figure 44). From levels below 10,000 services p.a.,
claims increased to over 90,000 in 2009, with 61,000 services in the first 6 months of 2010, making
it the 3rd highest item in frequency for 2010. Similarly, the cost has been considerable, with $25m
in 2009, and already more than $16m in 2010, an increase over the 2009 rate of 31 per cent. In
2009 it was the 2nd highest cost item of the 61 items analysed, and remains so in January-June
2010, but has closed the gap behind the cost of cataract surgery.
This item has application for a variety of conditions, with claims often accompanying those related
to cataracts, vitrectomy and retinal photography (see Appendix D, Table 145). However, the most
frequent occurrence is for treatment of wet age-related macular degeneration. Hence the service
is most commonly provided to those aged over 65 years, especially to females. Prior to 2007,
either ranibizumab (Lucentis) or bevacizumab (Avastin) were the substances generally injected on
a regular basis, but in March 2007, ranibizumab became the only approved substance to be used if
the item was to be claimed. Ranibizumab itself was listed on the Pharmaceutical Benefits Schedule
in August 2007. A graph of the scripts paid for by Pharmaceutical Benefits on a monthly basis
since September 2007 shows the steady increase in its use (see
Page 157
Appendix E, Figure 56). The annual numbers of scripts were 52,205 for 2008, 90,317 for 2009, and
60,684 for the first six months of 2010, the last two closely approximating the number of services
for MBS item 42740.
Data relating to hospital separations by procedure show that for the financial year 2007-2008,
there were 25,078 procedures incorporating injections to the eye, with the majority being sameday. Of the hospital separations, 71 per cent were for “administration of a therapeutic agent into
the posterior chamber” (this is also reflected in item 209 of the graph of hospital procedures,
posterior segment, retina – see
Page 158
Appendix E, Figure 55), with 18 per cent relating to the anterior chamber, and 11 per cent for
aspiration of aqueous or vitreous.
As part of the Guideline concordance exercise, MBS item 42740 was assessed with regard to
whether, as suggested by the RANZCO, this item number should be changed to two item numbers,
on the basis that the existing item number is used for a variety of procedures of varying
complexity and for different clinical situations. The most common use of this item is intravitreal
injection of therapeutic substances, in particular ranibizumab (Lucentis) for wet age-related
macular degeneration. Its usage is expected to continue to increase. It is suggested that it would
be more appropriate to have a separate item number for these injections as independent
procedures (given they are primarily performed as such), and another item number for intravitreal
injections performed during other ocular surgery, and also anterior chamber paracentesis +/intracameral injection of therapeutic substances. This might allow more accurate tracking of the
use of intravitreal therapies, which include ranibizumab but also injection of other therapeutic
agents.
Current definition of 42740:
"PARACENTESIS OF ANTERIOR OR POSTERIOR SEGMENT (including the vitreous) OR BOTH, for the
injection of therapeutic substances, or the removal of aqueous or vitreous for diagnostic purposes,
1 or more of (Anaes.) (Assist.)
Suggested amendments:
1. Deletion of item number 42740
2. Creation of 2 new separate item numbers:
A. Descriptor: "PARACENTESIS OF VITREOUS CAVITY, for the intravitreal injection of therapeutic
substances, or the removal of vitreous for diagnostic purposes, 1 or more of, as a procedure
associated with other intraocular surgery (Anaes)."
B. Descriptor: "PARACENTESIS OF ANTERIOR CHAMBER and/or VITREOUS CAVITY, for the injection
of therapeutic substances, or the removal of aqueous or vitreous for diagnostic purposes, 1 or
more of, as an independent procedure (Anaes.) "
One moderate quality (AAO 2008) and one low quality (RCO 2009) guideline recommended
intravitreal administration of anti-VEGF for the treatment of various lesions in AMD.
No recommendations regarding the injection of other therapeutic substances or the injection into
other areas of the eye were reported.
Clinical advice indicates that the decision to do a paracentesis in conjunction with intravitreal
injection primarily relates to the potential damage caused by the elevation of intraocular pressure.
This is usually associated with the volume of the agent injected (and also some patient factors).
Paracentesis is generally only required when a volume of 0.1 ml or greater is injected. The
standard volume for ranibizumab (Lucentis), for example, is 0.05 ml therefore paracentesis is
seldom required. Injection of silicone oil, gas or perfluorocarbons is generally done at the time of
Page 159
vitrectomy (item 42725) and thus does not require paracentesis per se as the intraocular pressure
is controlled by the constant infusion into the eye, controlled by the vitrectomy machine.
Negotiation between the RANZCO and the Department, regarding the proposed amendments to
the MBS descriptor for this item, will be undertaken following the tabling of this report.
Concordance conclusions
The imprecision of the MBS descriptor for 42740 has rendered sensible comment regarding the
appropriateness of its wording difficult. It is not clear whether 42740 is intended to be used for
intravitreal injections (of anti-VEGF, steroids, antibiotics or other pharmaceuticals), or whether it is
intended for the introduction of gas, silicone oil or perfluorocarbons for the treatment of retinal
detachment. Furthermore, the safety and effectiveness of the introduction of pharmaceutical or
other agents into the eye are likely to be highly contingent upon the indication for which they are
being used. Given the increasing number of procedures billed to 42740 in recent years,
clarification of this item descriptor is necessary. Given that injection of pharmaceutical agents,
tamponade agents and removal of fluid from the eye are likely to be undertaken for vastly
different indications, as well as require different time and material commitments, separation of
these procedures into distinct MBS item numbers seems warranted.
The current MBS item descriptor for paracentesis (42740) broadly covers the removal of fluid from
the anterior or posterior segment of the eye (including the vitreous) for diagnostic purposes or for
the introduction of therapeutic substances. While guidelines support intravitreal injection of antiVEGF, paracentesis during this procedure was not discussed perhaps because it is seldom
performed. As the complexity of the intravitreal injection procedure is likely reduced without the
need for paracentesis, it may be reasonable to have two intravitreal injection items, one with and
one without associated ocular procedures, reflecting the difference in procedure complexity.
It is suggested also that there is a distinct item for the injection of other tamponade substances
such as gas, silicone oil and perfluorocarbons, which is to be used in association with the
vitrectomy item (42725).
Qualitative analysis
A consumer preferences analysis was undertaken regarding intra-vitreal injection.
Research question
What is the patient experience of and perspective on the ophthalmology service described by MBS
Item 42740, including the ‘off-label’ use of Avastin in intra-vitreal injections?
Search strategy
A qualitative literature search was undertaken using the Scopus and Embase databases. Articles in
English were sourced from developed nations (previously defined) using the search terms
described in Table 49.
Table 49
Search terms used for identifying relevant literature in journal databases for retinal
detachment
Page 160
Disease/disorder description
(Avastin[TW] OR Lucentis[TW]); (“bevacizumab” [substance name] OR “ranibizumab”
[substance name]); “wet macular degeneration” [MeSH]
‘Umbrella’ terms describing the activity
“eye injection” [TW]; “intravitreal injenction”[TW]; injections [MeSH]; Wet Macular
Degeneration/drugtherapy” [MeSH]
What are we trying to canvass
“patient satisfaction” [MeSH]; attitude to health [MeSH]; patient compliance [MeSH]; public
opinion [MeSH]; health knowledge, attitudes, practice [MeSH]; patient acceptance of health
care [MeSH]
Methods that might be employed in canvassing views
“qualitative research” [MeSH]; “focus Groups” [MeSH]; “focus groups”[TW]; interviews[TW]
Papers were selected on the basis that they included the patient perspective of the experience of
an intra-vitreal injection including the period before and after the intra-vitreal injection and any
side effects which the patient associated with the intra-vitreal injection. Studies (n=120) identified
were culled further based on a reading of titles/abstracts and full text articles to 18 publications.
Four articles related to the ‘Avastin vs Lucentis controversy’ and were set aside. The remaining 14
publications were analysed although only six provided relevant findings useful for this review.
English language blogs from developed countries which described the experience of intra-vitreal
injection were identified through a Google advanced domain search. Searches were restricted to
English Language and the period January 2000 to August 2010. Papers were selected on the basis
that they presented the perspectives of people who had experienced an intra-vitreal injection as
described above. Only personal blogs written in the English language from developed countries
presenting personal views were included. Commercial blogs were excluded.
A Google blog search using http://blogsearch.google.com.au selected for blogs primarily
providing health advice from doctors and companies. A Google advanced domain search, with
blogspot.com as the domain, provided more targeted results as follows (Table 50):
Table 50
Search terms for weblogs for retinal detachment
Number
Domain
Search
Number of
results
Viewed
Relevant
sites
1
blogspot.com
Eye injection’
63, 600
First 100
1
2
blogspot.com
eye injection” AND
macular
degeneration
2120
First 400
24
In search 2, after searching the first 400 it became apparent that all of the weblogs identified were
repeats of earlier findings. Therefore the search was discontinued at this point. One Malaysian
blogger, who provided a very detailed description of her experience, was included even though it
is not on the list of developed countries. In total nine blogs from seven bloggers provided
Page 161
sufficient detail to be useful for this review. All selected peer reviewed papers and weblogs were
imported into NVivo 8 for thematic coding and analysis.
Results
All but one of the peer reviewed papers presenting patient perspectives were quantitative surveys
primarily recording pain levels using pain rating scales or pain scores. The weblogs generally
support the data provided in these publications but provide a richer description of the experience.
For example, the finding that the anticipation of the injection was often worse than the actual
procedure was presented in both pain rating studies and weblogs: the pain level experienced was
generally described as less than anticipated and categorized as low level pain by patients
(approximately 1.5 – 2.2 on a scale of 0-10 where 0 was no pain and 10 unbearable pain) (Kozak,
Cheng et al. 2005; Chua, Mitrut et al. 2009; Knecht, Michels et al. 2009). Furthermore, both the
weblogs and peer reviewed literature suggested that patients experienced less fear when they had
more knowledge about the procedure. Another recurring theme in the weblogs was that despite
the risk associated with intra-vitreal injections and the occasional discomfort, the bloggers
indicated that it was worth it, if it meant they would retain sight, that is, the bloggers were very
aware of the relevance of the therapy. This was supported in the peer-reviewed literature. In
contrast, in the weblog entries, individual patient’s satisfaction with the procedure appeared to be
heavily influenced by the severity of the side effects suffered as a result of the intra-vitreal
injections but this issue was not explored in the literature. Some studies compared patient
experiences and perceptions of different techniques used in the procedure, particularly choice of
anaesthetic before an intra-vitreal injection. The effect of anaesthesia choice on the patient’s
experience was explored to a limited extent in some weblogs. Overall, although not all the
reported experiences of intra-vitreal injections were positive, most patients viewed intra-vitreal
injections as necessary and were appreciative of the service provided.
Anticipation of Procedure
A common theme in relevant weblogs and peer-reviewed literature was the finding that
anticipation of the procedure caused more discomfort and anxiety to patients than the procedure
itself. Chua et al investigated patient perspectives of intra-vitreal injections with ranibizumab
(Lucentis), comparing perspectives before and after injection. This quantitative study using a
validated questionnaire found that negative perspectives were much higher pre-injection than
post-injection (Chua, Mitrut et al. 2009). A quantitative study exploring patient perceptions of
steroid injections into the eye presented similar findings (Roth, Scott et al. 2006) and several
bloggers described the fear experienced before their intra-vitreal injection. One Canadian blogger
asked:
…seriously, who wouldn’t get freaked out by the prospect of having their eye stabbed with
a needle? (Firda 27 May, 2010).
Both the peer-reviewed literature and blogs showed that the fears held by patients prior to their
first intra-vitreal injection were allayed by the experience of the injection itself. Chua et al found
that nearly all patients (93%) reported no longer feeling fearful or anxious about the procedure
Page 162
after they had received one injection treatment. Furthermore, a study by Kandula et al found that
66 per cent of patients reported that they were less afraid before their second injection compared
with their first (Kandula, Lamkin et al. 2010). These findings, that the anxiety felt by patients was
high before the first procedure, and that the procedure was not as distressing as expected, were
supported by a number of the weblogs (Dan Walker April 15, 2009). Dan Walker from the United
States demonstrates this with his comment:
Actually, it wasn’t as bad as it sounds (Dan Walker April 15, 2009).
One American blogger ‘DobroJimbo’ explains the feeling of anxiety experienced before an
injection:
Funny how when your [sic] facing something unknown like taking this injection, your mind
conjures up all kinds of monstrous thoughts (DobroJimbo January 9, 2010).
Pain felt during procedure
Accordingly, anticipated pain and discomfort levels were significantly higher amongst patients
than the actual pain experienced during procedures (Kozak, Cheng et al. 2005; Roth, Scott et al.
2006; Knecht, Michels et al. 2009; DobroJimbo January 9, 2010). Given the findings reported
above, it is somewhat surprising that only 51 per cent of participants in Chua’s study reported that
intra-vitreal injections were less uncomfortable than anticipated. However, the results may be
skewed by the fact that 66 of the patients had experienced intra-vitreal injections previously or by
the wording of the survey since in the same survey, 62 per cent of patients reported no discomfort
during the injection (Chua, Mitrut et al. 2009). In contrast, 75 per cent of patients, in a study by
Kandula et al, had a “better than expected experience” with their first intra-vitreal injection. The
most common sentiment throughout the literature and weblogs was that the procedure was not
very painful at all. The study by Chua and colleagues found the mean score of reported discomfort
during the procedure to be 2.2 out of 10 (with a score of 1 indicating not at all and 10 indicating
worst possible). This finding was supported by the blogs. One American blogger suggested that it is
a commonly held belief among intra-vitreal injection patients that the injections do not hurt:
Well, I'm now an official member of the exclusive club, ‘People Who've Had Injections in
Their Eyeballs’, also known as ‘It Doesn't Hurt, But It Really Feels Weird (Rita September 25,
2007).
The author reaffirms the lack of pain involved in a comment after another intra-vitreal injection:
The injection didn't hurt at all. Love those numbing drops! (Rita September 25, 2007)
These sentiments were also supported by ‘DobroJimbo’ from the United States:
it didn't really hurt, but it was uncomfortable feeling (DobroJimbo January 9, 2010).
Despite this opinion being evident in most of the blogs found, there was not a consensus on the
issue. The comments by Malaysian blogger, Deviki Prabhakaran, suggest a different experience
which she attributed to inadequate local anaesthesia:
Page 163
And I felt as she pressed the needle into the eye. Did it hurt? HELL YEAH IT DID!!! It felt like
someone is jabbing and pinching your eye ball. But that is not the most painful part….at
least not until she pressed the fluid into the eyeball that’s when it hurt like hell (Deviki
Prabhakaran May 28, 2009).
Although this experience was not in a country with similar health standards to Australia, in any
case we might not expect consensus on this amongst bloggers as Chua’s study of Scottish patients
reported 16 per cent of participants having experienced more discomfort than expected.
Presentation of information to patients
As reported earlier, both the literature and weblogs show that a fear of the unknown is a major
factor for prospective patients before they have received their first intra-vitreal injection (Chua,
Mitrut et al. 2009; Kandula, Lamkin et al. 2010; Dan Walker April 15, 2009; DobroJimbo January 9,
2010). Hence dissemination of information about the procedure to patients is an important part of
the process. The study by Kandula found that, although most patients thought they were well
informed about the condition and the treatment, many had significant gaps in their knowledge.
Most patients (89%) indicated that they would prefer to receive more information on age related
macular degeneration directly from their physician than from another source such as internet,
video or pamphlet (Kandula, Lamkin et al. 2010). The provision of information from another health
care worker such as a nurse was not explored in the study. Likewise, American ‘DobroJimbo’
writes:
I felt a little better since talking to him. Funny how when your[sic] facing something
unknown like taking this injection, your mind conjurs[sic] up all kinds of monstrous thoughts
(DobroJimbo January 9, 2010).
Page 164
Perception of whether procedure is worth it, given the alternative
Another common theme throughout the literature and the weblogs is the idea that the discomfort
or adverse affects associated with procedure were worth it given risks and consequences
associated with not receiving treatment. For example ‘DobroJimbo’ states:
It's better than going blind (DobroJimbo February 3, 2010).
They are definitely a necessary trip to Monkey Hell though, the alternative is a heck of a lot
worse (DobroJimbo June 24, 2010) (USA).
Other bloggers, from the United States and Canada, respectively, suggest:
There is a slight improvement and so the right thing to do (Russell Elias September 19,
2005).
Who wants to have a permanent blind spot? Not me! Eye injection? Bring it on! (Firda 27
May, 2010).
This is supported in the study done by Kandula et al, which reported that although 61 per cent of
participants were “somewhat afraid” or “very afraid” about getting their first intra-vitreal
injection, no patients reported missing appointments. This suggests that intra-vitreal injection
patients understood how important the treatment was and felt it to be worth the perceived risks
and discomfort, despite their fear.
Side effects of the procedure
An issue that featured prominently in the weblogs was that of side effects of the procedure. Every
blog collected made some mention of the side effects experienced from intra-vitreal injections
although most symptoms were slight and well tolerated:
you have this white gooey thing coming outta[sic] your eyes for awhile and the teary starts
but it’s ok coz that shows the med is working (Deviki Prabhakaran May 28, 2009)
(Malaysia).
...my eye started running water like a faucet. That went on for several hours, which was
really aggravating. For about three days my eye ran fluid off and on. Then, for the next two
weeks or so, I would see floaters drifting by, which looked like spiders crawling around.
Sometimes it looked so real and appeared so fast, I would actually jerk back (DobroJimbo
January 9, 2010) (USA).
...and the only side effect i have is a small black area in my lower right vision area, which i
am told goes away in 2-3 days, also that night my eye was VERY red and almost felt dry to
the point of hurting, but that has gone away already(24 hours later) (Simon James January
23, 2007) (New Zealand).
Page 165
it just felt like I had an eyelash stuck in my eye for the rest of the day, which was rather
annoying (Firda 27 May, 2010) (Canada).
Considering the prominence of this issue in the weblogs it gets little to no traction in the literature.
It is briefly mentioned as one of the questions administered to patients in a study by Roth et al,
however the response to the question regarding side effects is not reported.
Techniques used in the intra-vitreal injection
The use of different techniques in the injection process is explored in four papers with
comparisons of different methods of local anaesthesia or in the technique of the actual injection
itself the studies look at how this affects the outcomes of the injection, and the patient
experience.
Different methods of anaesthesia administration pre-injection were discussed in the literature. In
their 2005 study, Kozak et al explored the pain experience of patients receiving anaesthesia, prior
to intra-vitreal injection, with gel or subconjunctival (SC) injection. The results showed that pain
experiences of intravitreal (IV) injection did not differ between the two groups but anaesthesia
delivered via SC injection produced more adverse effects after the IV injection than did the topical
gel. There was some comment on anaesthetic technique in the blogs:
The nurse said they tried a new anesthetic today. It didn't deaden my eye as good as the
other ones they used. I felt the needle go in my eyeball. It didn't hurt bad. I just felt it more
than before (DobroJimbo February 3, 2010) (USA).
As well as different anaesthetic compositions, literature was found discussing different techniques
for injection. Knecht and colleagues compare outcomes and patients reported discomfort in
tunnelled scleral IV injection and straight sclera IV injection (Knecht, Michels et al. 2009). The
results showed that while patients reported that the most commonly used technique, straight
scleral injections, hurt less, more adverse events were seen post-injection than for the tunnelled
technique. This raises questions around whether it may be better to use the tunnelled technique
since, as described above, patients have higher expectations of the level of pain than they actually
experience. A US study compared patient experiences and outcomes with the process of bilateral
simultaneous injections with the common-practice, unilateral injections, finding that patients
administered the bilateral injections did not request to return to the unilateral injection schedule
afterwards (Bakri, Risco et al. 2009). The results suggested that the bilateral process was welltolerated and should be a consideration for treatment options in the office setting.
Recognition of different injection techniques does not feature in the patient blogs. This may be
due to the fact that patients do not have experience with different techniques or are not aware of
the techniques involved in the intra-vitreal injection process.
Page 166
3.17
Laser trabeculoplasty services
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA
review
42782, 42783
Laser trabeculoplasty
Stakeholder
negotiation**
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
Summary of Findings
Item 42782- This is a commonly used item and, according to evidence-based guidelines, its use is
supported in glaucoma. The descriptor could mention glaucoma as the appropriate patient indication.
MBS item 42782 currently allows 4 treatments to each eye per 2 year period. Guidelines reported the
need for repeated laser trabeculoplasty treatments although this was not quantified. Clinical advice
suggests that four treatments per 2 year period would not commonly be done using current protocols.
Therapy is usually given as a 180 degree treatment to the filtration angle followed by the second 180
degrees at a future date if needed. Thus two treatments in a 2 year period would be reasonable. In
the event of requiring a greater number of treatments, MBS item 42783 may be used.
Laser trabeculoplasty (item 42782 only, as 42783 has no data) shows a steady increase in services
since 2003, with around 25,000 services performed in 2009 (see Appendix D, Figure 45). This item
currently rates as the 5th highest of the items being reviewed, in terms of cost of benefits paid,
with almost $9m incurred in 2009.
Guideline concordance analysis for item 42782 identified three guidelines of good quality
reporting on the use of trabeculoplasty in patients with glaucoma. NHMRC (2009) reported high
level evidence and NICE (2009) and COG (2009) reported consensus based evidence for the use of
trabeculoplasty to reduce intra-ocular pressure for patients who are not compliant with
medication, or who refuse or are poor candidates for incisional surgery (NHMRC 2009; NICE 2009;
Rafuse P.E., Buys Y.M. et al. 2009). No guidelines reported on the required frequency of laser
trabeculoplasty, although NHMRC (2009) provided consensus based evidence that repeated
treatments will be required.
The COG (2009) guideline suggests that laser trabeculoplasty is an effective procedure in lowering
intraocular pressure (IOP) and is commonly used as an adjunctive treatment with medication.
These guidelines also suggest that patients with mild glaucoma controlled with medication and/ or
with laser trabeculoplasty, in the presence of clinically evident cataract, should be treated with
phacoemulsification/ IOL implantation alone. Patients with moderate to advanced glaucoma with
clinically evident cataract should be treated with combined phacoemulsification / IOL implantation
and trabeculectomy. Patients with uncontrolled glaucoma with cataract should undergo
trabeculectomy first, followed by phacoemulsification/IOL implantation several months later, in
order to diminish the risk of intra-operative complications such as suprachoroidal hemorrhage
Page 167
(Rafuse P.E., Buys Y.M. et al. 2009). Clinical advice suggests that individual circumstances might
require some variation in the treatment approach.
Concordance conclusions
The MBS item numbers for laser trabeculoplasty do not specify the indication for which the
procedure may be used. This concordance analysis has supported the use of laser trabeculoplasty
for glaucoma. This could be reflected in the wording of the descriptor.
MBS item 42782 currently allows 4 treatments to each eye per 2 year period. Guidelines reported
the need for repeated treatments although this was not quantified. Clinical advice suggests that
four treatments per eye per 2 year period would not commonly be done using current protocols.
Therapy is usually given as a 180 degree treatment to the filtration angle followed by the second
180 degrees at a future date if needed. Thus two treatments in a 2 year period per eye would be
reasonable. In the event of requiring a greater number of treatments, MBS item 42783 may be
used.
Page 168
3.18
Retinal photocoagulation services
MBS ITEM
SERVICE
REVIEW METHOD †
Mini HTA review
42809
Retinal photocoagulation ‡
x
Stakeholder
negotiation**
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
‡ Consumer views and preferences, as discussed in qualitative and blog literature, were also reviewed for these
specific items.
Summary of Findings
Item 42809 – This is item is commonly used and of significant cost. The MBS item descriptor for
retinal photocoagulation does not contradict current guideline recommendations. It is unclear whether
greater precision is required, however, to capture the nature of the indication for which
photocoagulation is being applied. Guideline concordance analysis suggests that it should be used for
the repair of acute, symptomatic horshoe retinal tears and traumatic retinal breaks, extrafoveal and
juxtafoveal choroidal neovascularisation (although not subfoveal choroidal neovascularisation) and
treatment of diabetic retinopathy.
Retinal detachment
The evidence for laser photocoagualation for the prevention of retinal detachment is not convincing.
Diabetic retinopathy
Peripheral pan-retinal photocoagulation for the treatment of diabetic retinopathy is associated with a
reduced risk of severe visual loss and blindness than observation or deferred treatment. High risk
eyes tend to experience greater benefit than low risk eyes.
Single session treatments of pan-retinal photocoagulation (PRP) may be equivalent to multisession
treatments. Pattern scan PRP appears to be better tolerated than single spot laser. In patients who
require cataract surgery and PRP for diabetic retinopathy, performing surgery prior to
photocoagulation may result in lower incidence and progression of diabetic macular oedema. These
conclusions are based on single RCTs and a more extensive search targeted to these outcomes is
necessary to make substantive conclusions.
The effectiveness of PRP may be improved with the addition of intravitreal injection of anti-VEGF, in
particular for patients with clinically significant macular oedema. However, intravitreal triamcinolone
acetonide was associated with the risk of increased intra-ocular pressure and cataract formation.
Therefore, these risks must be weighed against the likely benefits in the treatment of diabetic
retinopathy. Visual acuity in patients with diabetic retinopathy treated with intravitreal bevacizumab
and PRP may be better than PRP alone, although more evidence is required. Although intravitreal
pegnaptanib did not alter visual outcomes in patients it was included in only one trial. A full systematic
review of intravitreal and sub-Tenon’s injections of corticosteroids and anti-angiogenic drugs as
adjuncts to PRP should be conducted to assess the safety and effectiveness of these interventions.
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Summary of Findings (cont)
Choroidal neovascularisation associated with pathologic myopia
There is insufficient evidence to address the safety or effectiveness of photocoagulation for the
treatment of choroidal neovascularisation in patients with pathologic myopia. There is insufficient
evidence to demonstrate that different wavelength lasers will result in different patient outcomes.
Macular oedema
When laser photocoagulation was compared with observation or delayed treatment, it resulted in
fewer moderate losses in visual acuity up to three years and was more likely to gain visual acuity up
to two years. A definitive conclusion regarding laser photocoagulation for the treatment of macular
oedema is dependent on the specific indication being treated but is limited by the lack of available
evidence. It is, however, generally accepted as an effective treatment. The evidence does not indicate
a benefit of one laser wavelength over another. Given the prevalence of diabetes and the debilitating
nature of vision loss, additional research in this area is warranted. The addition of intravitreal steroid
injections to laser photocoagulation may improve visual acuity at six months but may be associated
with side effects. Given the clinical importance of macular oedema, further research into combined or
alternative therapies is warranted. Intravitreal triamcinolone acetonide is no more effective than
photocoagulation in patients with macular oedema secondary to branch retinal vein occlusion.
Intravitreal bevacuzimab may be more effective than grid laser photocoagulation for patients with
macular oedema secondary to branch retinal vein occlusion; however a larger study is required to
confirm these findings.
Age-related macular degeneration (AMD)
Current evidence on the use of photocoagulation to treat drusen in patients with age-related macular
degeneration indicates that this treatment option is no better than observation for progression of AMD
or visual acuity outcomes. However, research into different laser technology is being conducted and
could result in different outcomes.
As was suggested in the guideline concordance analysis, direct photocoagulation to extrafoveal CNV
is an effective method for halting visual deterioration in patients with AMD compared with observation.
However, the effectiveness of photocoagulation to subfoveal or juxtafoveal CNV is limited or delayed,
and treatment to sufoveal CNV may result in early visual loss.
Macular holes
The evidence relating to photocoagulation in patients with idiopathic macular holes was of poor
quality. Clinical advice suggests that the available research conducted in this area is now dated, with
the current treatment of choice being vitrectomy surgery - the exception being the uncommon macular
holes in highly myopic eyes with posterior staphyloma which may lead to retinal detachment and for
which laser photocoagulation is occasionally used.
Retinoblastoma
There is insufficient evidence to support or reject the use of photocoagulation in children with
retinoblastoma. Further research of photocoagulation for the treatment of retinoblastoma is required to
ascertain the comparative safety and effectiveness of this modality.
In summary, this item is commonly used for a number of indications, the evidence for which was
generally disappointing and insufficient to suggest a change to the wording of the item descriptor.
Page 170
Summary of Findings (cont)
Qualitative analysis
Poor adherence to photocoagulation treatment - a particular problem in patients with diabetes - may
be due to a number of different reasons including the painful and/or stressful nature of the procedure,
post-treatment side effects, poor understanding about the reasons for treatment and the
asymptomatic nature of the disorder. Delay in presentation for retinal tears may be due to a lack of
understanding about the nature of the symptoms present and the need for urgent treatment to prevent
blindness. Effective doctor-patient communication and pleasant clinic conditions can decrease patient
anxiety and increase patient compliance.
The retinal photocoagulation item (42809) is significant in terms of both number of services
(currently about 45,000 p.a.) and cost ($16m in 2009). It ranks as 4th across the analysis period for
frequency, dropping to 5th for frequency in January – June 2010. For each of these time periods, it
has been the 3rd highest cost item of the 61 items analysed (see Appendix D for further detail).
The graphs produced from hospital data reflect the general increase in retinal procedures,
especially since 2006, whether looking at hospital separations by AR-DRG (see
Page 171
Appendix E, Figure 49), by principal diagnosis (disorders of choroid and retina – see
Page 172
Appendix E, Figure 52), or by procedure (posterior segment, retina, and retinal photocoagulation –
see
Page 173
Appendix E, Figure 55).
Guideline concordance analysis on retinal photocoagulation was undertaken and one guideline of
moderate quality (AAO 2008) reported on the use of laser photocoagulation for the treatment of
retinal tears. The AAO 2008 reported moderate level evidence to support the use of laser
photocoagulation in the treatment of acute symptomatic horseshoe tears. However, no evidence
of quality exceeding consensus was reported for treatment of other retinal tears, breaks or lattice
degeneration, as listed below:





Traumatic retinal breaks are usually treated
Asymptomatic horseshoe tears usually do not require treatment
Asymptomatic lattice degeneration with or without holes usually does not require
treatment
Acute symptomatic operculated tears may not require treatment
Treatment is rarely recommended for asymptomatic operculated tears or atrophic round
holes
One guideline of moderate quality (AAO 2008) and one guideline of poor quality (RCO 2009)
reported on the use of laser photocoagulation in patients with age-related macular degeneration
(AMD). Both guidelines provide high level evidence recommending the use of photocoagulation to
treat extrafoveal choroidal neovascularisation. The AAO 2008 reports a slight visual improvement
in patients with well demarcated juxtafoveal CNV treated with photocoagulation though both the
AAO 2008 and RCO 2009, referring to the same high level evidence, recommend against the
treatment of subfoveal CNV with laser photocoagulation.
Page 174
Concordance conclusions
The MBS item descriptor for retinal photocoagulation does not contradict current guideline
recommendations. It is unclear whether greater precision is required, however, to capture the
nature of the indication for which photocoagulation is being applied.
An evidence-based analysis using a mini-HTA format was undertaken for this item and results have
been synthesised according to patient indication for the procedure.
Laser photocoagulation is a surgical procedure used to coagulate or cauterise blood vessels.
Photocoagulation with lasers was developed in the 1960s has been used in a number of
ophthalmological procedures and is used for a number of indications, including diabetic
retinopathy, age related macular degeneration, neovascularisation of the choroid or retina, retinal
ischaemia, glaucoma, to treat or prevent retinal detachment and retinal ischaemia. While the
mechanism of treatment for the different indications may be similar, differences in the location of
treatment within the eye, as well as differences in available treatment alternatives, make the
safety and effectiveness of photocoagulation indication specific and for this reason, it is important
to appraise photocoagulation for each indication independently.
Search strategy
A search of the Cochrane library – including the Cochrane database of systematic reviews,
Database of abstracts of reviews of effects (DARE) and the HTA database, the economics database,
EconLit, and Embase.com (consisting of both Embase and Medline) was conducted using the
search terms outlined in Table 51.
Table 51
Search terms utilised for photocoagulation
Population
('eye'/exp OR 'eye disease'/exp) AND
Intervention
('laser coagulation'/exp OR photocoagulat*)
Limits
1. [English language]/lim AND [humans]/lim AND [2005-2011]/py AND [systematic review]/lim
2. [humans]/lim AND [2005-2011]/py AND ([systematic review]/lim OR [controlled clinical trial]/lim OR [meta
analysis]/lim OR [randomized controlled trial]/lim)
3. [article]/lim AND [humans]/lim AND [2005-2011]/py
Availability and level of evidence
The Cochrane Library, EconLit, Medline and Embase were searched from January 2005 to
November 2010 according to the pre-specified search strategy. When Limit 2 was applied
(systematic reviews and RCTs), 286 articles were retrieved. Following a review of the abstract and
full-text (if eligibility was unclear), 46 studies were found to be eligible. Thirteen studies addressed
the use of photocoagulation in patients with diabetic retinopathy, 22 studies involved patients
with macular oedema, two studies involved patients with macular holes, two studies reported on
photocoagulation for the prevention of age-related macular degeneration, four studies involved
photocoagulation for the prevention or treatment of retinal detachment and two studies involved
photocoagulation as a treatment for choroidal neovascularisation in patients with myopia. The
complete article was retrieved and assessed for quality using the PRISMA checklist for systematic
reviews and the SIGN checklist for randomised controlled trials.
Page 175
3.18.1
Photocoagulation for the treatment or prevention of retinal
detachment
Background
Given that tears and holes are readily visible to ophthalmologists during routine evaluations,
asymptomatic tears are easily diagnosed. Photocoagulation of areas surrounding retinal holes or
tears to create an adhesion between the retina and the underlying epithelium may inhibit further
fluid accumulation underneath the retina.
Treatment for the prevention of future retinal detachments (RDs) must be weighed against the
likely effectiveness of such treatment, as well as the potential harm that may be caused. In the
case of a giant retinal tear (GRT), a form of tractional retinal detachment, at least 90 degrees of
the retina, attached to the vitreous, is lifted from the underlying epithelium. Surgical interventions
to repair the retina are complex due to the attachment of the vitreous to the retina. However, a
second giant retinal tear in fellow eyes is common, occurring in 12.8 per cent at an average of 3.5
years following the first GRT (Freeman 1978). Given the likely poor vision in the first eye with a
GRT, prevention of a GRT in the fellow eye is of importance.
Research question
Is photocoagulation a safe and effective procedure for the prevention or treatment of retinal
detachment?
Results
Prevention of retinal detachment in patients with asymptomatic retinal breaks
One Cochrane review was identified that addressed the use of photocoagulation to prevent retinal
detachment in patients with asymptomatic retinal breaks and/or lattice degeneration (Wilkinson
Charles 2005). However, this review did not identify any relevant RCTs addressing the research
question (Table 52).
Prevention of RD in the fellow eye of patients with unilateral giant retinal tears
One Cochrane review was identified that addressed the use of photocoagulation to prevent GRTs
and RD in the unaffected eye of patients with unilateral GRT (Ang Ghee, Townend et al. 2009).
However, this review did not identify any relevant RCTs that addressed the research question
(Table 52).
Prevention of retinal detachment following silicone oil removal after vitrectomy
One RCT of poor quality compared retinal detachment (RD) following silicone oil removal in
patients who received prophylactic 360° laser retinopexy or observation alone (
Page 176
Table 66) (Avitabile, Longo et al. 2008). This large study randomised 139 eyes to laser retinopexy
and 129 eyes to observation only after silicone oil removal. Patients who were treated with 360°
retinopexy, either during vitrectomy or soon after, were 59 per cent less likely to experience RD
following the removal of silicone oil than patients randomised to the observation group (RR 0.41,
95% CI [0.22, 0.78]). However, there are concerns regarding the reporting of these results as the
definition of the primary outcome measure of a subsequent RD, was different for those patients
who received retinopexy compared with those patients who received observation alone. RD in the
laser retinopexy group was separated into anterior (outside the ring of laser treatment) and
posterior (central to the ring of laser treatment). As this definition could not be used in the
observation arm, it appears that all retinal detachments were tallied, regardless of their location.
This rationale infers that retinal tears or detachments outside of the ring of laser treatment will
not spread centrally and threaten vision. However, any retinal detachment in an eye not treated
with 360° retinopexy may spread centrally. Therefore, all retinal detachments in the observation
arm required treatment compared with only the posterior retinal detachments.
Including all retinal detachments, both posterior and anterior to the laser retinopexy, RDs
occurred in 26/139 (18.7%) patients who received laser retinopexy and 27/129 (20.9%) patients
who were observed. It therefore does not appear that retinopexy reduces the incidence of RD
following silicone removal. However, of those who received retinopexy, only 12 of the 26 (46%)
RDs required an intervention compared with 100 per cent of RDs in patients who were observed.
Therefore, the attributable risk reduction (i.e., the absolute percentage of interventions for retinal
detachment avoided due to prophylactic laser treatment) is 12.3 per cent. To achieve this
reduction in required interventions, 100 per cent of patients undergoing vitrectomy must be
treated prophylactically with 360° laser photocoagulation retinopexy.
Conclusion
Given that laser photocoagulation can be an uncomfortable procedure for patients, the overall
benefits of avoiding subsequent reattachment surgery must be weighed against the financial costs
and patient wellbeing associated with the treatment of all patients undergoing vitrectomy. The
body of evidence for safety, accuracy and effectiveness is summarised in the matrix at Box 14.
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Box 14
Body of evidence matrix for prevention of retinal detachment following silicone oil removal
after vitrectomy
Component
Evidence base
Rating
D
Consistency
NA
Clinical impact
D
Generalisability
B
Applicability
B
Description
RCT (level II) with differential loss to follow up and different
definitions for outcome measure between the groups (no
justification provided).
Only one study
Overall, no outcome can be drawn from this study therefore it is
unlikely that prophylactic 360° laser retinopexy will be used to
prevent subsequent retinal detachment following silicone oil
removal. The impact of this finding is therefore small.
Study undertaken in a developed country (Italy). There may be
some dietary or racial predisposition differences between Italy
and Australia, however populations are likely to be largely similar.
Performed in a country with a good health care system,
comparable to Australia, although there will be some differences
in the delivery of health care.
Page 178
Table 52
Study profiles and results of systematic reviews comparing photocoagulation to
control or alternative treatments in the prevention of retinal detachment
Systematic reviews comparing photocoagulation to control or alternative treatments in the prevention of
retinal detachment
Study, review period and
quality appraisal
Population characteristics, inclusion criteria
(Wilkinson Charles 2005)
Level of evidence: NA
Assessment of quality: NA
Cochrane review
Cochrane Library to Issue 4,
2008
Medline: Jan 1966 to Nov 2008
Embase: Jan 1980 to Nov 2008
Systematic review – no publications found relevant to this review.
Population:
Studies of patients with asymptomatic retinal break and / or lattice
degeneration.
Intervention:
Studies of patients receiving any type of treatment (including
photocoagulation and trans-conjunctival cryotherapy)
Included studies, population characteristics and
inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
No RCTs found relevant to this review.
NA
NA
Study, review period and
quality appraisal
Population characteristics, inclusion criteria
(Ang Ghee, Townend et al.
2009)
Level of evidence: NA
Assessment of quality: NA
Cochrane review
Cochrane Library to Issue 4,
2009
Medline: Jan 1950 to Oct 2009
Embase: Jan 1980 to Oct 2009
Lilacs: Jan 1982 to Oct 2009
Systematic review – no comparative studies were found relevant to this
review.
Population:
Randomised controlled trials involving patients with unilateral giant retinal tear
(GRT).
Intervention:
Randomised controlled trials of 360-degree laser photocoagulation or 360degree transscleral cryotherapy or 360-degree encircling sclera buckling in
the unaffected eye as prophylactic treatment for GRT or retinal detachment.
Included studies, population characteristics and
inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
No RCTs found relevant to this review.
6 case series reported on prophylactic treatment of fellow
eyes and 2 involved the use of laser photocoagulation.
Reported on 2 case series involving laser
photocoagulation.
1. (Al-Khairi, Al-Kahtani et al. 2008)
21 fellow eyes of 21 patients with spontaneous GRT – 360
degree laser or cryotherapy
2. (Ghosh, Banerjee et al. 2004)
18 fellow eyes of 18 patients with spontaneous GRT – 360
degree laser or cyrotherapy
NA
NA
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Qualitative analysis
A consumer preferences analysis was undertaken regarding retinal photocoagulation.
Research question
What is the patient experience of and perspective on the ophthalmology service described by MBS
Item 42809?
Search strategy
A qualitative literature search was undertaken using the Scopus and Embase databases. Articles in
English were sourced from developed nations using the search terms described in Table 53.
Table 53
Search terms used for identifying relevant literature in journal databases for
photocoagulation
Disease/disorder description
“Retinal detachment [MeSH] OR detached retina OR diabetes OR ‘diabetic retinopathy’ OR vasoocclusive
disease OR ‘retina* tear*’ OR macroaneurysm OR macular oedema
‘Umbrella’ terms describing the activity
Light Coagulation [MeSH] OR Retinal photocoagulation OR laser photocoagulation OR panretinal
photocoagulation OR laser
What are we trying to canvass
“patient satisfaction” [MeSH]; attitude to health [MeSH]; patient compliance [MeSH]; public opinion
[MeSH]; health knowledge, attitudes, practice [MeSH]; patient acceptance of health care [MeSH]
Methods that might be employed in canvassing views
“qualitative research” [MeSH]; “focus Groups” [MeSH]; “focus groups”[TW]; interviews[TW]
Papers were selected on the basis that they included the patient perspective of the experience of
retinal photocoagulation including the period before and after the procedure and any side effects
which the patient associated with the procedure. They were excluded on the basis that they were
written in a language other than English, written by a commercial entity, and not from a
developed country. Studies deemed be relevant based on the title were identified (n=190) and
combined into one EndNote X3 database. The abstracts of these studies were then read, and 167
studies were excluded based on our original inclusion and exclusion criteria. Selected articles
(n=23) were subjected to full text reading. Upon the reading of full text 17 were excluded. The
reference list of relevant reviews sourced from the database were scrutinised and one additional
relevant article was found. The key findings of the final seven publications were tabulated and
analysed for the purpose of the following report.
Weblogs from developed countries which described the experience of retinal photocoagulation
were identified through a Google advanced domain search. Searches were restricted to English
Language and the period January 2000 to August 2010. Papers were selected on the basis that
they presented the perspectives of people who had experienced retinal photocoagulation as
described above. Only personal blogs written in the English language from developed countries
presenting personal views were included. Commercial blogs were excluded. All weblogs were
imported into NVivo for thematic coding and analysis.
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A Google advanced domain search was conducted for ‘blogspot.com’, as this is the domain that,
from our experience, retrieves the most relevant results for ophthalmology procedures, and is
generally a widely used blogging domain. A general Google search was also carried out using
relevant terms as shown in Table 54.
A review of search results was discontinued when it became apparent that all of the weblogs
identified were repeats of earlier findings (as seen in search 1, 6 & 7). One blog by an Australian
living in Kuala Lumpur is included even though Malaysia is not included in our ‘developed country’
list because the blogger is Australian and provides a very rich and relevant description of the
experience of retinal detachment and retinal photocoagulation treatment (David Astley 2005). In
total, 12 blogs from 10 bloggers provided sufficient detail of the experience for inclusion in this
review.
Table 54
Weblog search terms for photocoagulation
Search
Number
Domain
Search terms
Number of
results
Viewed first
Relevant
sites
1
blogspot.com
1420
500
18
2
blogspot.com
95
All
0
3
blogspot.com
“detached retina” or
“retinal
photocoagulation”
“retinal
photocoagulation”
“retinal tear”
210
All
7
4
No domain used
“detached retina”
and “retinal
photocoagulation”
AND blog
75
all
0
5
No domain used
6,860
100
1
6
blogspot.com
“detached retina”
and (“retinal
photocoagulation”
OR laser) AND blog
(Diabetes OR
“diabetic
retinopothy”) AND
(laser OR
photocoagulation)
59,200 results
100
1
7
blogspot.com
817
100
0 (all
professional
or
commercial
8
blogspot.com
'retinal
neovascularization'
AND (laser OR
photocoagulation)
site:blogspot.com
(macroaneurysm or
'macular oedema')
AND (laser OR
photocoagulation)
site:blogspot.com
4
all
0 (all
professional
or)
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Results
Pre-operative experience
Patient preferences for treatment choices
Adherence to recommended retinal photocoagulation treatment regimes is a particular issue with
diabetic patients possibly because patients may be asymptomatic for some time. Chang and
colleagues (Chang, Fine et al. 2007) investigated patient treatment preferences amongst patients
presenting for treatment with retinal vein occlusion. This was quite a difficult questionnaire where
patients were asked, in a hypothetical exercise, to weigh the benefits of potentially improved
eyesight against the risks of potentially reduced eyesight associated with particular treatment
choices. Chang et al found that 70 per cent of patients were either moderately or very enthusiastic
about undergoing retinal photocoagulation, this was compared with intravitreal injection (50%) or
observation only (33%). The patients indicated that their choices primarily related to consideration
of treatments’ risk-benefit ratios rather than to fears about the nature of the treatment choices
themselves.
Comparing randomly allocated laser photocoagulation and submacular surgical treatments for
choroidal vascularisation secondary to age-related macular degeneration, De Juan and associates
found that the two procedures produced similar post-operative survey results for quality of life
rating and patient visual acuity (Submacular Surgery Trials Pilot Study Investigators 2000). These
findings, in conjunction with the observed similar ophthalmic outcomes, led them to conclude that
the two treatments provided very similar outcomes in these patients. However, the study was a
pilot and was limited by the small number of patients: there was insufficient power in the study to
detect meaningful differences in summary scores between the two treatment arms.
Jones & Sampat (2003) found in face to face structured interviews that most of the British
diabetes patients (n=44) in their study preferred a one-stop, one-visit treatment model, even if it
meant having to wait at the clinic for around three hours. The advantages of such an arrangement
over a multiple-visit model are reduced treatment default, no waiting lists for laser treatment and
reduced visual deterioration in patients (Jones, Sampat et al. 2003). Such a finding might be seen
to be at odds with the study by Mozaffarieh et al who reported that Austrian diabetes patients
identified long clinic waiting times as the most common reason for defaulting (Mozaffarieh,
Benesch et al. 2005). Of course, if the patients are treated on the same day as their diagnosis this
would not be a problem but it may be a factor if subsequent treatment sessions are required.
Chuah & Yeo (1999) examined diabetes patients’ reported reasons for discontinuing
photocoagulation treatment. Other commitments (especially work) was the most commonly given
reason for missing treatment (31%), followed by having forgotten appointments (21%), as well as
the occurrence of other medical problems that rendered the patients unable to attend
appointments (13%). Chuah and Yeo suggest that undesirable side effects such as temporary
vision loss post treatment or impaired colour vision may impact on patient adherence to
treatment but they did not explore this in their study. Nor did they include the issue that the
retinal deterioration is not painful or uncomfortable whereas the treatment may be both. All
patients who were contacted were willing to make a new appointment with their doctor but
nearly a third of patients could not be contacted (Chuah and Yeo 1999). There was no discussion in
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the weblogs about patients defaulting from treatment; however, bloggers did mention reasons for
putting off treatment longer than they should have. For example, one American blogger who
experienced sudden partial vision loss which lasted for several hours gave cost as the primary
reason for delay:
I however have to put this off until November when my health insurance kicks in (Stroll
September 19, 2010).
Mozaffarieh et al reported that a significant number of the patients in their study were not aware
of the need to attend treatment sessions either because they were not instructed to attend these
sessions or because of misconceptions on the part of the patient as to the necessity for treatment
sessions (Mozaffarieh, Benesch et al. 2005).
Access to information
With delay the condition may deteriorate to the point that retinal photocoagulation is no longer
sufficient, and more invasive surgery may be needed. Several bloggers discuss not understanding
that the symptoms they were experiencing were serious. For example, one blogger who
experienced partial retinal detachment requiring surgery and extended convalescence described
symptoms over several days culminating in:
That night when I was driving home, I suddenly became aware that I had completely lost
the sight of the bottom right hand corner of my eye. I had dinner organised that night with
some guests from CNN... so I decided to put off going to the hospital until the morning,
because there was no pain or discomfort in the eye. Australian blogger living in Malaysia
(David Astley 2005).
He had looked up his initial symptoms of floaters online and found that
...floaters were quite common, and nothing to worry about, and would disappear of their
own accord. I thought about going to see a doctor, but after reading the Internet write-up,
decided to do nothing about it (that should be a lesson in itself). Australian blogger living in
Malaysia (David Astley 2005)
But even when forewarned, bloggers may not act. As described above, American blogger ‘Stroll’
delayed treatment until he was covered by work health insurance:
I made the mistake of Googling this symptom upon which I discovered it is indicative of a
DETACHED RETINA and I need to seek immediate eye care or else permantly lose my eye
site (Stroll September 19, 2010).
People are complex in their responses as this American blogger shows when she first talks about
why she does not wish to have her eyes checked:
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It's inconvenient. You lose the rest of the day, pretty much, if you're in my line of work and
need to be able to read to get work done. Once my eyes are dilated, I pretty much can't
read for a long time. Nor can I go out in the sun (Bardiac 22 march, 2010).
But in the same entry describes her feelings after finally making the appointment:
So I called to make an appointment today. And instantly I felt sick, like sick like I wanted to
vomit out my window sick. Ugh. It's purely anxiety. I never used to be anxious about eye
stuff, but then I had a detached retina, and now I'm anxious about eye stuff (Bardiac 22
march, 2010).
Pre-treatment anxiety
A case-control study recruited patients waiting for procedures to rate their anxiety about the
impending treatment (Trento, Tomelini et al. 2006). Comparisons of ratings showed that patients
waiting for laser photocoagulation reported significantly higher levels of anxiety compared with
patients waiting for screening or a non-intervention appointment. Unlike with cataract surgery
described elsewhere in this report, previous experience with laser treatment did not alleviate
anxiety. Most patients had negative perceptions of the treatment and some patients described the
therapy using “words evoking cruelty and pain” (page 1108 Trento (2006)). Given this response, it
is apparent that the patients must attribute considerable value to the treatment presumably
because they are aware of the risks posed by non-treatment. The authors comment that their
data, which compares four clinics, suggests that a relaxed clinic environment and an emphasis on
good patient information communication may help to reduce patient anxiety (Trento, Tomelini et
al. 2006).
A different perspective is represented in the weblogs with an American female blogger
commenting:
I assumed this laser stuff was no big deal. Isn't that what lasik is? (Babs April 25, 2007).
Similarly, blogger Michele, from Canada, notes a low level of anxiety in comparison to that
experienced with another type of treatment for retinal detachment:
By the way, did you ever experience any anxiety attacks going through this? I didn’t with
the laser, but the gas bubble drove me crazy the 4 days I had to sit still. Michele in (Mike
November 4th, 2009).
Patient understanding of the procedure
Patients writing in the blogs demonstrated considerable knowledge of the range of treatments
available to them as well as the positive and negative aspects of each one, suggesting that at least
in some cases effective communication between doctor and patient was occurring. For example,
one blogger described being presented with different options:
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My eye surgeon said I had two choices. One was to take it easy for the next six months
(with no travel) and go to the hospital to have the retina sealed with a laser every time a
new tear occurs (least risky and least painful option), or the other option is to have the
retina sealed with a laser 360 degrees around the outside to stop any retinal detachment
occurring when I get new retinal tears (which would enable me to travel as it wouldn’t be
so urgent to have the tears fixed). Australian blogger living in Malaysia (David Astley 2005).
However, not all bloggers reported adequate information provision and this may have impacted
negatively on their satisfaction with the experience. For example, Mel from the United States
blogs about her dissatisfaction with the lack of choice and explanation she received about the
process:
He then told me that I needed immediate laser surgery or would likely go blind in that eye.
He had me sign papers, walked me down a hall, sat me in an office chair (which he
explained was not to correct chair but that it would have to do), had me lean my head
against the wall (Mel Eppich February 22, 2010).
Knowledge of the disease and knowledge of the procedure is explored in an Italian study where
most patients were unable to describe the photocoagulation procedure or explain why they were
to undergo the procedure (Trento, Tomelini et al. 2006).
Doctor-patient communication
Knowledge poorly disseminated can increase anxiety as demonstrated in this American blogger’s
experience:
[The doctor] was about to shoot a laser into my eye when I finally got the courage to ask if
this procedure would correct the fireworks and if there were any risks. At this point I was in
shock and trembling slightly. He stated that it would likely not fix the current visual
annomaly but would hopefully prevent my retina from detatching. He then proceded to tell
me that if I looked at the laser I would be blind in that eye and that there was still a chance
that I could go blind following the procedure. At this point I was not just trembling but
shaking. (Mel Eppich February 22, 2010)
This blog posting suggests that the way in which information is delivered can seriously affect
patient experience of the procedure, an observation which fits well with the findings of Trento et
al (2006) and Mozaffarieh et al (2005). In these studies, with Italian and Austrian diabetic patients
respectively, the authors point to the importance of pre-treatment counselling and education in
order to set realistic expectations for outcomes, reduce patient anxiety and increase patient
satisfaction (Mozaffarieh, Benesch et al. 2005; Trento, Tomelini et al. 2006). In particular, the
Austrian study supports the importance of informing diabetic patients that the treatment is to
prevent further deterioration rather than to improve visual acuity (Mozaffarieh, Benesch et al.
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2005). This study also found that younger patients were less satisfied with their treatment possibly
because they found their loss of visual acuity more difficult to deal with than older patients who
may see it as part of the ageing process.
Good pre-treatment counselling may be more difficult to provide in the case of retinal tears since
the treatment is often on an urgent emergency basis. For example, see (Nancy Voogd October 1,
2008; Nancy Voogd September 29, 2008). However, even these patients may benefit from
formalised communication strategies which may make an anxious wait in a clinic less burdensome
and improve patient satisfaction.
Several bloggers commented on doctor patient communication and its impact, for example one
blogger from the United States recovering from retinal detachment treatment observes:
The thing about my eye doc is he can say, "you are dying" so calmly, you would be glad to
hear it. However, the tech I had today was a little more in your face, here's the real deal,
type person. The type I prefer. The doc confirmed the same things she said. But he says it
like it's no big deal. "It will be a while before you regain vision in that eye." (with the
understood side-note that my vision may not get better at all) (Babs April 24, 2007).
Communication may suffer where care is shared between doctors as American blogger Nancy
Voogd describes when she goes to a follow up appointment armed with questions:
This doctor was unwilling to answer most of my questions saying that Dr. Ward was much
more conservative than he was, so he wasn't willing to tell me what things I could start
doing again(Nancy Voogd October 1, 2008).
Intra-operative experience
Pain and visual experiences
Journal articles focus on outcomes such as visual acuity and patient satisfaction and only Trento et
al refer to the pain experienced during treatment and then only in passing. Several bloggers
describe the pain experienced during retinal photocoagulation treatment. Bloggers provide some
insight into the intensity of pain experienced by patients:
“Holy jalapenos! That laser stuff hurts like hell. Ouch, it's burning my eye. My eye is on fire.
Be done quick. Stop it, stop it. I didn't say any of this out loud. Instead, I blasted him with
my mental telepathy. But the laser was to [sic] strong for my mental telepathy skills to have
an effect. I clenched my fist like a warrior and made little soft pain noises to indicate to the
Doc that this was not comfortable. Finally, the cruel and unusual punishment ended and my
tense muscles melted into a pool on the floor. (Babs April 25, 2007) (USA).
He's not kidding. Yeah, there aren't very many nerves back there, but there are some. This is
one of the most intense experiences I've ever had, and I've given birth to two children. At
one point, near the end, I felt like I would have passed out if I had been able to close my
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eye. It was a funny thought, because of course passing out doesn't require closing one's
eyelid, but I definitely felt like I didn't want to be in my body any more. (Nancy Voogd
September 29, 2008) (USA).
In all I had about ten bouts of laser treatment after leaving hospital to seal small holes or
tears in the retina. The first session was terribly painful, and a few of the subsequent ones
were too. I recall one session where my head was not properly strapped to the machine and
I was sitting on a chair with roller castors. One of the laser bursts hit a nerve in the back of
the eye, and it was so painful that I pulled my head back from the machine with so much
force that the chair (with me on it) traveled [sic] several metres across the room! Normally
your head is strapped to the machine so that this doesn’t happen, but not all doctors bother
to strap you in. ...Several people have asked what it is like to have the argon laser welds
performed on the eye. It is difficult to describe because the pain is not like I have
experienced in any other part of the body. It is not an excruciating pain, but is quite
unpleasant if the doctor turns the power up high. I did not experience much pain from the
laser that I had done in Bangkok, but that was because the doctor there used quite a low
power setting – and when I returned to Kuala Lumpur my regular doctor insisted on
reinforcing it with some more laser at a higher power. Because the pain is experienced at
the back of the eye, it is not possible to use an anaesthetic, so you have to grin and bear it.
Someone once asked me whether it was a sharp pain or a dull pain. It actually feels like a
cross between the two. Fortunately the pain occurs only for the duration of the laser burst
(a fraction of a second) but it is accompanied by a very bright green light which is
uncomfortable in itself. Not every laser burst causes pain. At a relatively high setting,
perhaps one in three bursts is painful – but you get nervous wondering whether the next
one is going to be a painful one or not! Australian blogger living in Malaysia (David Astley
2005).
It is apparent that the discomfort experienced during treatment is in part related to the intensity
of the visual experience as these bloggers relate:
Then the lights started which would make me blink and hit the lens with my eye lid. ... and
OMG when is he going to stop that awful light (Babs April 25, 2007) (USA).
He began firing a green laser into my eye which caused me to see only green after a short
time and which made it impossible to know whether I was looking at the laser or not (Mel
Eppich February 22, 2010) (USA).
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I thought it might only involve a dozen or so zaps to seal the errant flap but it was more like
1,000. Very Very bright zaps. Very bright Made for a rather psychedelic light show within
my phosphenes. Some pressure/pain, but not worse than an average cavity filling (Brian
Olewnick October 02, 2009) (USA).
Treatment involves getting numbing drops and/or gel squirted into your eye(s), having a
glass lens pressed up against your eyeball, putting your face in a machine that makes you
feel like you should be on A Clockwork Orange, and then getting a couple of thousand (yes,
thousand) of laser zaps on your retina (called pan-retinal laser treatments). It's not as
painful as it sounds like it could be, but it is painful, and it's VERY stressful. The light is very
bright, and with every zap it takes your breath away and makes your other eye want to roll
back in your head. It only lasts a few minutes, but it's pretty low down on most people's list
of enjoyable ways to spend a few minutes (Bethany Rose April 29, 2009) (Canada).
Doctor patient communication and intra-operative compliance with instructions
Mozaffarieh et al (2005) examined the proportion of patients who complied with physicians’
instructions during the procedure. They found that around 23 per cent of patients failed to comply
with the physician’s instructions and highlighted that this could possibly lead to the experience of
adverse events. Interestingly, they observed that failure to comply was in part due to
misinstruction by the attending physician (Mozaffarieh, Benesch et al. 2005). Poor doctor-patient
communication during the procedure is noted in several of the weblogs. For example one blogger
from Singapore observed:
When he was fixing the lens on my eyes, his mobile rang and he answered it with one hand
still holding the lens that was kind of stuck on my eye! I was in that awkard position for a
couple of minutes while he yakked on his mobile! He is so so lacking in bedside manners! He
didn't even inform me when he started zapping my eye. After the procedure, gel was
flowing down my face and he didn't pass me a tissue nor did he asked me whether I was
alright (Kathy September 23, 2005).
And another from the United States describes:
She pokes around, looks at my eye with a very bright light and then puts numbing drops in
the left eye saying, "You'll feel some pressure now." She doesn't mention that she's now got
a needle in her hand and she's approaching my eye (Nancy Voogd September 29, 2008).
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Post-operative experience
Patient satisfaction
Patient satisfaction was canvassed, to a minor extent, in the literature. Work by Mozaffarieh &
colleagues (2005) examined patient satisfaction with laser photocoagulation treatment. The
results showed that half of all patients who responded to the Diabetes Treatment Satisfaction
Questionnaire (DTSQ) initially after the procedure, compared with just over 40 per cent sixmonths after the treatment. This study also examined overall satisfaction with treatment and
found that after nine months nearly 70 per cent reported their overall satisfaction with the
treatment and that their pre-procedure expectations corresponded with the results – this
surprised the researchers as of this 70 per cent only nine per cent reported an improvement in
their visual acuity (Mozaffarieh, Benesch et al. 2005). Satisfaction with treatment and results also
features in the on-line community perspectives, where alternative views are presented:
My experience so far (5 days) has been extremely positive. (Dan commenting in response to
(Press September 7, 2007) (USA).
All I know now is that lasers suck (Babs April 25, 2007) (USA).
As described above it is clear detailed information imparted with a degree of sensitivity is a key
component in patient satisfaction. It is perhaps apt to finish this section with one American
blogger’s description of what appears to be an example of poor communication post-procedure:
As I blinked, I could see nothing but black in my right eye and began to panic, just as he was
about to push me through the door, tears streaming down my face I forced the words "I
can't see, is this normal?" He casually stated that I wouldn't be able to see for a few
minutes and that if I had any problems to call in the next few days. . . and if I woke up blind
in that eye to come back in immediately and then he was gone (Mel Eppich February 22,
2010).
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3.18.2
Laser photocoagulation for diabetic retinopathy
Background
Diabetic retinopathy is a progressive condition associated with vascular changes in the retinal
circulation, such as increased permeability, formation of micro-aneurysms, ischaemia and
angiogenesis accompanied by haemorrhage, scarring and tractional retinal detachment. Vision
impairment is often due to macular oedema or the neovascularisation of the retina, which leads to
haemorrhage.
Diabetic retinopathy is classified as non-proliferative or proliferative. Non-proliferative diabetic
retinopathy is characterised by increased vessel permeability, micro-aneurysms, haemorrhages
and hard exudates, whereas proliferative diabetic neuropathy is characterised by
neovascularisation with the development of new, abnormal blood vessels. Neovascularisation may
lead to haemorrhage resulting in vision loss, or cause fibrous adhesions between the retina and
vitreous, which may “pull” on the retina and result in tractional retinal detachment.
Research question
Is laser photocoagulation a safe and effective treatment for diabetic retinopathy?
Results
One systematic review of poor quality, containing seven randomised controlled trials (RCTs) and a
meta-analysis, including 6,195 patients, compared laser photocoagulation with observation in the
treatment of patients with non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic
retinopathy (PDR) (Mohamed, Gillies et al. 2007). The profiles of the studies included in this
systematic review are described in Table 55. However, due to the poor quality of this systematic
review, only the results from the better quality individual studies (RCTs) from this systematic
review were included for assessment. In addition, 11 RCTs with a total of 1,694 eyes, compared
laser photocoagulation with; intravitreal triamcinolone acetonide (IVTA) with and without
photocoagulation; intravitreal bevacizumab (IVB) with photocoagulation or intravitreal pegaptanip
(IVP); or compared different methods of photocoagulation or timing of photocoagulation; for the
treatment of NPDR or PDR.
Photocoagulation versus observation
Two large RCTs (Diabetic Retinopathy Study Research Group 1981; Early Treatment Diabetic
Retinopathy Study Research Group 1991; Flynn, Chew et al. 1992) from the systematic review by
Mohammed et al (2007) provided the strongest evidence for the effectiveness of
photocoagulation (Table 56). The Diabetic Retinopathy Study (DRS) (n= 1,742) reported that
peripheral pan-retinal photocoagulation (PRP) with or without focal treatment decreased severe
visual loss (defined a visual acuity <5/200 on 2 consecutive visits) by more than 50 per cent. Eyes
with “high risk” features, such as new vessels at the optic disc (NVD) or vitreous haemorrhage with
new vessels elsewhere (NVE) had an even greater benefit from photocoagulation. The Early
Treatment Diabetic Retinopathy Study (ETDRS) (n=3,711) reported reduced severe visual loss in
patients randomised to immediate peripheral PRP with or without focal treatment compared with
patients in whom treatment was deferred. However, patients randomised into the Diabetic
Retinopathy Study had more severe diabetic retinopathy and showed a greater absolute reduction
in severe visual loss compared with patients from the ETDRS, in whom low rates of severe visual
loss were detected in both groups.
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The criteria for selecting studies and data regarding the quality of each included study are not
reported in Mohamed et al 2007. In addition, actual numbers of patients in each group are absent
from data extraction tables making appraisal difficult. However, an informal search of the
literature supports that the Diabetic Retinopathy Study and the Early Treatment Diabetic
Retinopathy Study are likely to be the largest studies of photocoagulation to date, and additional
studies, if excluded or overlooked, are unlikely to markedly affect findings. In addition, in all other
included studies, photocoagulation appears perform better than observation with regard to visual
outcomes. Rohan et al (1989), a meta-analysis of five RCTs, reported a 61 per cent reduction in the
incidence of blindness in eyes treated with photocoagulation compared with observed eyes (Table
56). Assuming independence of treatment response by each eye27, the reduction in the incidence
of blindness of both eyes would be 85 per cent over eyes which are not treated. The British
Multicentre Study (1984) also provided evidence for the effectiveness of photocoagulation in the
form of a dose response, with eyes that became blind following treatment having fewer
photocoagulation burns than eyes that did not (Table 56).
Conclusion
Peripheral pan-retinal photocoagulation for the treatment of diabetic retinopathy is associated
with a reduced risk of severe visual loss and blindness than observation or deferred treatment.
High risk eyes tend to experience greater benefit than low risk eyes. The body of evidence for
safety, accuracy and effectiveness is summarised in the matrix at Box 15.
Box 15
Body of evidence matrix for photocoagulation for the treatment of diabetic retinopathy
Component
Rating
Description
Evidence base
A
One poor quality systematic review (level I evidence) of 7 RCTs and
one meta analysis. Poor quality due to lack of reporting, however
involves a high level of evidence.
Consistency
B
Most studies involved report improvement in visual outcomes among
PRP patients, though the effect size varies. Variation may be due to
differences in technique or patient disease severity.
Clinical impact
A
Very large clinical impact given the relative risk of blindness (by the
meta analysis) is 0.39 when comparing PRP to observation.
Generalisability
A
The largest studies providing the most evidence arise from the US
and UK. These populations are highly generalisable to the Australian
population.
Applicability
B
The healthcare systems in the UK and US are slightly different,
though are of comparable quality to Australia and results can be
viewed as applicable to the Australian healthcare context.
27
However, if one eye responds to photocoagulation the fellow eye is more likely to respond with the reverse being
true also, therefore this is likely to be an over estimate of photocoagulation effect.
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Table 55
Study profiles and results of systematic reviews comparing photocoagulation to
control or alternative treatments for the treatment of diabetic retinopathy
Systematic reviews comparing photocoagulation to control or alternative treatments for the treatment of
diabetic retinopathy
Study, review period and
quality appraisal
Population characteristics, inclusion criteria
(Mohamed, Gillies et al. 2007)
Level of evidence: I
Assessment of quality: poor
Systematic Review
Medline, Embase, Cochrane
Collaborations, Association for
Research in Vision and
Ophthalmology database and the
National Institutes of Health
Clinical Trials Database through
to 2007
Overall quality assessment: poor
Systematic review based on 44 studies (including 3 meta analyses)
addressed the management of diabetic retinopathy.
7 RCTs and one meta-analysis with a total of 6,195 patients* reported on the
effect of laser photocoagulation for the treatment of non-proliferative diabetic
retinopathy (NPDR) and proliferative diabetic retinopathy (PDR).
Population:
Studies of patients with NPDR or PDR, with or without diabetic macular
oedema (DME).
Intervention:
Studies comparing laser treatment with observation
* 1,948 patients of Rohan et al 1989 are excluded from this count as they are
included in RCTs
Studies included in Mohamed et al (2007), population
characteristics and inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
(Rohan, Frost et al. 1989)
note: this study is a meta-analysis of 5 RCTs including DRS
(1981) and BMS (1984 and 1983)
N= 2,243
Inclusion: NPDR or PDR with or without DME
Follow up: 1-5 years
Peripheral pan-retinal
laser
photocoagulation with
or without focal laser
treatment.
Control: observation
Rate of blindness in eyes
treated vs observed
(Diabetic Retinopathy Study Research Group 1981)
N=1,742
Inclusion: severe NPDR (bilateral) or PDR (with or without
DME)
Follow up: 5 years
Peripheral pan-retinal
laser
photocoagulation with
or without focal laser
treatment.
Control: observation
Severe visual loss
(Early Treatment Diabetic Retinopathy Study Research
Group 1991; Flynn, Chew et al. 1992)
N=3,711
Inclusion: Mild to severe NPDR or early PDR with or without
DME in both eyes
Follow up: 5 years
1 eye of each patient randomised to each study arm
Early pan-retinal laser
photocoagulation with
or without focal laser
treatment.
Control: treatment
deferral
Severe visual loss, risk of
vitrectomy,
(British Multicentre Study Group 1984)
N=107
Inclusion: PDR (bilateral and symmetrical)
Follow up: 5-7 years
Xenon-arc laser
photocoagulation
Control: observation
Rate of blindness in eyes
treated vs observed
(British Multicentre Study Group 1983)
N=99
Inclusion: NPDR
Follow up: 5 years
Peripheral xenon-arc
laser
photocoagulation
Control: observation
Visual deterioration
(Hercules, Gayed et al. 1977)
N=94
Inclusion: Symmetrical PDR involving optic disc
Pan-retinal laser
photocoagulation
Control: observation
Rate of blindness in eyes
treated vs observed
Page 192
Follow up: 3 years
(Patz, Schatz et al. 1973)
N=66
Inclusion: NPDR with DME
Follow up: 26 months
Pan-retinal laser
photocoagulation
Control: observation
Visual deterioration
(Lovestam-Adrian, Agardh et al. 2003)
N=81
Inclusion: Severe NPDR and PDR in patients with type 1
diabetes
Follow up: 2.9 ± 1.5 years
1 eye of each patient randomised to each study arm
Pan-retinal laser
photocoagulation
Control: observation
Rate of
neovascularisation,
vitreous haemorrhage,
risk of vitrectomy, visual
impairment
Table 56
Study profiles and results of RCTs included in systematic reviews comparing
photocoagulation to control or alternative treatments for the treatment of diabetic
retinopathy.
RCTs included in the Mohamed et al (2007) systematic reviews comparing photocoagulation to
observation or deferred treatment for the treatment of diabetic retinopathy
Studies included in Mohamed et al (2007), population
characteristics and inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
(Diabetic Retinopathy Study Research Group 1981)
N=1,742
Inclusion: severe NPDR (bilateral) or PDR (with or without
DME)
Follow up: 5 years
Peripheral pan-retinal
laser
photocoagulation with
or without focal laser
treatment.
Control: observation
Severe visual loss
Results
Severe Visual Loss1
Treated
% (n/N)
14 (90/650)
Observed
% (n/N)
33 (171/519)
(Early Treatment Diabetic Retinopathy Study Research
Group 1991; Flynn, Chew et al. 1992)
N=3,711
Inclusion: Mild to severe NPDR or early PDR with or without
DME in both eyes
Follow up: 5 years
1 eye of each patient randomised to each study arm
RR [95% CI]
0.42 [0.43, 0.53]
Early pan-retinal laser
photocoagulation with
or without focal laser
treatment.
Control: treatment
deferral
Severe visual loss, risk of
vitrectomy,
Results
Severe Visual Loss1
Risk of Vitrectomy
SVL or Vitrectomy
Treated
%
2.6
2.3
4
Deferred
%
3.7
4
6
(Rohan, Frost et al. 1989)
Note: this study is a meta-analysis of 5 RCTs including
DRS (1981) and BMS (1984 and 1983)
N= 2,243
Inclusion: NPDR or PDR with or without DME
Follow up: 1-5 years
Estimated RR
(Data not provided)
0.70
0.58
0.67
Peripheral pan-retinal
laser
photocoagulation with
or without focal laser
treatment
Control: observation
Page 193
Rate of blindness in eyes
treated vs observed
(British Multicentre Study Group 1984)
N=107
Inclusion: PDR (bilateral and symmetrical)
Follow-up: 5-7 years
Xenon-arc laser photocoagulation
Control: observation
(British Multicentre Study Group 1983)
N=99
Inclusion: NPDR
Follow-up: 5 years
Peripheral xenon-arc laser photocoagulation
Control: observation
(Hercules, Gayed et al. 1977)
N=94
Inclusion: Symmetrical PDR involving optic disc
Follow up: 3 years
Pan-retinal laser photocoagulation
Control: observation
Results:
Risk of blindness
BMS (1984)2
BMS (1983)
Hercules et al (1977)
Rohan et al (1989)3
Treated
% (n/N)
9.3 (10/107)
19.2 (19/99)
7 (7/94)
Observed
% (n/N)
31.8 (34/107)
39.4 (39/99)
38 (36/94)
-
RR [95% CI]
0.29 [0.11, 0.77]
0.49 [NR]
0.19 [0.09, 0.41]
0.39 [0.28, 0.55]
Defined as a visual acuity <5/200 on two consecutive visits at 2 years; 2 percentages of patients becoming blind differs from the
reported percentages in Mohamed et al 2007, possibly due to a calculation error by Mohamed et al. 3 Meta analysis of 5 RCTs
includes patients from Hercules et al and BMS.
1
Different techniques for delivering photocoagulation
Three RCTs reported on different methods of delivering peripheral pan-retinal photocoagulation
(PRP) (Table 57). Fong et al (2007), an RCT of moderate quality (n=323 eyes), reported consistently
improved measurements on optical coherence tomography using the modified ETDRS technique
compared to the mild macular grid (MMG) technique. These differences, however, did not
manifest as significant outcomes in visual acuity. Muqit et al (2010), an RCT of good quality (n= 40
eyes) reported a statistically greater reduction in central retinal thickness in eyes treated in a
single session with 1,500 burns compared with those treated over three sessions with 500 burns
each session. No statistical difference in visual acuity was found. However, it was postulated by
the authors that, outside of a clinical trial environment, patient compliance may increase using a
single session rather than multiple sessions, as well as result in an overall reduction in costs.
Nagpal et al (2010), a good quality RCT of 120 eyes, compared PRP with a single spot laser with
PRP with a multispot pattern scan laser. There was no difference in visual acuity at six months
between the procedures; however the multispot laser resulted in significantly less pain during the
procedure.
One good quality RCT (n=58 eyes) reported the best corrected visual acuity (BCVA) and
progression to, or worsening of, macular oedema in patients treated with PRP prior to cataract
surgery versus patients treated with cataract surgery prior to PRP (Suto, Hori et al. 2008). At 12
months, a significantly higher proportion of patients had improved BCVA (> 20/40) in the arm that
underwent surgery first compared to the PRP followed by surgery group (96.6% vs 69%, p= 0.012).
In addition, the progression of macular oedema was more likely in the PRP first group (RR = 2.0,
95% CI [1.49, 2.51]).
Page 194
All four included studies compare different techniques of delivering PRP in patients with diabetic
retinopathy. Without a formal systematic review, it is difficult to draw definitive conclusions
regarding each trial’s findings. However, the results reported by Nagpal and Suto are persuasive
given that they show a statistical difference in patient discomfort and functional outcomes,
respectively.
Table 57
Study profiles and results of RCTs reporting on the different techniques for delivering
photocoagulation
RCTs reporting on the different techniques for delivering photocoagulation
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Fong, Strauber et al. 2007)
Level II evidence RCT of moderate quality
N=323 eyes
Country: US (multicentre)
Mean age: 58 ± 11 (Direct+Grid) and 59 ± 11 (Grid alone)
Sex:38% female (Direct+Grid) and 43% female (Grid alone)
Inclusion: Visual acuity of 20/400 or better, DME, optical
coherence tomography retinal thickness >250µm and no prior
laser therapy.
Follow up: 12 months
Direct treatment of all
leaking
microaneurysms in
areas of retinal
thickening plus grid
pattern
photocoagulation
(modified ETDRS
technique)
Versus
Grid pattern
photocoagulation alone
(MMG technique).
Visual acuity and
retinal thickening
Results
At 12 months
Change in:
Central thickening
Inner zone thickening
Max retinal thickening
Retinal volume (mm3)
Visual acuity (letters)
Modified ETDRS
µm
-88
-42
-66
-0.8
0
MMG
µm
-49
-28
-39
-0.4
-2
Adj mean difference
µm [95% CI]
p value
-33 [-5, -61]
0.02
-14 [-1, -27]
0.04
-27 [-6, -47]
0.01
-0.3 [-0.02, -0.53] 0.03
2 [-0.5, 5]
0.1
(Muqit, Marcellino et al. 2010)
Level II evidence RCT of good quality
N=24 (40 eyes)
Country: UK
Mean age: 46 years (SS-PRP) and 44 (SS-PRP)
Sex: 34% of eyes were female
Inclusion: VA of 6/60 or greater, newly diagnosed PDR and
central retinal thickness < 300 µm on optical coherence
tomography
Follow up: 12 weeks
Results
At 12 weeks
Change in:
Central thickening
Analysis on aggregate data1
Single session panretinal
photocoagulation (1500
burns)
Versus
Multiple session panretinal
photocoagulation (500
burns x 3 sessions)
Visual acuity at 4
weeks and 12 weeks
Single
Multi
Session
Session
µm
µm
-2
+20
comparative statistics not reported
Mean diff [95% CI] p value
-22 [-31.7, -12.3] <0.0001
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RCTs reporting on the different techniques for delivering photocoagulation
Included studies, population characteristics, inclusion
Intervention(s) and
Outcome(s)
criteria and quality assessment
comparator(s)
Clinical effect of laser2
74% positive
53% positive
not statistically diff
Visual acuity (letters)3
Single +4 letters from baseline (SD 6) compared with multi
(Nagpal, Marlecha et al. 2010)
Level II evidence RCT of good quality
N=60 (120 eyes)
Country: India
Mean age: 52 years
Sex: 43% female
Inclusion: bilateral symmetrical PDR, VA 6/24 or greater,
diabetic maculopathy was excluded
Follow up: 6 months
1 eye of each patient randomised to each study arm
Pan-retinal
photocoagulation with
solid state green laser
(GLX)
Versus
Pan-retinal
photocoagulation with
multispot pattern scan
laser (PASCAL)
Safety: Pain
Effectiveness: Best
corrected visual
acuity
Results
Pain during procedure
(0-10 VAS)
Visual acuity (BCVA)
Better than 6/12
At baseline
At 6 months
Change
Single Spot
mean (range)
4.6 (3-9)
Multi Spot
mean (range)
0.33 (0-1)
p value
0.007
45%
52%
7%
47%
57%
10%
0.508 (chi-square)
(Suto, Hori et al. 2008)
Level II evidence RCT of good quality
N=29 (58 eyes)
Country: Japan
Mean age: 66 years
Sex: 69% female
Inclusion: untreated severe NPDR or early PDR of similar
severity in both eyes and similar cataract severity in both eyes.
Follow up: 12 months
1 eye of each patient randomised to each study arm
Results
At 12 months
Visual acuity (BCVA)
Better than 20/40
Progression to DME4
Pan-retinal
photocoagulation
followed by cataract
surgery (1 to 3 months
post PRP)
Versus
Cataract surgery
followed by PRP (3
months post cataract
surgery)
PRP first
% (n)
Surgery first
% (n)
p value
69 (20)
51.7 (16)
96.6 (28)
27.6 (8)
0.012
0.033
Effectiveness: best
corrected visual
acuity at 12 months,
number of patients
progressing to
macular oedema
Analysis undertaken using STATA 11.1 using two-tailed t test (SD of means are reported by author); 2 Graded by masked
evaluators using pre-specified measures; 3 visual fields assessed by masked evaluator – reported using mean deviation (MD); 4
Progression to DME from no DME or worsening of DME, DME = diabetic macular oedema.
1
Conclusion
Single session treatments of PRP may be equivalent to multisession treatments. Pattern scan PRP
appears to be better tolerated than single spot laser. In patients who require cataract surgery and
pan-retinal photocoagulation for diabetic retinopathy, performing surgery prior to
Page 196
photocoagulation may result in better outcomes. However, these conclusions are based on single
RCTs and a more extensive search targeted to these outcomes is necessary to make substantive
conclusions. The body of evidence for safety, accuracy and effectiveness is summarised in the
matrix at Box 16.
Box 16
Body of evidence matrix for different methods of delivering photocoagulation
Component
Evidence base
Rating
B
Consistency
NA
Clinical impact
C
Generalisability
B
Applicability
B
Description
Randomised controlled trials (level II evidence). Three included trials
were of good quality and one was of moderate quality.
All trials had different research questions.
Muqit et al (2010), Nagpal et al (2010) and Suto et al (2010) will have
moderate impact because they may improve patient compliance,
reduce pain during the procedure and improve visual outcomes,
respectively. The impact of Fong et al (2007) is unknown.
All studies were performed in developed countries with the exception
of Nagpal et al (2010) which was performed in India. It is likely that the
populations treated are similar, though there may be some disparities
in diet, co-morbid disease prevalence or other unknown confounders
in all studies, though particularly in the case of Nagpal et al (2010).
Again, the healthcare systems of the UK, US and Japan are likely to
be of comparable quality to that of Australia, however there may be
some differences between the healthcare system in India. All
healthcare systems will have some differences although overall
applicability is deemed to be good with a few caveats.
Photocoagulation versus intravitreal or sub-Tenon’s corticosteroid or intravitreal anti- vascular
endothelial growth factor
Two randomised controlled trials (RCTs) of good quality (Maia Jr, Takahashi et al. 2009; Unoki,
Nishijima et al. 2009) and five RCTs of moderate quality (Tonello, Costa et al. 2008; Bressler,
Edwards et al. 2009; Gonzalez, Giuliari et al. 2009; Cho, Moon et al. 2010; Mirshahi, Shenazandi et
al. 2010) compared pan-retinal photocoagulation (PRP) for diabetic retinopathy with intravitreal or
sub-Tenon’s injection of a corticosteroid or anti-vascular endothelial growth factor (anti-VEGF)
with or without PRP (Table 58). Of seven trials involving corticosteroid or anti-VEGF injections
versus PRP alone, six reported on visual outcomes. Two RCTS compared intravitreal triamcinolone
acetonide (IVTA) with PRP, one RCT compared posterior sub-Tenon’s capsule injection of
triamcinolone acetonide (PSTA) with PRP, another RCT compared IVTA, intravitreal bevacuzimab
(IVB) and PRP, one RCT compared IVB with PRP and the remaining RCT compared intravitreal
pegaptanib with PRP. The RCT that did not report on visual outcomes compared two dose
strengths of IVTA without PRP with PRP alone and reported on retinopathy progression.
Triamcinolone acetonide with PRP was reported to result in significant visual improvement
compared with PRP alone in three of four trials, with the final trial showing a difference only at
one month and not at six months. Unoki et al (2009), an RCT of good quality, reported a mean
improvement in best corrected visual acuity (BCVA) of 0.072 logMAR among patients treated with
PRP and PSTA at six months compared with a mean worsening in BCVA of 0.010 logMAR among
patients who received PRP alone (p=0.04). No other trial reported on the mean change from
Page 197
baseline and may be confounded by different baseline visual acuities. However, the good quality
RCT by Maia Jr et al (2009) reported significantly better BCVA among patients treated with IVTA
and PRP at 12 months compared to patients treated with PRP alone (p<0.001) despite the IVTA
patients having a significantly worse BCVA at baseline (p=0.019). Cho et al (2010) also reported on
the change in BCVA as the number of patients who attained a 0.1 logMAR (or greater) and 0.2
logMAR (or greater) increase or decrease in BCVA. However, this has the effect of limiting
reporting to those patients who experience a clinically significant change in BCVA and excludes the
effect of small, less significant changes that together may add up to a significant finding. Without a
single metric for BCVA change, it is difficult to compare interventions or to generate an effect size.
Cho et al (2010) reported significantly more patients experienced a 0.1 logMAR improvement (or
greater) following IVTA and PRP versus PRP alone in patients with clinically significant macular
oedema (CSME) (p<0.01) and in patients without CSME (p<0.05). Patients treated with IVTA and
PRP were also less likely to experience a 0.1 logMAR or greater visual loss than patients treated
with PRP alone in patients with (p<0.05) and without CSME (p<0.05). Only one trial, involving
triamcinolone acetonide, failed to show an improvement in BCVA at its endpoint (6 months),
however a difference in BCVA at one month favouring the IVTA group was demonstrated
(Mirshahi, Shenazandi et al. 2010). This study is likely to be confounded by disparities in BCVA at
baseline between the randomised groups, with the IVTA group having a mean BCVA of 0.1 logMAR
lower (better) than the PRP control group (p=0.32). After one month, the BCVA had worsened by
0.04 logMAR in the IVTA group and by 0.05 logMAR in the control group and comparisons of mean
logMAR between the groups were statistically different (p=0.04) at this time point. However, it is
unlikely that a difference would be detected if a comparison of the change from baseline between
the two groups was conducted, as per Unoki et al (2009) and Cho et al (2010).
Improvements in visual acuity are supported by findings on optical coherence tomography (OCT),
with studies reporting significant improvements in the IVTA group compared with the PRP group,
including: reduced central macular thickness (CMT) at 12 months (p<0.001) (Maia Jr, Takahashi et
al. 2009); reduced total macular volume (TMV) at 12 months (p<0.001) (Maia Jr, Takahashi et al.
2009), reduced foveal (p <0.03) and parafoveal thickness at six months (p <0.04) (Unoki, Nishijima
et al. 2009); and reduced progression of retinopathy among patients treated with 4mg of IVTA
alone compared with PRP alone at 3-years (30% vs 37%, p=0.02) (Bressler, Edwards et al. 2009).
Two RCTs of moderate quality compared IVB and PRP with PRP alone. Cho et al (2010) reported
that IVB with PRP resulted in significantly fewer patients, without CSME, experiencing a visual loss
of 0.1 logMAR or greater at three months compared with PRP alone (p<0.05). However, no
significant difference was reported between the two groups for patients without CSME
experiencing a visual gain, or any differences between the IVB and PRP groups among patients
with CSME. A larger sample size may have revealed a statistically significant difference between
the IVB and PRP groups. At a confidence level of five per cent and with statistical power of 80 per
cent, 35 eyes in each group would be needed to show a significant difference between 37.4 and
7.1 per cent of eyes experiencing at least a 0.1 logMAR improvement in visual acuity, as seen
among patients with CSME. There were only, however, between 14 and 16 patients in each
macular oedema subgroup.
Page 198
Tonello et al (2008) did not report a difference in mean logMAR at 16 weeks between the IVB and
PRP groups, however a significant decrease in area of active (leaking) new vessels at 16 weeks
(p<0.001) was evident. There may be some confounding of this result due to non-significant
differences in baseline values, with the IVB group having a mean of 11.15 mm 2 of active new
vessels compared with the PRP only group having a mean of 15.31 mm2.
One moderate quality RCT reported no difference in change of visual acuity from baseline to 36
weeks in patients treated with intravitreal pegaptanib (IVP) and PRP compared with patients
treated with PRP alone (p=0.22) (Gonzalez, Giuliari et al. 2009). However, this study was small
with10 eyes in each study arm and may not have been powered to find a clinically meaningful
difference in BCVA. The IVP arm experienced a mean improvement of 5.8 letters on the Snellen
chart compared to a loss of 6.0 letters in the PRP arm. This difference is greater than two lines on
an ETDRS letter chart and is a clinically significant difference. One reservation in respect to this
result is the wide range of visual acuities within the groups. An ETDRS letter score may be an
inappropriate metric given that a loss of five letters in a person with good acuity may be a smaller
change than the loss of five letters in a person with poor acuity. A linear score, such as logMAR,
may have been a more appropriate measure.
It is important to consider that all studies allowed or required the presence of clinically significant
macular oedema (CSME). While Cho et al (2010) reported a significant improvement in visual
acuity among IVTA patients compared with PRP patients alone who did not have CSME, the effect
was smaller than in those patients with CSME. Therefore, it is likely that the treatments for
diabetic retinopathy will also have some effect upon macular oedema, and visual outcomes may
be a consequence of the improvement of both conditions. Bressler et al (2009) reported that,
among the 4mg IVTA group, 51 per cent and 64 per cent of patients with phakic eyes28 required
cataract surgery at 2-years and 3-years, respectively, compared with only 13 per cent and 21 per
cent in the PRP alone group. Cho et al (2010) reported only one cataract progression and four eyes
with raised IOP in the IVTA group, with none in either the IVB or PRP group, and recommended
that IVB be considered in patients with phakic eyes or eyes prone to glaucoma.
Conclusion
The effectiveness of pan-retinal photocoagulation may be improved with the addition of
intravitreal injection of anti-VEGF, in particular for patients with CSME. However, IVTA was
associated with the risk of increased intra-ocular pressure and cataract formation. Therefore,
these risks must be weighed against the likely benefits in the treatment of diabetic retinopathy.
Visual acuity in patients with diabetic retinopathy treated with intravitreal bevicuzimab and PRP is
probably better than PRP alone, though more evidence is required. Although intravitreal
pegaptanib did not alter visual outcomes in patients it was included in only one trial. A full
systematic review of intravitreal and sub-Tenon’s injections of corticosteroids and anti-angiogenic
drugs compared with PRP should be conducted to assess the safety and effectiveness of these
interventions. The body of evidence for safety, accuracy and effectiveness is summarised in the
matrix at Box 17.
28
An eye with its natural lens
Page 199
Box 17
Body of evidence matrix for photocoagulation versus intravitreal or sub-Tenon’s
corticosteroid or anti- vascular endothelial growth factor
Component
Evidence base
Rating
B
Consistency
B
Clinical impact
B
Description
Two RCTs of good quality and 5 RCTs of moderate quality have
reported on outcomes of retinal photocoagulation compared with
intravitreal or posterior sub-Tenon’s injection of either corticosteroids
or anti-VEGF.
All studies show an effect in the same direction and some of the
disparity in magnitude might be explained by technique or disease
severity.
The addition of triamcinolone acetonide resulted in marked
improvements in optical coherence tomography measurements (in
most cases) and BCVA (in both of the good quality RCTs and one
moderate quality RCT).
D
The addition of pegnaptanib will have a small clinical impact given that
it was not shown to alter visual outcomes in patients over PRP alone.
B
Intravitreal bevacuzimab did not appear as effective as triamcinolone
acetonide, however was less likely to result in raised IOP or cataract
formation (based on one trial).
Studies were performed in a variety of populations. The good quality
studies were performed in Japan and Brazil, with other study locations
in US, Korea and Iran. It is likely that the patient groups are generally
similar across populations, though there may be differences in diet,
co-morbidities and other unknown confounders, therefore overall
generalisability is deemed satisfactory.
Generalisability
C
Applicability
B
As above, the included studies involved a range of hospital systems. It
is likely that the results are applicable to the Australian healthcare
context with a few caveats.
Page 200
Table 58
Study profiles and results of RCTs comparing photocoagulation to control or
alternative treatments for the treatment of diabetic retinopathy
RCTs comparing photocoagulation to control or alternative treatments for the treatment of diabetic
retinopathy
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Bressler, Edwards et al. 2009)
Level II evidence RCT of moderate quality
N= 693 (840 eyes)
Country: US
Mean age: 63 years
Sex: 49% female
Inclusion: Patients with DME, optical coherence
tomography central subfield thickness >250µm and best
corrected visual acuity between 20/40 to 20/320
Follow up: 2 years
Randomised to one of
three treatments.
Focal / grid
photocoagulation
Versus
1mg triamcinolone (up
to 4 monthly)
Versus
4mg triamcinolone (up
to 4 monthly)
Safety: cataract formation
Effectiveness: Cumulative
progression to
proliferative diabetic
retinopathy
Results
Focal / grid pan-retinal photocoagulation (PRP) versus intravitreal triamcinolone acetonide (IVTA) 1mg versus
IVTA 4mg
Percentages
P values
Progression
Focal / grid IVTA
IVTA
PRP vs
PRP vs
1mg vs
of retinopathy
PRP
1mg
4mg
1mg
4mg
4mg
Year 1
21%
19%
14%
0.71
0.03
0.08
Year 2
31%
29%
21%
0.64
0.005
0.03
Year 3
37%
35%
30%
0.73
0.02
0.07
Cataract extraction (comparative statistics not reported)
Year 2
13%
23%
51%
Year 3
21%
35%
64%
Page 201
RCTs comparing photocoagulation to control or alternative treatments for the treatment of diabetic
retinopathy
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Cho, Moon et al. 2010)
Level II evidence RCT of moderate quality
N=76 (91 eyes)
Country: Korea
Mean age: 49.8 to 51.2 years across the three groups
Sex: 31.25% to 37.5% female across the three groups
Inclusion: very severe NPDR to high risk PDR (with or
without DME)
Follow up: 3 months
Note: the study by Cho et al (2009) is assumed to be
encompassed by the population in the Cho et al (2010)
study.
Pan retinal
photocoagulation
(PRP)
Versus
PRP with Intravitreal
tramcinolone
acetonide (IVTA)
Versus
PRP with Intravitreal
bevacizumab (IVB)
Safety: Cataract
progression
Effectiveness: Best
corrected visual acuity
(BCVA) at 3 months
Results
At 3 months: PRP versus IVTA + PRP versus intravitreal bevacuzimab (IVB) + PRP
With CSME
(1) IVTA (2) IVB
(3) PRP p values
+PRP
+PRP
alone
1 vs 2 1 vs 3 2 vs 3
Visual Gain
≥0.1 logMAR 75%
37.5%
7.1%
<0.05
<0.01 NS
Visual Loss
≥0.1 logMAR 18.8%
31.3%
57.1%
NS
<0.05 NS
Without CSME (1) IVTA
+PRP
Visual Gain
≥0.1 logMAR 42.9%
Visual Loss
≥0.1 logMAR 21.4%
(2) IVB
+PRP
(3) PRP
alone
p values
1 vs 2 1 vs 3
2 vs 3
33.3%
6.3%
NS
<0.05
NS
26.7%
62.5%
NS
<0.05
<0.05
One cataract progression in the IVTA group. 4 eyes with raised IOP in the IVTA group, although were normalised
with topical glaucoma medications.
NOTE: Significantly more patients experienced an increase in BCVA of 0.1 logMAR or greater and significantly
fewer patients experienced a loss of BCVA of 0.1 logMAR or greater in the IVTA group than the PRP group. This
effect was more pronounced in eyes with CSME. IVB was not as effective though did not result in any cataracts
or IOP and may be more suitable for phakic eyes or eyes predisposed to glaucoma.
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RCTs comparing photocoagulation to control or alternative treatments for the treatment of diabetic
retinopathy
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Gonzalez, Giuliari et al. 2009)
Level II evidence RCT of moderate quality
N=20
Country: US
Mean age: 57.6 years
Sex:35% female
Inclusion: Patients with active PDR and either new vessels
close to the optic nerve or vitreous or preretinal
haemorrhage.
Follow up: 36 weeks
Pan-retinal laser
photocoagulation
Versus
Intravitreal Pegaptanib
Safety: All observed
adverse events
Effectiveness: regression
of PDR at 36 weeks
(defined as regression of
neovascularisation of the
disc)
Results
PRP versus intravitreal pegaptanib
Change in visual acuity from baseline is not significantly different between the groups (p=0.09, removing an outlier
p=0.17).
Data cannot be extracted from study.
(Maia Jr, Takahashi et al. 2009)
Level II evidence RCT of good quality
N=22 (44 eyes)
Country: Brazil (single centre)
Mean age: 61.9 years
Sex: 54.5 % female
Inclusion: Patients with progressive diabetic retinopathy,
new vessels ≥ 0.5 disc areas within 1 disc diameter of the
optic disc with CSME, symmetric disease, CMT greater
than 250 µm on optical coherence tomography
Follow up: 12 months
1 eye of each patient randomised to each study arm
Pan-retinal laser
photocoagulation
(performed over 3
episodes according to
ETDRS guidelines)
Versus
PRP + intravitreal
triamcinolone
acetonide (IVTA)
Safety: systematic
adverse events.
Effectiveness: best
corrected visual acuity
(BCVA), central macular
thickness (CMT) and total
macular volume (TMV).
Results
PRP versus IVTA + PRP
IVTA + PRP
PRP only
pvalue
BCVA (mean logMAR ± SD)
Baseline
0.44 ± 0.17
0.38 ± 0.17
0.019
Month 12
0.12 ± 0.07
0.32 ± 0.16
<0.001
Central macular thickness (µm ± SD)
Baseline
360.05 ± 84.85 331.68 ± 78.88 0.148
Month 12
236.37 ± 16.14 265.74 ± 27.27 <0.001
Total macular volume (mm3 ± SD)
Baseline
8.59 ± 1.68
8.44 ± 1.51
0.483
Month 12
7.32 ± 0.60
7.78 ± 0.59
<0.001
NOTE: despite starting from worse values at baseline, IVTA+PRP resulted in significant (and in the case of
logMAR) quite significant improvements over PRP alone
Safety
IOP was reported to be higher at 1 month in eyes assigned to IVTA (p=0.012) but not at 3 months or thereafter.
Anti-glaucoma drops were prescribed in 4 eyes for 4 to 6 weeks. No cataracts.
NOTE: this is in patients with CSME.
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RCTs comparing photocoagulation to control or alternative treatments for the treatment of diabetic
retinopathy
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Mirshahi, Shenazandi et al. 2010)
Level II evidence RCT of moderate quality
N=23 (46 eyes)
Country: Iran
Mean age: 55.6 years
Sex: NR
Inclusion: bilateral CSME (at same stage), high-risk PDR,
visual acuity from 20/200 and 20/30, CMT more than 230
µm on optical coherence tomography
Follow up: 6 months
1 eye of each patient randomised to each study arm
Pan-retinal (PRP) and
macular
photocoagulation
(MPC)
Versus
Intravitreal
triamcinolone
acetonide (IVTA) one
week prior to PRP +
MPC
Safety: Intra-ocular
pressure (IOP)
Effectiveness: best
corrected visual acuity
(BCVA) and central
macular thickness
Results
PRP + macular photocoagulation (MPC) versus IVTA + PRP + MPC
IVTA + laser
laser only
BCVA (mean logMAR ± SD)
Baseline
0.46 ± 0.29
0.56 ± 0.27
Month 6
0.39 ± 0.29
0.55 ± 0.33
Central macular thickness (µm ± SD)
Baseline
319.2 ± 79.1
345.9 ± 100.6
Month 6
279.5 ± 76.9
316.3 ± 105.7
Intraocular pressure (mmHg ± SD)
Baseline
15.72 ± 2.32
16.11 ± 2.16
Month 6
16.71 ± 1.89
16.35 ± 1.66
(Tonello, Costa et al. 2008)
N=22 (30 eyes)
Country: Brazil
Mean age: 54.1 years (RPR+ IVB), 51.4 years (PRP alone)
Sex: 37% of eyes are female
Inclusion: high risk PDR with new vessels (NVs) at the disc
(NVD) or elsewhere (NVE) with more than half the disc
associated with vitreous or preretinal haemorrhage.
Follow up: 16 weeks
Patients with presenting with one eligible eye were
randomised to one or the other treatment. In patients
presenting with two eyes eligible, the worst eye was treated
with IVB arm.
Overall quality assessment: moderate
pvalue
0.32
0.08
0.65
0.36
0.48
0.52
Pan-retinal
photocoagulation
(PRP) performed at 2
time points (weeks 1
and 3)
Versus
PRP plus intra-vitreal
injection of
bevacuzimab (IVB)
Page 204
Effectiveness: Best
corrected visual acuity
(BCVA) and total area of
leaking NVs.
RCTs comparing photocoagulation to control or alternative treatments for the treatment of diabetic
retinopathy
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
Results
PRP versus PRP + IVB
IVB + PRP
PRP only
pvalue
BCVA (mean logMAR ± SE)
Baseline
0.26 ± 0.07
0.26 ± 0.05
NS
Week 16
0.29 ± 0.04
0.31 ± 0.06
NS
2
Active New Vessels (mm ± SE)
Baseline
11.15 ± 2.24
15.31 ± 4.81
NS
Week 16
4.46 ± 1.09
13.58 ± 4.29
<0.001*
* significantly greater reduction in leakage from NVs in IVB group compared with PRP only group
NOTE: changes in NVs did not translate into BCVA
No difference in IOP between groups.
(Unoki, Nishijima et al. 2009)
N=41 (82 eyes)
Country: Japan
Mean age: 60.1 years
Sex: 44% female
Inclusion: severe NPDR or PDR with or without CSME
Follow up: 6 months
1 eye of each patient randomised to each study arm
Overall quality assessment: good
Pan-retinal
photocoagulation
Versus
PRP + posterior subTenon injection of
triamcinolone (PSTA)
20mg
Safety: intraocular
pressure
Effectiveness: Best
corrected visual acuity,
retinal thickness
Results
PRP vs posterior sub-Tenon’s capsule injection of triamcinolone acetonide (PSTA) +PRP
At 6 months
PSTA + PRP
PRP only
pvalue
BCVA (mean logMAR ± SD)
Change from baseline*
-0.072 ± 0.028 0.010 ± 0.029 0.04
Retinal thickness (µm ±SD)
Change from baseline (foveal)
-9.7 ± 85.6
32.8 ± 82.8
0.03
Change from baseline (paraoveal) -5.1 ± 66.0
23.2 ± 55.0
0.04
Change from baseline (perifoveal) 0.5 ± 34.4
18.3 ± 44.8
0.06
Intraocular pressure – no difference between groups at any time point
No cataract formation
NOTE: some patients with CSME
1
Defined as change from NPDR to PDR, occurrence of PRP or occurrence of vitreous haemorrhage
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3.18.3
Photocoagulation for the treatment of choroidal neovascularisation
associated with pathologic myopic
Background
Myopia, or near-sightedness, is a refractive defect of the eye which causes light to be focused in
front of the retina. It is usually caused by an increased axial length of the eyeball (axial myopia), or
by increased curvature of the cornea or lens (curvature myopia). Pathologic myopia, in this review,
has been defined as the need for corrective lenses of -6 diopters29 or higher.
Choroidal neovascularisation (CNV) is the creation of new blood vessels in the choroid layer, which
may involve the macula. Newly formed vessels tend to bleed, damaging the photoreceptors of the
retina and resulting in scarring, which may manifest as a blind spot in the visual field. If the
macular is involved, this blind spot will be central and debilitating.
Although the authors of a Cochrane review (Fredrick 2002) stated that CNV is more common in
patients with higher levels of myopic refractive error, the reference cited does not contain any
evidence to suggest that the rate of CNV is any different in patients with myopia. A recent review
article by (Saw, Gazzard et al. 2005) reported that CNV in myopic adults has not been reported in
cross-sectional, case-control or cohort studies. However, one retrospective study found that
subretinal (choroidal) neovascularisation was present in 5.2 per cent of eyes with pathologic
myopia (Grossniklaus and Green 1992).
Several treatments of CNV are possible, including laser photocoagulation, photodynamic therapy,
macular translocation, surgical removal and more recently, injection of anti-vascular endothelial
growth factors into the vitreous cavity.
Research question
Is photocoagulation a safe and effective procedure for the treatment of CNV associated with
pathologic myopia?
Results
One Cochrane review of two RCTs (Brancato, Menchini et al. 1988; Fardeau, Soubrane et al. 1992)
reported on the effectiveness of photocoagulation for the treatment of choroidal
neovascularisation in pathologic myopic (Table 59). The RCT by (Brancato, Menchini et al. 1988)
compared distance acuity and CNV recurrence during follow-up of laser photocoagulation of three
wavelengths (577nm, 590nm and 620nm). No difference was reported in the proportion of
patients who lost two or more Snellen lines at follow-up at different time points who were treated
with different lasers. The study population was small (n=27) and the study was underpowered.
The RCT by Fardeau et al (1992)(Fardeau, Soubrane et al. 1992) compared near and distance
acuity at two follow up time points in patients treated with a krypton laser or observation alone.
Results from this RCT indicated that patients treated with photocoagulation to the CNV had better
visual acuity at the first follow up time point (6 to 48 months, p<0.001), but not the second (36 to
29
A diopter or dioptre is the unit of measurement of the optical power of a lens, which is equal to the reciprocal of the
focal length measured in metres eg a 3-dioptre lens brings parallel rays of light to focus at 1⁄3 metre.
Page 206
72 months) compared with patients who were not treated. However, these results should be
interpreted with caution as there was a differential loss to follow-up in this study.
Conclusion
There is insufficient evidence to address the safety or effectiveness of photocoagulation for the
treatment of choroidal neovascularisation in patients with pathologic myopia. There is insufficient
evidence to demonstrate that different wavelength lasers will result in different patient outcomes.
The body of evidence for safety, accuracy and effectiveness is summarised in the matrix at Box 18.
Box 18
Body of evidence matrix for photocoagulation for the treatment of choroidal
neovascularisation associated with pathologic myopia
Component
Evidence base
Rating
C
Description
One good quality systematic review (level I evidence), however
evidence base has been down-graded due to small size of the 2
included RCTs (n=27 and n=70). Despite the systematic review
recording each of the trial’s handling of bias as A (adequate),
differential loss to follow up in one trial, and variable timing of
follow up in both trials make interpretation of data difficult and
potentially open to bias or confoundin). Therefore, evidence base
is deemed satisfactory.
Trials are assessing different outcomes.
Consistency
NA
Clinical impact
B
Photocoagulation may result in better visual acuity than control
(observation) in patients with CNV. The difference in the arms is
substantial and hence the clinical impact may be large. Brancato
found no difference in outcomes of lasers of different wavelength.
The clinical impact of this information is unclear.
Generalisability
B
Both studies of the systematic review were undertaken in
developed countries (Italy and France). The populations are likely
to be largely comparable to Australia, although with small
differences.
Applicability
B
These studies concern patients treated in France and Italy, two
healthcare systems of similar quality to Australia, therefore the
results are largely applicable to the Australian healthcare context.
Table 59
Study profiles and results of systematic reviews comparing photocoagulation to control or
alternative treatments for choroidal neovascularisation in pathologic myopia
Systematic Reviews comparing photocoagulation to control or alternative treatments for choroidal
neovascularisation in pathologic myopia
Study, review period and
quality appraisal
(Virgili and Menchini 2005)
Level of evidence: I
Assessment of quality: good
Cochrane review
Cochrane Library to Issue 1, 2007
Medline: Jan 1966 to Mar 2007
Embase: Jan 1980 to Mar 2007
LILACS: to Mar 2007
Population characteristics, inclusion criteria
Systematic review based on 2 RCTs with a total of
96 patients (97 eyes).
Population:
Studies of patients with choroidal neovascularisation (CNV) and myopia of -6 diopters or
higher
Intervention:
Studies comparing photocoagulation with
observation or different photocoagulation techniques
(either to the whole CNV or part of it)
Page 207
Included studies, population characteristics and
inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
Individual studies included in the systematic review by Virgili & Menchini (2005)
(Brancato, Menchini et al. 1988)
N=26 (27 eyes)
Country: Italy
Mean age: 44 years
Sex: 80.1% female
Inclusion: myopia -6D or worse, visual acuity 20/200 or
more, choroidal neovascularisation 100 to 400 µm from
the foveola
Follow-up: 3 to 17 months
Laser
photocoagulation of
the choroidal
neovascularisation
with 3 wavelengths
(577 nm, 590 nm, 620
nm)
Randomised 1:1:1 to
each wavelength
No control group
Distance acuity; recurrence
during follow up
Photocoagulation for CNV associated with pathologic myopia with different wavelengths of laser
Results
577nm
590nm
620nm
% (n/N)
% (n/N)
RR [95% CI]
Loss of ≥ 2 Snellen lines*
22.2 (2/9)
33.3 (3/9)
33.3 (3/9)
*Measured at 3-17 months
(Soubrane, Pison et al. 1986; Fardeau, Soubrane et al.
1992)
N=70
Country: France
Mean age: NR
Sex: 65.7% female
Inclusion: myopia -5D or worse, visual acuity 6/60 or more,
choroidal neovascularisation 100 to 400 µm from the
foveola
Follow-up: 6 to 48 months
Randomised to laser or observation.
Krypton laser
photocoagulation with
200 µm spot size, 0.2
second duration on
choroidal
neovascularisation
Near acuity and distance
acuity at 2 follow up time
points (1985 and 1990)
Control: observation
Photocoagulation versus observation for the treatment of CNV associated with pathologic myopia
Results
Treated
Observed
% (n/N)
% (n/N)
RR [95% CI]
20/100 or worse*π
45.7 (16/35)
88.6 (31/35)
0.52 [0.35, 0.75]†
*Measured at 6-48 months
†Calculated on aggregate data using STATA 11.1
π laser vs control p<0.001, Mann-Whitney U test (no difference was observed at the second assessment at 36 to
72 months post photocoagulation).
Page 208
3.18.4
Photocoagulation for the treatment of macular oedema
Background
Macular oedema is the deposition of fluid and hard exudates at the central retina.
Diabetic macular oedema (DME) is a consequence of retinal micro-vascular changes resulting in
increased permeability of the retinal vessels in patients with diabetes. Leakage of plasma into the
surrounding retina results in retinal oedema (Ciulla, Amador et al. 2003). Surrounding hypoxic
tissue may also add to macular oedema by stimulating vascular endothelial growth factor resulting
in new vessel growth in the retina (Aiello, Avery et al. 1994). DME accompanies diabetic
retinopathy and is the leading cause of vision loss in patients with diabetes (Klein, Klein et al.
1998).
Cystoid macular oedema (CME) refers to the formation of fluid-filled spaces within the retina.
Although there are many causes of cystoids macular oedema, the mechanisms of development are
not well understood. CME is common following cataract extraction and in patients with tumours
of the eye, age-related macular degeneration and retinal vein occlusion. Often, the treatment for
CME is to treat the underlying cause.
Research question
Is photocoagulation a safe and effective procedure for the treatment of macular oedema?
Results
Two systematic reviews and 20 RCTs were identified that compared laser photocoagulation with
observation, different methods of photocoagulation or pharmaceuticals in patients with diabetic
macular oedema or cystoid macular oedema. Due to the difficulty of separating the two types of
macular oedema, the two groups have been combined; although cystoid macular oedema
secondary to branch retinal vein occlusion has been considered a separate entity. Six of the 17
RCTs were included in one or both of the systematic reviews.
For diabetic macular oedema, the two systematic reviews were deemed sufficient to address the
research question. Two of the RCTs have been extracted because they specifically address macular
oedema secondary to branch retinal vein occlusion (BRVO). The remaining RCTs were read and
additional commentary provided when deemed appropriate, however data was not formally
extracted.
Photocoagulation for the treatment of macular oedema
One poor quality systematic review reported on the use of laser photocoagulation (without antiVEGF or corticosteroid injections) in patients with macular oedema (Table 60). O’Doherty et al
(2008) reported on two randomised and one non-randomised studies that compared laser
photocoagulation to observation or delayed treatment. Both randomised studies were large
(ETDRS et al 1985 n=2,244 and Olk et al 1984 n=160) and reported that laser photocoagulation
resulted in improved visual acuity.
The non-randomised study included by O’Doherty et al (2008) reported no difference between
groups who were treated with photocoagulation compared with matched controls. However, this
Page 209
study is of a poorer design (case series with matched controls) than the two large randomised
studies and is likely to suffer both bias and confounding that may affect the results.
Another case series included by O’Doherty et al (2008) reported on 221 patients who underwent
photocoagulation with no comparison (Lovestam-Adrian and Agardh 2000). Complications were
reported in 49 per cent of eyes following photocoagulation. Sub-retinal fibrosis or atrophic creep,
to within 1/3 optic disc diameter of the centre of the macula, developed in 21 per cent of eyes. A
significant proportion of these patients were blind or visually impaired than those patients with
no, or more peripheral, complications (p<0.001). As this was not a randomised study, the rate of
loss of vision among patients who receive photocoagulation cannot be compared directly with a
control group. Given that this population of patients are likely to experience vision loss and
blindness, the measurement of safety of photocoagulation is substantially hindered by the lack of
a non-laser group.
Seven RCTs reported by O’Doherty et al (2008) compared the effectiveness or safety of different
laser wavelengths or different laser techniques. Visual acuity was not significantly different
between the groups in any of the studies that compared different lasers or techniques for the
treatment of macular oedema. The modified ETDRS technique was superior to the mild macular
grid technique in regard to central macular thickness, retinal volume, degree of macular oedema,
however the two techniques were no different in regard to visual acuity outcomes. Light
treatment and classic treatment did not appear different in respect to central macular thickness or
visual acuity. Neither treatment altered average CMT from baseline, however all other included
studies reported that CMT was reduced following photocoagulation. It may be possible that the
“classic” technique was inadequately dosing patients, and therefore the comparison between
“classic” and “light” treatments will be erroneous, in particular if a threshold of treatment must be
reached prior to the onset of measurable changes.
Conclusion
Based on two large RCTs that compared laser photocoagulation with observation or delayed
treatment, laser photocoagulation resulted in fewer moderate losses in visual acuity up to 3-years
and was more likely to gain visual acuity up to 2-years. However, photocoagulation is not without
risks and the potential for harm should be considered prior to any treatment. A definitive
conclusion regarding laser photocoagulation for the treatment of macular oedema is limited by
the lack of studies; however it is generally accepted as an effective treatment. In addition, the
evidence does not indicate a benefit of one laser wavelength over another and the modified
ETDRS technique appears to be equivalent to the mild macular grid technique. The body of
evidence for safety, accuracy and effectiveness is summarised in the matrix at Box 19.
Page 210
Box 19
Body of evidence matrix for photocoagulation for the treatment of macular oedema
Component
Evidence base
Rating
B
Consistency
B
Clinical impact
A
Generalisability
B
Applicability
B
Description
One poor quality systematic review (level I evidence) reported on the
effectiveness of photocoagulation compared with observation for the
treatment of diabetic macular oedema. This contained 2 large RCTs. 7
RCTs from the same systematic review compared different techniques
and lasers for the treatment of macular oedema.
Both RCTs reported a benefit of photocoagulation for macular
oedema, though outcome measures were different and difficult to
compare. No difference was observed in outcome when comparing
photocoagulation delivered by different laser wavelengths or different
techniques.
Macular oedema is a leading cause of blindness in patients with
diabetes and improvements in vision are likely to have a very large
impact on patient quality of life.
Both the ETDRS (1985) and the Olk (1986) study were conducted in
the US, therefore populations are likely to be similar to those in
Australia. Both studies were conducted almost 3 decades ago and
improvements in diabetic management or changes to common
medications may have an unknown impact upon macular oedema.
Both of the large RCTs were conducted in the US, therefore the
healthcare system is likely to be broadly similar to Australia.
Page 211
Table 60
Study profiles and results of RCTs within SR describing photocoagulation versus
observation for the treatment of diabetic macular oedema
Systematic reviews comparing photocoagulation to control or alternative treatments for diabetic macular
oedema
Study, review period and
quality appraisal
Population characteristics, inclusion criteria
(O'Doherty, Dooley et al. 2008)
Level of evidence: I
Assessment of quality: Poor
Cochrane Library and Medline to
2007
Review is split into: 1. Laser
treatment, 2. Surgical
management, 3. Intravitreal
corticosteroids, and 4. Intravitreal
anti-VEGF.
However, trials comparing laser
treatment are in all sections
Systematic review based on 19 RCTs with a total of 4,130 eyes (31 articles
were included, though only 19 considered laser photocoagulation).
Population:
Studies of patients with diabetic macular oedema.
Intervention:
Randomised controlled trials comparing treatments for diabetic macular
oedema (note: this assessment has only included the studies with laser
photocoagulation).
RCTs within SR describing photocoagulation versus observation for the treatment of diabetic macular
oedema
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Early Treatment Diabetic Retinopathy Study Research
Group 1985)
N=2244 eyes
Follow up: 3 years
Randomised to immediate laser (n=754) or delayed laser
(n=1490).
Immediate
photocoagulation
Visual acuity
Control: delayed
photocoagulation
Results
Treated
Loss of 15 letters or more*
%
Year 1
5
Year 2
7
Year 3
12
* approximately 3 lines on the ETDRS eye chart
† estimated – not provided by O’Doherty et al 2008.
(Olk 1986)
N=160
Follow up: 2 years
Observed
%
8
16
24
RR†
0.625
0.438
0.5
No significance or confidence intervals reported.
Grid argon blue laser
photocoagulation
Control: observation
Results
Treated
Observed
Loss of 2 lines or more* %
%
RR† (p value)
Year 2
9.5
43
0.221 (p<0.05)
Gain of 2 lines or more*
Year 2
45
8
5.625 (p<0.05)
* measured on the ETDRS eye chart
†estimated, not provided by O’Doherty et al 2008. p values are reported by O’Doherty.
Page 212
Visual acuity, proportion
of patients with reduced
macular oedema
Non-randomised study within SR describing photocoagulation versus observation for the treatment of
diabetic macular oedema
(Reeser, Fleischman et al. 1981)
N=115 eyes
Follow up: average 2.4 years
Prospective case series with matched controls.
Argon laser
photocoagulation to
leaking vessels (n=68)
Resolution of macular
oedema, visual acuity.
Control: observation
(n=47)
Results
3% of treated eyes and no untreated eyes experienced complete resolution of macular oedema. Visual acuity
improved in treatment group however magnitude and significance not reported.
Table 61
Study profiles and results of RCTs within SR describing the comparison of different
lasers or techniques in the treatment of diabetic macular oedema
Comparisons of different lasers or techniques in the treatment of diabetic macular oedema
Study, review period and
quality appraisal
Population characteristics, inclusion criteria
(O'Doherty, Dooley et al. 2008)
Level of evidence: I
Assessment of quality: Poor
Cochrane Library and Medline to
2007
Review is split into: 1. Laser
treatment, 2. Surgical
management, 3. Intravitreal
corticosteroids, and 4. Intravitreal
anti-VEGF.
However, trials comparing laser
treatment are in all sections
Systematic review based on 19 RCTs with a total of 4,130 eyes (31 articles
were included, though only 19 considered laser photocoagulation).
Population:
Studies of patients with diabetic macular oedema.
Intervention:
Randomised controlled trials comparing treatments for diabetic macular
oedema (note: this assessment has only included the studies with laser
photocoagulation).
Included studies, population characteristics and
inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
(Striph, Hart et al. 1988)
N=64
Follow up: 3 months
Grid argon green laser vs grid krypton red laser
Grid argon green laser
Versus
Grid krypton red laser
Visual acuity
Sub threshold
micropulse diode laser
Versus
Argon laser
Visual acuity
Results
No difference between the lasers regarding visual acuity.
(Laursen, Moeller et al. 2004)
N=23
Follow up: minimum of 5 months
Sub-threshold micropulse diode laser vs argon laser
Results
No difference in VA between the two groups. VA was stable (±10 letters)
(Casswell, Canning et al. 1990)
N=91
Follow up: 2 years
Grid argon laser vs grid krypton laser
Grid argon laser
Versus
Grid krypton laser
Results
Page 213
Visual acuity
Improvement of 2 or more Snellen lines (not ETDRS chart) in 12.5% in argon group vs 2% in krypton group at 2
years. Loss of vision by 2 or more lines in 15% of argon group vs 21% of krypton group (significance for values
not provided). Caswell abstract concludes no difference, and no statistical difference.
(Olk 1990)
N=225
Follow up: 2 years
Grid argon laser vs grid krypton laser
Grid argon laser
Versus
Grid krypton laser
Visual acuity, reduction in
macular oedema, number
of treatments required,
effect on visual field
Results
No difference in visual acuity at the 12 and 24 month visits. No difference in reduction of macular oedema,
number of treatments per eye, effect on visual field.
(Khairallah, Brahim et al. 1996)
N=151
Follow up: 1 year
Argon green laser vs krypton red laser
Argon green laser
Versus
Krypton red laser
Visual acuity
“Classic” laser
treatment with 100250 mW
Versus
“Light” laser treatment
with <100 mW
Visual acuity and central
macular thickness
Results
No statistical difference between laser wavelengths
(Bandello, Polito et al. 2005)
N=29
Follow up: 1 year
“Classic” 100-250 mW treatment vs “light” <100mW
treatment
Results
VA did not change in either group at 12 months. “light” photocoagulation may be as effective for CSME as
“classic” photocoagulation.
(Fong, Strauber et al. 2007)
N=323
Follow up: 1 year
Modified ETDRS direct / grid photocoagulation (standard)
vs mild macular grid photocoagulation
Modified ETDRS
direct / grid
photocoagulation
Versus
Mild macular grid
(MMG) laser
photocoagulation
Visual acuity, retinal
thickness, retinal volume.
Results
ETDRS outperformed MMG in most structural outcomes, but VA was no different at 12 months between the group.
Photocoagulation versus vitrectomy for the treatment of diabetic macular oedema
One poor quality systematic review reported on the safety and effectiveness of laser
photocoagulation compared with vitrectomy for the treatment of diabetic macular oedema
(O'Doherty, Dooley et al. 2008). Four of the RCTs included in this systematic review addressed this
comparison (Table 62). The total number of eyes randomised to either laser photocoagulation or
vitrectomy was small (n=103) and therefore conclusions regarding the comparative effectiveness
or safety are limited.
All four of the studies that compared photocoagulation with vitrectomy reported on visual
outcomes. Three studies (Thomas, Bunce et al. 2005; Patel, Hykin et al. 2006; Kumar, Sinha et al.
2007) reported no difference in the magnitude of visual acuity change from baseline between the
two modes of treatment. Yanyali et al (2005) concluded that vitrectomy was a more effective
treatment for patients with macular oedema; however there was no statistical difference in the
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change from baseline between the two groups. Visual acuity was significantly better in the
vitrectomy group at six months compared with baseline and was not significantly different form
baseline in the laser group; however there was a large, but not statistically significant, difference
in baseline visual acuity. If patients with poor visual acuity at baseline are prone to improve more
than patients with better visual acuity, then this may bias the results presented by Yanyali.
Conclusion
There is insufficient evidence to determine whether photocoagulation is more or less effective
than vitrectomy as a treatment for diabetic macular oedema. Clinical advice suggests that these
studies are reporting on a select group of patients and thus may not be generalisable to the vast
majority of patients with diabetic macular oedema. Given the prevalence of diabetes and the
debilitating nature of vision loss, additional research in this area is warranted. The body of
evidence for safety, accuracy and effectiveness is summarised in the matrix at Box 20.
Box 20
Body of evidence matrix for photocoagulation versus vitrectomy for the treatment of
diabetic macular oedema
Component
Evidence base
Rating
B
Consistency
C
Clinical impact
D
Generalisability
D
Applicability
B
Description
One poor quality systematic review (level I evidence) including 4
RCTs compared vitrectomy with photocoagulation for the treatment of
macular oedema.
3 RCTs reported no difference in change in visual acuity from baseline
between the 2 groups and 1 RCT reported a difference favouring
photocoagulation, although it is unclear whether baseline values have
been taken into account. One RCT reported that vitrectomy performed
better than photocoagulation, though differences in visual acuity at
baseline may explain these results.
Given that there is little clear evidence regarding the comparative
effectiveness of photocoagulation and vitrectomy, the clinical impact
of this evidence is slight.
The populations involved in 2 of the RCTs will be broadly similar to
Australia There may be some differences in populations of Yanyali
(Turkey) and Kumar (India). These very small studies are looking at a
select group of patients and the results are not ble to be extrapolated
to the vast majority of patients with diabetic macular oedema.
2 RCTs were performed in a healthcare system similar to Australia
(UK) and 2 were performed in healthcare systems that may be
different (Turkey and India).
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Table 62
Study profiles and results of RCTs within SR describing the comparison of
photocoagulation versus vitrectomy for the treatment of diabetic macular oedema
Photocoagulation versus vitrectomy for the treatment of diabetic macular oedema
Study, review period and quality
appraisal
Population characteristics, inclusion criteria
(O'Doherty, Dooley et al. 2008)
Level of evidence: I
Assessment of quality: Poor
Cochrane Library and Medline to
2007
Review is split into: 1. Laser
treatment, 2. Surgical management,
3. Intravitreal corticosteroids, and 4.
Intravitreal anti-VEGF.
However, trials comparing laser
treatment are in all sections
Systematic review based on 19 RCTs with a total of 4,130 eyes (31 articles
were included, though only 19 considered laser photocoagulation).
Population:
Studies of patients with diabetic macular oedema.
Intervention:
RCTs comparing treatments for diabetic macular oedema (note: this
assessment has only included the studies with laser photocoagulation).
Included studies, population characteristics and inclusion
criteria
Intervention(s) and
comparator(s)
Outcome(s)
(Thomas, Bunce et al. 2005)
N=40
Follow-up: 1 year
Vitrectomy in patients
unresponsive to laser
photocoagulation
Versus
Further laser
photocoagulation
Visual acuity, central
macular thickness
Change in VA
ETDRS logMAR
Photocoagulation
Vitrectomy
p value
At 12 months
-0.03 (±0.25)
0.05 (±0.26)
0.277†
† Analysis of covariance adjusting for baseline differences in acuity and central macular thickness
No difference in VA between the groups at 1 year.
(Patel, Hykin et al. 2006)
N= 15
Follow up: 1 year
Pars plana vitrectomy
Versus
Macular argon
photocoagulation
Visual acuity
ETDRS letters
Photocoagulation
Vitrectomy
p value
Letters (range)
Letters (range)
At baseline
62.5 (42-75)
58 (41-71)
At 12 months
67.5 (61-80)
60 (40-74)
0.03†
† Analysis of covariance (unclear whether controlled for baseline differences)
Photocoagulation had significant improvement in VA – however small numbers and a quarter of patients were lost
to follow up.
(Yanyali, Nohutcu et al. 2005)
N=24
Follow up: 6 months
Modified grid laser
photocoagulation
Versus
Pars plana vitrectomy
Visual acuity
Snellen logMAR
Photocoagulation
Vitrectomy
At baseline
0.59
0.75
At 6 months
0.49
0.53
Mean change†
ND
ND
† No comparative statistics are provided by Yanyali et al (2005) however raw data is. Analysis of raw data does
Page 216
not show a difference between the groups in change from baseline (p=0.2749). Yanyali et al (2005) concludes
that vitrectomy outperforms photocoagulation because the change from baseline is significant for vitrectomy but
not photocoagulation (p=0.0014 vs p=0.1056, statistics performed by reviewer on STATA v11.1)
Non-comparative statistics make it difficult to provide conclusions. The authors claim that PPV is better than
photocoagulation, but my stats do not show this to be the case.
(Kumar, Sinha et al. 2007)
N=24
Follow up: 6 months
Modified grid laser
photocoagulation
Versus
Vitrectomy with LM
peel
Visual acuity and
central macular
thickness
ETDRS logMAR
Photocoagulation
Vitrectomy
At baseline
1.043 (±0.028)
1.046 (±0.037)
At 6 months
0.965 (±0.1)
0.932 (±0.117)
Change from baseline (p) 0.003
0.008
No difference in change from baseline between the two groups (p=0.525, Mann-Whitney U test)
No difference in visual acuity between the groups at 6 months, though CMT reduction was greater in the
vitrectomy group.
Photocoagulation versus steroid or anti-VEGF injections with or without photocoagulation for
the treatment of macular oedema
One systematic review of moderate quality (Steijns, Duijvesz et al. 2010) and one systematic
review of poor quality (O'Doherty, Dooley et al. 2008) reported on photocoagulation versus
steroid injection (4 studies, Table 63) or anti-vascular endothelial growth factor (1 study, Table 64)
for the treatment of macular oedema. Two of the four studies to report on steroid injections are
included in both systematic reviews and data has been taken from both.
Steijns et al (2010) reported that there was no difference in change in visual acuity between
groups of patients with macular oedema treated with laser or with laser plus IVTA. This result was
based on two of the included RCTs that showed no difference and one RCT that showed a
difference. However, when the results are pooled and weighted according to sample variance,
there is a marginally statistically significant difference between the groups favouring IVTA plus
laser. IVTA plus laser had, on average, a 0.078 logMAR greater improvement at six months
compared to laser alone. It is important to note that this is based on only three trials, that the
difference is small and probably clinically unimportant and the confidence intervals include
clinically insignificant differences. One possible explanation for the differences in findings between
the studies is that all three differ in baseline visual acuities. The average a visual acuity at baseline
in the study by Avitabile et al (2005) was 0.805 logMAR compared with 0.665 logMAR and 0.49
logMAR for Lam et al (2007) and Shimura et al (2007), respectively. Perhaps a more likely
explanation is that the patients in Avitabile et al (2005) tended to have greater central foveal
thickness compared with patients from the other two trials, and therefore may have had greater
capacity to improve with reduced oedema.
Kang et al (2006), as reported by O’Doherty et al (2008), demonstrated a significant improvement
in visual acuity at six months in the laser plus IVTA group whilst patients in the IVTA alone group
had a non-significant decline in visual acuity. While Kang et al (2006) did not compare change from
baseline between the groups; it is likely that this comparison would reveal statistical differences.
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One phase II RCT (Scott, Edwards et al. 2007) included in O’Doherty et al (2008) compared five
groups with and without laser photocoagulation, and with and without intravitreal bevacuzimab
(Table 65). Patients who received intravitreal bevacuzimab (either 1.25mg or 2.5mg) at baseline
and six weeks had a greater improvement in visual acuity than patients who received laser alone.
As these findings are based on a small RCT primarily designed to assess the safety of IVB, further
data is required to make a definitive conclusion. Of the 107 subjects who received bevacuzimab,
two had myocardial infarctions and one was diagnosed with congestive heart failure.
Conclusion
Based on three RCTs in two systematic reviews, the addition of intravitreal steroid injections to
laser photocoagulation may improve visual acuity at six months. However, two of the three trials
reported no difference in change of visual acuity from baseline. Based on a single RCT, the addition
of laser photocoagulation to intravitreal steroid injections may improve visual acuity at six months.
IVB may result in improved visual acuity in patients with macular oedema compared with patients
who receive photocoagulation, though may be associated with side effects. Given the clinical
importance of macular oedema, further research into combined or alternative therapies is
warranted. The body of evidence for safety, accuracy and effectiveness is summarised in the
matrix at Box 21.
Box 21
Body of evidence matrix for photocoagulation versus steroid or anti-VEGF injections with
or without photocoagulation for the treatment of macular oedema
Component
Evidence base
Consistency
Rating
B
C – steroids
NA – anti
VEGF
Clinical impact
C
Generalisability
B
Applicability
B
Description
One systematic review of moderate quality and 1 systematic review of
poor quality reported on 5 RCTs addressing the use of intravitreal
steroids or anti-VEGF in patients with macular oedema. Trials involve
small numbers of patients.
One study reported a benefit of adding IVTA to laser and 2 studies
reported no difference. One study reported that IVTA and laser were
better than IVTA alone. Only 1 study reported on anti-VEGF.
While the effectiveness of either steroids or anti-VEGF remains
unclear following this review, the potential clinical impact of these
interventions, alone or in addition to photocoagulation, remains at least
moderate. Further research of steroids and anti-VEGF interventions
are required.
The included RCTs were performed in Italy, China, Japan, Korea and
USA. There may be some differences in populations across these
countries.
The healthcare systems of 3 of the 5 countries to produce the RCTs
will be of similar quality to that of Australia. It is unclear how applicable
results from China or Korea will be to the Australian healthcare
system.
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Table 63
Study profiles and results of systematic reviews comparing photocoagulation versus
steroid injection (with or without photocoagulation) for the treatment of diabetic
macular oedema
Systematic reviews comparing photocoagulation versus steroid injection (with or without
photocoagulation) for the treatment of diabetic macular oedema
Study, review period and
quality appraisal
Population characteristics, inclusion criteria
(Virgili and Menchini 2005;
Steijns, Duijvesz et al. 2010)
Level of evidence: I
Assessment of quality: Moderate
Cochrane Library, Medline and
Embase to 31 October 2008.
Systematic review based on 3 RCTs with 146 eyes
Population:
Studies of patients with diabetic macular oedema
Intervention:
Studies comparing macular grid photocoagulation with steroid injection plus
macular grid photocoagulation
Included studies, population characteristics and
inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
(Avitabile, Longo et al. 2005)
N=31
Follow up: 6 months
(a third study group was excluded by the SR as was not
eligible)
This study is already included in the SR by O’Doherty. VA
difference claimed and probably significant (direct
comparisons of change from baseline not made).
Macular grid
photocoagulation
Versus
4mg IVTA plus
macular grid
phototcoaguation
Visual acuity and central
macular thickness
Results
Change in VA
ETDRS logMAR
6 months
Laser only
0.01 (±0.16)
IVTA+laser
-0.2 (±0.23)
(Lam, Chan et al. 2007)
N=73
Follow up: 6 months
(a third study group was excluded by the SR as was not
eligible)
This study is already included in the SR by O’Doherty.
Results
Change in VA
ETDRS logMAR
Laser only
6 months
0.04 (±0.38)
No difference in VA at 6 months with IVTA
(Shimura, Nakazawa et al. 2007)
N=42
Follow up: 6 months
Results
Change in VA
ETDRS logMAR
Laser only
Difference
-0.21 [-0.35, -0.07]
Macular grid
photocoagulation
Versus
4mg IVTA plus
macular grid
photocoagulation
IVTA+laser
0.02 (±0.36)
Difference
-0.02 [-0.19, 0.15]
Macular grid laser
photocoagulation
Versus
Sub-Tenon’s injection
of triamcinolone
acetonide plus
macular grid
photocoagulation
IVTA+laser
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Visual acuity and central
macular thickness
Difference
Visual acuity and central
macular thickness
6 months
-0.16 (±0.18)
-0.18 (±0.18)
Shows no difference in VA between TA and laser only groups.
Pooled statistics
Table 64
-0.02 [-0.13,0.09]
Pooled estimate of difference
-0.078 [-0.155, -0.001] (p=0.048)
Meta-analysis of studies weighted according to variance.
Study profiles and results of systematic reviews comparing photocoagulation versus
anti-VEGF (with or without photocoagulation) for the treatment of diabetic macular
oedema
Systematic reviews comparing photocoagulation versus anti-VEGF (with or without photocoagulation) for
the treatment of diabetic macular oedema
Study, review period and
quality appraisal
Population characteristics, inclusion criteria
(O'Doherty, Dooley et al. 2008)
Level of evidence: I
Assessment of quality: Poor
Cochrane Library and Medline to
2007
Review is split into: 1. Laser
treatment, 2. Surgical
management, 3. Intravitreal
corticosteroids, and 4. Intravitreal
anti-VEGF.
However, trials comparing laser
treatment are in all sections
Systematic review based on 19 RCTs with a total of 4,130 eyes (31 articles
were included, though only 19 considered laser photocoagulation).
Population:
Studies of patients with diabetic macular oedema.
Intervention:
Randomised controlled trials comparing treatments for diabetic macular
oedema (note: this assessment has only included the studies with laser
photocoagulation).
Included studies, population characteristics and
inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
(Kang, Sa et al. 2006)
N=86
Follow up: 6 months
4mg IVTA followed by
laser at 3 months
Versus
4mg IVTA alone
Visual acuity and central
macular thickness
ETDRS logMAR
Baseline
6 months
Change from baseline
Laser +IVTA
0.90 (±0.36)
0.71 (±0.41)
0.19 [0.03,0.35]
IVTA only
0.97 (±0.41)
1.06 (±0.45)
-0.09 [-0.29,0.11]
Laser vs IVTA
p=0.4
p<0.001
NA
Change from baseline not calculated by authors and comparisons of change from baseline are not made, however
it is possible that the change from baseline is different in the two groups.
Table 65
Study profiles and results of systematic reviews comparing photocoagulation versus
intravitreal anti-vascular endothelial growth factor injection (with or without
photocoagulation) for the treatment of diabetic macular oedema
Photocoagulation versus intravitreal anti-vascular endothelial growth factor injection (with or without
photocoagulation) for the treatment of diabetic macular oedema
Study, review period and
quality appraisal
Population characteristics, inclusion criteria
(O'Doherty, Dooley et al. 2008)
Level of evidence: I
Assessment of quality: Poor
Systematic review based on 19 randomised controlled trials (RCTs) with a
total of 4130 eyes (31 articles were included, though only 19 considered
laser photocoagulation).
Page 220
Cochrane Library and Medline to
2007
Review is split into: 1. Laser
treatment, 2. Surgical
management, 3. Intravitreal
corticosteroids, and 4. Intravitreal
anti-VEGF.
However, trials comparing laser
treatment are in all sections
Population:
Studies of patients with diabetic macular oedema.
Intervention:
Randomised controlled trials comparing treatments for diabetic macular
oedema (note: this assessment has only included the studies with laser
photocoagulation).
Included studies, population characteristics and
inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
(Scott, Edwards et al. 2007)
N=121
Follow up: 12 months
5 arm study
Focal
photocoagulation
Versus
Intravitreal
bevacizumab
(IVB)1.25mg (baseline
and at 6 weeks)
Versus
IVB 2.5mg (baseline
and at 6 weeks)
Versus
IVB 1.25mg (baseline
and sham injection at
6 weeks)
Versus
IVB 1.25mg (baseline
and 6 weeks) with
photocoagulation at 3
weeks
Visual acuity and central
macular thickness
Results
Median change from baseline in
visual acuity – letters (interquartile range)
1
-1 (-6, 5)
2
5 (1,12)
(compared with group 1 p=0.01)
3
7 (4,11)
(compared with group 1 p=0.003)
4
4 (-3,7)
5
0 (-5,8)
† 1=laser only, 2=intravitreal bevacuzimab (IVB) 1.25mg at baseline (0) and 6 weeks, 3=IVB 2.5mg at 0 and 6
weeks, 4=IVB 1.25mg at 0 weeks only, 5=IVB 1.25 at 0 and 6 weeks plus laser at 3 weeks.
Treatment of exudative RD secondary to ischaemic branch retinal vein occlusion
One RCT of moderate quality compared visual acuity following macular grid laser
photocoagulation with observation in patients with severe macular oedema and exudative retinal
detachment (ERD) secondary to branch retinal vein occlusion (BRVO) (
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Table 66,
Page 222
Table 72) (Parodi, Di Stefano et al. 2008). Thirty one patients with ERD secondary to ischaemic
BRVO were randomised to macular grid laser photocoagulation (MGLP) (n=16) or observation
(n=15). At 24 months, six patients (37.5%) in the MGLP group had gained at least three lines of
visual acuity compared to none in the observation group. Of equal importance, no patient in the
MGLP group lost three lines or more of visual acuity compared with 14 patients (93.3%) in the
control group. Best corrected visual acuity improved in the MGLP group by an average of 0.15
logMAR30 compared with a mean worsening of 0.40 logMAR in the control group. ERD was
reabsorbed in all patients in both groups by 24 months, though occurred earlier in the MGLP
group (9.1 ± 1.7 months versus 15.8 ± 3.4 months).
Conclusion
Eyes treated with macular grid laser photocoagulation (MGLP) for ERD secondary to BRVO results
in better visual acuity at 24 months than eyes that underwent observation alone. No eyes treated
with MGLP showed a decline in best corrected visual acuity (BCVA) of one line or greater
compared with 100 per cent of observed eyes (93% experienced a decrease in BCVA of 3 lines or
greater). Among eyes treated with MGLP, 37 per cent experienced an improvement in BCVA of
three or more lines. However, this conclusion is based on one study. Further research into MGLP
for exudative retinal detachment is needed, including research involving modern intravitreal
pharmaceuticals. The body of evidence for safety, accuracy and effectiveness is summarised in the
matrix at Box 22.
Box 22
Body of evidence matrix for the treatment of exudative retinal detachment secondary to
ischaemic branch retinal vein occlusion
Component
Evidence base
Rating
B
Description
One RCT (level II evidence) of moderate quality and low risk of
bias.
Consistency
NA
Only one study.
Clinical impact
A
Large differences between the study groups are presented,
therefore the use of macular grid laser photocoagulation for ERD
secondary to branch retinal vein occlusion could potentially have
a very large impact upon patient quality of life.
Generalisability
B
Study undertaken in a developed country (Italy). There may be
some dietary or racial predisposition differences between Italy and
Australia, however populations are likely to be largely similar.
Applicability
B
Performed in a country with a good health care system,
comparable to Australia, although there will be some differences
in the delivery of health care.
30
Visual acuity is measured according to the size of letters viewed on a Snellen chart and using the foot as a unit of
measurement, (fractional) visual acuity is expressed relative to 20/20. Using the metre, visual acuity is expressed
relative to 6/6. LogMAR is another commonly used scale which converts the geometric sequence of a traditional chart
to a linear scale. It measures visual acuity loss; positive values indicate vision loss, while negative values denote
normal or better visual acuity.
Page 223
Table 66
Study profiles and results of randomised controlled trials comparing photocoagulation
to control or alternative treatments in the prevention of retinal detachment
RCTs comparing photocoagulation to control or alternative treatments in the prevention of retinal
detachment
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Avitabile, Longo et al. 2008)
Level II evidence RCT of poor quality
N= 303 patients (303 eyes)
Country: Italy
Mean age: 45 years
Gender: 46.5% female
Inclusion: Patients with rhegmatogenous retinal
detachment (RD) with or without previous episcleral
surgery, vitrectomy indicated (ie proliferative
vitreoretinopathy grade CP6 or greater, multiple retinal
breaks, large retinal breaks, posterior breaks,
pseudophakiea, high myopia and recidivant RD). Patients
with post traumatic RD, giant tear or macular hole,
tractional RD (in PDR), uveitic RD or RD post vitrectomy
were excluded.
Follow up: 9 months
Vitrectomy plus
silicone oil (SO)
tamponade plus
endolaser
photocoagulation (LP)
around retinal breaks
with or without
silicone encircling
band
Versus
The above plus
prophylactic laser
retinopexy of 3 or 4
lines of 200µm 300µm spots
delivered 360°
(intraoperatively or at
follow up within the
next 3 months).
Silicone oil is
removed after at least
4 months
Effectiveness: Degree of
retinal attachment following
SO removal, success rate
of vitrectomy with SO.
Results
Treated
Observed
% (n/N)
% (n/N)
RR [95% CI]
RD requiring intervention 8.6 (12/139)
20.9 (27/129)
0.41 [0.22, 0.78]
All RD
18.7 (26/139)
20.9 (27/129)
0.89 [0.55, 1.45]*
* Relative Risk and confidence interval generated using STATA 11.0 – not provided by authors
(Parodi, Di Stefano et al. 2008)
Level II evidence RCT of moderate quality
N=31 patients
Country: Italy
Mean age: 68.2 years (laser group), 66.8 years (control
group)
Gender: 42% female
Inclusion: exudative retinal detachment (ERD) secondary
to ischaemic branch retinal vein occlusion (BRVO), BCVA
20/40 or worse, duration of BRVO less than 3 months
Follow up: 24 months
Macular Grid Laser
Photocoagulation
(MGLP)
Versus
Observation
Page 224
Effectiveness: Number of
eyes that gained at least 15
letters (approximately 3
lines) of visual acuity
RCTs comparing photocoagulation to control or alternative treatments in the prevention of retinal
detachment
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
Results
months1
BCVA change at 24
≥ 3 lines increase
≥ 1 to < 3 lines increase
Less than 1 line change
≥ 1 to < 3 lines decrease
≥ 3 lines decrease
MGLP
% (n/N)
37 (6/16)
12 (2/16)
50 (8/16)
0
0
Observed
% (n/N)
0
0
0
7 (1/15)
93 (14/15)
Best corrected visual acuity (BCVA) is measured using a standard ETDRS chart. The BCVA scoring is based upon the number of
letters identified at 2 metres plus 15 (there are 5 letters per line, therefore an improvement in three lines is approximately 15
letters). If the patient read fewer than 20 letters (5 lines) at 2 metres, the patient was tested on the top three lines at 1 metre and
their score was the total number of letters read at 1 metre + those read at 2 metres.
1
Photocoagulation for the treatment of cystoid macular oedema secondary to branch retinal vein
occlusion (BRVO)
One good quality RCT (Scott, Ip et al. 2009) and one moderate quality RCT (Russo, Barone et al.
2009) reported on the outcomes of patients with cystoid macular oedema, secondary to branch
retinal vein occlusion, treated with either photocoagulation or with steroid (Scott et al 2009) or
anti-VEGF (Russo et al 2009) intravitreal injections (Table 67).
The proportion of participants who attained at least a 15 letter (ETDRS letter score) improvement
in best corrected visual acuity at 12-months was similar amongst the photocoagulation, 1mg IVTA
and 4mg IVTA groups. There was no difference in change in BCVA between the treatments in any
of the pre-specified subgroups (dense macular haemorrhage, prior photocoagulation, duration of
macular oedema, baseline visual acuity and CMT).
Russo et al (2009) reported on 30 patients randomised to either grid laser photocoagulation or
intravitreal bevacuzimab. At 12-months, BCVA had improved by 0.2 logMAR in the
photocoagulation group, and 0.31 in the IVB group. Baseline BCVA was similar in both groups,
however at 12-months BCVA was significantly different between the groups, favouring the
patients in the IVB group. Russo et al (2009) did not report on change from baseline, which is a
more appropriate metric for comparing the success of an intervention, especially in light of small,
non-significant differences in BCVA at baseline. However, by imputing the standard deviation of
the change from baseline (Higgins, Green et al. 2009) and assuming the correlation between
baseline and follow up is the same as in (Soheilian, Ramezani et al. 2007), the change from
baseline is statistically different between the two groups, with a greater improvement in the IVB
group. This still holds true if the correlation between baseline and follow up measures is reduced
to 0.5. However, this statistic is based on a small number of observations (n=15 in each group) and
outliers may have influenced the results.
Page 225
Conclusion
Intravitreal triamcinolone acetonide is no more effective than photocoagulation in patients with
macular oedema secondary to branch retinal vein occlusion. Intravitreal bevacuzimab may be
more effective than grid laser photocoagulation for patients with macular oedema secondary to
branch retinal vein occlusion, however a larger study is required to confirm these findings. The
body of evidence for safety, accuracy and effectiveness is summarised in the matrix at Box 23.
Box 23
Body of evidence matrix for photocoagulation for the treatment of cystoid macular
oedema secondary to branch retinal vein occlusion (BRVO)
Component
Evidence base
Consistency
Rating
B
NA
Clinical impact
C – steroids
B – anti VEGF
Generalisability
B
Applicability
B
Description
One good quality RCT with a low risk of bias reported on the
effectiveness of intravitreal triamcinolone acetonide compared with
photocoagulation in patients with cystoid macular oedema. One
moderate quality RCT with a low risk of bias (though small sample
size) reported on the effectiveness of intravitreal bevacuzimab
compared with photocoagulation.
Only 1 study comparing each intervention.
Intravitreal triamcinolone acetonide was reported to be no different to
photocoagulation, and therefore may present an alternative to
photocoagulation. This has moderate clinical impact. Intravitreal
bevacuzimab was reported to be more effective than photocoagulation
though further research will be required before IVB can be
recommended for patients with macular oedema secondary to BRVO.
The included RCTs were conducted in the US (Scott et al 2009) and
Italy (Russo et al 2009). Both will contain populations largely similar to
Australia.
The healthcare systems of two countries in the RCTs will be similar to
Australia, with some differences. Scott et al (2009) reports on a large
multicentre trial which is likely to increase the applicability by removing
the RCT from a single, high volume, centre of expertise.
Page 226
Table 67
Study profiles and results of RCTs comparing photocoagulation to intravitreal injections
for the treatment of cystoid macular oedema
(RCTs comparing photocoagulation to intravitreal injections for the treatment of cystoid macular oedema
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Scott, Ip et al. 2009)
Level II evidence RCT of good quality
N= 411
Country: US (multicentre)
Mean age: 64.7 years
Sex: 49% female
Inclusion: BCVA between 20/400 and 20/40, macular
oedema secondary to BRVO, CMT ≥ 250µm.
Exclusion: macular oedema due to other causes, another
eye condition that would not improve with the improvement
of oedema, substantial cataracts, photocoagulation within
15 weeks of randomisation, pars plana vitrectomy, major
ocular surgery, IOP ≥ 25 mmHg, glaucoma or aphakia.
Follow up: 12 months (primary endpoint)
Randomised to one of
three treatments.
Grid photocoagulation
(plus focal leaks) with
re-treatment if
necessary
Versus
1mg triamcinolone
with second or third
injections if necessary
Versus
4mg triamcinolone
with second or third
injections if necessary
Safety: any adverse event
Effectiveness: Visual
acuity (gain of 15 letters
or more)
Results
No difference in number of patients achieving VA >=15 letters at 12 months between the three groups.
IVTA patients experienced IOP (41% in 4mg group started IOP lowering medication, 7% in 1mg group and 2% in
standard group), one patient required a tube shunt and 1 required a trabeculectomy after 12 months (in the 4mg
group) and 1 patient experienced infectious endophthalmitis (1 or 914 injections). New onset lens opacity was
estimated at 13% in the standard care vs 25% and 35% in the 1mg and 4mg respectively.
Authors conclude that photocoagulation has a better safety profile than IVTA with similar effectiveness and should
remain the standard of care
(Russo, Barone et al. 2009)
Level II evidence RCT of moderate quality
N=30
Country: Italy
Mean age: not reported
Sex: 23.3% female
Inclusion: perfused BRVO of at least 3 months, logMAR of
0.4 or worse, CMT of at least 300 µm or greater.
Exclusion: diabetic retinopathy, AMD, prior cataract
surgery.
Grid laser
photocoagulation
(GLP) with Argon
green laser, 100 µm
spots of duration 100
ms, one half burn
width apart
Versus
Intravitreal
bevacizumab (IVB)
1.25 mg
Page 227
Safety: not reported
Effectiveness: Best
corrected visual acuity
(BCVA) and CMT at 12
months
(RCTs comparing photocoagulation to intravitreal injections for the treatment of cystoid macular oedema
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
Results
Russo reports that bevacizumab outperforms GLP at each time point (p<0.05), however does not consider change
from baseline but only compares logMAR at each time point.
Using Soheilian et al 2007 –the SD of the change has been estimated (from Cochrane Handbook 16.1.3.2)
SD change = sqrt(SDbaseline squared + SD final squared – (2 x Corr x SDbaseline x SDfinal)),
where Corr = estimated correlation coefficient between baseline and final values.
Not having another IVB study of BRVO, Soheilian et al 2007 (IVB in diabetic macular oedema) was used to
calculate the correlation coefficient using
Corr = (SDbaseline squared + SDfinal squared – Sdchange squared)/(2 x SD baseline x SD final)
With these calculations it appears that the difference from baseline is significantly different between the groups –
the correlation coefficient has to be reduced to below 0.5 before the difference is no longer statistically significant
(which is unlikely). Therefore, while the difference from baseline should have been measured, it is still likely that
the difference from baseline is statistically significant between the groups.
This is supported by an obvious significant difference in CMT between the two groups favouring the IVB group.
Page 228
3.18.5
Photocoagulation for the treatment of age-related macular
degeneration
Background
Age-related macular degeneration is a condition in which cellular debris (drusen), are deposited
between the retina and the choroid. It is the leading cause of vision loss in industrialised countries
(Klein, Peto et al. 2004).
Age-related macular degeneration (AMD) is classified as “dry” or “wet”. Dry age-related macular
degeneration occurs when drusen build up beneath the retinal pigment ephithelium, resulting in
progressive atrophy of the retinal pigment epithelium and photoreceptive tissues (Young 1987).
The “wet” or exudative form of AMD is characterised by choroidal neovascularisation. Exudation
and bleeding from leaking new vessels result in the destruction of photoreceptors and vision loss.
Research question
Is photocoagulation a safe and effective procedure for the treatment of patients with age-related
macular degeneration?
Results
One good quality systematic review reported on the effectiveness of treating drusen with laser
photocoagulation in patients with AMD (Parodi Maurizio, Virgili et al. 2009). It is likely that this
systematic review related primarily to a population with “dry” or early macular degeneration. A
second, good quality, systematic review reported on the effectiveness of treating choroidal
neovascularisation primarily in patients with “wet” or exudative macular degeneration AMD
(Virgili and Bini 2007).
Photocoagulation of drusen in patients with age-related macular degeneration
Parodi et al (2009) reported that there was a significantly greater reduction in drusen among
patients treated with photocoagulation compared with patients who only underwent observation
(OR=6.07 95% CI 1.84, 20.01) (Table 68). However, a reduction in drusen did not translate to the
prevention of CNV or visual loss. The authors point out that a finding of no difference in visual loss
between the groups (OR upper limit = 1.14, favouring observation) tends to exclude important
harms among patients treated with photocoagulation.
Photocoagulation for the treatment of CNV in patients with age-related macular degeneration
Virgili et al reported that the proportion of patients losing visual acuity to a level less than 20/200
at three and five years was smaller in the photocoagulation arm than in the observation arm
(Table 69). The proportion of patients whose contrast threshold worsened to less than 10 per cent
at 3-months and 2-years was smaller in the photocoagulation arm than in the observation arm.
Fewer patients with perifoveal CNV who were treated with photocoagulation lost three or more
lines of visual acuity31 compared with observation at six months based on a single trial. The
treatment of subfoveal CNV with photocoagulation resulted in between 10 and 300 per cent more
patients losing 2-3 or more lines of visual acuity than observation at 3-months. At one year, the
difference was not significant.
31
On the Snellen chart
Page 229
Conclusion
The good quality systematic review by Parodi et al (2009) found that the use of photocoagulation
to treat drusen in patients with age-related macular degeneration is not currently warranted as
this treatment option is no better than observation for progression of AMD or visual acuity
outcomes. Clinical advice, however, suggests that research into other forms of laser technology is
being conducted and could result in different outcomes.
Virgili et al (2007) reported that direct photocoagulation to extrafoveal CNV is an effective method
for halting visual deterioration in patients with AMD compared with observation. However, the
effectiveness of photocoagulation to subfoveal or juxtafoveal CNV is limited or delayed, and
treatment to sufoveal CNV may result in early visual loss. The authors concluded that laser
photocoagulation should be preferred to observation as a control group for future studies of
treatments for extrafoveal or juxtafoveal CNV. It is important to note that no studies compared
photocoagulation of CNV to modern intravitreal pharmaceuticals. The body of evidence for safety,
accuracy and effectiveness is summarised in the matrix at Box 24.
Box 24
Body of evidence matrix for photocoagulation for the treatment of patients with agerelated macular degeneration
Component
Evidence base
Rating
A
Consistency
B
Clinical impact
C
Generalisability
B
Applicability
B
Description
One systematic review with a low risk of bias compared the
progression of AMD in patients who received photocoagulation
treatment of drusen and those who were observed. A second
systematic review compared visual acuity in patients with AMD who
received photocoagulation to CNV and those who were observed.
In Parodi et al (2009), there is considerable heterogeneity of the
results of the included studies, however all studies include the null
hypothesis for both development of CNV and visual acuity outcomes.
In Virgili et al (2007), consistency of studies is more difficult to
measure due to the few studies that address each CNV location.
Overall, there is some heterogeneity, however the effect, when there is
one, tends to be in the same direction.
Photocoagulation to the drusen does not decrease the progression to
advanced AMD or improve visual outcomes in patients with AMD.
Photocoagulation to extrafoveal and juxtafoveal CNV results in
improved visual acuity outcomes compared to observation. In patients
with subfoveal CNV, it is not effective.
The included RCTs were performed in USA, UK, Spain, Sweden,
France, Canada, Italy, Netherlands and Israel. Overall, the populations
will be similar to Australian patients, with a few differences.
All studies were carried out in developed countries with healthcare
systems of similar quality to Australia. Therefore, the results are
largely applicable to the Australian context.
Page 230
Table 68
Study profiles and results of systematic reviews comparing photocoagulation with
observation to prevent progression of age-related macular degeneration
Systematic reviews comparing photocoagulation with observation to prevent progression of age-related
macular degeneration
Study, review period and
quality appraisal
Population characteristics, inclusion criteria
(Parodi Maurizio, Virgili et al.
2009)
Level of evidence: I
Assessment of quality: Good
Cochrane Library to Issue 4, 2008
Medline: Jan 1950 to Nov 2008
Embase: Jan 1980 to Nov 2008
Systematic review based on 9 RCTs with a total of 2,216 people.
Population:
Any study including patients with retinal drusen associated with age-related
macular degeneration (AMD) in one or both eyes.
Intervention:
Laser photocoagulation to the drusen compared with no intervention or sham
treatment. No trials involving sham treatment were identified.
Photocoagulation versus observation for the treatment of drusen in patients with age-related macular
degeneration
Results
Development of CNV (progression of AMD)
Meta-analysis of 5 studies with bilateral eyes randomised and 6 studies with unilateral eyes randomised. Total
number of patients = 1,523
Photocoagulation versus Observation
Odds ratio [95% CI]
1.04 [0.71, 1.51]
All sensitivity analyses reported have confidence intervals including no difference.
Visual loss of 2-3 or more lines at 2 years
Meta-analysis of 3 studies with bilateral eyes randomised and 5 studies with unilateral eyes randomised.
Photocoagulation versus Observation
Odds ratio [95% CI]
0.88 [0.67, 1.14]
Page 231
Table 69
Study profiles and results of systematic reviews comparing photocoagulation with
observation to prevent progression to age-related macular degeneration
Systematic reviews comparing photocoagulation with observation to prevent progression to age-related
macular degeneration
Study, review period and quality
appraisal
Population characteristics, inclusion criteria
(Virgili and Bini 2007)
Level of evidence: I
Assessment of quality: Good
Cochrane Library, Medline,
Embase, Latin American and
Caribbean Health Sciences
Literature Database (LILACS),
National Research Register
(NRR) and ZETOC.
Last searched 30 March 2007
Systematic review based on 15 RCTs with a total of 2,064 participants.
Population:
Any study involving participants affected by choroidal neo-vascularisation
(CNV) associated with age-related macular degeneration (AMD).
Intervention:
Laser photocoagulation of choroidal neo-vascularisation compared with no
intervention, sham intervention or alternate comparator.
Photocoagulation versus observation for the treatment of CNV in patients with age-related macular
degeneration
Study
Outcome
Proportion of patients with visual acuity <20/200
Direct photocoagulation versus observation
At 3 years
Pooled RR [95% CI]
0.73 [0.61, 0.86]
At 5 years
Pooled RR [95% CI]
0.77 [0.66, 0.90]
based on 2 studies
based on 2 studies
Proportion of patients with contrast threshold worse than 10%
Direct photocoagulation versus observation
At 3 months
Pooled RR [95% CI]
0.83 [0.72, 0.96]
At 2 years
Pooled RR [95% CI]
0.73 [0.64, 0.83]
based on 2 studies
based on 2 studies
Proportion of patients with a loss of 3+ lines of visual acuity
Perifoveal photocoagulation versus observation
Coscas et al 1991
3 months RR [95% CI]
0.45 [0.16, 1.24]
single trial
6 months RR [95% CI]
0.55 [0.36, 0.86]
single trial
Proportion of patients with a loss of 2-3+ lines of visual acuity
Grid photocoagulation of occult (subfoveal) CNV versus observation
At 3 months
Pooled RR [95% CI]
1.83 [1.1, 3.05]
based on 2 studies
At 1 year
Pooled RR [95% CI]
1.17 [0.91, 1.51]
based on 2 studies
Other results
No difference in number losing more than 5 points on SF-36 physical or mental score
between patients who receive photocoagulation and those that receive submacular surgery
at 6, 12, 24 months (1 trial).
No difference in visual outcomes of argon or krypton lasers (based on 3 trials).
Page 232
Table 70
Study profiles of RCTs included in systematic reviews comparing photocoagulation
with observation to prevent progression of age-related macular degeneration
Systematic reviews comparing photocoagulation with observation to prevent progression of age-related
macular degeneration
Study, review period and
quality appraisal
Population characteristics, inclusion criteria
(Parodi Maurizio, Virgili et al.
2009)
Level of evidence: I
Assessment of quality: Good
Cochrane Library to Issue 4, 2008
Medline: Jan 1950 to Nov 2008
Embase: Jan 1980 to Nov 2008
Systematic review based on 9 RCTs with a total of 2,216 people.
Population:
Any study including patients with retinal drusen associated with age-related
macular degeneration (AMD) in one or both eyes.
Intervention:
Laser photocoagulation to the drusen compared with no intervention or sham
treatment. No trials involving sham treatment were identified.
Included studies, population characteristics and
inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
Complications of age-related macular degeneration
prevention trial (CAPT)1
N=1052
Country: USA
Mean age: 71 years
Sex: 60.6% female
Follow up: 5 years
All participants randomised to either treatment or
observation, with the fellow eye receiving the opposite study
arm.
Intervention: Argon
laser, 60 burns in a
grid using 100 µm
spot size, 0.1 second
duration.
Primary: loss of 15 letters
or more.
Secondary: change in
Visual Acuity, change in
contrast sensitivity,
incidence of late AMD
Choroidal neovascularisation prevention trial (CNVPT)2
N=276
Country: USA
Mean age: 73 years
Sex: 63% female in the treatment group, 59% female in the
control group
Follow up: 2 years
n=156 randomised to treatment or observation with the
fellow eye receiving the opposite study arm.
n=120 randomised to either treatment or observation of one
eye. Fellow eye not randomised.
Intervention: Argon
laser, 20 burns in 3
rows using 100 µm
spot size, 0.1 second
duration.
Drusen Laser Study (DLS)3
N=282
Country: UK
Age: 70.1 years (52 to 100) (bilateral randomised group) –
72 years (54 to 87) (unilateral randomised group).
Sex: 60.6% female
Follow up: 3 years
n=105 randomised to either treatment of observation with
the fellow eye receiving the opposite study arm.
n=177 had single eye randomised to treatment or
observation.
Intervention: Argon
laser, 12 burns, 200
µm spot size, 0.2
second duration.
Control: observation
Visual acuity, contrast
threshold, reading ability.
Development of CNV or
geographic atrophy,
disappearance of drusen.
Control: observation
Control: observation
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Proportion of patients
who developed CNV,
visual acuity.
Figueroa4
N=30
Country: Spain
Inclusion criteria: AMD with large confluent soft drusen
involving the fovea
Mean age: 69 (62 to 74)
Sex: NR
Follow up: 3 years (mean)
Randomised to laser or observation.
Intervention: Argon
laser, 100 µm spot
size, 0.1 second
duration, spot on
drusen in temporal
fovea or grid pattern if
drusen larger than
300 µm.
Control: observation
Occurrence of CNV,
reduction of drusen,
visual acuity.
Frennesson5
N=38
Country: Sweden
Mean Age: 71.6 in treated patients and 68.5 in control
patients
Sex: NR
Inclusion criteria: soft drusen, visual acuity at least 0.8.
Follow up: 3 years
Randomised to laser or observation.
Intervention: Argon
laser, 200 µm spot
size, 0.05 second
duration, horseshoeshaped treatment
pattern with direct
treatment of the
drusen.
Anatomic: mean drusen
area, development of
CNV.
Functional: visual acuity,
colour vision, central
visual field.
Laser to Drusen Study (unpublished data)6
N=99
Country: USA
Mean Age: 74 (55 – 84)
Sex: 69.7% female
Inclusion: large drusen (>63 µm in diameter), focal
hyperpigmentation and no AMD in study eye. Evidence of
AMD in fellow eye. Visual acuity of 20/40 or better.
Randomised to observation or temporal laser or nasal and
temporal laser (2:1:1)
Follow up: 2 years
Intervention: Dye
yellow laser, 50 µm
spot size, 0.1 second
duration, either 1)
temporal (180
degree) pattern or 2)
temporal and nasal
(360 degree) pattern
Little7
N=27
Country: USA
Mean age: 69.7
Sex: 67% female
Inclusion: symmetrical drusen at least 100 µm, at least 20
drusen, or 10 drusen + 2 drusen > 500 µm, visual acuity
at least 20/60.
Exclusion: eye disorders which could affect visual acuity
Follow up: 1 to 6 years
One eye randomised to photocoagulation and one eye to
observation.
Intervention: Dye
Visual acuity, colour
laser (577 to 620 nm), vision, central visual
field.
200 µm spot size,
0.05 to 0.1 second
duration – direct
treatment to the
drusen.
(Olk, Friberg et al. 1999)
N=152
Country: USA
Mean age: 74.5 (54 to 88)
Sex: 62.5% female
Inclusion: diagnosis of AMD with at least 5 large drusen
(>63 µm)
Exclusion: exudative macular degeneration or other ocular
diseases
Intervention: Diode
laser, 125 µm spot
size, 0.2 second
duration, 48 burns in
grid pattern.
Control: observation
Development of CNV,
visual acuity.
Control: observation
Control: observation
Control: observation
Page 234
Anatomic: reduction of
drusen, development of
CNV.
Functional: visual acuity
n=77 randomised to the bilateral arm (one eye
randomised to treatment or observation with the fellow
eye given the opposite treatment)
n=75 randomised to the unilateral arm.
Prophylactic Treatment of Age Related Macular
Degeneration (PTAMD)8
N=244
Country: USA
Mean age: 75.4 (treated), 75.1 (control)
Sex: 59.3% female (treated), 61.5% female (control)
Inclusion: Visual acuity > 20/63, at least 5 drusen >63 µm.
Unilateral patients have one eye ineligible due to vision
loss attributed to advanced AMD.
Systematic review only considered unilateral patients
Intervention: Diode
laser, 125 µm spot
size, 0.1 second
duration, 48 burns in
a grid pattern.
Anatomic: drusen
reduction, development
of CNV.
Functional: visual acuity.
Control: observation
(Alexander, Elsner et al. 2004; Complications of Age-Related Macular Degeneration Prevention Trial study
group 2004; Figueroa, Schocket et al. 2004; Grunwald, Figueroa et al. 2004; Maguire 2004; Sbarbaro, Maguire
et al. 2004; Stoltz, Ying et al. 2004; Ying, Liu et al. 2005; Complications of Age-Related Macular Degeneration
Prevention Trial research group 2006; Figueroa, Schocket et al. 2006; Friberg, Musch et al. 2006)
2 (Anonymous 1998; Anonymous 1998; Ho, Maguire et al. 1999; Fine, Maguire et al. 2001; Kaiser, Berger et al.
2001; Rosenblatt, Prenner et al. 2001; Choroidal Neovascularization Prevention Trial Research Group 2003;
Prenner, Rosenblatt et al. 2003; Regillo 2003)
3 (Owens, Guymer et al. 1999; Owens, Bunce et al. 2003; Kertes 2006; Owens, Bunce et al. 2006)
4 (Figueroa, Regueras et al. 1994; Figueroa, Regueras et al. 1997)
5 (Frennesson and Nilsson 1995; Frennesson and Nilsson 1996; Frennesson and Nilsson 1998; Frennesson
2003)
6 (Bressler, Vitale et al. 1995)
7 (Little and Showman 1995; Little, Showman et al. 1997)
8 (Rodanant, Friberg et al. 2002; Friberg, Musch et al. 2006)
1
Page 235
Table 71
Study profiles of RCTs included in systematic reviews comparing photocoagulation
with observation to prevent progression to age-related macular degeneration
Systematic reviews comparing photocoagulation with observation to prevent progression to age-related
macular degeneration
Study, review period and quality
appraisal
Population characteristics, inclusion criteria
(Virgili and Bini 2007)
Level of evidence: I
Assessment of quality: Good
Cochrane Library, Medline,
Embase, Latin American and
Caribbean Health Sciences
Literature Database (LILACS),
National Research Register
(NRR) and ZETOC.
Last searched 30 March 2007
Systematic review based on 15 RCTs with a total of 2,064 participants.
Population:
Any study involving participants affected by choroidal neo-vascularisation
(CNV) associated with age-related macular degeneration (AMD).
Intervention:
Laser photocoagulation of choroidal neo-vascularisation compared with no
intervention, sham intervention or alternate comparator.
Included studies, population characteristics and
inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
(Arnold, Algan et al. 1997)
N= 55 patients (57 eyes)
Country: France (single centre)
Mean age: 73 years
Sex:76.4% female
Inclusion: visual acuity of 20/200 or greater, subfoveal
occult CNV
Exclusion: serous or fibrovascular PED.
Follow up: 2 to 84 months
Intervention: Mild
intensity grid krypton
laser, horseshoe
pattern beyond the
area of visible occult
CNV
Visual acuity, resolution
of fluid with
biomicroscopy and of
leakage with fluorescein
angiography
(Bressler, Maguire et al. 1996)
N=100 patients (103 eyes)
Country: USA (2 centres)
Age: 77% 70 years or older
Sex: 69% female
Inclusion: decreased visual acuity and subretinal fluid,
subfoveal CNV, visual acuity 20/320 or greater and 20/40 or
less (changed to 20/25 or less)
Follow up: up to 24 months
Intervention: grid
photocoagulation to
the CNV (red or yellow
wavelength at one
centre, red at the
other)
(Canadian Ophthalmology Study Group 1993; Willan,
Cruess et al. 1996)
N=210 (191 eligible and analysed)
Country: Canada (multicentre)
Mean age: 71 years (argon), 72 years (krypton)
Sex: 48% female (argon), 50% female (krypton)
Inclusion: CNV edge 200 to 5000 micron from the FAZ
centre, drusen present, visual acuity 20/200 or better, visual
symptoms due to CNV, no prior photocoagulation, >50
years of age
Follow up: 3 years
Intervention: argon
versus krypton laser
photocoagulation to
achieve uniformly
white laser burns
covering the CNV
extending 100 microns
beyond it (krypton
used if CNV
recurrence within 200
microns of the FAZ
centre even if
allocation was to
argon)
Control: observation
Visual acuity, contrast
sensitivity, fluorescein
leakage, presence of
CNV and CNV size
Control: observation
Page 236
Visual acuity, persistent
or recurrent CNV at 1
year
Systematic reviews comparing photocoagulation with observation to prevent progression to age-related
macular degeneration
(Cardillo Piccolino, Ghiglione et al. 1993)
N=23 patients (24 eyes)
Country: Italy (single centre)
Mean age: 74 years
Sex: 65.2% female
Inclusion: occult subfoval CNV, subretinal fluid in the
macular, visual acuity 20/200 to 20/40
Exclusion: classic CNV or serous PED
Follow up: mean 18 months treated, 21 months control
Intervention: light
intensity grid
photocoagulation with
argon laser directed to
the CNV and
perimacular region
(foveal sparing).
(Coscas and Soubrane 1982; Coscas and Soubrane
1984; Soubrane, Coscas et al. 1987)
N=60 patients
Country: France (single centre)
Mean age: 69.8 years
Sex: 55% female
Inclusion criteria: extrafoveal and juxtafoveal (2:1) well
defined CNV, visual acuity 1/10 or greater
Exclusion: PED
Follow up: up to 24 months (mean: 22 months for treated,
14 months for control)
Intervention:
photocoagulation
covering the entire
CNV area extending
beyond the CNV.
(Coscas, Soubrane et al. 1991)
N=160 (127 followed to 1 year)
Country: France (single centre)
Age: 56.7% 75 years or older
Sex:66.1% female
Inclusion: visual acuity 20/100 to 10/1000, subfoveal CNV
(with or without serous PED), CNV size less than 2.5 disc
diameters
Follow up: max 4 years (mean: 26 months treated, 24
months controls)
Intervention: krypton
laser (if
haemorrhage), argon
or dye laser to uniform
heavy grey/white
burns of the CNV
area.
(Duch Mestres, Vilaplana et al. 1993)
N=41 (29 affected by AMD)
Country: Spain (single centre)
Mean age: 74 years
Sex: 56% female
Inclusion: occult sufoveal CNV, subretinal fluid in the
macula, visual acuity 20/200 to 20/40
Exclusion: classic CNV or serous PED
Follow up: variable, minimum 3 months
Intervention: argon
laser compared with
dye red laser
photocoagulation.
Grey-white
photocoagulation.
(The Moorfields Macular Study Group 1982)
N=128
Country: UK (single centre)
Mean age: NR
Sex: NR
Inclusion: well-defined CNV with closest edge from 100 to
1500 micron from the centre of the fovea
Follow up: max 24 months (51/63 treated and 50/65 control
patients still followed at 24 months)
Intervention: heavy
confluent argon laser
to the whole of the
lesion and at least 100
micron beyond the
edge of the CNV.
Visual acuity, resolution
of fluid with
biomicroscopy and of
leakage with fluorescein
angiography
Control: observation
Visual acuity, near acuity.
Control: observation
Visual acuity, reading
visual acuity, central
visual field.
Control: observation
Visual acuity, central
visual field.
Control: observation
Control: observation
Page 237
Visual acuity, rate of
recurrence (treated
eyes).
Systematic reviews comparing photocoagulation with observation to prevent progression to age-related
macular degeneration
MPS Argon Extra1
N=224
Country: USA (multicentre)
Age: 30% aged 75 or more
Sex: 50.4% female
Inclusion: CNV at a distance of 200 to 2500 micron from the
centre of the fovea, visual acuity of 20/100 or more
Follow up: 5 years
Juxta2
Intervention: argon
green
photocoagulation for
uniform white laser
burns covering and
extending 100 microns
past the CNV
Visual acuity.
Control: observation
MPS Krypton
N=496
Country: USA (multicentre)
Age: 48% aged 70 or more
Sex: 53% female
Inclusion: CNV with edge between 1 and 199 micron from
the centre of the FAZ; or between 200 to 2500 micron from
the centre if blood extended within the FAZ, visual acuity of
20/400 or more.
Follow up: 5 years
Intervention: krypton
red photocoagulation
for uniform whit laser
burns covering and
extending 100 microns
past the CNV
MPS Subf. New3
N=371 patients (373 eyes)
Country: USA (multicentre)
Age: 50% aged 70 or more
Sex: 56% female
Inclusion: subfoveal CNV no larger than 3.5 disc ares with
new vessels under centre of FAZ, visual acuity between
20/40 and 20/320
Follow up: 4 years
Intervention: intense
white
photocoagulation to
100 micron from the
perimeter of the
lesion.
MPS Subf. Recurrent4
N=206
Country: USA (multicentre)
Age: 70% aged 70 or more
Sex: 51.9% female
Inclusion: leaking subfoveal CNV within 150 micron of FAZ
centre contiguous with scar (or expanded scar) from
previous photocoagulation, visual acuity between 20/40 and
20/320.
Follow up: 4 years
Intervention: intense
white
photocoagulation
extending 100 micron
beyond the perimeter
of the lesion and 300
micron into the old
laser scar.
(Bressler, Bressler et al. 2000; Submacular Surgery
Trials Pilot Study Investigators 2000)
N=70
Country: USA (15 centres)
Median age: 73 years
Sex: 54.3% female
Inclusion: subfoveal recurrent lesion from earlier
photocoagulation, no larger than 9 disc areas, visual acuity
between 20/64 to 20/800
Exclusion: submacular surgery or vitrectomy
Follow up: 2 years
Intervention:
submacular surgery
(removal of entire
choroidal neovascular
lesion and laser
lesion)
Visual acuity, reading
acuity
Control: observation
Visual acuity, contrast
sensitivity, reading speed
Control: observation
Visual acuity, contrast
sensitivity, reading speed
Control: observation
Control: laser
photocoagulation
according to MPS
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Visual acuity, reading
speed, contrast threshold,
lesion size, quality of life
Systematic reviews comparing photocoagulation with observation to prevent progression to age-related
macular degeneration
(Versteeg-Tijmes, de Jong et al. 1982)
N=13
Country: Netherlands (single centre)
Age: NR
Sex: NR
Inclusion: CNV (ill defined)
Exclusion: ill defined
Follow up: at least 1 year
Intervention: heavy
confluent argon laser
photocoagulation
(Yassur, Axer-Siegel et al. 1982)
N=96 patients (140 eyes)
Country: Israel (single centre)
Age: NR
Sex: NR
Inclusion: CNV with FA extending into the FAZ
Follow up: 2 years
Intervention: mild to
moderate intensity
krypton laser
1
2
3
4
Visual acuity, visual field
Control: observation
Visual acuity
Control: observation
(Macular Photocoagulation Study Group 1982; Macular Photocoagulation Study Group 1986; Macular
Photocoagulation Study Group 1991; Macular Photocoagulation Study Group 1993)
(Macular Photocoagulation Study Group 1990; Macular Photocoagulation Study Group 1994; Macular
Photocoagulation Study Group 1996)
(Macular Photocoagulation Study Group 1991; Macular Photocoagulation Study Group 1991; Macular
Photocoagulation Study Group 1993; Macular Photocoagulation Study Group 1994; Macular Photocoagulation
Study Group 1994; Macular Photocoagulation Study Group 1994)
(Macular Photocoagulation Study Group 1991; Macular Photocoagulation Study Group 1991; Macular
Photocoagulation Study Group 1993; Macular Photocoagulation Study Group 1994; Macular Photocoagulation
Study Group 1994; Macular Photocoagulation Study Group 1994)
Page 239
3.18.6
Photocoagulation for the treatment of macular holes
Background
A macular hole is a break in the central part of the retina and is primarily caused by traction
between the vitreous and the retina. As a person ages, the vitreous shrinks and pulls away from
the retina. Occasionally, the vitreous is firmly attached to the retina and movement of the vitreous
away from the retina results in a hole. If left untreated, fluid may enter through the macular hole
and build up underneath the retinal tissues, causing further loss of vision and may potentially
result in retinal detachment.
Research question
Is photocoagulation a safe and effective procedure for the treatment of patients with macular
holes?
Results
One poor quality RCT evaluated the effectiveness of laser photocoagulation as an adjuvant
therapy to pars plana vitrectomy for the closure of large macular holes (Cho, Kim et al. 2006).
Another poor quality RCT evaluated the effectiveness of laser photocoagulation versus
observation in the treatment of macular holes in patients with high myopic eyes (Cai, Cheng et al.
2008).
Cho et al (2006) randomised 31 eyes from 29 patients to three laser burns of 100 µm in the centre
of the macular hole plus pars plana vitrectomy or to pars plana vitrectomy alone (
Page 240
Table 72). The method of randomisation was poor and it is not clear whether there was adequate
masking of the randomisation method or of the assessors. In addition, few baseline patient
characteristics were presented. Although visual acuity values were given, these values were
different at baseline, however not significantly. Therefore the potential for bias in this study is
high, and results must be interpreted with caution.
Cai et al (2008) applied a krypton laser circumferentially to the edge of the macular hole in a single
row with a space between each burn to preserve vision (
Page 241
Table 73). This study was poorly designed, with few baseline patient characteristics reported.
More importantly, results from more than a quarter of the study group were not reported due to
incomplete data. This loss is substantial in a small study (20 randomised into each arm: 15
photocoagulation and 12 control patients are reported on), therefore the potential for bias in this
study is high.
Conclusion
The evidence relating to photocoagulation in patients with idiopathic macular holes was of poor
quality. Clinical advice suggests that the available research conducted in this area is now dated,
with the current treatment of choice being vitrectomy surgery - the exception being the
uncommon macular holes in highly myopic eyes with posterior staphyloma which may lead to
retinal detachment and for which laser photocoagulation is occasionally used. The body of
evidence for safety, accuracy and effectiveness is summarised in the matrix at
Page 242
Box 25.
Page 243
Box 25
Body of evidence matrix for for photocoagulation for the treatment of macular holes
Component
Evidence base
Rating
D
Consistency
NA
Clinical impact
D
Generalisability
C
Applicability
C
Description
Both RCTs of photocoagulation for the treatment of macular holes
have a high risk of bias.
Photocoagulation was used in different populations and applied using
a different technique in the two included RCTs, therefore consistency
is not applicable.
The clinical impact of the evidence is slight given that the results are of
small groups and may be biased. Further higher quality research is
needed to improve the clinical impact of photocoagulation as a
treatment for macular holes.
Little description of the population is given in both RCTs. Studies
undertaken in China and Korea and there may be significant
differences between the populations in terms of diet, general health,
comorbidities and predisposition to myopia compared with an
Australian population.
Studies carried out in China and Korea. Depending upon the quality of
the institution, the results may or may not be applicable to the
Australian healthcare context.
Page 244
Table 72
Study profile and results of RCTs comparing photocoagulation with pars plana vitrectomy
versus pars plana vitrectomy alone for the treatment of macular holes
RCTs comparing photocoagulation to control or alternative treatments in the treatment of macular holes
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Cho, Kim et al. 2006)
Level II evidence RCT of poor quality
N= 29 patients (31 eyes)
Country: Korea
Mean age: 66.9 years (control), 65.9 years (laser)
Gender: 80.6% female
Inclusion: Patients with idiopathic full thickness macular
holes with a diameter greater than 400µm.
Exclusion: Eyes with other ocular diseases including
macular degeneration, diabetic retinopathy, glaucoma or
with an IOP greater than 30mmHg at baseline.
Follow up: 3 months
Laser
photocoagulation to
the centre of the
macular hole followed
by vitrectomy (same
day)
Versus
Vitrectomy alone
Effectiveness: best
corrected visual acuity,
successful closure of
macular hole
Photocoagulation with pars plana vitrectomy versus pars plana vitrectomy alone for the treatment of
macular holes
Results
Visual acuity (logMAR ± SD)
Photocoagulation
Control
Baseline
1.09 ± 0.29
0.92 ± 0.25
3 months
0.69 ± 0.23
0.73 ± 0.23
Change
0.40 ± 0.29
0.19 ± 0.23
† Data are not normally distributed therefore Mann-Whitney test used.
p value†
0.13
0.52
0.03
Closure of macular hole¥
Photocoagulation
Control
Full closure
16
6
Partial closure
1
4
Failure / re-opening
1
3
¥ Full closure defined as closure with no bare retinal pigment epithelium, partial closure is closure with some bare
retinal pigment epithelium, failure refers to a failure of the hole to close and has been grouped with patients in
whom the hole re-opens.
The risk of not achieving full closure in the laser group compared to the control group was 0.11 [95% CI 0.54, 0.29]
p=0.0097
Page 245
Table 73
Study profile and results of RCTs comparing photocoagulation versus observation in
the treatment of macular holes in patients with high myopic eyes
RCTs comparing photocoagulation to control or alternative treatments in the treatment of macular holes
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Cai, Cheng et al. 2008)
Level II evidence RCT of moderate quality
N=27 patients (40 patients began trial)
Country: China
Mean age: 56.2 years (laser group), 53.8 years (control group)
Gender: 70.4% female
Inclusion: all patients with macular holes willing to accept nonsurgical treatment
Exclusion: patients with white macular holes
Follow up: 47.3 months (mean) [range 24 – 71 months]
Krypton yellow laser
treatment to the edge
of the macular hole
plus oral ‘placebo’
Versus
Oral ‘placebo’
Effectiveness: rate of
retinal detachment
due to the macular
hole and best
corrected visual
acuity.
Photocoagulation versus observation in the treatment of macular holes in patients with high myopic eyes
Results
Visual acuity
Photocoagulation
Control
Baseline
20/200
24/200
>6 months
24/200
30/200
No difference in baseline, follow up or change in visual acuity
Retinal detachment n (%)
>6 months
† chi square test
Photocoagulation
3 (20%)
Control
7 (58.3%)
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p value†
0.04
3.18.7
Photocoagulation for the treatment of childhood retinoblastoma
Background
Retinoblastoma is a rare cancer of the retina, typically occurring in children under two years of
age, affecting approximately 1 in 16,000 to 18,000 births. Retinoblastoma may be heritable,
associated with a mutation of the RB1 gene, or non-heritable (Kivela 2009; Houston, Murray et al.
2011). Treatment for retinoblastoma is complex, and can range from enucleation to local, vision
preserving treatments, including photocoagulation, cryotherapy, transpupillary thermotherapy or
brachytherapy. Local therapy may be accompanied by chemotherapy (Houston, Murray et al.
2011).
Laser photocoagulation may be used for small tumours (<4.5mm in diameter) that are confined to
the retina with no evidence of seeding (McDaid, Hartley et al. 2005) and works by coagulating the
blood supply to the tumour (Chintagumpala, Chevez-Barrios et al. 2007). However, it is important
to note that no good quality evidence is used to support the use of photocoagulation in the
treatment of retinoblastoma.
Research question
Is photocoagulation a safe and effective procedure for the treatment of patients with
retinoblastoma?
Results
One good quality systematic review reported on 31 comparative studies (no RCTs) for the
treatment of retinoblastoma (McDaid, Hartley et al. 2005). Three studies described local
treatments (such as cryotherapy or photocoagulation) versus radiotherapy, however only one
study specifically compared photocoagulation with radiotherapy (Hadjistilianou, Greco et al.
1991). While new tumours were reported more commonly in the photocoagulation group than the
radiotherapy group, treatment allocation was not random and it is not clear whether the
treatment groups were similar at baseline. The risk of bias in the included study is high and the
study quality is consequently poor (
Page 247
Table 74).
Conclusion
There is insufficient evidence to support or reject the use of photocoagulation in children with
retinoblastoma. Presently, a clinical judgement of likely success of treatment modalities must be
weighed against the severity of the retinoblastoma (Wilson 2010). Further research of
photocoagulation for the treatment of retinoblastoma is required to ascertain the comparative
safety and effectiveness of this modality.
Page 248
Table 74
Systematic reviews comparing photocoagulation with external beam radiotherapy for
the treatment of retinoblastoma
Systematic reviews comparing photocoagulation with external beam radiotherapy for the treatment of
retinoblastoma
McDaid, C., Hartley, S. et al (2005). 'Systematic review of effectiveness of different treatments for childhood
retinoblastoma', Health Technology Assessment, 9 (48), iii-48.
Study, review period and quality
appraisal
Population characteristics, inclusion criteria
(McDaid, Hartley et al. 2005)
Level of evidence: I
Assessment of quality: Good
Cochrane Library, Medline,
Embase, Science Citation Index,
BIOSIS, Pascal, LILACS.
Searched from database inception
to April 2004
Systematic review based on 1 non randomised study with a total of 23 eyes
Population:
Children aged 18 years or under
Intervention:
Any intervention or combination of interventions given for the treatment of
retinoblastoma (only 1 study directly compared photocoagulation with
another intervention).
Included studies, population characteristics and
inclusion criteria
Intervention(s) and
comparator(s)
Outcome(s)
(Hadjistilianou, Greco et al. 1991)
N= 23
Country: Italy
Mean age: 6.7 months (photocoagulation), 12.2 months
(external beam radiotherapy)
Inclusion: children with bilateral retinoblastoma treated
between 1960 and 1990
Follow up: not reported
Photocoagulation after
enucleation of the
worse eye (n=7)
Versus
External beam
radiotherapy after
enucleation of the
worse eye (n=16)
Occurrence of new
tumours, months to
occurrence of new
tumours, recurrence of
tumours and months to
recurrence of tumours.
Page 249
3.19
Removal of silicone oil
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA review
42815
Removal of silicone oil
Stakeholder
negotiation**
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
Summary of Findings
Item 42815 – There are several liquid vitreous substitutes available for the treatment of complex
retinal detachment including balanced salt solutions, silicone oil, hydrogels and heavy silicone oil.
Perfluorocarbon liquid is used intra-operatively and removed after surgery, when a tamponade agent
is then inserted. The most common liquid tamponade used is silicone oil which has proved to be
effective, particularly for superior tears and breaks. Inferior detachments appear to respond better to
the use of heavy silicone oils such as Oxane HD and Densiron 68. Heavy silicone oils provide a more
effective tamponade for inferior retinal breaks as the increased specific gravity causes them to sink in
the eye. Complications of vitreous substitutes are similar for both conventional and heavy silicone oil,
however the need for a prone posture post-operatively is eliminated with the use of the heavier oils.
Choice of which vitreous substitute to use will depend on clinical imperatives such as the patient’s
ability to assume prone posture post-operatively, necessity for removal of vitreous substitute and
potential complications.
The modification of the descriptor for 42815 suggested by RANZCO therefore appears reasonable
based on the range of liquid vitreous substitutes in current use ie "VITREOUS CAVITY, removal of
silicone oil or other liquid vitreous substitute from, during a procedure other than that in which the
vitreous substitute is inserted (Anaes.) (Assist.)"
Removal of silicone oil (42815) has increased consistently, with a doubling in number of services
over the last 6 years (see Appendix D, Figure 47). There is a higher proportion of males receiving
this service, with the majority over the age of 55 years.
This mini-HTA is intended to provide an overview of the safety and effectiveness of the removal of
silicone oil (MBS item number 42815).
Background
Vitreous substitutes are used to improve outcomes after surgical intervention for retinal disorders
such as retinal detachment (RD). These substances are used to re-establish vitreous volume and
maintain the attachment of the retina post surgery until natural attachment is achieved.
Tamponade is necessary to reduce the flow rate of fluid through open retinal tears which cause
recurrent RD (Schwartz, Flynn Jr et al. 2009). The natural vitreous body cannot regenerate and
therefore needs to be filled with a suitable artificial substitute which will prevent the retina from
detaching again (Gao, Chen et al. 2009). Recent developments in the use of vitreous substitutes
include the integration of stem cell therapies, long term delivery of medications to the posterior
segment and reducing the development of proliferative vitreoretinopathy and redetachment.
Available options in artificial vitreous substitutes are aqueous miscible (balanced salt solution) and
aqueous immiscible substance including perfluorocarbon liquids (PFCL), fluorinated silicone oil
Page 250
(SO), polymeric gels, as well as various types of gas such as perfluorocarbon (PFC), sulfur
hexafluoride (SF6) and air (Gurunadh, Banarji et al. 2010). Conventional perfluorocarbon liquids
such as perfluorodecalin, perfluoro-n-octane, perfluorotributylamine and
perfluoroperhydrophenanthrene can cause mechanical or toxic damage to the retinal pigment
epithelium and photoreceptors as well as the ganglion nerve cell layer and nerve fibres, due to the
high specific gravity (1.72 to 2.21 g/cm3) (Rizzo, Genovesi-Ebert et al. 2006). Gas and silicone oil
are lighter than vitreous fluid and therefore do not tamponade the inferior quadrants of the
vitreous chamber, leaving uncovered retinal breaks and areas of unsupported retina (Meng, Zhang
et al. 2010). This allows cellular and molecular elements to accumulate and cause proliferative
vitreoretinopathy (PVR) and reoccurrence of rhegmatogenous RD (RRD) (Boscia, Furino et al.
2008). Where the RRD is complicated by PVR, the use of silicone oil with scleral buckling and
heavier than water endotamponades or heavy silicon oil (HSO) may be used.
Vitreous substitutes are used intraoperatively and for postoperative tamponade, however only
PFCL is useful for the intra-operative surgery usually necessary for complex RD (Boscia, Furino et
al. 2008). The PFCL is removed after surgery and replaced with other vitreous substitutes such as
Oxane HD®32 (Bausch and Lomb, France) which remains stable in the presence of air, water or
perfluorocarbon liquid. Oxane HD® has a high specific gravity and sinks in the eye making it
effective as a tamponade in the inferior quadrants of the eye. Removal is achieved using
substances such as warmed balanced salt infusion which reduces the viscosity of the Oxane HD®
allowing for easier aspiration. The usual time to removal of Oxane HD® is three months, however
it has been reported to have been retained for nine months without complications (Ang, Mehta
Jod et al. 2010). Densiron 68 is a liquid composed of perfluorohexyloctane (F6H8) and
polydiethylsiloxane (silicone oil) and is denser than Oxane HD®, with a viscosity of 1400 cs, and is
therefore more effective as an endotamponade especially for inferior RD (Tomlins, Woodcock et
al. 2007). Other vitreous substitutes need to be removed following treatment as complications can
arise if they remain in situ for any length of time. Retinal toxicity and emulsification may occur due
to the lack of viscosity of the vitreous substitutes (Li, Zheng et al. 2010).
Complications arising from the use of vitreous substitutes include increased intraocular pressure
(IOP), inflammatory conditions such as PVR and cataracts (Gao et al 2009). Prolonged use of
silicone oil can lead to emulsification which necessitates the removal of the oil.
RANZCO requested a modification to the descriptor for item 42815 to reflect current use of liquid
vitreous substitutes:
Current wording: "POSTERIOR CHAMBER, removal of silicone oil from (Anaes.) (Assist.)"
Initial suggested revision: "VITREOUS CAVITY, removal of silicone oil or other liquid vitreous
substitute from (Anaes.) (Assist.)"
This suggestion was subsequently modified when concerns were raised that if the MBS descriptor
was expanded to include other agents removed from the eye (or generically for any tamponade
32
Oxane HD is a commercial product that is a combination of 5,700-cs silicone oil (Viscosity is of oils is measured as
kinematic viscosity (KV), with units in mm2/sec, but more commonly the centiStoke (cS or cs): 1 cs = 1mm2/sec.) and
RMN3 mixed fluorinated and hydrocarbonated olefin.
Page 251
agent) then the removal of perfluorocarbons may be billed at the end of a retinal reattachment
procedure when this should be considered as part of the procedure.
Thus, RANZCO suggested a further revision of the wording of the descriptor:
"VITREOUS CAVITY, removal of silicone oil or other liquid vitreous substitute from, during a
procedure other than that in which the vitreous substitute is inserted (Anaes.) (Assist.)"
Research question
What liquid vitreous substitutes are used in the treatment of complex RDs?
The PICO criteria for Question 14 are described in Table 75.
Table 75
Characteristic
Inclusion Criteria
Population
(3) People with retinal detachment
(4) People having undergone a previous retinal attachment procedure
Interventionsa
(3) Primary retinal attachment procedures
(4) Revision of retinal attachment procedures
Comparatorsa
(3) Primary retinal attachment procedures will be compared with each other
(4) Revision procedures will be compared with each other
Outcomea
a
PICO criteria for vitreous substitutes
Safety
(3) Complications associated with the revision procedure
Effectiveness
(3) Revision rate (failure of primary retinal reattachment), reoperation rate for reasons
other than revision (eg removal of scleral buckling material, silicone band)
(4) Procedure duration, procedure complexity/need for assistance
Numbering relates to the population of interest ie population (1) or population (2)
Search strategy
A search of the Cochrane library – including the Cochrane database of systematic reviews,
Database of abstracts of reviews of effects (DARE) and the HTA database, the economics database,
EconLit, and Embase.com (consisting of both Embase and Medline) was conducted using the
search terms outlined in Table 76.
Table 76
Search terms utilised for vitreous substitutes
Population
'vitreous'/exp OR 'retina detachment'/exp OR detach* OR 'vitreous body detachment'/exp OR
'vitrectomy'/exp AND
Intervention
(intraocular NEAR/2 tamponade OR 'vitreous' NEAR/10 substitut* OR 'silicone gel'/exp OR
'organofluorine derivative'/exp OR 'glycosaminoglycan'/exp) AND
Limits
4. [English language]/lim AND [humans]/lim AND [2005-2011]/py AND [systematic review]/lim
5. [English language]/lim AND [humans]/lim AND [2005-2011]/py AND ([systematic review]/lim OR
[controlled clinical trial]/lim OR [meta analysis]/lim OR [randomized controlled trial]/lim)
6. [English language]/lim AND [humans]/lim AND [article]/lim AND [2005-2011]/py
Availability and level of evidence
Limited to systematic reviews and randomised controlled trials (Limit 2 of the Medline and
Embase search), five articles were retrieved. Further levels of evidence (Limit 3, pseudoPage 252
randomised trials, comparative studies and case series) were then searched and 72 articles were
retrieved. Following a review of the abstract and full-text (if eligibility was unclear), 13 studies
were found to be eligible, however only 10 studies could be retrieved.
Results
In the pseudo-randomised study by Boscia et al (2008) the use of silicone oil together with scleral
buckling was compared to the use of the heavy silicone oil, Oxane HD (Table 77). Outcomes were
similar for both groups with time of operation being the only statistically significant difference
between groups. Pre-operatively none of the patients had glaucoma; however post-surgery eight
patients (40%) had a rise in intraocular pressure (IOP). After two weeks of treatment with beta
blockers or topical alpha-agonist and systemic carbonic anhydrase inhibitors, the IOP was under
control in all patients. Oxane HD reduced operating time and also eliminated the need to use
scleral buckling, which may have several serious potential complications including choroidal
haemorrhage, perforation of the sclera, refractive change, dyplopia, explants protrusion,
inflammatory processes, decreased retinal blood flow and anterior segment ischaemia. Oxane HD
also eliminated the need for postoperative posturing in a prone position for two days.
The case series study by Meng et al (2010) also investigated the use of Oxane HD as an intraocular
tamponade for the treatment of complicated RD (Table 79). An anatomical success rate of 87.5
per cent was reported which rose to 97.5 per cent after further intervention, with 77 per cent of
treated eyes showing an improvement in visual acuity. The authors also noted that for superior
retinal breaks patients were able to maintain a post-operative supine position, rather than the
prone position usually required with conventional silicone oil, for retinal reattachment to be
successful, which has implications for patient comfort. The use of Oxane HD was also associated
with an increase in early emulsification compared to conventional silicone oil, necessitating its
post-operative removal within three months.
To assess the effectiveness of different viscosities of silicone oil, Yang et al (2009) compared the
use of 3,700-cs silicone oil versus 5,000-cs silicone oil (Table 78). Visual acuity, axial length and
refraction in eyes, before and after removal of silicone oil, and after retinal reattachment surgery
were compared. A statistically significant decrease in refraction was found in the 3700-cs group,
however no other significant differences were observed.
The case series by Rizzo et al (2006) investigated the use of perfluorohexyloctane (F6H8) gas
combined with 1,000 cs silicone oil for the treatment of complicated RD. Combining the two
tamponades was thought to optimise the effect of each individual tamponade and reduce the
potential risk of emulsification. After treatment with the combined tamponades, 63 per cent of
eyes required further tamponade with silicone oil due to gas absorption and the persistence of RD.
Overall, the success rate was 98 per cent, however in some patients the tamponade was required
to remain in situ at the 12-month follow-up (Table 79).
In a prospective interventional case series, Li et al (2010) sought to identify post-operative
complications and improvement in visual acuity for patients undergoing intraocular tamponade
with Densiron 68 for the management of complicated RD with proliferative vitreoretinopathy
(Table 79). Densiron 68 is a solution of perfluorohexyloctane (F6H8) and 5000 cs silicone oil with
viscosity 1387 cs which reduces its tendency to disperse, making it more favourable as a long-term
tamponade. The authors reported complications including the development of cataracts (25%),
Page 253
which required the removal of the lens when the vitreous substitute was removed, opacification
of the posterior capsule and intraocular inflammation in 25.9 and 22 per cent of patients,
respectively. Elevated IOP was initially found in five (18.5%) patients but by the three month
follow-up these had all resolved. Elevated IOP is common in patients with complicated RD
irrespective of the tamponade agent and can be controlled medically without causing long-term
damage. This study suggests that emulsification and temporary inflammation may occur more
often using Densiron 68 possibly due to its low viscosity, which predisposes emulsification of oil
droplets, in turn precipitating ocular inflammation. The most serious complication reported was
recurring RD, which occurred in approximately 15 per cent of eyes.
Sandner et al (2007) also investigated the use of Densiron 68 high density silicone oil for the
treatment of complex RD (Table 79). Only four (33%) patients achieved stable retinal
reattachment without further intervention. Ensuing interventions after the initial surgery involved
the use of other tamponades (silicone oil and gas) in all but one eye, which had a second attempt
with Densiron 68. Success after the second treatment was 9/1233 (75%) with two patients keeping
the tamponade in situ. There was a statistically significant post-operative improvement in
logMAR34 (p = 0.02), with five patients achieving a final outcome of better than, or equal to,
20/200. Increased IOP was detected in four patients after the Densiron 68 was removed, however
all responded successfully to treatment.
The case series by Wong et al (2010) reported the findings of a pilot study on the use of Densiron
68 for the treatment of PVR and RD arising from posterior and inferior retinal breaks, particularly
in patients unable to maintain a prone posture post-operatively (Table 79). The use of Densiron 68
provided better outcomes than reported outcomes of previous studies that used Oxane HD, which
may be due to Oxane HD being too light to successfully tamponade inferior retinal breaks. The use
of Densiron 68 as a temporary internal tamponade for detached retinas was also reported by
Auriol et al (2008) who made similar conclusions to Wong et al (2010); Sandner et al (2007) and Li
et al (2010). Auriol et al (2008) reported better outcomes and less complications than the
aforementioned studies, however all studies agreed that the use of Densiron was beneficial for
patients unable to maintain a prone position for 7–10 days post-operatively. Saeed et al (2009), in
a retrospective case series monitored five patients with persistent macular holes who were unable
to assume a prone posture following initial conventional surgery. Further surgery using heavy
silicone oil (Densiron 68) was then undertaken and patients were able to recover in a supine
posture. Saeed et al (2009) reported a 60 per cent success rate for repair of the macular hole using
the heavy silicone oil with no reported complications.
Ang et al (2010) in a retrospective consecutive case series of patients with RD or PVR reported that
all patients treated with Oxane HD had complications and a particularly high rate of emulsification.
Speculation as to the high complication rate focused on the exchange of perfluorodecalin heavy
liquid (PFDL) for the Oxane HD and suggested that contact between the two substances may have
caused the increased rate of emulsification. Ang et al (2010) suggest that to prevent this contact
33
One patient experienced retinal detachment at 5-months and received subsequent, successful treatment, hence 9
patients, rather than 8 patients, successfully treated after second treatment.
34
LogMAR is visual acuity scale which converts the geometric sequence of a traditional chart to a linear scale. It
measures visual acuity loss; positive values indicate vision loss, while negative values denote normal or better visual
acuity.
Page 254
contamination, the replacement of the PFDL with air before insertion of the Oxane HD would
avoid direct contact with those liquids and thereby minimise complications.
Conclusion
The modification of the descriptor for 42815 suggested by RANZCO therefore appears reasonable
based on the range of liquid vitreous substitutes in current use. There are several liquid vitreous
substitutes available for the treatment of complex RD including balanced salt solutions, silicone
oil, hydrogels and heavy silicone oil. Perfluorocarbon liquid is used intra-operatively and removed
after surgery, when a tamponade agent is then inserted. The most common liquid tamponade
used is silicone oil which has proved to be effective, particularly for superior tears and breaks.
Inferior detachments appear to respond better to the use of heavy silicone oils such as Oxane HD
and Densiron 68. Heavy silicone oils provide a more effective tamponade for inferior retinal breaks
as the increased specific gravity causes them to sink in the eye. Complications of vitreous
substitutes are similar for both conventional and heavy silicone oil; however the need for a prone
posture post-operatively is eliminated with the use of the heavier oils. In addition, heavy oils can
be left in situ for longer periods of time than conventional silicone oil and reduce the need for
scleral buckling. Choice of which vitreous substitute to use will depend on clinical imperatives such
as the patient’s ability to assume prone posture post-operatively, necessity for removal of vitreous
substitute and potential complications. The body of evidence for safety, accuracy and
effectiveness is summarised in the matrix at
Page 255
Box 26.
Page 256
Box 26
Body of evidence matrix for liquid vitreous substitutes used in the treatment of complex
retinal detachments
Component
Evidence base
Rating
C
B
Consistency
Description
Five limit 2 and 13 limit 3 studies of moderate risk of bias
Most studies are consistent and any inconsistency can be explained
Clinical impact
N/A
Generalisability
A
Majority of evidence is directly generalisable to the target population
Applicability
B
Applicable to the Australian health care context with few caveats
however applicability of evidence from studies in developing countries
if questionable
Table 77
Few studies provided statistical analysis data
Randomised Controlled Trials for liquid vitreous substitutes used in the treatment of
complex retinal detachment
Randomised Controlled Trials (RCTs)
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s) and
comparator(s)
Outcome(s)
(Boscia, Furino et al. 2008)
Level III-1 pseudo-RCT
N= 20 patients with primary inferior RRD and PVR ≥CP2
Country: Italy
Mean age: Group 1: 59.6±10.7 years; Group 2: 65.3±9.5
years
Sex: Group 1: 7 (70%) male; Group 2: 7 (70%) male
Inclusion criteria: > 18 years of age, primary RRD, one or
more equatorial and pre-equatorial retinal break, PVR
≥CP2 and PPV surgically indicated
Follow-up: 6 months
Overall quality assessment: moderate
Group 1: 10 patients
undergoing PPV with
1300cs silicone oil
and scleral buckling,
head in upright
position for 2 days
post-operatively.
Group 2: 10 patients
undergoing PPV with
Oxane HD
tamponade, head
upright for 3 hours
post-operatively.
Complete reattachment of
RRD and inferior retinal
breaks (IFB) in the
absence of any
tamponade agent
BCVA.
Change in logarithm of
MAR
Complications arising
from surgery
Results
Group 1
Group 2
Reattachment
n patients (%)*
n patients (%)*
With a single operation
8 (80)
8 (80)
Recurrence of RRD
2 (20)
2 (20)
Final reattachment
9 (90)
8 (80)
Operating time (mins)
71.1±10.22
58.83±9.60
Postoperative change of best corrected visual acuity (number of patients):
VA change
Group 1
Group 2
Improved
8
8
Stable
2
2
Worse
0
0
Mean ∆logMAR
0.52±0.34
0.47±0.27
BCVA ≥ 20/40
1
2
BCVA ≥ 5/200
1
1
IOP ≥ 21 mmHg
3 (30%)
4 (40%)
*Except where otherwise specified
Page 257
p-value
1.4
NR
1.0
0.012
p-value
NR
NR
1.4
0.70
NR
NR
NR
PVR = proliferative vitreoretinopathy, RD = retinal detachment, IOL = intraocular lens, BCVA = best corrected visual acuity, IOP =
intraocular pressure, MAR = minimum angle of resolution, RRD = rhegmatogenous retinal detachment, cs= centistokes, VA = visual
acuity, NR = not reported
Table 78
Comparative studies for liquid vitreous substitutes used in the treatment of complex
retinal detachment
Comparative studies
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s)
and comparator(s)
Outcome(s)
(Gurunadh, Banarji et al. 2010)
Level III-2 case-control study
N= 60, RD 32 (53.34%),
Country: India
Age: Range 4–72 years (50% 51–70 years)
Sex: 49 (83.3% male)
Inclusion criteria:
Follow-up:
Surgery with PFCL
versus surgery
without PFCL
Post operative
silicone oil versus
PFC gas or SF6 gas
BCVA
Results
Final BCVA >6/36
Final BCVA 5/60 to 6/36
p-value
n eyes (%)
n eyes (%)
between group difference
Non-PFCL group 19/30 (63.3)
NR
<0.001
PFCL group
27/30 (90)
5/30 (16.7)
<0.001
All subjects had pre-operative BCVA which could not detect hand movement close to the face
Difference between pre and post operative BCVA for the non PFCL group and PFCL group was statistically
significant at
p < 0.0001
PVR = proliferative vitreoretinopathy, RD = retinal detachment, IOL = intraocular lens, BCVA = best corrected visual acuity, IOP =
intraocular pressure, MAR = minimum angle of resolution, VA= visual acuity, RRD = rhegmatogenous retinal detachment, PFC =
perfluorocarbon, SF6 = sulphur hexafluoride, cs= centistoke , PFCL = perfluorocarbon liquids
Page 258
Table 79
Non-comparative studies for liquid vitreous substitutes used in the treatment of complex
retinal detachment
Non-comparative studies
Included studies, population characteristics, inclusion
criteria and quality assessment
Intervention(s)
and comparator(s)
Outcome(s)
(Auriol, Pagot-Mathis et al. 2008)
Level IV retrospective case series
N= 27 patients with RDs treated with large inferior retinectomy,
complicated RDs with severe posterior and anterior PVR
Country: France
Mean age: 61.7 years (range 21 – 87)
Sex: 16 (59%) male
Inclusion criteria: >18 years of age
Follow-up: mean 57.5 weeks (range 24-82)
Densiron 68
Safety and efficacy of
Densiron 68
Results
Complete retinal attachment at end of vitrectomy and tamponade
27/27 (100%)
Final anatomical success rate
25/27 (93%)
Complications, n (%)
Inflammatory reaction with fibrin accumulations in the anterior chamber
Patients with visual acuity ≤20/800 prior to surgery
Patients with visual acuity ≥20/800
Visual acuity following surgery, n (%)
Improved
14 (51.9)
Unchanged
9 (33.3)
Decreased
4 (14.8)
Change in logMAR
Before
After
p-value
1.56±0.21
1.35±0.4
0.01
(Li, Zheng et al. 2010)
Level IV prospective interventional case series
N= 27 eyes in 27 patients
Country: China
Age: Mean 49.2±19.7 years
Sex: NR
Inclusion criteria: PVR, posterior or inferior retinal breaks and
patient’s inability to posture
Follow-up: 1 day, 1, 4, and 8 weeks, 3, 6, 10 and 15 months
Results
Mean duration of Densiron 68 left in situ, days
Complications, n (% eyes)
Posterior capsule opacification
Cataract development
Intraocular inflammation
Emulsification and dispersion and raised IOP
Redetachment and PVR
Success rate, n (% eyes)
Primary
With further surgery
Visual acuity
Mean pre treatment logMAR
Vitreoretinal surgery Visual acuity
with Densiron 68
Complications of surgery
intraocular
tamponade
64±23.2
7 (25.9)
2/8 (25)
6 (22.2)
5 (18.5)
4 (14.8)
23/27 (85.2)
25/27 (92.5)
2.12 ± 0.68
Page 259
11 (40.7)
12 (44.4)
7 (25.9)
Non-comparative studies
Included studies, population characteristics, inclusion
Intervention(s)
criteria and quality assessment
and comparator(s)
Mean post treatment logMAR
1.16 ± 0.84
p = 0.0001
Vision improvement, n eyes (%)
24/27 (88.8)
Final logMAR ≥1 (Snellen equivalent 6/60)
17/27 (62.9)
Final logMAR ≥0.6 (Snellen 6/24)
5/27 (18.5)
Final logMAR ≥0.3 (Snellen 6/12)
3/27 (11.1)
Outcome(s)
(Meng, Zhang et al. 2010)
Level IV case series
N= 40 eyes with retinal breaks (19), giant retinal tear (6), or
macular/posterior hole with posterior staphyloma (11)
Country: China
Age: Mean 51.3±11.7 years (range 20-76)
Sex: 23 (58%) male
Inclusion criteria: PVR grade ≥CP2, mainly inferior and
posterior retinal breaks or superior retinal breaks with patient’s
inability to posture
Exclusion criteria: Severe systemic disease, any uncontrolled
ocular disease other than RD, pseudophakia with a silicone
IOL, and inability to undergo regular follow-up examinations
Follow-up: 1-3 days, 1 week, 1 and 3 months after initial
surgery, then 1-3 days, 1 week, 1, 3, 6, 12, 18 and 24 months
after Oxane HD removal
Retinal status
BCVA
Complications
Results
Mean duration of Oxane HD endotamponade
87.9±10.4 days
Anatomical success rate, n eyes (%)
With Oxane HD
35/40 (87.5)
With further intervention
39/40 (97.5)
BCVA, n eyes (%)
Improved
31/40 (77.5)
Unchanged
7/40 (17.5)
Decreased
2/40 (5%)
logMAR
Before Oxane HD
2.12±0.60
After Oxane HD
1.38±0.59
Complications, n eyes (%)
Temporary inflammatory reaction
18/40 (45)
Moderately high IOP (> 30 mmHg)
7/40 (17.5)
Heavy silicone oil emulsification
9/40 (22.5)
Lens opacity
21/27 (77.8)
Retinal proliferative membranes
12/40 (30)
Progression to RD with significant
traction requiring re-operation
5/12 (41.7)
No further intervention
7/12 (58.3)
Page 260
Oxane-HD
p=0.001, t statistic = 5.59
(Rizzo, Genovesi-Ebert et al. 2006)
Level IV interventional case series
N= 60 patients with complicated RD and visual acuity of 20/40
in the other eye, retinal breaks and severe PVR of the lower
two quadrants, inferior giant retinal tears, RD secondary to
penetrating trauma or retinal and choroidal detachment also
involving the inferior retina
Country: Italy
Mean age: 62 years (range 18-80)
Sex: 43 (72%) male
Exclusion criteria: <18 years of age, severe systemic disease,
pregnancy, any uncontrolled ocular disease other than RD,
participation in another study, missing informed consent
Follow-up: Mean 23 months (range 3-34)
Results
Complete retinal reattachment, n (eyes) (%)
1 month
54 (90)
12 months
51/52 (98)
Without tamponade
40 (77)
Complications, n (eyes) (%)
Macro bubbles detected in the anterior chamber
Elevated IOP of at least 30 mmHg
Persistent hypotony (IOP of < 5 mmHg) with DF in situ
Posterior subcapsular opacity 20–40 days after surgery
Epiretinal membranes
Subretinal membrane in
Recurrent detachment of the upper retina
Final BCVA, n eyes (%)
Improved
46 (77)
Decreased
2 (3)
Unchanged
12 (20)
≥20/400
29 (48)
Combined use of
70% perfluorohexyloctane (F6H8)
and 30% 1,000
centistoke silicone
oil
Efficacy and safety of
double filling (DF)
tamponade
Visual acuity with followup at 1 day, 1 week, 1, 3,
6, and 12 months after
surgery and DF
tamponade
2 (0.3)
2 (0.3)
1 (2)
5 (8)
22 (37)
3 (0.5)
6 (10)
(Sandner, Herbrig et al. 2007)
Level IV interventional case series
N= 12 patients with inferior complex RRD with secondary PVR
grades CP2 to CA8; mean duration of Densiron
endotamponade 78.3±29.74 (range 33 – 126) days
Country: Germany
Age (range): 31-85 years
Sex: 7 (58%) male
Inclusion criteria:
Follow-up: 400.6±85.4 (range 219 – 535) days after Densiron
removal
High density
Densiron 68 (a
mixture of F6H8 with
silicone oil)
Results*
Stable reattached retina without further intervention 4 (33)
Recurrent retinal redetachment within 2 months
6 (50)
Detachment 5 months after Densiron removal
1 (8.3)
Final success rate after further intervention
9 (75)
Visual acuity, logMAR [95% CI]
Before intervention
After intervention
p-value
2.95±1.21
1.87±1.32 [0.19, 1.96]
0.02
Complications
Temporary inflammatory reaction/
fibrin accumulation
2 (17)
Page 261
Efficacy and safety
Complete reattachment
of retina Visual acuity
Follow-up at day 1-3, day
10, 6 weeks
postoperatively and
before removal at 3
months, after removal at
2 and 6 weeks and 3, 6,
9and 12 months.
Moderate to severe intraretinal fibrosis 3 (25)
Elevated IOP
3 (25)
Emulsification
2 (17)
Sterile hypopyon
1 (8)
Vitreous haemorrhage
1 (8)
Chronic hypotony
1 (8)
*Outcomes are n patients (%) unless otherwise specified
(Saeed, Heimann et al. 2009)
Level IV retrospective case series
N= 5 patients with persistent macular holes following
conventional surgery who were unable to posture prone post
operatively; duration of visual symptoms 7–10 weeks; visual
acuity before surgery was 6/60, 2/60, 6/24, 6/36, and 6/30 for
patients 1-5, respectively
Country: UK
Age: NR
Sex: NR
Inclusion criteria: persistent macular holes following conventional
surgery
Follow-up: 3 months
Heavy silicone
oil
Resolution of macular hole
Visual acuity
Densiron 68,
(perfluorohexylo
ctane and
silicone oil) with
specific gravity
1.06 g/cm3 and
viscosity 1397
mPas
Safety and efficacy
Visual acuity
Anatomical reattachment of
the retina
Complications
Results
Silicone oil removal, range11–14 weeks
Visual acuity post surgery
Patient 1
6/60
Patient 2
6/24
Patient 3
6/18
Patient 4
6/36
Patient 5
6/9
Successful closure of macular hole at follow-up
3/5 (60%)
(Wong, Van Meurs et al. 2005)
Level IV prospective case series
N= 42 patients with PVR, RD arising from posterior or inferior
retinal breaks and inability to posture (required for 10–14 days
post surgery); previous RD repair 26 (62%), previous gas
tamponade 10/19 (53%), mean number of previous RD
operations 1.36±0.62, mean duration of Densiron left in situ
72±24.8 days
Country: UK and Netherlands
Mean age: 58.45±16.27 years
Sex: 22 (52%) male
Inclusion criteria:
Follow-up: 1 week and 1 month post operatively then after
removal of Densiron at 1 week, 1 and 3 months
Results
Success rate, n (%)
After one operation
34 (81)
After further surgery
39 (93)
With silicone oil remaining
4 (10%)
Without any tamponade 36 (86)
Mean visual acuity, logMAR
Before surgery
1.41±0.64
After surgery
0.94±0.57
Vision improvement, n eyes (%)
p =0.001
27/41 (66)
Page 262
Final logMAR ≥1 (Snellen equivalent 6/60)
Final logMAR ≥0.6 (Snellen 6/24)
Final logMAR ≥0.3 (Snellen 6/12)
Mean baseline IOP, mmHg
17.8±8.86
Mean IOP >30 mmHg, n (%)
1 week
6 (14)
1 month
6 (14)
3 months
3 (7)
32 (76)
15 (37)
9 (22)
(Yang, Jin et al. 2009)
Level IV case series
N= 89 patients with surgically reattached retinas
Country: China
Mean age: 36.8 ± 4.3 years
Sex: 62 (70%) male
Inclusion criteria: Aphakia on removal of silicone oil, intact iris,
clear central cornea, pupil dilated to > 5mm, virtreous cavity
filled ≥95%, retina completely reattached, eiliconeoil removed
using the clear-cornea technique, parameters measured ≤ 2
days before and ≤ 1 month after removal of silicone oil
Exclusion criteria: highly myopic eyes ≥-6.0 diopters, eyes with
a re-detached retina or an anterior chamber with silicone oil
bulging through the pupil
Follow-up: mean 8 months
Group 1: 42
patients who
received 3,700 cs
silicone oil.
Group 2: 47 patient
who received 5,000
cs silicone oil.
Visual acuity
Stable retinal
reattachment assessed
≤2 days and ≤ 1 month
post removal of silicone
oil
Results
Outcome*
Interval between installation
and removal of silicone oil, months
Changes in visual acuity before and after surgery
Increase in axial length, mm
Decrease in refraction, dioptres (D)
Anatomic success rate, n patients (%)
Group 1
Group 2
5.37
13/100
11.92±1.97
5.80±1.51
39/42 (92.9)
5.10
15/100
12.33±1.28
6.88±2.31
43/47 (91.5)
Re-detachment of retina within3 months of oil removal, n patients (%)
Overall
7/89 (7.9)
Due to PVR
5 (5.6)
Due to retinal traction
2 (2.2)
*Outcomes are means unless otherwise specified
Page 263
p-value
<0.05
(Ang, Mehta Jod et al. 2010)
Level IV retrospective consecutive case series
Country: UK
N= 18 eyes in 18 patients; 4 (22%) with total RD and 12
(72.2%) with PVR
Mean age: 57.6 ± 21.6 years
Sex: 12 (66.6%) male
Inclusion: patients with inferior RD
Follow-up: Total RD, 27±38 weeks; PVR, 66±39 weeks
Results
Eventual anatomic success rate (%)
Redetachment associated with PVR
while oxane HD was in situ (%)
Post-operative complications (%)
Emulsification
Epiretinal membrane
Posterior capsular opacification
Change in logMAR VA
Preoperative
Final
Endotamponade
with oxane HD
following RD repair
Postoperative BCVA,
anatomical reattachment
and postoperative
complications
14 (77.8)
3 (16.7)
14 (77.8)
6 (33.3)
5 (27.8)
4 (22.2)
1.46±1.24
1.25±1.14
p = 0.52
PVR = proliferative vitreoretinopathy, RD = retinal detachment, IOL = intraocular lens, BCVA = best corrected visual acuity, IOP =
intraocular pressure, MAR = minimum angle of resolution, VA= visual acuity, RRD = rhegmatogenous retinal detachment, PFC =
perfluorocarbon, SF6 = sulphur hexafluoride, cs= centistoke
Page 264
3.20 Surgical assistance
MBS ITEMS
SERVICE
REVIEW METHOD †
Mini HTA
review
51315*
Surgical assist (*)
Stakeholder
negotiation**
Guideline
concordance
x
† With the exception of the optometry perimetry items, patterns of use were assessed on the basis of MBS claims
data for all of the listed items
The item relating to surgical assistance for cataracts (51315) shows a decline over the years to a
very small number, in both frequency and cost, with a further decline at the rate of 46% in the first
6 months of 2010 (see Appendix D, Figure 48).
Stakeholder negotiation regarding minor wording amendments to the MBS descriptor for item
51315 was undertaken. The RANZCO suggested that there is an anomaly in the wording of the
item descriptor (Box 27) as it does not allow for surgical assistants to participate in surgery where
both phacoemulsification to remove the lens (42698, 42702) and vitrectomy (42725) are required.
The insertion of “42725” was therefore suggested by the RANZCO and this was agreed by the
Department.
Box 27 Surgical assist item descriptor amendments
51315
Assistance at cataract and intraocular lens surgery covered by item 42698, 42701,
42702, 42704 or 42707, when performed in association with services covered by
item 42551 to 42569, 42653, 42656, 42725, 42746, 42749, 42752, 42776 or 42779
Page 265
4. CONCLUSIONS
Reviews are expected to result in primary and supplementary review outcomes as shown below:
Primary review outcomes
Where an evaluation suggests that an item under review is supported by the evidence, the likely
recommendation will be that the MBS listing will be retained in its current form. However, should
an evaluation suggest that listed MBS items or services are inconsistent with contemporary
evidence in relation to its clinical use or effectiveness, direct amendments to the MBS may be
recommended. These may include one or more of the following changes:
• addition or removal of MBS items;
• changes to the Schedule fee;
• refinement of MBS item descriptors to better target patient groups, clinical indicators and/or
promote the use of optimal clinical pathways; and/or
• potential for interim-listing pending the collection of item-specific data.
Potential amendments to the MBS arising from reviews will be undertaken through consultation
with the relevant stakeholder groups.
Supplementary review outcomes
In addition to primary review outcomes relating to MBS reimbursement, reviews may indicate the
need for secondary investment strategies aimed at bridging the divide between current evidence,
including clinical guidelines and current clinical practice. To achieve this, a number of strategies
may be implemented following the evaluation of individual items or services. These may include,
but are not limited to, the following:
• development or revision of clinical practice guidelines for evaluated services where there is an
identified need;
• strengthening or targeting of auditing/compliance activities;
• education and training initiatives for practitioners and/or consumers;
• exploring incentive-based initiatives to promote improved clinical practices or linking education
and training programs to access incentives; and
• the development of research opportunities where gaps in effective service provision are evident.
The identification of mechanisms to support evidence-based best practice will complement and
reinforce any primary outcome MBS amendments to help improve health outcomes for patients,
whilst ensuring the most efficient use of limited resources.
Page 266
5.
REFERENCES
. "Is sty in the eye removal surgery painful?" Wiki Answers. Retrieved November 17, 2010, from
http://wiki.answers.com/Q/Is_sty_in_the_eye_removal_surgery_painful.
(August 27, 2009 ). "Abortion in QLD and equal pay for women." Crikey. Retrieved Sepember 15, 2010,
from http://www.crikey.com.au/2009/08/27/comments-corrections-clarifications-and-cckups-69/.
AAO (2005). Preferred Practice Pattern Guidelines. Primary Angle Closure Glaucoma. San Francisco,
American Academy of Opthalmology.
AAO (2006). Preferred Practice Pattern Guidelines. Cataract in the adult eye. San Francisco, American
Academy of Opthalmology.
AAO (2008). Preferred Practice Pattern Guidelines. Age-related macular degeneration. San Francisco,
American Academy of Ophthalmology Retina/Vitreous Panel.
AAO (2008). Preferred Practice Pattern Guidelines. Posterior vitreous detachment, retinal breaks, and
lattice degeneration. San Francisco, American Academy of Opthalmology.
Aiello, L. P., R. L. Avery, et al. (1994). "Vascular endothelial growth factor in ocular fluid of patients with
diabetic retinopathy and other retinal disorders." N Engl J Med 331(22): 1480-1487.
Al-Khairi, A. M., E. Al-Kahtani, et al. (2008). "Prognostic factors associated with outcomes after giant
retinal tear management using perfluorocarbon liquids." Eur J Ophthalmol 18(2): 270-277.
Alexander, J., K. S. Elsner, et al. (2004). "Characteristics of Exudation in Patients with Bilateral Large
Drusen." Invest. Ophthalmol. Vis. Sci. 45(5): 2989-.
Andrea J (March 20, 2009). "Doctor my Eyes." Samildnach. Retrieved September 9, 2010, from
http://samildanach.blogspot.com/.
Andrea J (March 23, 2009). "Doctor my Eyes Part 2." Samildnach. Retrieved September 9, 2010, from
http://samildanach.blogspot.com/.
Ang, C. L., K. G. Au Eong, et al. (2007). "Patients' expectation and experience of visual sensations during
phacoemulsification under topical anaesthesia." Eye 21(9): 1162-1167.
Ang Ghee, S., J. Townend, et al. (2009) Interventions for prevention of giant retinal tear in the fellow
eye. Cochrane Database of Systematic Reviews DOI: 10.1002/14651858.CD006909.pub2
Ang, M., S. Mehta Jod, et al. (2010) Extracapsular cataract extraction (ECCE) with posterior chamber
intraocular lens versus manual small incision cataract surgery (MSICS) with posterior chamber
intraocular lens for age-related cataract. Cochrane Database of Systematic Reviews DOI:
10.1002/14651858.CD008811
Anonymous (1998). "Choroidal neovascularization in the Choroidal Neovascularization Prevention Trial.
The Choroidal Neovascularization Prevention Trial Research Group." Ophthalmology 105(8): 1364-1372.
Anonymous (1998). "Laser treatment in eyes with large drusen. Short-term effects seen in a pilot
randomized clinical trial. Choroidal Neovascularization Prevention Trial Research Group."
Ophthalmology 105(1): 11-23.
Anonymous (February 10, 2010). "The girl with the leaky eye." The World’s Worst Housewife. Retrieved
November 2010, from http://worldsworsthousewife.blogspot.com/2010/02/girl-with-leaky-eye.html.
Arbabi, E. M., R. J. Kelly, et al. (2010). "10 Minute consultation: Chalazion." BMJ 341(7768): 345.
Arnold, J., M. Algan, et al. (1997). "Indirect scatter laser photocoagulation to subfoveal choroidal
neovascularization in age-related macular degeneration." Graefes Arch Clin Exp Ophthalmol 235(4):
208-216.
Ashton, N. (1980). "Oxygen and the retinal blood vessels." Trans Ophthalmol Soc U K 100(3): 359-362.
Page 267
Auriol, S., V. Pagot-Mathis, et al. (2008). "Efficacy and safety of heavy silicone oil densiron 68(registered
trademark) in the treatment of complicated retinal detachment with large inferior retinectomy."
Graefe's Archive for Clinical and Experimental Ophthalmology 246(10): 1383-1389.
Avitabile, T., A. Longo, et al. (2008). "Retinal detachment after silicone oil removal is prevented by
360(degrees) laser treatment." British Journal of Ophthalmology 92(11): 1479-1482.
Avitabile, T., A. Longo, et al. (2005). "Intravitreal triamcinolone compared with macular laser grid
photocoagulation for the treatment of cystoid macular edema." American Journal of Ophthalmology
140(4): 695.e691-695.e610.
Awasthi, N., S. Guo, et al. (2009). "Posterior capsular opacification: a problem reduced but not yet
eradicated." Arch Ophthalmol 127(4): 555-562.
Ayoglu, H., H. Altunkaya, et al. (2007). "Dexmedetomidine sedation during cataract surgery under
regional anaesthesia [9]." British Journal of Anaesthesia 99(3): 448.
Azad, R. V., B. Chanana, et al. (2007). "Primary vitrectomy versus conventional retinal detachment
surgery in phakic rhegmatogenous retinal detachment." Acta Ophthalmologica Scandinavica 85(5): 540545.
Babs (April 24, 2007). "1 month post-op follow up." How to go insane. Retrieved October 14, 2010,
from http://howtogoinsane.blogspot.com/search/label/vision%20loss%20in%20one%20eye.
Babs (April 25, 2007). "Lasers are cruel." How to go insane. Retrieved October 14, 2010, from
http://howtogoinsane.blogspot.com/search/label/vision%20loss%20in%20one%20eye.
Bagheri, A., H. R. R. Hasani, et al. (2009). "Effect of chalazion excision on refractive error and corneal
topography." European Journal of Ophthalmology 19(4): 521-526.
Bakri, S. J., M. Risco, et al. (2009). "Bilateral Simultaneous Intravitreal Injections in the Office Setting."
American Journal of Ophthalmology 148(1).
Bakri, S. J., L. Sculley, et al. (2006). " Imaging techniques for uveal melanoma." International
Ophthalmology Clinics 46(1): 1-13.
Bandello, F., A. Polito, et al. (2005). ""Light" versus "classic" laser treatment for clinically significant
diabetic macular oedema." British Journal of Ophthalmology 89(7): 864-870.
Bardiac (22 march, 2010). "Insta-anxiety." Bardiac-just another academic blogger. Retrieved 13 January
2011, from http://bardiac.blogspot.com/2010_03_01_archive.html.
Bassett, K., S. W. Smith, et al. (2007). "Nurse anaesthetic care during cataract surgery: A comparative
quality assurance study." Canadian Journal of Ophthalmology 42(5): 689-694.
Becker, B. B. (2006). "The Treatment of Congenital Dacryocystocele." American Journal of
Ophthalmology 142(5): 835.e831-835.e835.
Beers, M. and R. Berkow, Eds. (1999). The Merck Manual of Diagnosis and Therapy. Whitehouse
Station, New Jersey, Merck Research Laboratories.
Ben Simon, G. J., L. Huang, et al. (2005). "Intralesional triamcinolone acetonide injection for primary
and recurrent chalazia: Is it really effective?" Ophthalmology 112(5): 913-917.
Bennett, C. (August 26, 2009). Consumer advocate goes eye to eye with ophthalmologists. Crikey.
Bertrand, R. H. C., J. B. S. Garcia, et al. (2008). "Topical anesthesia associated with sedation for
phacoemulsification. Experience with 312 patients." Anestesia tópica associada à sedação para
facoemulsificação. Experiência com 312 pacientes 58(1): 23-34.
Bethany Rose (April 29, 2009). "Some difficult news." Life as a pregnant diabetic. Retrieved January 13,
2010, from http://pregnantbethany.blogspot.com/2009/04/some-difficult-news.html.
Biotext Pty Ltd (2008). Risk factors for eye disease and injury: Literature review. Canberra, National
Health and Medical Research Council.
Page 268
Biro, Z. and M. Schvoller (2008). "Subjective visual sensations during cataract surgery performed under
topical anaesthesia." Acta Ophthalmologica 86(8): 894-896.
Boezaart, A., R. Berry, et al. (2000). "Topical anesthesia versus retrobulbar block for cataract surgery:
The patients' perspective." Journal of Clinical Anesthesia 12(1): 58-60.
Boisjoly, H., E. E. Freeman, et al. (2010). "Reducing wait time for cataract surgery: Comparison of 2
historical cohorts of patients in Montreal." Canadian Journal of Ophthalmology 45(2): 135-139.
Bores, L. D. (2007). "Ocular anatomy." Retrieved 14th December, 2010, from http://www.esunbear.com/anatomy_04.html.
Boscia, F., C. Furino, et al. (2008). "Oxane HD vs silicone oil and scleral buckle in retinal detachment
with proliferative vitreoretinopathy and inferior retinal breaks." Graefe's Archive for Clinical and
Experimental Ophthalmology 246(7): 943-948.
Brancato, R., U. Menchini, et al. (1988). "Dye laser photocoagulation of macular subretinal
neovascularization in pathological myopia. A randomized study of three different wavelengths." Int
Ophthalmol 11(4): 235-238.
Brazitikos, P. D., S. Androudi, et al. (2005). "Primary pars plana vitrectomy versus scleral buckle surgery
for the treatment of pseudophakic retinal detachment: A randomized clinical trial." Retina 25(8): 957964.
Bressler, N. M., S. B. Bressler, et al. (2000). "Submacular surgery trials randomized pilot trial of laser
photocoagulation versus surgery for recurrent choroidal neovascularization secondary to age-related
macular degeneration: I. Ophthalmic outcomes submacular surgery trials pilot study report number 1."
Am J Ophthalmol 130(4): 387-407.
Bressler, N. M., A. R. Edwards, et al. (2009). "Exploratory analysis of diabetic retinopathy progression
through 3 years in a randomized clinical trial that compares intravitreal triamcinolone acetonide with
focal/grid photocoagulation." Archives of Ophthalmology 127(12): 1566-1571.
Bressler, N. M., M. G. Maguire, et al. (1996). "Macular scatter ('grid') laser treatment of poorly
demarcated subfoveal choroidal neovascularization in age-related macular degeneration. Results of a
randomized pilot trial." Archives of Ophthalmology 114(12): 1456-1464.
Bressler, S. B., S. Vitale, et al. (1995). "Laser to Drusen Trial: an assessment of short term safety within
randomized, prospective, controlled clinical trial." Investigative ophthalmology & visual science: ARVO
Abstract 1028.
Brian Olewnick (October 02, 2009). Just Outside. Retrieved October 14, 2010, from
http://olewnick.blogspot.com/2009/10/once-in-while-it-pays-off-to-be-married.html.
British Multicentre Study Group (1983). "Photocoagulation for diabetic maculopathy. A randomized
controlled clinical trial using the xenon arc. British Multicentre Study Group." Diabetes 32(11): 10101016.
British Multicentre Study Group (1984). "Photocoagulation for proliferative diabetic retinopathy: a
randomised controlled clinical trial using the xenon-arc." Diabetologia 26(2): 109-115.
Byer, N. E. (1998). "What happens to untreated asymptomatic retinal breaks, and are they affected by
posterior vitreous detachment?" Ophthalmology 105(6): 1045-1049; discussion 1049-1050.
Cai, J. P., J. W. Cheng, et al. (2008). "Krypton yellow laser for the treatment of macular hole in high
myopia without retinal detachment." Clinical and Investigative Medicine 31(6): E357-E361.
Cakmak, S. S., M. Yildirim, et al. (2010). "Is it necessary to accompany probing with endoscopy in cases
of congenital nasolacrimal canal obstruction?" International Journal of Pediatric Otorhinolaryngology
74(9): 1013-1015.
Canadian Ophthalmology Study Group (1993). "Argon green vs krypton red laser photocoagulation of
extrafoveal choroidal neovascular lesions. One-year results in age-related macular degeneration. The
Canadian Ophthalmology Study Group." Archives of Ophthalmology 111(2): 181-185.
Page 269
Cardillo Piccolino, F., D. Ghiglione, et al. (1993). "Grid laser treatment of occult choroidal
neovascularization in age related macular degeneration." Int Ophthalmol 17(2): 77-83.
Casswell, A. G., C. R. Canning, et al. (1990). "Treatment of diffuse diabetic macular oedema: a
comparison between argon and krypton lasers." Eye (Lond) 4 ( Pt 5): 668-672.
Cavazza, S., G. L. Laffi, et al. (2008). "Congenital dacryocystocele: diagnosis and treatment." Acta
otorhinolaryngologica Italica : organo ufficiale della Societ? italiana di otorinolaringologia e chirurgia
cervico-facciale 28(6): 298-301.
Celia Preusse (October 29, 2007). "The elevation under the iris update." Preusse familie web journal.
Retrieved January 17, 2011, from http://preussefamilie.blogspot.com/2007_10_01_archive.html.
Chan, C. W. N., J. C. C. Wong, et al. (2003). "Evaluation of quality of life in patients with cataract in Hong
Kong." Journal of Cataract and Refractive Surgery 29(9): 1753-1760.
Chan, F. W., A. H. Fan, et al. (2009). "Waiting time for cataract surgery and its influence on patient
attitudes." Investigative Ophthalmology and Visual Science 50(8): 3636-3642.
Chang, M. A., H. F. Fine, et al. (2007). "Patients' preferences in choosing therapy for retinal vein
occlusions." Retina 27(6): 789-797.
Chen, C. L., C. H. Chen, et al. (2006). "Tarsal squamous cell carcinoma masquerading as chalazion."
Journal of Medical Sciences 26(4): 145-148.
Cheung, D. and S. Sandramouli (2005). "The consent and counselling of patients for cataract surgery: A
prospective audit." Eye 19(9): 963-971.
Chintagumpala, M., P. Chevez-Barrios, et al. (2007). "Retinoblastoma: review of current management."
Oncologist 12(10): 1237-1246.
Chiquet, C., J. C. Zech, et al. (1998). "Visual outcome and prognostic factors after magnetic extraction of
posterior segment foreign bodies in 40 cases." British Journal of Ophthalmology 82(7): 801-806.
Cho, H. Y., Y. T. Kim, et al. (2006). "Laser photocoagulation as adjuvant therapy to surgery for large
macular holes." Korean Journal of Ophthalmology : KJO 20(2): 93-98.
Cho, W. B., J. W. Moon, et al. (2010). "Intravitreal triamcinolone and bevacizumab as adjunctive
treatments to panretinal photocoagulation in diabetic retinopathy." British Journal of Ophthalmology
94(7): 858-863.
Choroidal Neovascularization Prevention Trial Research Group (2003). "Laser treatment in fellow eyes
with large drusen: updated findings from a pilot randomized clinical trial." Ophthalmology 110(5): 971978.
Chow, D. R., B. R. Garretson, et al. (2000). "External versus internal approach to the removal of metallic
intraocular foreign bodies." Retina 20(4): 364-369.
Chua, P. Y. S., I. Mitrut, et al. (2009). "Evaluating patient discomfort, anxiety, and fear before and after
ranibizumab intravitreous injection for wet age-related macular degeneration." Archives of
Ophthalmology 127(7): 939-940.
Chuah, C. T. and K. T. Yeo (1999). "A study of defaulters of treatment for diabetic retinopathy."
Singapore Medical Journal 40(3): 133-137.
Chung, C. F., J. S. Lai, et al. (2006). "Subcutaneous extralesional triamcinolone acetonide injection
versus conservative management in the treatment of chalazion." Hong Kong Medical Journal 12(4):
278-281.
Ciulla, T. A., A. G. Amador, et al. (2003). "Diabetic retinopathy and diabetic macular edema:
pathophysiology, screening, and novel therapies." Diabetes Care 26(9): 2653-2664.
Colin, J., S. El Kebir, et al. (2010). "Assessment of patient satisfaction with outcomes of and ophthalmic
care for cataract surgery." Journal of Cataract and Refractive Surgery 36(8): 1373-1379.
Page 270
Colman Carter (November 24, 2008 ). "I have a meibomian gland lipogranuloma " Colman, Aubrey,
Adeline, Penelope. Retrieved 13 January, 2011, from Http://ccarterfam.blogspot.com/2008/11/i-havemeibomian-gland-lipogranuloma.html.
Complications of Age-Related Macular Degeneration Prevention Trial research group (2006). "Laser
Treatment in Patients with Bilateral Large Drusen: The Complications of Age-Related Macular
Degeneration Prevention Trial." Ophthalmology 113(11): 1974-1986.
Complications of Age-Related Macular Degeneration Prevention Trial study group (2004). "The
Complications of Age-Related Macular Degeneration Prevention Trial (CAPT): rationale, design and
methodology." Clinical Trials 1(1): 91-107.
Conner-Spady, B. L., S. Sanmugasunderam, et al. (2004). "Determinants of patient satisfaction with
cataract surgery and length or time on the waiting list." British Journal of Ophthalmology 88(10): 13051309.
Conner-Spady, B. L., S. Sanmugasunderam, et al. (2005). "Patient and physician perspectives of
maximum acceptable waiting times for cataract surgery." Canadian Journal of Ophthalmology 40(4):
439-447.
COS (2008). "Canadian Ophthalmological Society evidence-based clinical practice guidelines for cataract
surgery in the adult eye." Canadian Journal of Ophthalmology 43 Suppl 1: S7-57.
Coscas, G. and G. Soubrane (1982). "[Argon laser photocoagulation of subretinal neovascularization in
senile macular degeneration. Results of a randomized study of 60 cases]." Bull Mem Soc Fr Ophtalmol
94: 149-154.
Coscas, G. and G. Soubrane (1984). "[Indications, technics and results of argon laser photocoagulation
of macular subretinal neovascularization]." J Fr Ophtalmol 7(2): 99-105.
Coscas, G., G. Soubrane, et al. (1991). "Perifoveal laser treatment for subfoveal choroidal new vessels in
age-related macular degeneration. Results of a randomized clinical trial." Archives of Ophthalmology
109(9): 1258-1265.
Cunningham, M. J. (2006). "Endoscopic management of pediatric nasolacrimal anomalies." Otolaryngol
Clin North Am 39(5): 1059-1074, viii-ix.
Curt Miller (February 11, 2010). "No More Cataract Surgery!!! ." Curt’s Mobile Blog. Retrieved
September 9, 2010., from http://curt-mobile.blogspot.com/2010/02/.
Dahan, E. (2008). Pediatric cataract surgery. Ophthalmology. M. Yanoff and J. S. Duker, Elsevier Health
Sciences: 479pp.
Dan Cooksey and Betty Cooksey (November 25, 2009). "The Eyes Have It." Dan and Betty’s Place.
Retrieved September 9, 2010, from http://danandbettysplace.blogspot.com/2009.
Dan Walker (April 15, 2009). "Shot in the Eye." Journey Back To Self Reliance. Retrieved September 24,
2010, from http://ozarkdans.blogspot.com/2009/04/shot-in-eye.html.
David (April 4, 2007). "Cataract Operation. A Nervous Patients Eye View." Puchspot Retrieved
September 9, 2010, from http://puchspot.blogspot.com/search?updated-min=2007-0101T00%3A00%3A00Z&updated-max=2008-01-01T00%3A00%3A00Z&max-results=18.
David (April 5, 2007 ). "Cataract Two." Puchspot Retrieved September, 2010, from
http://puchspot.blogspot.com/search?updated-min=2007-01-01T00%3A00%3A00Z&updatedmax=2008-01-01T00%3A00%3A00Z&max-results=18.
David Astley (2005). "My Detached Retina." xyzAsia. Retrieved October 14, 2010, from
http://www.xyzasia.com/detached-retina/.
Demircan, N., M. Soylu, et al. (2005). "Pars plana vitrectomy in ocular injury with intraocular foreign
body." Journal of Trauma - Injury, Infection and Critical Care 59(5): 1216-1218.
Deviki Prabhakaran (May 28, 2009). "Eye injection (for the second time)." Going to Hell with Her
Spectacles. Retrieved 26 August, 2010, from
http://hellspectacles.blogspot.com/2009_05_01_archive.html.
Page 271
Dhaliwal, U. and A. Bhatia (2005). "A rationale for therapeutic decision-making in chalazia." Orbit 24(4):
227-230.
Diabetic Retinopathy Study Research Group (1981). "Photocoagulation treatment of proliferative
diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS Report
Number 8. The Diabetic Retinopathy Study Research Group." Ophthalmology 88(7): 583-600.
Dithmar, S. and F. G. Holz (2008). Fluorescence angiography in ophthalmology. Heidelberg, Springer
Medizin Vertag.
Do, D. V., B. Hawkins, et al. (2008) Surgery for post-vitrectomy cataract. Cochrane Database of
Systematic Reviews DOI: 10.1002/14651858.CD006366.pub2
DobroJimbo (February 3, 2010). "New Injection." Monkey Hell. Retrieved August 26, 2010, from
http://dobrojimbo.blogspot.com/2010/02/new-injection.html
DobroJimbo (January 9, 2010). "Macular Degeneration." Monkey Hell. Retrieved 26 August 2010, from
http://dobrojimbo.blogspot.com/2010/01/macular-degeneration.html.
DobroJimbo (June 24, 2010). "Hot in Monkey Hell." Monkey Hell. Retrieved 26 August, 2010, from
http://dobrojimbo.blogspot.com/2010/02/new-injection.html
Dobson, V., G. E. Quinn, et al. (2006). "Visual acuity at 10 years in cryotherapy for retinopathy of
prematurity (CRYO-ROP) study eyes: Effect of retinal residua of retinopathy of prematurity." Archives of
Ophthalmology 124(2): 199-202.
Duch Mestres, F., D. Vilaplana, et al. (1993). "Static perimetry evaluation of argon green and dye red
laser treatment for choroidal neovascular membranes." Lasers and Light in Ophthalmology 6(1): 27-32.
Dunlevy, S. (November 18, 2009 ). Eye surgeons 'earning $28,000 a day' for cataract surgery. The Daily
Telegraph.
Dunlop, N. (2010). "Advancing the role of minor surgery for nurses." British Journal of Nursing 19(11):
685-686, 688-691.
Early Treatment Diabetic Retinopathy Study Research Group (1985). "Photocoagulation for diabetic
macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment
Diabetic Retinopathy Study research group." Arch Ophthalmol 103(12): 1796-1806.
Early Treatment Diabetic Retinopathy Study Research Group (1991). "Early photocoagulation for
diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research
Group." Ophthalmology 98(5 Suppl): 766-785.
Ehlers, J. P., D. Y. Kunimoto, et al. (2008). "Metallic Intraocular Foreign Bodies: Characteristics,
Interventions, and Prognostic Factors for Visual Outcome and Globe Survival." American Journal of
Ophthalmology 146(3): 427-433.e422.
El-Baha, S. M. and T. S. Hemeida (2009). " Comparison of refractive outcome using intraoperative
biometry and partial coherence interferometry in silicone oil-filled eyes." Retina 29(1): 64-68.
Emeline (November 16, 2008). "My Meibomian Cyst " The Kiwi files. Retrieved October 27, 2010, from
http://thekiwifiles.blogspot.com/2008/11/my-meibomian-cyst.html.
Erdurmus, M., B. Aydin, et al. (2008). "Patient comfort and surgeon satisfaction during cataract surgery
using topical anesthesia with or without dexmedetomidine sedation." European Journal of
Ophthalmology 18(3): 361-367.
Ezra, D. G. and B. D. Allan (2007). "Topical anaesthesia alone versus topical anaesthesia with
intracameral lidocaine for phacoemulsification." Cochrane Database of Systematic Reviews, Issue 3.
Art. No.: CD005276. DOI: 10.1002/14651858.CD005276.pub2.
Fardeau, C., G. Soubrane, et al. (1992). Photocoagulation des néo-vaisseaux sous-rétiniens compliquant
la dégénrescence myopique. Paris, FRANCE, Société d'ophtalmologie.
Fielder, A. R., D. E. Shaw, et al. (1992). "Natural history of retinopathy of prematurity: a prospective
study." Eye (Lond) 6 ( Pt 3): 233-242.
Page 272
Figueroa, M., L. S. Schocket, et al. (2004). "Effect of laser treatment for dry age related macular
degeneration on foveolar choroidal haemodynamics." Br J Ophthalmol 88(6): 792-795.
Figueroa, M., L. S. Schocket, et al. (2006). "Long-term effect of laser treatment for dry age-related
macular degeneration on choroidal hemodynamics." Am J Ophthalmol 141(5): 863-867.
Figueroa, M. S., A. Regueras, et al. (1994). "Laser photocoagulation to treat macular soft drusen in agerelated macular degeneration." Retina 14(5): 391-396.
Figueroa, M. S., A. Regueras, et al. (1997). "Laser photocoagulation for macular soft drusen. Updated
results." Retina 17(5): 378-384.
Findl, O., W. Buehl, et al. (2010) Interventions for preventing posterior capsule opacification. Cochrane
Database of Systematic Reviews DOI: 10.1002/14651858.CD003738.pub3
Fine, S. L., M. G. Maguire, et al. (2001). "The choroidal neovascularization prevention trial (CNVPT): 4year results." Investigative ophthalmology & visual science 42: ARVO Abstract 676.
Firda (27 May, 2010). "The epic saga of something in my left eye." Retrieved 24 September, 2010, from
http://www.wannabegirl.org/2010/05/the-epic-saga-of-something-in-my-left-eye.php.
Fleck, B. W. and Y. Dangata (1994). "Causes of visual handicap in the Royal Blind School, Edinburgh,
1991-2." Br J Ophthalmol 78(5): 421.
Flynn, H. W., Jr., E. Y. Chew, et al. (1992). "Pars plana vitrectomy in the Early Treatment Diabetic
Retinopathy Study. ETDRS report number 17. The Early Treatment Diabetic Retinopathy Study Research
Group." Ophthalmology 99(9): 1351-1357.
Fong, D. S., S. F. Strauber, et al. (2007). "Comparison of the modified early treatment diabetic
retinopathy study and mild macular grid laser photocoagulation strategies for diabetic macular
edema." Archives of Ophthalmology 125(4): 469-480.
Fredrick, D. R. (2002). "Myopia." British Medical Journal 324(7347): 1195-1199.
Freeman, G. and K. Pesudovs (2005). "The impact of cataract severity on measurement acquisition with
the IOLMaster." Acta Ophthalmologica Scandinavica 83(4): 439-442.
Freeman, H. M. (1978). "Fellow eyes of giant retinal breaks." Trans Am Ophthalmol Soc 76: 343-382.
Frennesson, C. and S. E. Nilsson (1998). "Prophylactic laser treatment in early age related maculopathy
reduced the incidence of exudative complications." Br J Ophthalmol 82(10): 1169-1174.
Frennesson, C. I. (2003). "Prophylactic laser treatment in early age-related maculopathy: an 8-year
follow-up in a randomized pilot study shows a reduced incidence of exudative complications." Acta
Ophthalmol Scand 81(5): 449-454.
Frennesson, I. C. and S. E. Nilsson (1995). "Effects of argon (green) laser treatment of soft drusen in
early age-related maculopathy: a 6 month prospective study." Br J Ophthalmol 79(10): 905-909.
Frennesson, I. C. and S. E. Nilsson (1996). "Laser photocoagulation of soft drusen in early age-related
maculopathy (ARM). The one-year results of a prospective, randomised trial." Eur J Ophthalmol 6(3):
307-314.
Friberg, T. R., D. C. Musch, et al. (2006). "Prophylactic treatment of age-related macular degeneration
report number 1: 810-nanometer laser to eyes with drusen. Unilaterally eligible patients."
Ophthalmology 113(4): 622 e621.
Friedman, D. S., S. W. Reeves, et al. (2004). "Patient preferences for anaesthesia management during
cataract surgery." Evidence-Based Eye Care 5(3): 174-175.
Fung, D., M. M. Cohen, et al. (2005). "What determines patient satisfaction with cataract care under
topical local anesthesia and monitored sedation in a community hospital setting?" Anesthesia and
Analgesia 100(6): 1644-1650.
Gao, Q., X. Chen, et al. (2009). "Refractive shifts in four selected artificial vitreous substitutes based on
Gullstrand-Emsley and Liou-Brennan schematic eyes." Investigative Ophthalmology & Visual Science
50(7): 3529-3534.
Page 273
Gary (January 10, 2008). "My Eye is Sore Again! ." Gary's Blog Retrieved October 27, 2010, from
http://garypickens.blogspot.com/search/label/Chalazion.
Ghosh, Y. K., S. Banerjee, et al. (2004). "Surgical treatment and outcome of patients with giant retinal
tears." Eye (Lond) 18(10): 996-1000.
Gilchrist, H. and G. Lee (2009). "Management of chalazia in general practice." Australian Family
Physician 38(5): 311-314.
Goawalla, A. and V. Lee (2007). "A prospective randomized treatment study comparing three treatment
options for chalazia: triamcinolone acetonide injections, incision and curettage and treatment with hot
compresses." Clin Experiment Ophthalmol 35(8): 706-712.
Gonzalez, V. H., G. P. Giuliari, et al. (2009). "Intravitreal injection of pegaptanib sodium for proliferative
diabetic retinopathy." British Journal of Ophthalmology 93(11): 1474-1478.
Graham Clements (November 12, 2009). "My Cataract Surgery." Graham Clements. Retrieved
September 9, 2010, from http://grahamclements.blogspot.com/2009/11/.
Grossniklaus, H. E. and W. R. Green (1992). "Pathologic findings in pathologic myopia." Retina 12(2):
127-133.
Grunwald, J. E., M. Figueroa, et al. (2004). "Effect of CAPT Laser Treatment on Choroidal
Hemodynamics in Age-Related Macular Degeneration (AMD)." Invest. Ophthalmol. Vis. Sci. 45(5): 3133.
Gurunadh, V. S., A. Banarji, et al. (2010). "Evaluation of vitreous substitutes in managing complicated
vitreo-retinal surgeries." Medical Journal Armed Forces India 66(2): 125-128.
Hadjistavropoulos, H. D., B. S. Snider, et al. (2001). "Anxiety in older persons waiting for cataract
surgery: Investigating the contributing factors." Canadian Journal on Aging 20(1): 97-111.
Hadjistilianou, T., G. Greco, et al. (1991). "Recurrent and new tumours during conservative treatment of
bilateral retinoblastoma." Ophthalmic Paediatr Genet 12(2): 79-84.
Han, D. P., N. C. Mohsin, et al. (1998). "Comparison of pneumatic retinopexy and scleral buckling in the
management of primary rhegmatogenous retinal detachment. Southern Wisconsin Pneumatic
Retinopexy Study Group." Am J Ophthalmol 126(5): 658-668.
Hercules, B. L., Gayed, II, et al. (1977). "Peripheral retinal ablation in the treatment of proliferative
diabetic retinopathy: a three-year interim report of a randomised, controlled study using the argon
laser." Br J Ophthalmol 61(9): 555-563.
Higgins, J., S. Green, et al. (2009). "Cochrane Handbook for Systematic Reviews of Interventions 5.0.2
[updated September 2009]." The Cochrane Library. Retrieved 14/12/2010, from www.cochranehandbook.org.
Ho, A. C., M. G. Maguire, et al. (1999). "Laser-induced drusen reduction improves visual function at 1
year. Choroidal Neovascularization Prevention Trial Research Group." Ophthalmology 106(7): 13671373; discussion 1374.
Ho, V. H., M. W. Wilson, et al. (2004). "Retained intraorbital metallic foreign bodies." Ophthalmic Plastic
and Reconstructive Surgery 20(3): 232-236.
Hodge, W., T. Horsley, et al. (2007). "The consequences of waiting for cataract surgery: A systematic
review." CMAJ 176(9): 1285-1290.
Holder, G. E., M. G. Brigell, et al. (2007). "ISCEV standard for clinical pattern electroretinography-2007
update." Doc Ophthalmol 114(3): 111-116.
Hood, D. C., M. Bach, et al. (2008). "ISCEV guidelines for clinical multifocal electroretinography (2007
edition)." Doc Ophthalmol 116(1): 1-11.
Houston, S. K., T. G. Murray, et al. (2011). "Current update on retinoblastoma." Int Ophthalmol Clin
51(1): 77-91.
Hussain, N., J. Clive, et al. (1999). "Current incidence of retinopathy of prematurity, 1989-1997."
Pediatrics 104(3): e26.
Page 274
Ishikawa, M., H. Watabe, et al. (2009). "Peripheral T-cell lymphoma of the eyelid." Clinical
Ophthalmology 3(1): 527-529.
Jackie Meyers (September 9, 2009 ). "A Stye in my Eye." Heart of the Matter. Retrieved January 13,
2011, from http://heartofthematter101.blogspot.com/2009/09/stye-in-my-eye.html.
Jackson, T. L. and L. Beun (2000). "A prospective study of cost, patient satisfaction, and outcome of
treatment of chalazion by medical and nursing staff." British Journal of Ophthalmology 84(7): 782-785.
Jain, S., M. Ragoussi, et al. (2007). "Incidence of visual sensations during cataract surgery under
regional anaesthesia." Clinical and Experimental Ophthalmology 35(8): 784.
Jan J (February 28, 2009). "Swimming and Surgery." Snapshots of Our Life Retrieved September 9,
2010, from http://bluewillowgirls.blogspot.com/2009/02/.
Jessica Tondre (October 29, 2010). "Blocked tear duct surgery scheduled." Retrieved 12 January, 2011,
from http://thetondrefamily.blogspot.com/.
JillyBeansMommy (2010 November 9). "Tear Duct Surgery." Stepping up to Mommyhood. Retrieved
November 18, 2010, from http://jillybeansmommy.blogspot.com/.
JMB (April 17, 2008). "Eye: Half Opened at Least." Nobody Important. Retrieved September 9, 2010,
from http://nobodyimportant-jmb.blogspot.com/2008_04_01_archive.html.
JMB (March 17, 2008). "The Eyes are the Window to the Soul." Nobody Important Retrieved September
9, 2010, from http://nobodyimportant-jmb.blogspot.com/2008_03_01_archive.html.
Jo (2008 February 6). "Goodbye Tears (hopefully) " Sheena Time. Retrieved November 22, 2010, from
<http://gearytime.blogspot.com/2008/02/goodbye-tears-hopefully.html>.
Jones, L. D., V. Sampat, et al. (2003). "One-stop laser clinics: Patients' preferences for treatment ." Acta
Ophthalmologica Scandinavica 81(4): 422-423.
Kaiser, R. S., J. W. Berger, et al. (2001). "Laser burn intensity and the risk for choroidal
neovascularization in the CNVPT Fellow Eye Study." Arch Ophthalmol 119(6): 826-832.
Kandula, S., J. C. Lamkin, et al. (2010). "Patients' knowledge and perspectives on wet age-related
macular degeneration and its treatment." Clinical Ophthalmology 4: 375-381.
Kang, S. W., H. S. Sa, et al. (2006). "Macular grid photocoagulation after intravitreal triamcinolone
acetonide for diffuse diabetic macular edema." Arch Ophthalmol 124(5): 653-658.
Kapadia, M. K., S. K. Freitag, et al. (2006). "Evaluation and management of congenital nasolacrimal duct
obstruction." Otolaryngol Clin North Am 39(5): 959-977, vii.
Kathleen Short (July 16, 2008). "Madelyn's eyes." Sassy shorts. Retrieved January 17, 2011, from
http://mammacakes.blogspot.com/search?q=eye+ultrasound.
Kathy (September 23, 2005). "OH NO!! I'VE GOT A TEAR IN MY RETINA !!! ." Simply Thoughts. Retrieved
October 14, 2010, from http://justforblogging.blogspot.com/2005/09/oh-no-ive-got-tear-in-myretina.html.
Kayris (November 29, 2007). "Today's Pediatrician Visit " The Great Walls of Baltimore. Retrieved
November 22, 2010, from <http://greatwallsofbaltimore.blogspot.com/2007/11/todays-pediatricianvisit.html>
Kerry (August 28, 2007 ). "Ah, the joy and wonderment of it all! ." Kicking Ass and Taking Names.
Retrieved November 22, 2010, from http://thycasux.blogspot.com/2007/08/ah-joy-and-wondermentof-it-all.html.
Kertes, P. J. (2006). "Prophylactic Laser Treatment Hastens Choroidal Neovascularization in Unilateral
Age-Related Maculopathy: Final Results of the Drusen Laser Study." Evidence-Based Ophthalmology
7(3): 135-137.
Keskinaslan, I., G. L. Pedroli, et al. (2008). "Eyelid sebaceous gland carcinoma in a young Caucasian
man." Klinische Monatsblatter fur Augenheilkunde 225(5): 422-423.
Page 275
Khairallah, M., R. Brahim, et al. (1996). "Comparative effects of argon green and krypton red laser
photocoagulation for patients with diabetic exudative maculopathy." Br J Ophthalmol 80(4): 319-322.
Khurana, A. K. A., B K. Rajan, Ch. (1988). "Chalazion therapy: intralesional steroids versus incision and
curettage." Acta Ophthalmologica 66: 352 - 354.
Kim, J. H., S. M. Yang, et al. (2006). "Inadvertent ocular perforation during lid anesthesia for hordeolum
removal." Korean Journal of Ophthalmology 20(3): 199-200.
Kimberly (2010 April 27). "Nasolacrimal Duct Obstruction (blocked tear duct)." Oh, My Soul Rejoice! .
Retrieved November 22, 2010, from http://ohmysoulrejoice.blogspot.com/.
Kireta (July 9, 2010 ). "Surgery Succesful!" Little Logan. Retrieved November 18, 2010, from
http://logannye.blogspot.com/.
Kirkwood, B. J., K. Pesudovs, et al. (2006). "The efficacy of a nurse-led preoperative cataract assessment
and postoperative care clinic." Medical Journal of Australia 184(6): 278-281.
Kivela, T. (2009). "The epidemiological challenge of the most frequent eye cancer: retinoblastoma, an
issue of birth and death." Br J Ophthalmol 93(9): 1129-1131.
Klein, R., B. E. Klein, et al. (1998). "The Wisconsin Epidemiologic Study of Diabetic Retinopathy: XVII.
The 14-year incidence and progression of diabetic retinopathy and associated risk factors in type 1
diabetes." Ophthalmology 105(10): 1801-1815.
Klein, R., T. Peto, et al. (2004). "The epidemiology of age-related macular degeneration." Am J
Ophthalmol 137(3): 486-495.
Knecht, P. B., S. Michels, et al. (2009). "Tunnelled versus straight intravitreal injection: Intraocular
pressure changes, vitreous reflux, and patient discomfort." Retina 29(8): 1175-1181.
Koriyama, M., T. Nishimura, et al. (2007). "Prospective study comparing the effectiveness of scleral
buckling to vitreous surgery for rhegmatogenous retinal detachment." Japanese Journal of
Ophthalmology 51(5): 360-367.
Kouri, A. S., M. Tsakanikos, et al. (2008). "Results of endoscopic assisted probing for congenital
nasolacrimal duct obstruction in older children." International Journal of Pediatric Otorhinolaryngology
72(6): 891-896.
Kozak, I., L. Cheng, et al. (2005). "Lidocaine gel anesthesia for intravitreal drug administration." Retina
25(8): 994-998.
Kreissig, I., J. Failer, et al. (1989). "Results of a temporary balloon buckle in the treatment of 500 retinal
detachments and a comparison with pneumatic retinopexy." Am J Ophthalmol 107(4): 381-389.
Kretzer, F. L. and H. M. Hittner (1988). "Retinopathy of prematurity: clinical implications of retinal
development." Arch Dis Child 63(10 Spec No): 1151-1167.
Kuhn, F. and V. Mester (2002). "Anterior chamber abnormalities and cataract." Ophthalmology Clinics
of North America 15(2): 195-203.
Kumar, A., S. Sinha, et al. (2007). "Comparative evaluation of vitrectomy and dye-enhanced ILM peel
with grid laser in diffuse diabetic macular edema." Graefe's Archive for Clinical and Experimental
Ophthalmology 245(3): 360-368.
Lam, D. S., C. K. Chan, et al. (2007). "Intravitreal triamcinolone plus sequential grid laser versus
triamcinolone or laser alone for treating diabetic macular edema: six-month outcomes."
Ophthalmology 114(12): 2162-2167.
Landers, J. and M. Goggin (2009). "Comparison of refractive outcomes using immersion ultrasound
biometry and IOL Master biometry." Clinical and Experimental Ophthalmology 37(6): 566-569.
Laura (2010). "Removing of a stye." Laura's medical journal. Retrieved January 13, 2011, from
http://lozsmedicaljourney.blogspot.com/2010_10_01_archive.html.
Laursen, M. L., F. Moeller, et al. (2004). "Subthreshold micropulse diode laser treatment in diabetic
macular oedema." Br J Ophthalmol 88(9): 1173-1179.
Page 276
Lee, D. H., S. J. Fudemberg, et al. (2005). "Success of simple probing and irrigation in patients with
nasolacrimal duct obstruction and otitis media." Journal of AAPOS 9(2): 192-194.
Len Micay (April 11, 2007). "My experience with cataract surgery." My cataract surgery. Retrieved
September 9, 2010, from http://mycataractsurgery.blogspot.com.
Li, W., J. Zheng, et al. (2010). "Clinical complications of Densiron 68 intraocular tamponade for
complicated retinal detachment." Eye 24(1): 21-28.
Liberati, A., D. Altman, et al. (2009). "The PRISMA Statement for Reporting Systematic Reviews and
Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration." PLoS
Med 6(7): e1000100.
Lindsay Lane (August 6, 2009 ). "Her eye part two." Crochet*D*Lane. Retrieved November 17, 2010,
from http://crochetdlane.blogspot.com/2009_08_01_archive.html.
Lindsay Lane (August 18, 2009 ). "Her eye part three." Crochet*D*Lane. Retrieved November 17, 2010,
from http://crochetdlane.blogspot.com/2009_08_01_archive.html.
Lindsay Lane (August 21, 2009 ). "Her eye part four." Crochet*D*Lane. Retrieved November 17, 2010,
from http://crochetdlane.blogspot.com/2009_08_01_archive.html.
Lindsley, K., J. Nichols Jason, et al. (2010) Interventions for acute internal hordeolum. Cochrane
Database of Systematic Reviews DOI: 10.1002/14651858.CD007742.pub2
Lisa Mosely (2010 June 19). "Long time no post!" My Road to recovery. Retrieved November 18, 2010,
from http://lisarmoseley.blogspot.com/2010/06/long-time-no-post.html?zx=e388456218afbe9.
Lit, E. S. and L. H. Y. Young (2002). "Anterior and posterior segment intraocular foreign bodies."
International Ophthalmology Clinics 42(3): 107-120.
Little, H. L. and J. M. Showman (1995). "A pilot randomized controlled study on the effect of laser
photocoagulation of confluent soft macular drusen." American Academy of Ophthalmology: 120.
Little, H. L., J. M. Showman, et al. (1997). "A pilot randomized controlled study on the effect of laser
photocoagulation of confluent soft macular drusen." Ophthalmology 104(4): 623-631.
Lockey, J. (2009). "The provision of information for patients prior to cataract surgery." British Journal of
Nursing 18(19): 1207-1211.
Lovestam-Adrian, M., C. D. Agardh, et al. (2003). "Type 1 diabetes patients with severe nonproliferative retinopathy may benefit from panretinal photocoagulation." Acta Ophthalmol Scand
81(3): 221-225.
Lovestam-Adrian, M. and E. Agardh (2000). "Photocoagulation of diabetic macular oedema-complications and visual outcome." Acta Ophthalmol Scand 78(6): 667-671.
Lundström, M., U. Stenevi, et al. (2001). "Quality of life after first- and second- eye cataract surgery:
Five-year data collected by the Swedish National Cataract Register." Journal of Cataract and Refractive
Surgery 27(10): 1553-1559.
Macedo, M., N. Ferreira, et al. (2005). "The posterior segment and intraocular foreign bodies." EVRS
Educational Electronic Journal 1(6).
MacEwen, C. J. and J. D. Young (1991). "Epiphora during the first year of life." Eye (Lond) 5 ( Pt 5): 596600.
Macular Photocoagulation Study Group (1982). "Argon laser photocoagulation for senile macular
degeneration. Results of a randomized clinical trial." Arch Ophthalmol 100(6): 912-918.
Macular Photocoagulation Study Group (1986). "Argon laser photocoagulation for neovascular
maculopathy. Three-year results from randomized clinical trials. Macular Photocoagulation Study
Group." Arch Ophthalmol 104(5): 694-701.
Macular Photocoagulation Study Group (1990). "Krypton laser photocoagulation for neovascular
lesions of age-related macular degeneration. Results of a randomized clinical trial. Macular
Photocoagulation Study Group." Arch Ophthalmol 108(6): 816-824.
Page 277
Macular Photocoagulation Study Group (1991). "Argon laser photocoagulation for neovascular
maculopathy. Five-year results from randomized clinical trials. Macular Photocoagulation Study
Group." Arch Ophthalmol 109(8): 1109-1114.
Macular Photocoagulation Study Group (1991). "Laser photocoagulation of subfoveal neovascular
lesions in age-related macular degeneration. Results of a randomized clinical trial. Macular
Photocoagulation Study Group." Arch Ophthalmol 109(9): 1220-1231.
Macular Photocoagulation Study Group (1991). "Laser photocoagulation of subfoveal recurrent
neovascular lesions in age-related macular degeneration. Results of a randomized clinical trial. Macular
Photocoagulation Study Group." Arch Ophthalmol 109(9): 1232-1241.
Macular Photocoagulation Study Group (1991). "Subfoveal neovascular lesions in age-related macular
degeneration. Guidelines for evaluation and treatment in the macular photocoagulation study. Macular
Photocoagulation Study Group." Arch Ophthalmol 109(9): 1242-1257.
Macular Photocoagulation Study Group (1993). "Five-year follow-up of fellow eyes of patients with agerelated macular degeneration and unilateral extrafoveal choroidal neovascularization. Macular
Photocoagulation Study Group." Arch Ophthalmol 111(9): 1189-1199.
Macular Photocoagulation Study Group (1993). "Laser photocoagulation of subfoveal neovascular
lesions of age-related macular degeneration. Updated findings from two clinical trials. Macular
Photocoagulation Study Group." Arch Ophthalmol 111(9): 1200-1209.
Macular Photocoagulation Study Group (1994). "Evaluation of argon green vs krypton red laser for
photocoagulation of subfoveal choroidal neovascularization in the macular photocoagulation study.
Macular Photocoagulation Study (MPS) Group." Arch Ophthalmol 112(9): 1176-1184.
Macular Photocoagulation Study Group (1994). "Laser photocoagulation for juxtafoveal choroidal
neovascularization. Five-year results from randomized clinical trials. Macular Photocoagulation Study
Group." Arch Ophthalmol 112(4): 500-509.
Macular Photocoagulation Study Group (1994). "Persistent and recurrent neovascularization after laser
photocoagulation for subfoveal choroidal neovascularization of age-related macular degeneration.
Macular Photocoagulation Study Group." Arch Ophthalmol 112(4): 489-499.
Macular Photocoagulation Study Group (1994). "Visual outcome after laser photocoagulation for
subfoveal choroidal neovascularization secondary to age-related macular degeneration. The influence
of initial lesion size and initial visual acuity. Macular Photocoagulation Study Group." Arch Ophthalmol
112(4): 480-488.
Macular Photocoagulation Study Group (1996). "Occult choroidal neovascularization. Influence on
visual outcome in patients with age-related macular degeneration. Macular Photocoagulation Study
Group." Arch Ophthalmol 114(4): 400-412.
Madge, S. N., C. H. Khong, et al. (2005). "Optimization of biometry for intraocular lens implantation
using the Zeiss IOLMaster." Acta Ophthalmologica Scandinavica 83 (4): 436-438.
Maguire, M. (2004). "Baseline characteristics, the 25-Item National Eye Institute Visual Functioning
Questionnaire, and their associations in the Complications of Age-Related Macular Degeneration
Prevention Trial (CAPT)." Ophthalmology 111(7): 1307-1316.
Mahdizadeh, M., M. Masoumpour, et al. (2008). "Anatomical retinal reattachment after scleral buckling
with and without retinopexy: A pilot study." Acta Ophthalmologica 86(3): 297-301.
Maheshwari, R. (2005). "Results of probing for congenital nasolacrimal duct obstruction in children
older than 13 months of age." Indian Journal of Ophthalmology 53(1): 49-51.
Maia Jr, O. O., B. S. Takahashi, et al. (2009). "Combined Laser and Intravitreal Triamcinolone for
Proliferative Diabetic Retinopathy and Macular Edema: One-year Results of a Randomized Clinical
Trial." American Journal of Ophthalmology 147(2): 291-297.e292.
McAllister, I. L., S. M. Meyers, et al. (1988). "Comparison of pneumatic retinopexy with alternative
surgical techniques." Ophthalmology 95(7): 877-883.
Page 278
McDaid, C., S. Hartley, et al. (2005). "Systematic review of effectiveness of different treatments for
childhood retinoblastoma." Health Technology Assessment 9(48): iii-48.
Mel Eppich (February 22, 2010). "Mixed emotions " Mel's haven. Retrieved October 14, 2010, from
http://watermelans.blogspot.com/2010/02/mixed-emotions.html.
Meng, Q., S. Zhang, et al. (2010). "Long-term outcomes of Oxane Hd as intraocular tamponade in the
treatment of complicated retinal detachment." Graefe's Archive for Clinical and Experimental
Ophthalmology 248(8): 1091-1096.
Merlin T, Weston A, et al. (2009). "Extending an evidence hierarchy to include topics other than
treatment: revising the Australian ‘levels of evidence’." BMC Medical Research Methodology 9(34 ).
Merrill, P. T., E. G. Buckley, et al. (1996). "New and recurrent tumors in germinal retinoblastoma: is
there a treatment effect?" Ophthalmic Genet 17(3): 115-118.
Messmer, E. P., W. Sauerwein, et al. (1990). "New and recurrent tumor foci following local treatment as
well as external beam radiation in eyes of patients with hereditary retinoblastoma." Graefes Arch Clin
Exp Ophthalmol 228(5): 426-431.
Mester, V. and F. Kuhn (1998). "Ferrous intraocular foreign bodies retained in the posterior segment:
management options and results." Int Ophthalmol 22(6): 355-362.
Mester, V. and F. Kuhn (2002). "Intraocular foreign bodies." Ophthalmology Clinics of North America
15(2): 235-242.
Mike (November 4th, 2009). "... from my E-mailbag." Eye Yi Eye. Retrieved October 14, 2010, from
http://eyeyieye.blogspot.com/.
Mills, D. M. and D. R. Meyer (2006). "Acquired nasolacrimal duct obstruction." Otolaryngol Clin North
Am 39(5): 979-999, vii.
Mirshahi, A., H. Shenazandi, et al. (2010). "Intravitreal triamcinolone as an adjunct to standard laser
therapy in coexisting high-risk proliferative diabetic retinopathy and clinically significant macular
edema." Retina 30(2): 254-259.
Modi, N., S. Shaw, et al. (2008). "Local anaesthetic cataract surgery: factors influencing perception of
pain, anxiety and overall satisfaction." Journal of Perioperative Practice 18(1): 28-33.
Moeini, H., F. Eslami, et al. (2008). "Comparison of ultrasound and optic biometry with respect to eye
refractive errors after phacoemulsification." Journal of Research in Medical Sciences 13(2): 43-47.
Mohamed, Q., M. C. Gillies, et al. (2007). "Management of diabetic retinopathy: A systematic review."
Journal of the American Medical Association 298(8): 902-916.
MonkeyMama (August 6, 2009). "Checkups." Monkey adventures. Retrieved November 22, 2010, from
http://ethanalex.blogspot.com/search?q=tear+duct.
MonkeyMama (March 28, 2009). "10 Months & Solved Dilemmas." Monkey adventures. Retrieved
November 22, 2010, from http://ethanalex.blogspot.com/search?q=tear+duct.
Motegi, S. I., A. Tamura, et al. (2006). "Squamous cell carcinoma of the eyelid arising from palpebral
conjunctiva." European Journal of Dermatology 16(2): 187-189.
Mozaffarieh, M., T. Benesch, et al. (2005). "Photocoagulation for diabetic retinopathy: Determinants of
patient satisfaction and the patient-provider relationship." Acta Ophthalmologica Scandinavica 83(3):
316-321.
Mozaffarieh, M., K. Krepler, et al. (2004). "Visual function, quality of life and patient satisfaction after
ophthalmic surgery: A comparative study." Ophthalmologica 218(1): 26-30.
Mrs Foreste (February 10, 2010 ). "Wednesday mingle?" As the Foreste Grows. Retrieved 2010, 19
November from <http://mrsforeste.blogspot.com/>.
MSAC (2005). Optical biometry using partial coherence interferometry prior to cataract surgery.
Canberra, Medical Services Advisory Committee.
Page 279
Mueller, J. B. and C. M. McStay (2008). "Ocular Infection and Inflammation." Emergency Medicine
Clinics of North America 26(1): 57-72.
Mulvihill, A., T. Fulcher, et al. (1996). "Pneumatic retinopexy versus scleral buckling: a randomised
controlled trial." Ir J Med Sci 165(4): 274-277.
Muqit, M. M. K., G. R. Marcellino, et al. (2010). "Single-session vs multiple-session pattern scanning
laser panretinal photocoagulation in proliferative diabetic retinopathy: The Manchester Pascal study."
Archives of Ophthalmology 128(5): 525-533.
Nagpal, M., S. Marlecha, et al. (2010). "Comparison of laser photocoagulation for diabetic retinopathy
using 532-nm standard laser versus multispot pattern scan laser." Retina 30(3): 452-458.
Nancy Voogd (October 1, 2008). "I can read! I can drive!" SongMom’s Twitterings. Retrieved October
14, 2010, from http://songmom.blogspot.com/2008_09_01_archive.html.
Nancy Voogd (September 29, 2008). "Two new floaters = retinal tear." SongMom’s Twitterings.
Retrieved October 14, 2010, from http://songmom.blogspot.com/.
Nepp, J., K. Krepler, et al. (2005). "Biometry and refractive outcome of eyes filled with silicone oil by
standardized echography and partial coherence interferometry." Graefe's Archive for Clinical and
Experimental Ophthalmology 243(10): 967-972.
Newman, D. K. (2000). "Visual experience during phacoemulsification cataract surgery under topical
anaesthesia." British Journal of Ophthalmology 84(1): 13-15.
Nguyen, Q. D., E. F. Kruger, et al. (2002). "Combat eye trauma: Intraocular foreign body injuries during
the Iran-Iraq war (1980-1988)." International Ophthalmology Clinics 42(3): 167-177.
NHMRC (2009). Guidelines for the Screening, Prognosis, Diagnosis, Management and Prevention of
Glaucoma. Canberra, National Health and Medical Research Council.
NHMRC (2009). NHMRC levels of evidence and grades for recommendations for developers of
guidelines. Canberra, ACT, National Health and Medical Research Council. 2010.
NICE (2009). Glaucoma: Diagnosis and management of chronic open angle glaucoma and ocular
hypertension. London, National Institute for Health and Clinical Excellence.
Nijkamp, M. D., R. M. M. A. Nuijts, et al. (2000). "Determinants of patient satisfaction after cataract
surgery in 3 settings." J. Cataract Refract. Surg. 26: 1379-1388.
Nijkamp, M. D., R. A. C. Ruiter, et al. (2002). "Factors related to fear in patients undergoing cataract
surgery: A qualitative study focusing on factors associated with fear and reassurance among patients
who need to undergo cataract surgery." Patient Education and Counseling 47(3): 265-272.
O'Doherty, M., I. Dooley, et al. (2008). "Interventions for diabetic macular oedema: A systematic review
of the literature." British Journal of Ophthalmology 92(12): 1581-1590.
Oldnovice (March 16, 2010). "Cataract surgery - what to expect." Familial in Sanity. Retrieved
September 9, 2010, from http://familialinsanity.blogspot.com/2010/03/.
Olk, R. J. (1986). "Modified grid argon (blue-green) laser photocoagulation for diffuse diabetic macular
edema." Ophthalmology 93(7): 938-950.
Olk, R. J. (1990). "Argon green (514 nm) versus krypton red (647 nm) modified grid laser
photocoagulation for diffuse diabetic macular edema." Ophthalmology 97(9): 1101-1112; discussion
1112-1103.
Olk, R. J., T. R. Friberg, et al. (1999). "Therapeutic benefits of infrared (810-nm) diode laser macular grid
photocoagulation in prophylactic treatment of nonexudative age-related macular degeneration: twoyear results of a randomized pilot study." Ophthalmology 106(11): 2082-2090.
Owens, S. L., C. Bunce, et al. (2003). "Prophylactic laser treatment appears to promote choroidal
neovascularisation in high-risk ARM: results of an interim analysis." Eye (Lond) 17(5): 623-627.
Page 280
Owens, S. L., C. Bunce, et al. (2006). "Prophylactic laser treatment hastens choroidal neovascularization
in unilateral age-related maculopathy: final results of the drusen laser study." Am J Ophthalmol 141(2):
276-281.
Owens, S. L., R. H. Guymer, et al. (1999). "Fluorescein angiographic abnormalities after prophylactic
macular photocoagulation for high-risk age-related maculopathy." Am J Ophthalmol 127(6): 681-687.
Pager, C. K. (2004). "Expectations and outcomes in cataract surgery: A prospective test of 2 models of
satisfaction." Archives of Ophthalmology 122(12): 1788-1792.
Pager, C. K. and P. J. McCluskey (2004). "Public versus private patient priorities and satisfaction in
cataract surgery." Clinical and Experimental Ophthalmology 32(5): 482-487.
Pager, C. K., P. J. McCluskey, et al. (2004). "Cataract surgery in Australia: A profile of patient-centred
outcomes." Clinical and Experimental Ophthalmology 32(4): 388-392.
Palmer, E. A., R. J. Hardy, et al. (2005). "15-Year outcomes following threshold retinopathy of
prematurity: Final results from the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity."
Archives of Ophthalmology 123(3): 311-318.
Parodi Maurizio, B., G. Virgili, et al. (2009). "Laser treatment of drusen to prevent progression to
advanced age-related macular degeneration." Cochrane Database of Systematic Reviews Issue 3. Art.
No.: CD006537. DOI: 10.1002/14651858.CD006537.pub2.
Parodi, M. B., G. Di Stefano, et al. (2008). "Grid laser treatment for exudative retinal detachment
secondary to ischemic branch retinal vein occlusion." Retina 28(1): 97-102.
Patel, J. I., P. G. Hykin, et al. (2006). "Diabetic macular oedema: Pilot randomised trial of pars plana
vitrectomy vs macular argon photocoagulation." Eye 20(8): 873-881.
Patz, A., H. Schatz, et al. (1973). "Macular edema-an overlooked complication of diabetic retinopathy."
Trans Am Acad Ophthalmol Otolaryngol 77(1): OP34-42.
Pavicic-Astalos, J., R. Ivekovic, et al. (2010). "Intralesional triamcinolone acetonide injection for
chalazion." Acta Clinica Croatica 49(1): 43-48.
Pavlovic, S., K. G. Schmidt, et al. (1998). "Management of intra-ocular foreign bodies impacting or
embedded in the retina." Australian and New Zealand Journal of Ophthalmology 26(3): 241-246.
Pediatric Eye Disease Investigator Group (2009). "Repeat probing for treatment of persistent
nasolacrimal duct obstruction." Journal of AAPOS 13(3): 306-307.
Pesudovs, K. and D. J. Coster (2005). "Patient-centred outcomes of cataract surgery in Australia [3]."
Clinical and Experimental Ophthalmology 33(2): 228.
Pesudovs, K., H. Weisinger, et al. (2003). "Cataract surgery and changes in quality of life measures." Clin
Exp Optom 86: 34-41.
Pick T.P., Ed. (1977). Gray's Anatomy. New York, Bounty Books.
Prasad, N., C. M. Kumar, et al. (2003). "Subjective visual experience during phacoemulsification cataract
surgery under sub-Tenon's block." Eye 17(3): 407-409.
Prenner, J. L., B. J. Rosenblatt, et al. (2003). "Risk factors for choroidal neovascularization and vision
loss in the fellow eye study of CNVPT." Retina 23(3): 307-314.
Press, L. (August 12, 2007). "Mistakes." Athletic senior. Retrieved 13 January, 2011, from
http://athleticsenior.blogspot.com/search/label/retina.
Press, L. (September 7, 2007). "Why subjective experience is important - an example." Athletic senior.
Retrieved 13 January, 2011, from http://athleticsenior.blogspot.com/search/label/retina.
Rafuse P.E., Buys Y.M., et al. (2009). "Canadian Ophthalmological Society evidence-based clinical
practice guidelines for the management of glaucoma in the adult eye." Can J Ophthalmol 44 Suppl 1:
S7-93.
Page 281
Rajan, M. S., I. Keilhorn, et al. (2002). "Partial coherence laser interferometry vs conventional
ultrasound biometry in intraocular lens power calculations." Eye 16(5): 552-556.
RANZCO (2006). Cataract and Intraocular lens surgery (Updated), The Royal Australian and New
Zealand College of Opthalmologists.
RANZCO (2009). Guidelines for collaborative care of glaucoma patients, The Royal Australian and New
Zealand College of Opthalmologists.
Raymond, S., I. Favilla, et al. (2009). "Comparing ultrasound biometry with partial coherence
interferometry for intraocular lens power calculations: A randomized study." Investigative
Ophthalmology and Visual Science 50(6): 2547-2552.
RCO (2007). Cataract surgery guidelines. London, The Royal College of Ophthalmologists.
RCO (2009). Age related macular degeneration guidelines for management. London, The Royal College
of Ophthalmologists.
Reeser, F., J. Fleischman, et al. (1981). "Efficacy of argon laser photocoagulation in the treatment of
circinate diabetic retinopathy." Am J Ophthalmol 92(6): 762-767.
Regillo, C. D. (2003). "Laser Treatment in Fellow Eyes With Large Drusen: Updated Findings From a Pilot
Randomized Clinical Trial." Evidence-Based Ophthalmology 4(4): 204-205.
Rita (September 25, 2007). "Eyeball injections and flights of fancy." Keeping Knit Simple. Retrieved 26
August, 2010, from http://keepingknitsimple.blogspot.com/2007_09_01_archive.html.
Rizzo, S., F. Genovesi-Ebert, et al. (2006). "The combined use of perfluorohexyloctane (F6H8) and
silicone oil as an intraocular tamponade in the treatment of severe retinal detachment." Graefe's
Archive for Clinical and Experimental Ophthalmology 244(6): 709-716.
Rodanant, N., T. R. Friberg, et al. (2002). "Predictors of drusen reduction after subthreshold infrared
(810 nm) diode laser macular grid photocoagulation for nonexudative age-related macular
degeneration." Am J Ophthalmol 134(4): 577-585.
Rodrigues, P. A., P. J. Vale, et al. (2008). "Topical anesthesia versus sub-Tenon block for cataract
surgery: Surgical conditions and patient satisfaction." European Journal of Ophthalmology 18(3): 356360.
Rohan, T. E., C. D. Frost, et al. (1989). "Prevention of blindness by screening for diabetic retinopathy: a
quantitative assessment." British Medical Journal 299(6709): 1198-1201.
Rosenblatt, B. J., J. L. Prenner, et al. (2001). "Predictors of visual acuity loss in the fellow eye study of
the Choroidal Neovascularization Prevention Trial (CNVPT)." Investigative ophthalmology & visual
science 42(ARVO Abstract 675).
Rositta (January 26, 2010). "The Cataract Surgery." The View From Here. Retrieved September 9, 2010,
from http://theviewfromher.blogspot.com/2010_01_01_archive.html.
Ross, M. A., A. J. Avery, et al. (2003). "Views of older people on cataract surgery options: An assessment
of preferences by conjoint analysis." Quality and Safety in Health Care 12(1): 13-17.
Roth, D. B., I. U. Scott, et al. (2006). "Patient Perceptions of Discomfort and Changes in Vision and
Functional Status Associated with Intravitreal Triamcinolone Injection." American Journal of
Ophthalmology 142(3): 492-494.
Rüschen, H., D. Celaschi, et al. (2005). "Randomised controlled trial of sub-Tenon's block versus topical
anaesthesia for cataract surgery: A comparison of patient satisfaction." British Journal of
Ophthalmology 89(3): 291-293.
Russell Elias (September 19, 2005). "Eye Injection." For the Elias Family Wherever They Are. Retrieved
26 August, 2010, from http://ailwers.blogspot.com/2005_09_01_archive.html.
Russo, V., A. Barone, et al. (2009). "Bevacizumab compared with macular laser grid photocoagulation
for cystoid macular edema in branch retinal vein occlusion." Retina 29(4): 511-515.
Page 282
SabilaK (April 27, 2009). "No pirate patch " Revenge of the nerd. Retrieved November 17, 2010, from
http://www.revengeofthenerddd.blogspot.com/.
Saeed, M. U., H. Heimann, et al. (2009). "Heavy silicone oil tamponade after failed macular hole surgery
with perfluoropropane (C3F8): A report of five cases." Graefe's Archive for Clinical and Experimental
Ophthalmology 247(5): 707-709.
Sandner, D., E. Herbrig, et al. (2007). "High-density silicone oil (Densiron) as a primary intraocular
tamponade: 12-month follow up." Graefe's Archive for Clinical and Experimental Ophthalmology
245(8): 1097-1105.
Sandra (August 18, 2010). "Cataract Surgery." Nightly News. Retrieved September 9, 2010, from
http://srmerrikinblog.blogspot.com/2010/08/.
Saw, S. M., G. Gazzard, et al. (2005). "Myopia and associated pathological complications." Ophthalmic
Physiol Opt 25(5): 381-391.
Saw, S. M., G. Gazzard, et al. (2006). "An evidence-based analysis of surgical interventions for
uncomplicated rhegmatogenous retinal detachment." Acta Ophthalmologica Scandinavica 84(5): 606612.
Sbarbaro, J. A., M. G. Maguire, et al. (2004). "Annual Changes in Refractive Error Over 3 Years Among
Eyes with Early AMD." Invest Ophthalmol Vis Sci 45(5): 3055-.
Schatz, H., T. C. Burton, et al. (1978). Interpretation of fundus flourescein angiography St Louis, C.V.
Mosby Co.
Schwartz, S. G., H. W. Flynn Jr, et al. (2009). "Tamponade in surgery for retinal detachment associated
with proliferative vitreoretinopathy." Cochrane Database of Systematic Reviews Issue 4. Art. No.:
CD006126. DOI: 10.1002/14651858.CD006126.pub2.
Scott, I. U., A. R. Edwards, et al. (2007). "A phase II randomized clinical trial of intravitreal bevacizumab
for diabetic macular edema." Ophthalmology 114(10): 1860-1867.
Scott, I. U., M. S. Ip, et al. (2009). "A randomized trial comparing the efficacy and safety of intravitreal
triamcinolone with standard care to treat vision loss associated with macular edema secondary to
branch retinal vein occlusion: The standard care vs corticosteroid for retinal vein occlusion (SCORE)
study report 6." Archives of Ophthalmology 127(9): 1115-1128.
Sharma, Y. R., S. Karunanithi, et al. (2005). "Functional and anatomic outcome of scleral buckling versus
primary vitrectomy in pseudophakic retinal detachment." Acta Ophthalmologica Scandinavica 83(3):
293-297.
Shimura, M., T. Nakazawa, et al. (2007). "Pretreatment of posterior subtenon injection of triamcinolone
acetonide has beneficial effects for grid pattern photocoagulation against diffuse diabetic macular
oedema." Br J Ophthalmol 91(4): 449-454.
Shrestha, J. B., S. Bajimaya, et al. (2009). "Outcome of probing under topical anesthesia in children
below 18 months of age with congenital nasolacrimal duct obstruction." Nepal Medical College journal :
NMCJ 11(1): 46-49.
SIGN (2008). A guideline developer's handbook. Edinburgh, Scottish Intercollegiate Guidelines Network.
Simon James (January 23, 2007). "My Initial Avastin Experience." My Eyes Diary. Retrieved 26 August,
2010, from http://myeyesdiary.blogspot.com/2006/08/my-avastin-experience.html.
Soheilian, M., A. Abolhasani, et al. (2004). "Management of magnetic intravitreal foreign bodies in 71
eyes." Ophthalmic Surgery Lasers and Imaging 35(5): 372-378.
Soheilian, M., M. Feghi, et al. (2005). "Surgical management of non-metallic and non-magnetic metallic
intraocular foreign bodies." Ophthalmic Surgery Lasers and Imaging 36(3): 189-196.
Soheilian, M., A. Ramezani, et al. (2007). "Intravitreal bevacizumab (Avastin) injection alone or
combined with triamcinolone versus macular photocoagulation as primary treatment of diabetic
macular edema." Retina 27(9): 1187-1195.
Page 283
Soubrane, G., G. Coscas, et al. (1987). "[Randomized study of the photocoagulation with blue-green
argon laser in subretinal neovascularization of senile macular degeneration. 5-year follow-up]." Bull Soc
Ophtalmol Fr 87(2): 249-250.
Soubrane, G., J. Pison, et al. (1986). "[Subretinal neovessels in degenerative myopia: results of
photocoagulation]." Bull Soc Ophtalmol Fr 86(3): 269-272.
Spiritus, A., M. Huygens, et al. (2000). "Topical anesthesia without intracameral lidocaine in cataract
surgery." Bulletin de la Societe Belge d'Ophtalmologie 275: 9-13.
Stallard, H. B. (1942). "War Surgery Of The Eye: Removal Of Magnetic Intra-Ocular Foreign Bodies By
The Posterior Route." British Medical Journal 2(4273): 629-631.
Steijns, D., D. Duijvesz, et al. (2010). "Steroid injection in addition to macular laser grid
photocoagulation in diabetic macular oedema: A systematic review." Acta Ophthalmologica 88(4): 389393.
Steindler, P., E. Mantovani, et al. (2009). "Efficacy of probing for children with congenital nasolacrimal
duct obstruction: A retrospective study using fluorescein dye disappearance test and lacrimal sac
echography." Graefe's Archive for Clinical and Experimental Ophthalmology 247(6): 837-846.
Stoltz, R. A., G. S. Ying, et al. (2004). "Fundus Features of Untreated Eyes with Visual Acuity Loss in
CAPT." Invest Ophthalmol Vis Sci 45(5): 1389-.
Striph, G. G., W. M. Hart, Jr., et al. (1988). "Modified grid laser photocoagulation for diabetic macular
edema. The effect on the central visual field." Ophthalmology 95(12): 1673-1679.
Stroll (September 19, 2010). "I'm just an old hippy at heart. ." The butch stroll. Retrieved October 14,
2010, from http://thebutchstroll.blogspot.com/2010/09/im-just-old-hippy-at-heart.html.
Submacular Surgery Trials Pilot Study Investigators (2000). "Submacular surgery trials randomized pilot
trial of laser photocoagulation versus surgery for recurrent choroidal neovascularization secondary to
age-related macular degeneration: II. Quality of life outcomes submacular surgery trials pilot study
report number 2." Am J Ophthalmol 130(4): 408-418.
Suto, C., S. Hori, et al. (2008). "Management of type 2 diabetics requiring panretinal photocoagulation
and cataract surgery." Journal of Cataract and Refractive Surgery 34(6): 1001-1006.
Tan, C. S. H., K. G. A. Eong, et al. (2005). "Fear caused by intraoperative visiual sensations during
cataract surgery [10]." Acta Ophthalmologica Scandinavica 83(5): 631-632.
Terri-Anne (March 5, 2008 ). "Colin's Surgery." Our Daily Treasures. Retrieved November 18, 2010, from
http://ourdailytreasures.blogspot.com/2008/03/colins-surgery.html.
The Moorfields Macular Study Group (1982). "Treatment of senile disciform macular degeneration: a
single-blind randomised trial by argon laser photocoagulation. The Moorfields Macular Study Group."
British Journal of Ophthalmology 66(12): 745-753.
Thomas, D., C. Bunce, et al. (2005). "A randomised controlled feasibility trial of vitrectomy versus laser
for diabetic macular oedema." British Journal of Ophthalmology 89(1): 81-86.
Thongthong, K., P. Singha, et al. (2009). "Success of probing for congenital nasolacrimal duct
obstruction in children under 10 years of age." Journal of the Medical Association of Thailand 92(12):
1646-1650.
TJ (November 13, 2003). "Ehlers Danlos Syndrome and Me." Retrieved January 13, 2011, from
http://moondancer.150m.com/ehlers.html.
Tomlins, P. J., M. G. Woodcock, et al. (2007). "Nuclear magnetic resonance analysis of emulsified
silicone oil RMN-3 (Oxane HD)." British Journal of Ophthalmology 91(10): 1379-1381.
Tonello, M., R. A. Costa, et al. (2008). "Panretinal photocoagulation versus PRP plus intravitreal
bevacizumab for high-risk proliferative diabetic retinopathy (IBeHi study)." Acta Ophthalmologica 86(4):
385-389.
Page 284
Tornambe, P. E., G. F. Hilton, et al. (1991). "Pneumatic retinopexy. A two-year follow-up study of the
multicentre clinical trial comparing pneumatic retinopexy with scleral buckling." Ophthalmology 98:
1115– 1123.
Tranos, P. G. and N. M. Peter (2006). "Visual perceptions during cataract surgery [9]." Acta
Ophthalmologica Scandinavica 84(3): 444.
Tranos, P. G., S. S. Wickremasinghe, et al. (2003). "Visual perception during phacoemulsification
cataract surgery under topical and regional anaesthesia." Acta Ophthalmologica Scandinavica 81(2):
118-122.
Trento, M., M. Tomelini, et al. (2006). "Perception of, and anxiety levels induced by, laser treatment in
patients with sight-threatening diabetic retinopathy. A multicentre study." Diabetic Medicine 23(10):
1106-1109.
Unal, M. (2008). "Chalazion Treatment." Orbit 27(6): 397-398.
Unoki, N., K. Nishijima, et al. (2009). "Randomised controlled trial of posterior sub-Tenon triamcinolone
as adjunct to panretinal photocoagulation for treatment of diabetic retinopathy." British Journal of
Ophthalmology 93(6): 765-770.
Vallance, J. H., M. Ahmed, et al. (2004). "Cataract surgery and consent: Recall, anxiety, and attitude
toward trainee surgeons preoperatively and postoperatively." Journal of Cataract and Refractive
Surgery 30(7): 1479-1485.
Versteeg-Tijmes, N. T., P. T. de Jong, et al. (1982). "Argon laser treatment of pigment epithelial
detachments and of subretinal neovascular membranes in Junius-Kuhnt's senile disciform macular
degeneration. A prospective, randomized study." Graefes Arch Clin Exp Ophthalmol 218(5): 271-274.
Virgili, G. and A. Bini (2007). "Laser photocoagulation for neovascular age-related macular
degeneration." Cochrane Database of Systematic Reviews Issue 3. Art. No.: CD004763. DOI:
10.1002/14651858.CD004763.pub2.
Virgili, G. and F. Menchini (2005). "Laser photocoagulation for choroidal neovascularisation in
pathologic myopia." Cochrane Database of Systematic Reviews Issue 4. Art. No.: CD004765. DOI:
10.1002/14651858.CD004765.pub2.
Vitreous-Retina-Macula Consultants of New York (2009). "Vitrectomy." Retrieved 15th December,
2010, from http://www.vrmny.com/pe/vitrectomy.html
Wallace, E. J., A. Cox, et al. (2006). "Endoscopic-assisted probing for congenital nasolacrimal duct
obstruction." Eye 20(9): 998-1003.
Wally and Leah Hansen (2010). "Tear duct surgery #2." The Hansen Family. Retrieved 11 January, 2011,
from http://copperandhurleysnewsib.blogspot.com/2010/11/tear-duct-surgery-2.html.
Wasfi, E. I., P. Pai, et al. (2008). "Patient satisfaction with cataract surgery." International Archives of
Medicine 1(22).
Waterman, H., S. Mayer, et al. (2002). "An evaluation of the administration of sub-Tenon local
anaesthesia by a nurse practitioner." British Journal of Ophthalmology 86(5): 524-526.
Whiting, P., Rutjes, A.W. et al (2003). "The development of QUADAS: a tool for the quality assessment
of studies of diagnostic accuracy included in systematic reviews." BMC Medical Research Methodology
3(1): 25.
Wickham, L., W. Xing, et al. (2006). "Outcomes of surgery for posterior segment intraocular foreign
bodies - A retrospective review of 17 years of clinical experience." Graefe's Archive for Clinical and
Experimental Ophthalmology 244(12): 1620-1626.
Wickremasinghe, S. S., P. G. Tranos, et al. (2003). "Visual perception during phacoemulsification
cataract surgery under subtenons anaesthesia." Eye 17(4): 501-505.
Wikipedia (2010). "Vitrectomy." Retrieved 23rd December, 2010, from
http://en.wikipedia.org/wiki/Vitrectomy#Indications.
Page 285
Wilkinson Charles, P. (2005) Interventions for asymptomatic retinal breaks and lattice degeneration for
preventing retinal detachment. Cochrane Database of Systematic Reviews DOI:
10.1002/14651858.CD003170.pub2
Willan, A. R., A. F. Cruess, et al. (1996). Argon green vs. krypton red laser photocoagulation for
extrafoveal choroidal neovascularization secondary to age-related macular degeneration : 3-year
results of a multicentre randomized trial. Plattsburgh, NY, ETATS-UNIS, National Research Council
Canada.
Wilson, M. E. and S. K. Pandey (2005). Lensectomy and anterior vitrectomy when an intraocular lens is
not being implanted. Pediatric cataract surgery: techniques, complications, and management. M. E.
Wilson, R. H. Trivedi and S. K. Pandey, Lippincott Williams & Wilkins: 101pp.
Wilson, M. W. (2010). Treatment of Intraocular Retinoblastoma. Retinoblastoma. C. Rodriguez-Galindo
and M. W. Wilson, Springer US: 91-101.
Wong, D., J. C. Van Meurs, et al. (2005). "A pilot study on the use of a perfluorohexyloctane/silicone oil
solution as a heavier than water internal tamponade agent." British Journal of Ophthalmology 89(6):
662-665.
Wong, R. K. and D. K. Vander Veen (2008). "Presentation and Management of congenital
dacryocystocele." Pediatrics 122(5): e1108-e1112.
Woodruff, T. (November 3, 2009 ). The fees war must have Hippocrates turning in his grave. Crikey.
Wormstone, I. M., L. Wang, et al. (2009). "Posterior capsule opacification." Exp Eye Res 88(2): 257-269.
Yang, A. H., W. Jin, et al. (2009). "Changes in visual acuity, axial length, and refraction after removal of
intraocular silicone oil following retinal reattachment surgery in Chinese patients: An open-label,
prospective study." Current Therapeutic Research - Clinical and Experimental 70(3): 221-227.
Yanyali, A., A. F. Nohutcu, et al. (2005). "Modified grid laser photocoagulation versus pars plana
vitrectomy with internal limiting membrane removal in diabetic macular edema." American Journal of
Ophthalmology 139(5): 795-801.
Yassur, Y., R. Axer-Siegel, et al. (1982). "Treatment of neovascular senile maculopathy at the foveal
capillary free zone with red krypton laser." Retina 2(3): 127-133.
Yeatts, R. P. (2000). "Acquired nasolacrimal duct obstruction." Ophthalmology Clinics of North America
13(4): 719-729.
Yeh, S., M. H. Colyer, et al. (2008). "Current trends in the management of intraocular foreign bodies."
Current Opinion in Ophthalmology 19(3): 225-233.
Ying, G.-S., C. Liu, et al. (2005). "Night-Vision Symptoms as a Risk Factor for Vision Loss and Choroidal
Neovascularization in the Complications of Age-related Macular Degeneration Prevention Trial (CAPT)."
Invest Ophthalmol Vis Sci 46(5): 204-.
Young, R. W. (1987). "Pathophysiology of age-related macular degeneration." Surv Ophthalmol 31(5):
291-306.
Zilelioglu, G. and B. M. Hosal (2007). "The results of late probing in congenital nasolacrimal duct
obstruction." Orbit 26(1): 1-3.
Page 286
APPENDIX A: CLINICAL WORKING
GROUP MEMBERSHIP
Alex P. Hunyor
Vitreoretinal / Medical Retina Specialist
Vitreoretinal Unit, Sydney Eye Hospital, NSW
Associate Professor of Ophthalmology and Visual Sciences, Australian School of Advanced
Medicine, Macquarie University
Clinical Senior Lecturer, Retinal Therapeutics Research Group, Save Sight Institute, University of
Sydney
Guy D’Mellow
Glaucoma Specialist
Terrace Eye Centre Brisbane, Qld
Queensland Eye Hospital, Brisbane, Qld
Ophthalmologist to the Greenslopes Hospital
Russell Bach
General/Cataract Specialist
Greenslopes Specialist Centre, Greenslopes, Qld
Ophthalmologist to Princess Alexandra Hospital
Mark Daniell
Cornea Specialist
Head of Ophthalmology, Royal Melbourne Hospital, Vic
Associate Professor, Centre for Eye Research, University of Melbourne
Ophthalmologist to Corneal Unit, Royal Victorian Eye and Ear Hospital
Ophthalmologist to Medical Eye Unit, Royal Melbourne Hospital
Ophthalmologist to Diabetic Clinic, Royal Women’s Hospital
Visiting Specialist, Freemasons Hospital
Craig Donaldson
General Ophthalmologist with special interest in Paediatric Ophthalmology, Strabismus and
Cataract Surgery
Epping and Macquarie Street, Sydney, NSW
Ophthalmologist to the Sydney Eye Hospital
Ophthamologist to Westmead Children’s Hospital
Ophthalmologist to Sydney Children’s Hospital
Ophthalmologist to Epping Surgery Centre
Frank Martin
Paediatric Ophthalmology/Strabismus Specialist
Vision Eye Institute, Chatswood, Cremorne and Sydney, NSW
Adjunct Associate Professor, Department of Paediatrics and Ophthalmology, University of Sydney
Visiting Medical Officer in Ophthalmology, Children’s Hospital, Westmead
Ophthalmologist to the Sydney Eye, Sydney Children’s, and Mater Misericordiae Hospitals
Page 287
APPENDIX B: REFERENCE DATA FOR MBS
DATA ANALYSIS
Australian Bureau of Statistics reference data
Table 80 Age breakdown of Australian population (source: ABS, June 2009)
AGE GROUP
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTAL
PERCENT
6.5%
12.6%
14.0%
14.0%
14.4%
13.8%
11.3%
7.1%
4.5%
1.8%
100.0%
Table 81 Gender breakdown of the Australian population (source: ABS June 2009)
Female
50.2%
Male
49.8%
Table 82 Geographic breakdown of Australian population (source: ABS December 2009)
STATE
New South Wales
Victoria
Queensland
South Australia
Western Australia
Tasmania
Australian Capital Territory
Northern Territory
TOTAL
NUMBER (‘000s)
7191.50
5496.40
4473.00
1633.90
2270.30
505.40
354.90
227.70
22155.40
PERCENT
32.5%
24.8%
20.2%
7.4%
10.2%
2.3%
1.6%
1.0%
100.0%
Table 83 Rurality of Australian population (source: AIHW 2004)1
RRMA
1
2
3
4
5
6
7
1
CLASS
Capital cities
Other metropolitan centre
Large rural centre
Small rural centre
Other rural area
Remote centre
Other remote centre
TOTAL
POP (m)
12.4
1.5
1.2
1.3
2.6
0.2
0.3
19.5
Using Rural, Remote and Metropolitan Areas (RRMA) classification.
Page 288
%
63.6%
7.7%
6.2%
6.7%
13.3%
1.0%
1.5%
100.0%
APPENDIX C: DESCRIPTORS FOR MBS
ITEMS UNDER REVIEW
The MBS services being reviewed are presented in Table 84, along with a description of each
service, and the conditions/diseases for which the service is most relevant or commonly used.
Table 84
Description of MBS Ophthalmological items under review
Conditions/diseases
relevant to the service
MBS
Item
Number
11200
11203
42746
42749
42752
42770
Glaucoma
42771
42782
42783
11204
11205
Various retinal
diseases
11210
11211
Item Descriptor for the Service
PROVOCATIVE TEST OR TESTS FOR
GLAUCOMA, including water drinking
TONOGRAPHY in the investigation or
management of glaucoma, 1 or both eyes using
an electrical tonography machine producing a
directly recorded tracing
GLAUCOMA, filtering operation for
GLAUCOMA, filtering operation for, where
previous filtering operation has been performed
GLAUCOMA, insertion of Molteno valve for, 1 or
more stages
CYCLODESTRUCTIVE procedures for the
treatment of intractable glaucoma, treatment to 1
eye, to a maximum of 2 treatments to that eye in
a 2 year period
CYCLODESTRUCTIVE PROCEDURES for the
treatment of intractable glaucoma, treatment to
one eye - where it can be demonstrated that a
3rd or subsequent treatment to that eye
(including any treatments to which 42770
applies) is indicated in a 2 year period (Anaes.)
LASER TRABECULOPLASTY - each treatment
to 1 eye, to a maximum of 4 treatments to that
eye in a 2 year period
LASER TRABECULOPLASTY - each treatment
to 1 eye - where it can be demonstrated that a
5th or subsequent treatment to that eye
(including any treatments to which item 42782
applies) is indicated in a 2 year period
ELECTRORETINOGRAPHY of one or both eyes
by computerised averaging techniques, including
3 or more studies performed according to
current professional guidelines or standards
ELECTROOCULOGRAPHY of one or both eyes
performed according to current professional
guidelines or standards
PATTERN ELECTRORETINOGRAPHY of one
or both eyes by computerised averaging
techniques, including 3 or more studies
performed according to current professional
guidelines or standards
DARK ADAPTOMETRY of one or both eyes with
a quantitative (log cd/m2) estimation of threshold
Page 289
Type of service
Diagnostic
Therapeutic
Diagnostic
Conditions/diseases
relevant to the service
MBS
Item
Number
Item Descriptor for the Service
Type of service
in log lumens at 45 minutes of dark adaptations
11212
Eye
11215
investigations/diseases
11218
11221
11222
Various eye, retinal,
optic nerve and brain
disorders
11224
OPTIC FUNDI, examination of, following
intravenous dye injection
RETINAL PHOTOGRAPHY, multiple exposures
of 1 eye with intravenous dye injection
RETINAL PHOTOGRAPHY, multiple exposures
of both eyes with intravenous dye injection
FULL QUANTITATIVE COMPUTERISED
PERIMETRY - (automated absolute static
threshold) not being a service involving
multifocal multichannel objective perimetry,
performed by or on behalf of a specialist in the
practice of his or her specialty, where indicated
by the presence of relevant ocular disease or
suspected pathology of the visual pathways or
brain with assessment and report, bilateral - to a
maximum of 2 examinations (including
examinations to which item 11224 applies) in
any 12 month period
FULL QUANTITATIVE COMPUTERISED
PERIMETRY (automated absolute static
threshold) not being a service involving
multifocal multichannel objective perimetry,
performed by or on behalf of a specialist in the
practice of his or her specialty, with assessment
and report, bilateral, where it can be
demonstrated that a further examination is
indicated in the same 12 month period to which
Item 11221 applies due to presence of one of
the following conditions:- established glaucoma (where surgery
may be required within a six month
period) where there has been definite
progression of damage over a 12
month period;
- established neurological disease which
may be progressive and where a visual
field is necessary for the management
of the patient; or
- monitoring for ocular disease or
disease of the visual pathways which
may be caused by systemic drug
toxicity, where there may also be other
disease such as glaucoma or
neurological disease
- each additional examination
FULL QUANTITATIVE COMPUTERISED
PERIMETRY - (automated absolute static
threshold) not being a service involving
multifocal multichannel objective perimetry,
performed by or on behalf of a specialist in the
practice of his or her specialty, where indicated
by the presence of relevant ocular disease or
Page 290
Diagnostic
Diagnostic
Diagnostic
Diagnostic
Conditions/diseases
relevant to the service
MBS
Item
Number
11225
11237
Diagnosis, monitoring
or measurement of
orbital masses or
orbital measurement to
determine intraocular
lens power
11240
11241
11242
Item Descriptor for the Service
suspected pathology of the visual pathways or
brain with assessment and report, unilateral - to
a maximum of 2 examinations (including
examinations to which item 11221 applies) in
any 12 month period
FULL QUANTITATIVE COMPUTERISED
PERIMETRY - (automated absolute static
threshold) not being a service involving
multifocal multichannel objective perimetry,
performed by or on behalf of a specialist in the
practice of his or her specialty, with assessment
and report, unilateral, where it can be
demonstrated that a further examination is
indicated in the same 12 month period to which
item 11224 applies due to presence of one of
the following conditions:- established glaucoma (where surgery
may be required within a 6 month
period) where there has been definite
progression of damage over a 12
month period;
- established neurological disease which
may be progressive and where a visual
field is necessary for the management
of the patient; or
- monitoring for ocular disease or
disease of the visual pathways which
may be caused by systemic drug
toxicity, where there may also be
other disease such as glaucoma or
neurological disease
- each additional examination
OCULAR CONTENTS, simultaneous ultrasonic
echography by both unidimensional and
bidimensional techniques, for the diagnosis,
monitoring or measurement of choroidal and
ciliary body melanomas, retinoblastoma or
suspicious naevi or simulating lesions, one eye,
not being a service associated with a service to
which items in Group I1 apply
ORBITAL CONTENTS, unidimensional
ultrasonic echography or partial coherence
interferometry of, for the measurement of one
eye prior to lens surgery on that eye, not being a
service associated with a service to which items
in Group I1 apply
ORBITAL CONTENTS, unidimensional
ultrasonic echography or partial coherence
interferometry of, for bilateral eye measurement
prior to lens surgery on both eyes, not being a
service associated with a service to which items
in Group I1 apply
ORBITAL CONTENTS, unidimensional
ultrasonic echography or partial coherence
Page 291
Type of service
Diagnostic
Diagnostic
Conditions/diseases
relevant to the service
MBS
Item
Number
11243
42551
42554
42557
Eye trauma
42560
42563
42566
42569
42644
Tarsal cysts/ chalazia
EYEBALL, PERFORATING WOUND OF, not
involving intraocular structures repair involving
suture of cornea or sclera, or both, not being a
service to which item 42632 applies
EYEBALL, PERFORATING WOUND OF, with
incarceration or prolapse of uveal tissue repair
EYEBALL, PERFORATING WOUND OF, with
incarceration of lens or vitreous repair
INTRAOCULAR FOREIGN BODY, magnetic
removal from anterior segment
INTRAOCULAR FOREIGN BODY, nonmagnetic
removal from anterior segment
INTRAOCULAR FOREIGN BODY, magnetic
removal from posterior segment
INTRAOCULAR FOREIGN BODY, nonmagnetic
removal from posterior segment
CORNEA OR SCLERA, removal of imbedded
foreign body from
TARSAL CYST, extirpation of
42610
NASOLACRIMAL TUBE (unilateral), removal or
replacement of, or LACRIMAL PASSAGES,
probing for obstruction, unilateral, with or without
lavage - under general anaesthesia
NASOLACRIMAL TUBE (bilateral), removal or
replacement of, or LACRIMAL PASSAGES,
probing for obstruction, bilateral, with or without
lavage - under general anaesthesia
NASOLACRIMAL TUBE (unilateral), removal or
replacement of, or LACRIMAL PASSAGES,
probing to establish patency of the lacrimal
passage and/or site of obstruction, unilateral,
including lavage, not being a service associated
with a service to which item 42610 applies
(excluding aftercare)
NASOLACRIMAL TUBE (bilateral), removal or
replacement of, or LACRIMAL PASSAGES,
42614
42615
Type of service
interferometry of, for the measurement of an eye
previously measured and on which lens surgery
has been performed, and where further lens
surgery is contemplated in that eye, not being a
service associated with a service to which items
in Group I1 apply
ORBITAL CONTENTS, unidimensional
ultrasonic echography or partial coherence
interferometry of, for the measurement of a
second eye where surgery for the first eye has
resulted in more than 1 dioptre of error or where
more than 3 years have elapsed since the
surgery for the first eye, not being a service
associated with a service to which items in
Group I1 apply
42575
42611
Epiphora /
dacryocystocele (Timo
cyst)
Item Descriptor for the Service
Page 292
Therapeutic
Therapeutic
Therapeutic
Conditions/diseases
relevant to the service
MBS
Item
Number
Item Descriptor for the Service
Type of service
probing to establish patency of the lacrimal
passage and/or site of obstruction, bilateral,
including lavage, not being a service associated
with a service to which item 42611 applies
(excluding aftercare)
42698
42701
42702
42703
Cataract
42704
42707
42710
42713
42716
42719
Removal of vitreous ±
lens
42722
LENS EXTRACTION, excluding surgery
performed for the correction of refractive error
except for anisometropia greater than 3 dioptres
following the removal of cataract in the first eye
ARTIFICIAL LENS, insertion of, excluding
surgery performed for the correction of refractive
error except for anisometropia greater than 3
dioptres following the removal of cataract in the
first eye
LENS EXTRACTION AND INSERTION OF
ARTIFICIAL LENS, excluding surgery performed
for the correction of refractive error except for
anisometropia greater than 3 dioptres following
the removal of cataract in the first eye
ARTIFICIAL LENS, insertion of, into the
posterior chamber and suture to the iris and
sclera
ARTIFICIAL LENS, REMOVAL or
REPOSITIONING of by open operation, not
being a service associated with a service to
which item 42701 applies
ARTIFICIAL LENS, REMOVAL of and
REPLACEMENT with a different lens, excluding
surgery performed for the correction of refractive
error except for anisometropia greater than 3
dioptres following the removal of cataract in the
first eye
ARTIFICIAL LENS, removal of, and replacement
with a lens inserted into the posterior chamber
and sutured to the iris or sclera
INTRAOCULAR LENSES, repositioning of, by
the use of a McCannell suture or similar
CATARACT, JUVENILE, removal of, including
subsequent needlings
CAPSULECTOMY OR REMOVAL OF
VITREOUS, or both, via the anterior chamber by
any method, not being a service associated with
a service to which item 42698, 42702 or 42716
applies
CAPSULECTOMY by posterior chamber
sclerotomy OR REMOVAL OF VITREOUS or
VITREOUS BANDS, or both, from the anterior
chamber by posterior chamber sclerotomy, by
cutting and suction and infusion, not being a
service associated with a service to which item
42698, 42702 or 42716 applies - 1 or both
procedures
Page 293
Therapeutic
Therapeutic
Conditions/diseases
relevant to the service
Retinal detachment,
macular pucker,
diabetic retinopathy,
macular holes, vitreous
haemorrhage or
opacity
MBS
Item
Number
42731
Item Descriptor for the Service
42725
VITRECTOMY by posterior chamber sclerotomy
including the removal of vitreous, division of
bands or removal of preretinal membranes
where performed, by cutting and suction and
infusion
42728
Eye disease
42818
42809
42773
Retinal detachment
42776
42779
42812
Type of service
CAPSULECTOMY or LENSECTOMY, or both,
by posterior chamber sclerotomy in conjunction
with the removal of vitreous or division of
vitreous bands or removal of preretinal
membrane from the posterior chamber by cutting
and suction and infusion, not being a service
associated with any other intraocular operation
Therapeutic
CRYOTHERAPY OF RETINA or other
intraocular structures with an internal probe,
being a service associated with a service to
which item 42725 applies
RETINA, CRYOTHERAPY TO, as an
independent procedure, with external probe
RETINA, photocoagulation of, not being a
service associated with photodynamic therapy
with verteporfin
Therapeutic
DETACHED RETINA, diathermy or cryotherapy
for, not being a service associated with a service
to which item 42776 applies
DETACHED RETINA, buckling or resection
operation for
DETACHED RETINA, revision operation for
DETACHED RETINA, removal of encircling
silicone band from
Therapeutic
Retinal and subretinal
vascular conditionsa,
bacterial, fungal and
viral infections,
intraocular lymphoma,
proliferative
vitreoretinopathy
prophylaxis,
submacular
haemorrhage
42740
PARACENTESIS OF ANTERIOR OR
POSTERIOR SEGMENT (including the vitreous)
OR BOTH, for the injection of therapeutic
substances, or the removal of aqueous or
vitreous for diagnostic purposes, 1 or more of
Complex retinal
detachments
42815
POSTERIOR CHAMBER, removal of silicone oil
from
Therapeutic
Cataract
51315
Assistance at cataract and intraocular lens
surgery covered by item 42698,42701, 42702,
42704 or 42707, when performed in association
with services covered by item 42551 to 42569,
42653, 42656, 42746, 42749, 42752, 42776 or
Therapeutic
Page 294
Diagnostic and
Therapeutic
Conditions/diseases
relevant to the service
MBS
Item
Number
Item Descriptor for the Service
Type of service
42779
eg choroidal neovascularisation, age-related macular degeneration, diabetic macular oedema, diabetic retinopathy,
retinal vein occlusion, and neovascular glaucoma.
a
Page 295
APPENDIX D: DATA ANALYSIS ON
INDIVIDUAL MBS ITEMS
Glaucoma
11200 PROVOCATIVE TEST OR TESTS FOR GLAUCOMA, including water
drinking
Fee: $38.55 Benefit: 75% = $28.95 85% = $32.80
Number of services 1994-2009 – Total 33,847
Cost of Services 2009 = $35,937; Cost of Services Jan – June 2010 = $20,077
Figure 8
MBS item number 11200, number of services (1994 - 2009)
Table 85
MBS item number 11200 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.5%
0.9%
1.4%
2.9%
7.0%
16.0%
22.9%
29.4%
16.2%
2.7%
100.0%
Gender
Female
Male
55.8%
44.2%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
68.9%
5.7%
4.9%
10.7%
2.6%
1.0%
1.9%
4.3%
100.0%
Comments: With glaucoma being largely age-related, and there being an excess of females
over males in the older groups, the gender and age breakdowns are consistent with this.
Page 296
The proportion of services provided in NSW has been much higher than expected for the
population, and lower than expected in Victoria and Queensland (see Table 82). There has
been a marked reduction in the number of services over time.
11203 TONOGRAPHY in the investigation or management of glaucoma, 1 or both eyes
using an electrical tonography machine producing a directly recorded tracing
Fee: $65.15 Benefit: 75% = $48.90 85% = $55.40
Number of services 1994-2009 – Total 8,928
Cost of Services 2009 = $24,201; Cost of Services Jan – June 2010 = $12,496
Figure 9
MBS item number 11203, number of services (1994 - 2009)
Table 86
MBS item number 11203 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.2%
0.6%
2.6%
4.5%
9.6%
17.6%
22.1%
26.4%
14.2%
2.2%
100.0%
Gender
Female
Male
55.3%
44.7%
100.0%
Comments: As for item 11200 above.
Page 297
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
65.5%
5.7%
4.8%
8.9%
4.9%
9.8%
0.4%
0.0%
100.0%
42746 GLAUCOMA, filtering operation for
Fee: $902.55 Benefit: 75% = $676.95
Number of services 1994-2009 – Total 35,416
Cost of Services 2009 = $935,912; Cost of Services Jan – June 2010 = $426,223
Figure 10
MBS item number 42746, number of services (1994 - 2009)
Table 87
MBS item number 42746 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.3%
0.3%
0.3%
0.7%
1.7%
5.2%
13.3%
31.9%
37.5%
8.9%
100.0%
Gender
Female
Male
60.0%
40.0%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
39.8%
21.8%
18.6%
8.1%
7.4%
3.1%
1.0%
0.1%
100.0%
Comments: This glaucoma service predominantly relates to older people, with a higher
proportion of females receiving it than for other related services. The geographic spread is
more consistent with the population breakdown. The number of services has been
relatively constant for the last 5-6 years.
Page 298
42749 GLAUCOMA, filtering operation for, where previous filtering operation has been
performed
Fee: $1,130.05 Benefit: 75% = $847.55
Number of services 1994-2009 – Total 3,830
Cost of Services 2009 = $232,552; Cost of Services Jan – June 2010 = $97,862
Figure 11
MBS item numbers 42749, 42752, 42770 and 42771, number of services (1994 2009)
Table 88
MBS item number 42749 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.7%
0.9%
0.8%
1.0%
3.5%
8.7%
17.0%
30.1%
30.9%
6.3%
100.0%
Gender
Female
Male
55.0%
45.0%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
38.9%
26.8%
17.0%
6.7%
7.0%
2.1%
1.3%
0.3%
100.0%
Comments: This service has a lower frequency than the other major glaucoma services
reported on, and has been fairly consistent over time. It is mainly provided to persons
aged over 55, with a relatively standard mix of gender and geographical location (see Table
88).
Page 299
42752 GLAUCOMA, insertion of Molteno valve for, 1 or more stages
Fee: $1,265.00 Benefit: 75% = $948.75
Number of services 1994-2009 – Total 993 (see Figure 11)
Cost of Services 2009 = $102,964; Cost of Services Jan – June 2010 = $62,080
Table 89
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42752 use (1994 – 2009); by age, gender and state
1.7%
2.9%
4.2%
3.8%
8.1%
16.6%
18.1%
22.2%
18.2%
4.1%
100.0%
Gender
Female
Male
51.8%
48.2%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
100.0%
28.7%
23.4%
18.0%
3.5%
18.1%
5.8%
1.8%
0.6%
100.0%
Comments: This item shows a slight increase in numbers over time. It is received mainly by
older Australians, and applies equally to males and females. Western Australia and
Tasmania show a higher proportion of services than would be expected for their
population sizes (see Table 82).
42770 CYCLODESTRUCTIVE procedures for the treatment of intractable glaucoma,
treatment to 1 eye, to a maximum of 2 treatments to that eye in a 2 year period
Fee: $278.65 Benefit: 75% = $209.00 85% = $236.90
Number of services 1994-2009 – Total 1,990 (see Figure 11)
Cost of Services 2009 = $28,297; Cost of Services Jan – June 2010 = $14,053
Table 90
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42770 use (1994 – 2009); by age, gender and state
1.8%
1.9%
2.8%
2.1%
4.9%
6.2%
14.1%
26.4%
28.5%
11.4%
100.0%
Gender
Female
Male
49.8%
50.2%
100.0%
Page 300
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
23.7%
34.4%
28.4%
3.8%
7.2%
2.0%
0.5%
0.1%
100.0%
Comments: This item shows a small but steady increase in number of services over time. It
is provided especially to those aged over 65, with a mix of gender and location consistent
with Australian demographic data.
42771 CYCLODESTRUCTIVE PROCEDURES for the treatment of intractable glaucoma,
treatment to one eye - where it can be demonstrated that a 3rd or subsequent treatment
to that eye (including any treatments to which 42770 applies) is indicated in a 2 year
period
Fee: $274.35 Benefit: 75% = $205.80 85% = $233.20
Number of services 2002-2009 – Total 25 (see Figure 11)
Cost of Services 2009 = $398; Cost of Services Jan – June 2010 = No services provided.
Table 91
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42771 use (1994 – 2009); by age, gender and state
20.0%
4.0%
4.0%
4.0%
0.0%
8.0%
28.0%
16.0%
16.0%
0.0%
100.0%
Gender
Female
Male
36.0%
64.0%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
16.0%
48.0%
32.0%
0.0%
0.0%
4.0%
0.0%
0.0%
100.0%
Comments: This item commenced in 2002. The number of services per annum has been
very low, so the picture presented by the demographic breakdown is less valid than for
other glaucoma services.
Page 301
Electroretinography
11204 ELECTRORETINOGRAPHY of one or both eyes by computerised averaging
techniques, including 3 or more studies performed according to current professional
guidelines or standards
Fee: $102.30 Benefit: 75% = $76.75 85% = $87.00
Number of services 2001-2009 – Total 15,826
Cost of Services 2009 = $111,019; Cost of Services Jan – June 2010 = $52,474
Figure 12
MBS item numbers 11204 and 11205, number of services (2001 - 2009)
Table 92
MBS item number 11204 use (2001 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
3.1%
10.9%
11.8%
11.8%
14.8%
15.8%
15.4%
11.1%
4.8%
0.6%
100.0%
Gender
Female
Male
58.2%
41.8%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
36.7%
6.4%
7.9%
3.0%
7.3%
37.8%
0.8%
0.1%
100.0%
Comments: This item commenced in 2001, and has remained at a consistent level since
then. There is a higher proportion of women receiving the service, and a spread of ages
similar to that of the total population (see Table 92). Tasmania has provided a
proportionately high number of services, with Victoria and Queensland being relatively
low.
Page 302
11205 ELECTROOCULOGRAPHY of one or both eyes performed according to current
professional guidelines or standards
Fee: $102.30 Benefit: 75% = $76.75 85% = $87.00
Number of services 2001-2009 – Total 54,914 (see Figure 12)
Cost of Services 2009 = $628,700; Cost of Services Jan – June 2010 = $290,132
Table 93
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 11205 use (2001 – 2009); by age, gender and state
0.0%
1.0%
4.0%
8.9%
15.1%
20.1%
22.6%
17.9%
9.4%
1.1%
100.0%
Gender
Female
Male
63.2%
36.8%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
58.3%
17.2%
16.3%
0.3%
6.5%
0.6%
0.6%
0.1%
100.0%
Comment: This item commenced in 2001 with a slight decline in number of services
apparent over the last 3 years. There is a higher proportion of females receiving the
service, with the most common age groups being around 45-64. New South Wales has
provided a higher number of services than suggested by its population (see Table 82).
11210 PATTERN ELECTRORETINOGRAPHY of one or both eyes by computerised averaging
techniques, including 3 or more studies performed according to current professional
guidelines or standards
Fee: $102.30 Benefit: 75% = $76.75 85% = $87.00
Number of services 2001-2009 – Total 3,674
Cost of Services 2009 = $61,469; Cost of Services Jan – June 2010 = $44,726
Figure 13
MBS item numbers 11210 and 11211, number of services (2001 - 2009)
Page 303
Table 94
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 11210 use (2001 – 2009); by age, gender and state
0.5%
9.0%
9.2%
11.9%
15.9%
19.8%
18.0%
10.3%
4.9%
0.4%
100.0%
Gender
Female
Male
63.6%
36.4%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
100.0%
38.6%
2.6%
15.4%
0.3%
41.5%
0.2%
1.3%
0.1%
100.0%
Comment: This item commenced in 2001, and has continued to increase in frequency of
claims. The service was provided to all age groups, with a higher proportion of females
receiving it. Geographically, Western Australia has a much higher percentage of services
than its share of population, while Victoria and South Australia are much lower (ref Table
82).
11211 DARK ADAPTOMETRY of one or both eyes with a quantitative (log cd/m2)
estimation of threshold in log lumens at 45 minutes of dark adaptations
Fee: $102.30 Benefit: 75% = $76.75 85% = $87.00
Number of services 2001-2009 – Total 1,702 (see Figure 13)
Cost of Services 2009 = $18,335; Cost of Services Jan – June 2010 = $7,639
Table 95
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 11211 use (2001 – 2009); by age, gender and state
0.0%
1.5%
2.8%
3.8%
6.0%
15.2%
21.6%
24.0%
20.5%
4.8%
100.0%
Gender
Female
Male
57.9%
42.1%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
46.2%
16.1%
22.1%
3.1%
6.3%
3.2%
2.6%
0.4%
100.0%
Comment: This item commenced in 2001 and has remained consistent at around 200
services per annum. The services have been mainly to those over 55 years, with females
predominating. New South Wales has a higher level of service provision on a per capita
basis (see Table 82).
Page 304
Examination of optic fundi
11212 OPTIC FUNDI, examination of, following intravenous dye injection
Fee: $66.25 Benefit: 75% = $49.70 85% = $56.35
Number of services 1994-2009 – Total 562
Cost of Services 2009 = $1,932; Cost of Services Jan – June 2010 = $654
Figure 14
MBS item numbers 11212, number of services (1994 - 2009)
Table 96
MBS item number 11212 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
1.6%
2.7%
2.3%
4.6%
8.2%
12.1%
14.8%
28.5%
20.6%
4.6%
100.0%
Gender
Female
Male
52.3%
47.7%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
72.1%
8.5%
7.7%
3.2%
4.6%
0.9%
1.8%
1.2%
100.0%
Comments: The trend for this item has been downwards, but with a slight increase since
2005, although numbers still remain low. People over the age of 65 years are the main
recipients, with a relatively even spread between males and females. New South Wales
has dominated the service provision.
Page 305
Retinal photography
11215 RETINAL PHOTOGRAPHY, multiple exposures of 1 eye with intravenous dye
injection
Fee: $116.25 Benefit: 75% = $87.20 85% = $98.85
Number of services 1994-2009 – Total 53,067
Cost of Services 2009 = $159,028; Cost of Services Jan – June 2010 = $60,526
Figure 15
MBS item numbers 11215, number of services (1994 - 2009)
Table 97
MBS item number 11215 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.0%
0.1%
0.6%
1.8%
4.5%
8.1%
13.4%
26.2%
34.6%
10.7%
100.0%
Gender
Female
Male
55.9%
44.1%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
42.7%
10.7%
21.1%
13.1%
8.6%
2.7%
1.0%
0.1%
100.0%
Comments: There has been a fall in the number of services since 2004. It has been
provided to mainly the over 65 age group, which largely accounts for the higher percentage
of females. Geographically, the provision of this service has been roughly in line with the
population spread, with Victoria and Western Australia being lower than expected.
Page 306
11218 RETINAL PHOTOGRAPHY, multiple exposures of both eyes with intravenous dye
injection
Fee: $143.60 Benefit: 75% = $107.70 85% = $122.10
Number of services 1994-2009 – Total 546,390
Cost of Services 2009 = $4,272,233; Cost of Services Jan – June 2010 = $1,937,116
Figure 16
MBS item numbers 11218, number of services (1994 - 2009)
Table 98
MBS item number 11218 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.0%
0.2%
0.8%
2.3%
4.6%
9.3%
16.7%
27.7%
29.8%
8.8%
100.0%
Gender
Female
Male
55.1%
44.9%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
43.2%
22.5%
14.4%
8.0%
7.1%
3.6%
1.0%
0.1%
100.0%
Comments: This item has been relatively constant since 1994, peaking in 2005. It has been
provided mainly to the over 55 age group, and to more females than males.
Page 307
Perimetry
11221 FULL QUANTITATIVE COMPUTERISED PERIMETRY - (automated absolute static
threshold) not being a service involving multifocal multichannel objective perimetry,
performed by or on behalf of a specialist in the practice of his or her specialty, where
indicated by the presence of relevant ocular disease or suspected pathology of the visual
pathways or brain with assessment and report, bilateral - to a maximum of 2
examinations (including examinations to which item 11224 applies) in any 12 month
period
Fee: $64.05 Benefit: 75% = $48.05 85% = $54.45
Number of services 1994-2009 – Total 3,024,057
Cost of Services 2009 = $13,896,053; Cost of Services Jan – June 2010 = $6,978,629
Figure 17
MBS item numbers 11221, number of services (1994 - 2009)
Table 99
MBS item number 11221 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.0%
0.4%
1.1%
1.9%
4.6%
12.0%
21.3%
31.0%
23.2%
4.6%
100.0%
Gender
Female
Male
59.0%
41.0%
100.0%
Page 308
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
40.9%
21.1%
17.4%
9.2%
6.9%
3.2%
1.0%
0.4%
100.0%
Comments: This item has shown a lineal increase in the number of services since 1994.
Those over 55 years have predominantly received the service, with a higher proportion of
females than expected by the Australian demographic breakdown (see Table 81).
11222 FULL QUANTITATIVE COMPUTERISED PERIMETRY (automated absolute static
threshold) not being a service involving multifocal multichannel objective perimetry,
performed by or on behalf of a specialist in the practice of his or her specialty, with
assessment and report, bilateral, where it can be demonstrated that a further
examination is indicated in the same 12 month period to which Item 11221 applies due to
presence of one of the following conditions:
established glaucoma (where surgery may be required within a six month period)
where there has been definite progression of damage over a 12 month period;
 established neurological disease which may be progressive and where a visual field is
necessary for the management of the patient; or
 monitoring for ocular disease or disease of the visual pathways which may be caused
by systemic drug toxicity, where there may also be other disease such as glaucoma or
neurological disease
o each additional examination
Fee: $64.05 Benefit: 75% = $48.05 85% = $54.45
Number of services 1997-2009 – Total 4,884
Cost of Services 2009 = $30,724; Cost of Services Jan – June 2010 = $23,939
Figure 18
MBS item numbers 11222 and 11225, number of services (1997 - 2009)
Page 309
Table 100
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 11222 use (1997 – 2009); by age, gender and state
0.0%
1.3%
4.7%
6.8%
8.4%
14.1%
19.1%
25.2%
17.5%
2.8%
100.0%
Gender
Female
Male
65.6%
34.4%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
47.9%
16.2%
20.1%
7.2%
4.9%
1.3%
2.4%
0.1%
100.0%
Comments: This item commenced in 1997 and has shown an upward trend in the number
of Medicare claims made. The majority are for people in the older age groups, with a
higher proportion of females. Nearly half of the total services have been performed in New
South Wales, which is much higher than would be expected given the Australian
population spread (see Table 82).
11224 FULL QUANTITATIVE COMPUTERISED PERIMETRY - (automated absolute static
threshold) not being a service involving multifocal multichannel objective perimetry,
performed by or on behalf of a specialist in the practice of his or her specialty, where
indicated by the presence of relevant ocular disease or suspected pathology of the visual
pathways or brain with assessment and report, unilateral - to a maximum of 2
examinations (including examinations to which item 11221 applies) in any 12 month
period
Fee: $38.60 Benefit: 75% = $28.95 85% = $32.85
Number of services 1994-2009 – Total 115,341
Cost of Services 2009 = $262,888; Cost of Services Jan – June 2010 = $130,551
Page 310
Figure 19
MBS item number 11224, number of services (1994 - 2009)
Table 101
MBS item number 11224 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.0%
0.3%
0.9%
1.5%
3.3%
7.9%
15.3%
27.5%
32.1%
11.2%
100.0%
Gender
Female
Male
51.3%
48.7%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
38.7%
23.8%
14.8%
13.1%
5.3%
3.2%
0.9%
0.1%
100.0%
Comments: There has been a slight but steady increase in this service since 1994, with
persons aged over 65years being the major recipients.
11225 FULL QUANTITATIVE COMPUTERISED PERIMETRY - (automated absolute static
threshold) not being a service involving multifocal multichannel objective perimetry,
performed by or on behalf of a specialist in the practice of his or her specialty, with
assessment and report, unilateral, where it can be demonstrated that a further
examination is indicated in the same 12 month period to which item 11224 applies due to
presence of one of the following conditions:


established glaucoma (where surgery may be required within a 6 month period) where
there has been definite progression of damage over a 12 month period;
established neurological disease which may be progressive and where a visual field is
necessary for the management of the patient; or
monitoring for ocular disease or disease of the visual pathways which may be caused
by systemic drug toxicity, where there may also be other disease such as glaucoma or
neurological disease
Page 311
o each additional examination
Fee: $38.60 Benefit: 75% = $28.95 85% = $32.85
Number of services 1997-2009 – Total 570 (see graph above for item 11222)
Cost of Services 2009 = $2,406; Cost of Services Jan – June 2010 = $602
Table 102
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 11225 use (1997 – 2009); by age, gender and state
0.0%
1.2%
3.3%
7.0%
5.3%
10.7%
21.1%
24.2%
23.3%
3.9%
100.0%
Gender
Female
Male
62.5%
37.5%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
38.6%
31.6%
7.7%
16.0%
3.7%
1.8%
0.7%
0.0%
100.0%
Comments: This item commenced in 1997, and has been relatively consistent since that
time. People aged over 55 are the main recipients, with females predominating.
Geographically, Queensland and Western Australia have performed fewer services than
would be expected for their population, with Victoria and South Australia being higher than
expected.
Ultrasound biometry
11237 OCULAR CONTENTS, simultaneous ultrasonic echography by both unidimensional
and bidimensional techniques, for the diagnosis, monitoring or measurement of
choroidal and ciliary body melanomas, retinoblastoma or suspicious naevi or simulating
lesions, one eye, not being a service associated with a service to which items in Group I1
apply
Fee: $77.00 Benefit: 75% = $57.75 85% = $65.45
Number of services 2001-2009 – Total 10,111
Cost of Services 2009 = $166,288; Cost of Services Jan – June 2010 = $80,518
Page 312
Figure 20
MBS item numbers 11237, 11242 and 11243, number of services (2001 - 2009)
Table 103
MBS item number 11237 use (2003 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.3%
0.7%
1.2%
3.2%
6.9%
14.2%
26.1%
25.9%
18.4%
3.2%
100.0%
Gender
Female
Male
55.3%
44.7%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
49.6%
28.8%
15.3%
0.2%
1.1%
1.6%
3.3%
0.1%
100.0%
Comments: This item commenced in 2003 and the number of Medicare claims has
increased quickly, with a jump especially in 2008 and 2009. The service is received mainly
by people aged over 55 years, with a slightly higher representation of females. New South
Wales predominates, with South Australia and Western Australia being under-represented.
Page 313
11240 ORBITAL CONTENTS, unidimensional ultrasonic echography or partial coherence
interferometry of, for the measurement of one eye prior to lens surgery on that eye, not
being a service associated with a service to which items in Group I1 apply
Fee: $77.00 Benefit: 75% = $57.75 85% = $65.45
Number of services 1994-2009 – Total 997,874
Cost of Services 2009 = $2,678,912; Cost of Services Jan – June 2010 = $1,278,277
Figure 21
MBS item number 11240, number of services (1994 - 2009)
Table 104
MBS item number 11240 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.0%
0.1%
0.2%
0.4%
1.2%
4.1%
12.1%
33.2%
38.8%
9.9%
100.0%
Gender
Female
Male
61.5%
38.5%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
41.4%
18.7%
19.7%
9.0%
7.3%
2.3%
1.3%
0.3%
100.0%
Comments: According to the MBS, this item only commenced in 1999. The provision of this
service peaked in 2001, with the numbers subsequently declining with the introduction of
new items 11241, 11242 and 11243. The numbers have levelled out over the last 4 years.
Those aged over 65 years, and especially females, are the recipients. The service has been
provided fairly evenly across the states, with NSW being a little higher on a per capita basis.
Page 314
11241 ORBITAL CONTENTS, unidimensional ultrasonic echography or partial coherence
interferometry of, for bilateral eye measurement prior to lens surgery on both eyes, not
being a service associated with a service to which items in Group I1 apply
Fee: $97.95 Benefit: 75% = $73.50 85% = $83.30
Number of services 1994-2009 – Total 468,886
Cost of Services 2009 = $7,048,262; Cost of Services Jan – June 2010 = $3,399,981
Figure 22
MBS item number 11241, number of services (2001 - 2009)
Table 105
MBS item number 11241 use (2001 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.0%
0.1%
0.2%
0.4%
1.2%
4.7%
14.6%
33.6%
37.8%
7.4%
100.0%
Gender
Female
Male
58.9%
41.1%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
35.0%
25.3%
16.9%
6.7%
10.7%
3.5%
1.5%
0.2%
100.0%
Comments: This item commenced in 2001, and shows a steady and regular rate of growth
in numbers of services provided. It is mainly provided to those aged over 65 years, with the
majority being performed on females. The geographic spread is consistent with population
size.
Page 315
11242 ORBITAL CONTENTS, unidimensional ultrasonic echography or partial coherence
interferometry of, for the measurement of an eye previously measured and on which
lens surgery has been performed, and where further lens surgery is contemplated in that
eye, not being a service associated with a service to which items in Group I1 apply
Fee: $75.70 Benefit: 75% = $56.80 85% = $64.35
Number of services 2001-2009 – Total 3055 (see Figure 20)
Cost of Services 2009 = $20,103; Cost of Services Jan – June 2010 = $11,038
Table 106
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 11242 use (2001 – 2009); by age, gender and state
0.0%
0.1%
0.1%
0.3%
1.1%
4.9%
14.6%
32.0%
38.9%
8.0%
100.0%
Gender
Female
Male
60.5%
39.5%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
41.2%
13.2%
26.7%
1.1%
5.1%
11.0%
0.8%
0.7%
100.0%
Comments: This item commenced in 2001, and has remained at a steady level in terms of
numbers of services claimed. It is mainly provided to those aged over 65 years, with the
majority being performed on females. Geographical dispersion is variable, with a
disproportionately higher number of services in NSW, Queensland and Tasmania, and a
lower number in Victoria, South Australia and Western Australia (see Table 82).
11243 ORBITAL CONTENTS, unidimensional ultrasonic echography or partial coherence
interferometry of, for the measurement of a second eye where surgery for the first eye
has resulted in more than 1 dioptre of error or where more than 3 years have elapsed
since the surgery for the first eye, not being a service associated with a service to which
items in Group I1 apply
Fee: $75.70 Benefit: 75% = $56.80 85% = $64.35
Number of services 2001-2009 – Total 7,053 (see Figure 20)
Cost of Services 2009 = $71,895; Cost of Services Jan – June 2010 = $39,064
Page 316
Table 107
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 11243 use (2001 – 2009); by age, gender and state
0.0%
0.0%
0.1%
0.1%
0.6%
2.8%
11.3%
30.2%
42.8%
12.0%
100.0%
Gender
Female
Male
59.3%
40.7%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
33.8%
28.9%
19.2%
4.2%
9.2%
4.1%
0.6%
0.1%
100.0%
Comments: This item commenced in 2001, and grew steadily until 2007, since when it has
levelled off and dropped slightly. It is mainly provided to those aged over 75 years, with the
majority being performed on females, as would be consistent with this age group. The
geographic spread is consistent with population size.
Removal of foreign body
42551 EYEBALL, PERFORATING WOUND OF, not involving intraocular structures repair
involving suture of cornea or sclera, or both, not being a service to which item 42632
applies
Fee: $597.05 Benefit: 75% = $447.80 85% = $527.95
Number of services 1994-2009 – Total 465
Cost of Services 2009 = $9,220; Cost of Services Jan – June 2010 = $7,946
Figure 23
MBS item numbers 42551, 42554 and 42557, number of services (1994 - 2009)
Page 317
Table 108
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42551 use (1994 – 2009); by age, gender and state
3.2%
9.2%
9.9%
10.8%
16.6%
14.0%
13.5%
10.5%
10.8%
1.5%
100.0%
Gender
Female
Male
27.7%
72.3%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
100.0%
39.1%
16.3%
17.2%
11.4%
8.0%
5.2%
1.7%
1.1%
100.0%
Comments: This item has fluctuated over time, but shows only a small number of services,
averaging about 25 over the last 5 years. The service is provided across all age groups and
geographic areas, with a disproportionate number of males requiring it.
42554 EYEBALL, PERFORATING WOUND OF, with incarceration or prolapse of
uveal tissue repair
Fee: $696.50 Benefit: 75% = $522.40
Number of services 1994-2009 – Total 426 (see Figure 23)
Cost of Services 2009 = $ 7,044; Cost of Services Jan – June 2010 = $2,743
Table 109
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42554 use (1994 – 2009); by age, gender and state
7.7%
13.1%
9.9%
6.1%
12.0%
12.9%
11.3%
9.2%
12.2%
5.6%
100.0%
Gender
Female
Male
30.8%
69.2%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
42.0%
21.1%
19.2%
6.1%
6.3%
3.8%
1.2%
0.2%
100.0%
Comments: This item shows a variable, but slightly declining, pattern of relatively low use.
It is mainly performed on males, across all age groups.
Page 318
42557 EYEBALL, PERFORATING WOUND OF, with incarceration of lens or vitreous repair
Fee: $973.65 Benefit: 75% = $730.25
Number of services 1994-2009 – Total 545 (see Figure 23)
Cost of Services 2009 = $21,334; Cost of Services Jan – June 2010 = $4,564
Table 110
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42557 use (1994 – 2009); by age, gender and state
4.2%
11.9%
9.2%
6.4%
13.2%
13.8%
12.5%
10.1%
11.9%
6.8%
Gender
Female
Male
28.8%
71.2%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
40.6%
18.9%
19.3%
5.9%
10.3%
5.0%
0.2%
0.0%
100.0%
Comments: This service has been performed, on average, around 30 times per annum. It
has been received by all ages, with a predominance of males. As for the other 2 items
relating to perforating wounds of the eyeball, the geographic spread of claims has been
consistent with the Australian population.
42560 INTRAOCULAR FOREIGN BODY, magnetic removal from anterior segment
Fee: $383.80 Benefit: 75% = $287.85 85% = $326.25
Number of services 1994-2009 – Total 61
Cost of Services 2009 = $319; Cost of Services Jan – June 2010 = $1,689
Figure 24
MBS item numbers 42560, 42563, 42566 and 42569, number of services (1994 2009)
Page 319
Table 111
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42560 use (1994 – 2009); by age, gender and state
0.0%
8.2%
3.3%
13.1%
16.4%
16.4%
23.0%
13.1%
6.6%
0.0%
100.0%
Gender
Female
Male
21.3%
78.7%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
100.0%
31.1%
21.3%
29.5%
8.2%
6.6%
3.3%
0.0%
0.0%
100.0%
Comments: This item has very low numbers of Medicare claims each year, and is a service
provided across most age groups and states, especially to males.
42563 INTRAOCULAR FOREIGN BODY, nonmagnetic removal from anterior segment
Fee: $490.45 Benefit: 75% = $367.85 85% = $421.35
Number of services 1994-2009 – Total 265 (see Figure 24)
Cost of Services 2009 = $9,820; Cost of Services Jan – June 2010 = $3,935
Table 112
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42563 use (1994 – 2009); by age, gender and state
1.1%
2.6%
6.4%
7.5%
7.9%
18.1%
13.2%
20.8%
18.1%
4.2%
100.0%
Gender
Female
Male
35.5%
64.5%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
31.3%
21.9%
28.3%
6.0%
7.5%
3.8%
1.1%
0.0%
100.0%
Comments: This item shows greater variability in number of services, but only a relatively
low number each year. As for the other items in this group, it applies to all ages,
predominately males, and across all states.
Page 320
42566 INTRAOCULAR FOREIGN BODY, magnetic removal from posterior segment
Fee: $696.50 Benefit: 75% = $522.40
Number of services 1994-2009 – Total 48 (see Figure 24)
Cost of Services 2009 = $70; Cost of Services Jan – June 2010 = $0
Table 113
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42566 use (1994 – 2009); by age, gender and state
0.0%
2.1%
8.3%
22.9%
25.0%
16.7%
14.6%
8.3%
2.1%
0.0%
100.0%
Gender
Female
Male
8.3%
91.7%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
100.0%
31.3%
27.1%
18.8%
2.1%
8.3%
8.3%
2.1%
2.1%
100.0%
Comments: There has been a small and consistent number of services provided, especially
to younger and middle-aged persons, and primarily males.
42569 INTRAOCULAR FOREIGN BODY, nonmagnetic removal from posterior segment
Fee: $973.65 Benefit: 75% = $730.25
Number of services 1994-2009 – Total 104 (see Figure 24)
Cost of Services 2009 = $3,360; Cost of Services Jan – June 2010 = $2,051
Table 114
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42569 use (1994 – 2009); by age, gender and state
0.0%
3.8%
8.7%
6.7%
16.3%
17.3%
11.5%
18.3%
14.4%
2.9%
100.0%
Gender
Female
Male
24.0%
76.0%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
52.9%
11.5%
18.3%
4.8%
5.8%
5.8%
1.0%
0.0%
100.0%
Comments: There has been some increase in the number of services since 2004, but the
figures are still relatively low. The service has been provided across most age groups,
predominately to males, and especially in NSW.
Page 321
Removal of foreign body from cornea or sclera
42644 CORNEA OR SCLERA, removal of imbedded foreign body from - not more than
once on the same day by the same practitioner (excluding aftercare)
Fee: $68.15 Benefit: 75% = $51.15 85% = $57.95
Number of services 1994-2009 – Total 644,441
Cost of Services 2009 = $1,646,748; Cost of Services Jan – June 2010 = $772,523
Figure 25
MBS item number 42644, number of services (1994 - 2009)
Table 115
MBS item number 42644 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.7%
3.7%
14.4%
23.2%
23.4%
17.0%
10.2%
5.1%
1.8%
0.3%
100.0%
Gender
Female
Male
12.2%
87.8%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
29.9%
20.0%
28.8%
8.8%
8.6%
2.5%
0.8%
0.6%
100.0%
Comments: The number of services for this item has declined steadily since the mid-1990s.
The majority have been performed on males, with ages mainly from the teens until the
60s.
Page 322
Extirpation of tarsal cyst
42575 TARSAL CYST, extirpation of
Fee: $78.20 Benefit: 75% = $58.65 85% = $66.50
Number of services 1994-2009 – Total 301,696
Cost of Services 2009 = $1,093,123; Cost of Services Jan – June 2010 = $502,507
Figure 26
MBS item number 42575, number of services (1994 - 2009)
Table 116
MBS item number 42575 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
1.6%
4.3%
9.7%
11.8%
17.6%
19.9%
15.3%
12.0%
6.5%
1.3%
100.0%
Gender
Female
Male
52.8%
47.2%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
38.6%
26.0%
13.3%
10.1%
8.3%
2.3%
1.2%
0.2%
100.0%
Comments: There has been a steady and consistent number of Medicare claims made for
this item. The service applies to all age groups, and its application across gender and state
is in accordance with Australian population data.
Page 323
Lacrimal passages
42610 NASOLACRIMAL TUBE (unilateral), removal or replacement of, or LACRIMAL
PASSAGES, probing for obstruction, unilateral, with or without lavage - under general
anaesthesia
Fee: $90.95 Benefit: 75% = $68.25 85% = $77.35
Number of services 1994-2009 – Total 8,734
Cost of Services 2009 = $36,624; Cost of Services Jan – June 2010 = $17,898
Figure 27
MBS item numbers 42610 and 42611, number of services (1994 - 2009)
Table 117
MBS item number 42610 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
60.3%
3.0%
0.7%
2.2%
2.5%
4.5%
6.8%
9.9%
7.9%
2.2%
100.0%
Gender
Female
Male
56.2%
43.8%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
30.7%
20.3%
19.7%
6.4%
15.5%
6.1%
1.1%
0.2%
100.0%
Comments: The number of services provided for this item has been steady over time.
Children under 4 years are the main recipients, with elderly people being the next most
common. It has been performed on proportionately more females, and across all states,
with a slightly higher percentage in WA and Tasmania than would be expected, given the
Australian population distribution (see Table 82).
Page 324
42611 NASOLACRIMAL TUBE (bilateral), removal or replacement of, or LACRIMAL
PASSAGES, probing for obstruction, bilateral, with or without lavage - under general
anaesthesia
Fee: $136.40 Benefit: 75% = $102.30 85% = $115.95
Number of services 1994-2009 – Total 9,964 (see graph above)
Cost of Services 2009 = $28,696; Cost of Services Jan – June 2010 = $16,116
Table 118
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42611 use (1994 – 2009); by age, gender and state
49.1%
1.8%
0.4%
1.5%
2.0%
4.2%
8.0%
17.4%
12.2%
3.3%
100.0%
Gender
Female
Male
56.2%
43.8%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
24.6%
30.0%
23.1%
6.9%
7.9%
3.2%
3.8%
0.6%
100.0%
Comments: There was a dramatic decline in provision of this service from 1994 to 1998,
since when the numbers have been relatively steady (possibly related to amendments
made to the item in 1998). The service has been provided mainly to children under 4 years,
followed by those over 65 years, with females receiving a slightly higher number.
Page 325
42614 NASOLACRIMAL TUBE (unilateral), removal or replacement of, or LACRIMAL
PASSAGES, probing to establish patency of the lacrimal passage and/or site of
obstruction, unilateral, including lavage, not being a service associated with a service to
which item 42610 applies (excluding aftercare)
Fee: $45.65 Benefit: 75% = $34.25 85% = $38.85
Number of services 1994-2009 – Total 170,900
Cost of Services 2009 = $316,459; Cost of Services Jan – June 2010 = $151,737
Figure 28
MBS item numbers 42614 and 42615, number of services (1994 - 2009)
Table 119
MBS item number 42614 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.3%
0.3%
1.0%
1.8%
4.2%
9.6%
18.4%
30.1%
27.0%
7.2%
100.0%
Gender
Female
Male
67.0%
33.0%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
36.8%
28.8%
12.4%
11.3%
6.7%
2.5%
1.4%
0.1%
100.0%
Comments: This item shows a slight decline in usage over time, but with numbers of
services being fairly steady in recent years. It applies primarily to those aged over 55 years,
with a preponderance of females receiving the service.
Page 326
42615 NASOLACRIMAL TUBE (bilateral), removal or replacement of, or LACRIMAL
PASSAGES, probing to establish patency of the lacrimal passage and/or site of
obstruction, bilateral, including lavage, not being a service associated with a service to
which item 42611 applies (excluding aftercare)
Fee: $68.25 Benefit: 75% = $51.20 85% = $58.05
Number of services 1994-2009 – Total 145,424 (see graph above)
Cost of Services 2009 = $666,298; Cost of Services Jan – June 2010 = $297,221
Table 120
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42615 use (1994 – 2009); by age, gender and state
0.2%
0.2%
0.5%
1.0%
2.9%
7.9%
18.0%
32.8%
28.8%
7.6%
100.0%
Gender
Female
Male
62.8%
37.2%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
45.0%
26.4%
11.8%
8.0%
4.9%
2.1%
1.6%
0.2%
100.0%
Comments: There has been a steady increase in the number of these services provided and
Medicare claims made. Persons aged over 65 are the major recipients, with the majority
being females. New South Wales has performed a proportionately higher number of
services than would be expected, with Queensland and Western Australia being a little
lower.
Cataract surgery
42698 LENS EXTRACTION, excluding surgery performed for the correction of refractive
error except for anisometropia greater than 3 dioptres following the removal of cataract
in the first eye
Fee: $572.20 Benefit: 75% = $429.15 85% = $503.10
Number of services 1994-2009 – Total 160,910
Cost of Services 2009 = $85,691; Cost of Services Jan – June 2010 = $25,486
Page 327
Figure 29
MBS item number 42698, number of services (1994 - 2009)
Table 121
MBS item number 42698 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.0%
0.1%
0.2%
0.3%
1.1%
3.9%
10.7%
31.4%
40.5%
11.8%
100.0%
Gender
Female
Male
64.8%
35.2%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
32.0%
23.7%
24.2%
9.3%
6.6%
3.0%
0.8%
0.2%
100.0%
Comments: There was a dramatic drop in the number of these services from around 55,000
in1996 to a few hundred only in subsequent years. This appears to be connected to the
introduction of the new/replacement item 42702. The item has related mainly to persons
aged over 65 years, especially females.
42701 ARTIFICIAL LENS, insertion of, excluding surgery performed for the correction of
refractive error except for anisometropia greater than 3 dioptres following the removal
of cataract in the first eye
Fee: $319.10 Benefit: 75% = $239.35 85% = $271.25
Number of services 1994-2009 – Total 163,029
Cost of Services 2009 = $74,570; Cost of Services Jan – June 2010 = $33,659
Page 328
Figure 30
MBS item number 42701, number of services (1994 - 2009)
Table 122
MBS item number 42701 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.1%
0.2%
0.3%
0.4%
1.2%
4.0%
10.7%
31.2%
40.2%
11.7%
100.0%
Gender
Female
Male
64.6%
35.4%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
31.8%
24.0%
24.2%
9.3%
6.7%
3.0%
0.8%
0.2%
100.0%
Comments: As with item 42698, there was a dramatic drop in the number of these services
from around 55,000 in1996 to a few hundred only in subsequent years.
Page 329
42702 LENS EXTRACTION AND INSERTION OF ARTIFICIAL LENS, excluding surgery
performed for the correction of refractive error except for anisometropia greater than 3
dioptres following the removal of cataract in the first eye
Fee: $731.80 Benefit: 75% = $548.85 85% = $662.70
Number of services 1996-2009 – Total 1,262,741
Cost of Services 2009 = $88,350,739; Cost of Services Jan – June 2010 = $32,721,970
Figure 31
MBS item number 42702, number of services (1996 - 2009)
Table 123
MBS item number 42702 use (1996 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.0%
0.0%
0.1%
0.2%
0.8%
4.0%
13.2%
32.8%
39.7%
9.2%
100.0%
Gender
Female
Male
61.1%
38.9%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
33.8%
22.6%
23.8%
8.0%
7.2%
3.2%
1.2%
0.3%
100.0%
Comments: This item commenced in 1996, as a combined replacement for items 42698
(lens extraction) and 42701 (lens insertion). From 1999, the number of services has been
increasing quickly, having doubled in 10 years. The service is mainly received by those aged
over 65 years, with females being over-represented. The geographical spread of services is
consistent with the Australian population.
Page 330
42703 ARTIFICIAL LENS, insertion of, into the posterior chamber and suture to the iris
and sclera
Fee: $540.65 Benefit: 75% = $405.50 85% = $471.55
Number of services 1996-2009 – Total 1,293
Cost of Services 2009 = $42,859; Cost of Services Jan – June 2010 = $16,030
Figure 32
MBS item number 42703, number of services (1996 - 2009)
Table 124
MBS item number 42703 use (1996 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.9%
3.2%
4.3%
4.9%
7.2%
11.8%
16.9%
23.4%
21.3%
6.3%
100.0%
Gender
Female
Male
42.8%
57.2%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
27.0%
8.7%
43.5%
3.6%
11.2%
4.5%
0.9%
0.6%
100.0%
Comments: This item commenced in 1996, and has continued at around 100 services per
annum. It appears to have partly replaced item 42701. Persons over 65 years are the
major recipients, with males constituting a higher percentage than would be expected.
There is a disproportionately high percentage of services being performed in Queensland,
with Victoria being particularly low.
Page 331
42704 ARTIFICIAL LENS, REMOVAL or REPOSITIONING of by open operation, not being a
service associated with a service to which item 42701 applies
Fee: $440.50 Benefit: 75% = $330.40 85% = $374.45
Number of services 1994-2009 – Total 3,408
Cost of Services 2009 = $116,771; Cost of Services Jan – June 2010 = $62,902
Figure 33
MBS item numbers 42704, 42707 and 42710, number of services (1994 - 2009)
Table 125
MBS item number 42704 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.2%
0.5%
1.2%
1.9%
4.4%
8.1%
15.5%
28.5%
31.6%
8.1%
100.0%
Gender
Female
Male
50.2%
49.8%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
36.8%
19.3%
24.0%
7.7%
7.6%
3.2%
0.9%
0.4%
100.0%
Comments: Performance of this item rose steadily until 2005, then increased at a faster
rate. Persons over 65 years have received the majority of services, with an even mix of
males and females, and geographic spread.
42707 ARTIFICIAL LENS, REMOVAL of and REPLACEMENT with a different lens, excluding
surgery performed for the correction of refractive error except for anisometropia greater
than 3 dioptres following the removal of cataract in the first eye
Fee: $753.35 Benefit: 75% = $565.05 85% = $684.25
Number of services 1994-2009 – Total 3,786 (see graph above)
Cost of Services 2009 = $173,454; Cost of Services Jan – June 2010 = $83,564
Page 332
Table 126
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42707 use (1994 – 2009); by age, gender and state
0.1%
0.2%
0.6%
0.8%
3.6%
10.2%
20.2%
27.5%
28.9%
8.0%
100.0%
Gender
Female
Male
52.0%
48.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
100.0%
31.6%
23.4%
23.8%
6.3%
7.4%
5.5%
1.7%
0.3%
100.0%
Comments: This item has increased steadily over time, and has been received especially by
those aged over 55 years, with an even mix of gender and geographical dispersion.
42710 ARTIFICIAL LENS, removal of, and replacement with a lens inserted into the
posterior chamber and sutured to the iris or sclera
Fee: $852.80 Benefit: 75% = $639.60 85% = $783.70
Number of services 1994-2009 – Total 1,233 (see graph above)
Cost of Services 2009 = $33,697; Cost of Services Jan – June 2010 = $25,624
Table 127
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42710 use (1994 – 2009); by age, gender and state
0.2%
0.2%
1.0%
1.6%
3.8%
7.1%
14.3%
26.8%
33.0%
12.1%
100.0%
Gender
Female
Male
48.3%
51.7%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
36.4%
8.9%
41.1%
0.7%
7.9%
2.8%
1.8%
0.3%
100.0%
Comments: The number of services for this item has been relatively low and static over the
past 16 years. It predominantly relates to those aged over 65 years, with a slightly higher
proportion of males receiving the service. Geographically, the percentage of services
provided in Queensland is much higher than would be expected, given the Australian
population spread, with Victoria and South Australia in particular being much lower.
Page 333
42713 INTRAOCULAR LENSES, repositioning of, by the use of a McCannell suture or
similar
Fee: $355.35 Benefit: 75% = $266.55 85% = $302.05
Number of services 1994-2009 – Total 290
Cost of Services 2009 = $5,526; Cost of Services Jan – June 2010 = $3,265
Figure 34
MBS item number 42713, number of services (1994 - 2009)
Table 128
MBS item number 42713 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.7%
3.1%
0.7%
2.4%
3.4%
9.3%
18.3%
26.6%
27.9%
7.6%
100.0%
Gender
Female
Male
48.3%
51.7%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
35.5%
19.0%
24.1%
5.5%
11.7%
2.8%
1.0%
0.3%
100.0%
Comments: There has been only a small number of services performed for this item,
largely to those aged over 65, with a slightly higher percentage of males than would be
expected.
Page 334
42716 CATARACT, JUVENILE, removal of, including subsequent needlings
Fee: $1,130.05 Benefit: 75% = $847.55 85% = $1,060.95
Number of services 1994-2009 – Total 1,020
Cost of Services 2009 = $43,906; Cost of Services Jan – June 2010 = $25,360
Figure 35
MBS item number 42716, number of services (1994 - 2009)
Table 129
MBS item number 42716 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
Unknown
TOTALS
55.4%
34.8%
6.2%
0.5%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
3.1%
100.0%
Gender
Female
Male
47.8%
52.2%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
29.6%
23.5%
19.7%
5.5%
14.4%
4.4%
1.7%
1.2%
100.0%
Comments: This item shows a small but steady number of services over the analysis
period. It applies to children, with over half being performed on those under 5. The gender
and geographical spreads for receipt of the service are fairly consistent with Australian
demographic data.
Page 335
Capsulectomy and lensectomy
42719 CAPSULECTOMY OR REMOVAL OF VITREOUS, or both, via the anterior chamber by
any method, not being a service associated with a service to which item 42698, 42702 or
42716 applies
Fee: $490.45 Benefit: 75% = $367.85 85% = $421.35
Number of services 1994-2009 – Total 3,078
Cost of Services 2009 = $56,355; Cost of Services Jan – June 2010 = $24,841
Figure 36
MBS item numbers 42719, 42722 and 42731, number of services (1994 - 2009)
Table 130
MBS item number 42719 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
1.8%
1.0%
0.7%
1.8%
3.1%
6.5%
12.5%
29.3%
33.3%
9.9%
100.0%
Gender
Female
Male
56.0%
44.0%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
52.8%
13.5%
14.6%
5.2%
10.0%
2.3%
1.2%
0.4%
100.0%
Comments: This item has demonstrated a slight decline in number of services over time.
Persons over 65 years have been the major recipients, with females receiving a higher
percentage, but consistent with age. New South Wales has provided a disproportionately
higher number of services than would be expected, with Victoria and Queensland being a
little lower.
Page 336
42722 CAPSULECTOMY by posterior chamber sclerotomy OR REMOVAL OF VITREOUS or
VITREOUS BANDS, or both, from the anterior chamber by posterior chamber sclerotomy,
by cutting and suction and infusion, not being a service associated with a service to
which item 42698, 42702 or 42716 applies - 1 or both procedures
Fee: $536.50 Benefit: 75% = $402.40
Number of services 1994-2009 – Total 1,107 (see graph above)
Cost of Services 2009 = $26,603; Cost of Services Jan – June 2010 = $9,754
Table 131
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42722 use (1994 – 2009); by age, gender and state
0.5%
0.5%
0.5%
2.3%
3.6%
7.4%
20.5%
32.8%
26.5%
5.5%
100.0%
Gender
Female
Male
47.9%
52.1%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
84.3%
3.5%
4.7%
0.5%
0.7%
1.2%
4.9%
0.3%
100.0%
Comments: This item had a very small number of Medicare claims until 2005, when it
increased at a higher rate, although dropped off somewhat in 2009. Persons aged over 55
years have primarily received the service, with a slightly higher representation of males
than would otherwise be expected. Geographically, the provision of this service has been
dominated by New South Wales and ACT.
42731 CAPSULECTOMY or LENSECTOMY, or both, by posterior chamber sclerotomy in
conjunction with the removal of vitreous or division of vitreous bands or removal of
preretinal membrane from the posterior chamber by cutting and suction and infusion,
not being a service associated with any other intraocular operation
Fee: $1,435.60 Benefit: 75% = $1,076.70
Number of services 1994-2009 – Total 4,071 (see graph above)
Cost of Services 2009 = $134,836; Cost of Services Jan – June 2010 = $70,310
Page 337
Table 132
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42731 use (1994 – 2009); by age, gender and state
1.9%
1.5%
2.4%
2.4%
4.9%
9.3%
15.8%
28.1%
26.8%
6.8%
100.0%
Gender
Female
Male
47.9%
52.1%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
24.2%
26.7%
34.7%
5.9%
6.2%
1.4%
0.5%
0.4%
100.0%
Comments: The provision of this item has been declining steadily since 1998. The majority
of patients receiving the service are aged over 65 years, with a slightly higher
representation of males than would otherwise be expected. In terms of geographic
location, a higher percentage of services has been performed in Queensland, with NSW
and WA being somewhat lower than expected, given the Australian population spread (see
Table 82).
Page 338
Vitrectomy
42725 VITRECTOMY by posterior chamber sclerotomy including the removal of vitreous,
division of bands or removal of preretinal membranes where performed, by cutting and
suction and infusion
Fee: $1,265.00 Benefit: 75% = $948.75
Number of services 1994-2009 – Total 53,093
Cost of Services 2009 = $6,199,889; Cost of Services Jan – June 2010 = $3,164,950
Figure 37
MBS item number 42725, number of services (1994 - 2009)
Table 133
MBS item number 42725 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.2%
0.5%
1.3%
2.4%
4.5%
10.8%
25.7%
33.0%
18.7%
2.9%
100.0%
Gender
Female
Male
47.4%
52.6%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
36.8%
20.1%
24.1%
4.6%
9.1%
3.4%
1.6%
0.3%
100.0%
Comments: This item has shown a lineal increase in the number of services provided over
time. It has been performed primary on those aged over 65 years, with a slightly higher
percentage of males. The geographical spread has been in line with the Australian
population.
Page 339
Cryotherapy of retina
42728 CRYOTHERAPY OF RETINA or other intraocular structures with an internal probe,
being a service associated with a service to which item 42725 applies
Fee: $213.30 Benefit: 75% = $160.00
Number of services 1994-2009 – Total 689
Cost of Services 2009 = $8,502; Cost of Services Jan – June 2010 = $5,247
Figure 38
MBS item number 42728, number of services (1994 - 2009)
Table 134
MBS item number 42728 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
1.3%
1.7%
1.9%
3.6%
4.6%
10.3%
23.7%
31.2%
18.7%
2.9%
100.0%
Gender
Female
Male
47.8%
52.2%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
23.1%
17.4%
9.7%
22.2%
9.4%
17.3%
0.4%
0.4%
100.0%
Comments: This item has attracted a relatively small number of claims over the analysis
period, although it has increased at a much faster rate since 2003. It is primarily provided
to those aged over 55 years, to a slightly higher percentage of males than expected. Service
provision has also been at a much higher rate than would be expected in South Australia
and Tasmania and lower in NSW and Queensland, given the Australian population
distribution.
Page 340
Retinal services
42773 DETACHED RETINA, diathermy or cryotherapy for, not being a service associated
with a service to which item 42776 applies
Fee: $852.80 Benefit: 75% = $639.60 85% = $783.70
Number of services 1994-2009 – Total 23,376
Cost of Services 2009 = $1,107,576; Cost of Services Jan – June 2010 = $544,034
Figure 39
MBS item number 42773, number of services (1994 - 2009)
Table 135
MBS item number 42773 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.1%
0.5%
1.2%
2.5%
4.6%
12.0%
28.8%
32.0%
16.1%
2.3%
100.0%
Gender
Female
Male
46.2%
53.8%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
53.6%
13.7%
24.0%
0.9%
3.3%
1.8%
2.6%
0.1%
100.0%
Comments: The provision of this item has increased sharply and consistently since 1997.
The service has been received especially by those aged over 55 years, by a slightly higher
proportion of males than expected in that age group. A higher percentage of services were
provided in NSW, with Victoria, SA and WA being much lower than expected, given the
population spread (see Table 82).
Page 341
42776 DETACHED RETINA, buckling or resection operation for
Fee: $1,265.00 Benefit: 75% = $948.75
Number of services 1994-2009 – Total 15,884
Cost of Services 2009 = $475,882; Cost of Services Jan – June 2010 = $248,110
Figure 40
MBS item number 42776, number of services (1994 - 2009)
Table 136
MBS item number 42776 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.2%
1.3%
3.5%
5.5%
8.2%
18.5%
27.0%
22.4%
11.4%
1.9%
100.0%
Gender
Female
Male
38.0%
62.0%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
32.0%
16.8%
28.4%
10.1%
8.3%
2.2%
1.5%
0.6%
100.0%
Comments: This item has shown a steady decline in number of services claimed over time.
The most common groups receiving it have been in the middle- and older-age groups, with
males being over-represented. The geographic spread of services is roughly consistent
with population size, although a little lower in Victoria than would be expected.
Page 342
42779 DETACHED RETINA, revision operation for
Fee: $1,577.80 Benefit: 75% = $1,183.35
Number of services 1994-2009 – Total 3,288
Cost of Services 2009 = $432,057; Cost of Services Jan – June 2010 = $184,014
Figure 41
MBS item number 42779, number of services (1994 - 2009)
Table 137
MBS item number 42779 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.2%
1.0%
3.0%
3.4%
7.8%
15.4%
28.2%
25.7%
13.6%
1.8%
100.0%
Gender
Female
Male
34.9%
65.1%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
38.6%
17.6%
17.2%
11.4%
6.8%
6.2%
1.9%
0.3%
100.0%
Comments: The provision of this item has increased dramatically since 2006, after having a
steady level of Medicare claims for the previous decade. Those aged over 55 years are the
major recipients of the service, with a predominance of males.
Page 343
42812 DETACHED RETINA, removal of encircling silicone band from
Fee: $156.35 Benefit: 75% = $117.30 85% = $132.90
Number of services 1994-2009 – Total 1,511
Cost of Services 2009 = $8,884; Cost of Services Jan – June 2010 = $3,997
Figure 42
MBS item number 42812, number of services (1994 - 2009)
Table 138
MBS item number 42812 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.3%
1.0%
3.2%
5.3%
9.1%
14.6%
26.2%
24.7%
13.5%
2.1%
100.0%
Gender
Female
Male
43.1%
56.9%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
34.4%
24.8%
14.6%
11.8%
6.8%
3.7%
3.5%
0.4%
100.0%
Comments: This item has been relatively constant in terms of number of services claimed.
As for the other items in the group, it tends to be more commonly provided to those aged
over 55 years, and to males.
Page 344
42818 RETINA, CRYOTHERAPY TO, as an independent procedure, with external probe
Fee: $554.25 Benefit: 75% = $415.70 85% = $485.15
Number of services 1994-2009 – Total 4,451
Cost of Services 2009 = $69,176; Cost of Services Jan – June 2010 = $35,522
Figure 43
MBS item number 42818, number of services (1994 - 2009)
Table 139
MBS item number 42818 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
2.6%
1.5%
2.3%
3.3%
5.7%
15.3%
33.8%
26.6%
7.5%
1.5%
100.0%
Gender
Female
Male
41.9%
58.1%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
36.6%
25.1%
24.8%
6.9%
3.2%
1.8%
1.5%
0.2%
100.0%
Comments: The provision of this item has declined steadily over the last 16 years, the
number of services per annum halving over that time period. Those aged 55-74 years are
the most common recipients, and again, males predominate. The service has been
provided across all states, with Western Australia’s percentage being somewhat lower than
expected, in comparison with population spread.
Page 345
Intra-vitreal injection
42740 PARACENTESIS OF ANTERIOR OR POSTERIOR SEGMENT (including the vitreous)
OR BOTH, for the injection of therapeutic substances, or the removal of aqueous or
vitreous for diagnostic purposes, 1 or more of
Fee: $284.25 Benefit: 75% = $213.20 85% = $241.65
Number of services 1994-2009 – Total 277,576
Cost of Services 2009 = $24,915,656; Cost of Services Jan – June 2010 = $16,351,953
Figure 44
MBS item number 42740, number of services (1994 - 2009)
Table 140
MBS item number 42740 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.0%
0.1%
0.3%
0.8%
1.6%
4.0%
11.1%
24.0%
41.6%
16.4%
100.0%
Gender
Female
Male
58.4%
41.6%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
44.2%
15.9%
18.4%
6.2%
10.7%
3.2%
1.3%
0.1%
100.0%
Comments: This item description changed in 2006, and subsequently shows a dramatic
increase (nearly 20-fold) in the number of services claimed. Persons aged over 65 have
received the most services, with a higher percentage of females. Based on population
spread, New South Wales has a higher-than-expected share of the total, with Victoria being
lower than expected.
Page 346
Laser trabeculoplasty
42782 LASER TRABECULOPLASTY - each treatment to 1 eye, to a maximum of 4
treatments to that eye in a 2 year period
Fee: $426.35 Benefit: 75% = $319.80 85% = $362.40
Number of services 1994-2009 – Total 205,725
Cost of Services 2009 = $8,813,409; Cost of Services Jan – June 2010 = $4,252,058
Figure 45
MBS item number 42782, number of services (1994 - 2009)
Table 141
MBS item number 42782 use (1994 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.0%
0.0%
0.1%
0.5%
1.9%
7.6%
18.3%
34.3%
30.1%
7.3%
100.0%
Gender
Female
Male
58.2%
42.8%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
49.6%
16.6%
13.6%
11.9%
5.6%
1.6%
1.0%
0.1%
100.0%
Comments: The provision of this item declined steady from 1996 until 2003, and since that
time has increased at a faster rate. The service has been provided primarily to those aged
over 65 years, with females predominating. New South Wales and SA have provided a
higher proportion of services than would be expected, with Victoria, Queensland and WA
being lower.
Page 347
42783 LASER TRABECULOPLASTY - each treatment to 1 eye - where it can be
demonstrated that a 5th or subsequent treatment to that eye (including any treatments
to which item 42782 applies) is indicated in a 2 year period
Fee: $426.35 Benefit: 75% = $319.80 85% = $362.40
Comment: Not analysed as only 3 services across the entire period. No data for 2009-10.
Retinal photocoagulation
42809 RETINA, photocoagulation of, not being a service associated with photodynamic
therapy with verteporfin
Fee: $426.35 Benefit: 75% = $319.80 85% = $362.40
Number of services 1994-2009 – Total 648,476
Cost of Services 2009 = $15,973,258; Cost of Services Jan – June 2010 = $7,437,331
Figure 46
MBS item number 42809, number of services (1994 - 2009)
Page 348
Table 142
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42809 use (1994 – 2009); by age, gender and state
0.1%
0.1%
1.1%
3.9%
6.1%
15.5%
28.6%
27.1%
14.5%
3.0%
100.0%
Gender
Female
Male
46.9%
53.1%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
100.0%
39.3%
20.6%
15.3%
11.3%
9.3%
2.5%
1.0%
0.7%
100.0%
Comments: This item has increased steadily in terms of number of services provided. The
major recipients have been those aged over 55 years, with a slightly higher percentage of
males. The geographic spread has been roughly consistent with the population spread.
Removal of silicone oil
42815 POSTERIOR CHAMBER, removal of silicone oil from
Fee: $597.05 Benefit: 75% = $447.80
Number of services 1994-2009 – Total 3,224
Cost of Services 2009 = $109,066; Cost of Services Jan – June 2010 = $54,471
Figure 47
MBS item number 42815, number of services (1994 - 2009)
Page 349
Table 143
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
MBS item number 42815 use (1994 – 2009); by age, gender and state
0.2%
1.9%
3.1%
4.3%
8.2%
14.3%
28.1%
24.9%
13.4%
1.7%
100.0%
Gender
Female
Male
37.6%
62.4%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
34.1%
21.8%
25.7%
6.9%
3.0%
5.2%
1.9%
1.5%
100.0%
Comments: The Medicare claims for this item have increased consistently over time,
roughly doubling in the last 6 years. The service has been provided mainly to those over 55
years, with a higher proportion of males receiving it. Western Australia shows a smallerthan-expected share of the total number of services, with Queensland and Tasmania being
a little higher than expected, given the Australian population distribution.
Surgical assist
51315 Assistance at cataract and intraocular lens surgery covered by item 42698,42701,
42702, 42704 or 42707, when performed in association with services covered by item
42551 to 42569, 42653, 42656, 42746, 42749, 42752, 42776 or 42779
Fee: $257.40 Benefit: 75% = $193.05 85% = $218.80
Number of services 1994-2009 – Total 4,856
Cost of Services 2009 = $28,024; Cost of services Jan-June 2010 = $7,512
Page 350
Figure 48
MBS item number 51315, number of services (1997 - 2009)
Table 144
MBS item number 51315 use (1997 – 2009); by age, gender and state
Age
0-4
5-14
15-24
25-34
35-44
45-54
55-64
65-74
75-84
>= 85
TOTALS
0.0%
0.1%
0.1%
0.2%
0.9%
2.8%
9.4%
31.2%
44.2%
11.0%
100.0%
Gender
Female
Male
61.6%
38.4%
100.0%
State
NSW
Vic
Qld
SA
WA
Tas
ACT
NT
53.4%
17.0%
22.2%
5.6%
0.9%
0.2%
0.6%
0.1%
100.0%
Comments: This item has been declining consistently over the years. The service has
related to people over 65 years, especially females. It has more commonly occurred in New
South Wales, when considering the spread of the Australian population, with Western
Australia being much lower than expected.
Page 351
Claims for multiple services
Data provided by the Department of Health and Ageing for the 3 financial years 2007-8 to 2009-10
was analysed to determine the most frequent combinations of claims for the specific services
being reviewed – ie services provided to the same patient on the same day. Combinations that
occurred a minimum of 500 times per annum are listed in Table 145.
Table 145
General
category
Cataractrelated
Ophthalmology items under review for which there was a combination of
claims, 2007-8 to 2009-10
Item numbers
Description
Year
42702, 42740
Lens extraction and insertion of artificial lens,
plus intra-vitreal injection
11240, 42702
Ocular biometry (1 eye), plus lens extraction and
insertion of artificial lens
11241, 42702
Ocular biometry (both eyes), plus lens extraction
and insertion of artificial lens
42782, 42782
Laser trabeculoplasty (1 eye x 2)
11221, 42782
Perimetry, plus laser trabeculoplasty
Intra-vitreal
injection
42740, 42740
Paracentesis (1 eye x 2)
Retinal
services
11218, 42809
Retinal photography, plus retinal
photocoagulation
11218,42740
Retinal photography, plus intra-vitreal injection
11221, 42809
Perimetry, plus retinal photocoagulation
42809, 42809
Retinal photocoagulation (x 2)
42725, 42740,
42773, 42809
42725, 42740,
42773
Vitrectomy, plus intra-vitreal injection, plus
diathermy or cryotherapy for detached retina,
plus retinal photocoagulation
Vitrectomy, plus intra-vitreal injection, plus
diathermy or cryotherapy for detached retina
42725, 42740,
42809
Vitrectomy, plus intra-vitreal injection, plus retinal
photocoagulation
42725, 42740
Vitrectomy, plus intra-vitreal injection
2007-08
2008-09
2009-10
2007-08
2008-09
2009-10
2007-08
2008-09
2009-10
2007-08
2008-09
2009-10
2007-08
2008-09
2009-10
2007-08
2008-09
2009-10
2007-08
2008-09
2009-10
2007-08
2008-09
2009-10
2008-09
2009-10
2007-08
2008-09
2009-10
2007-08
2008-09
2009-10
2007-08
2008-09
2009-10
2007-08
2008-09
2009-10
2007-08
2008-09
2009-10
Glaucomarelated
Page 352
No of times p.a.
6,504
4,825
1,607
1,276
1,099
1,029
766
687
637
684
1,298
1,797
1,036
1,527
1,654
574
964
2,169
1,559
1,585
1,391
2,566
2,328
2,689
558
588
884
1,057
1,058
1,140
1,154
1,173
971
972
1,017
628
717
731
925
875
885
Extirpation of
cyst
42575, 42575
Extirpation of tarsal cyst (x 2)
Page 353
2007-08
2008-09
2009-10
863
813
798
APPENDIX E: DATA ANALYSIS ON
OPHTHALMOLOGY SEPARATIONS
Data from the National Hospitals Morbidity Database was also reviewed, with a focus on the
conditions and procedures encompassed by the MBS items being reviewed. Selected information
is shown below for key items (ie ones with high frequency, high cost, or recent levels of sharp
increase).
For hospital separations by AR-DRG (surgical), the data is presented in 3 graphs representing 3 of
the major categories of items. These are shown separately, due to large differences in the
numbers of separations:
Figure 49
Hospital separations by AR-DRG - eye, surgical, retinal procedures, 1998-99 to
2007-08
The above category (ADRG C03) includes retinal procedures for capsulectomy, vitrectomy, retinal
detachment, retinal photocoagulation, removal of silicone oil, removal of foreign bodies, and
associated intra-vitreal injections. These make up nearly 70% of the total number of procedures
listed in the group.
The next category (ADRG C15) includes glaucoma-related procedures, and intra-vitreal injections
related to these, as well as trabeculoplasty by laser. There are 12 procedures of interest in this
group, out of 32.
Page 354
Figure 50
Hospital separations by AR-DRG - eye, surgical, glaucoma and complex
cataract procedures, 1998-99 to 2007-08
Lens procedures (ADRG C16) include all items relating to removal and insertion of lens for
cataracts, as well as capsulectomy of lens. These account for over 80% of the total number of
procedures listed in this group.
Figure 51
Hospital separations by AR-DRG - eye, surgical, lens procedures, 1998-99 to
2007-08
Page 355
Data on the numbers of hospital separations for 2002-03 to 2007-08 are shown in the following 2
graphs, presented according to principal diagnosis
Figure 52
Hospital separations by principal diagnosis - selected items, 1998-99 to 2007-08
Figure 53
Hospital separations by principal diagnosis - lens disorders, 1998-99 to 2007-08
Page 356
Hospital data are also provided below for selected items, according to a count of procedures:
Figure 54
Hospital procedures - selected items, 2002-03 to 2007-08
Figure 55
Hospital procedures - posterior segment, retina, 2002-03 to 2007-08
Page 357
PBS data relating to intra-vitreal injections
Figure 56
Scripts for ranibizumab (Lucentis), by month, Sept 2007 to June 2010
Page 358
APPENDIX F: CLINICAL PRACTICE
GUIDELINES (CONCORDANCE EXERCISE)
Glaucoma
• Guidelines for Screening, Prognosis, Diagnosis, Management and Prevention of Glaucoma
(Draft). Please note, it is expected these guidelines will be endorsed in August 2010. Access
from
http://www.nhmrc.gov.au/guidelines/consult/consultations/glaucoma_screening_guidelines.h
tm
• NICE Guidance: Glaucoma –diagnosis and management of chronic open angle glaucoma and
ocular hypertension (April 2009). Access from:
http://guidance.nice.org.uk/CG85/Guidance/pdf/English
• RANZCO: Guidelines for Collaborative Care of Glaucoma Patients (undated). Access from
http://www.ranzco.edu/aboutus/ranzco-policies-andprocedures/policy/GUIDELINES_FOR_COLLABORATIVE_CARE_OF_GLAUCOMA_PATIENTS.pdf
• American Academy of Ophthalmology Practice Patterns Open Angle Glaucoma
• European Glaucoma Society guidelines. www.eugs.org/
• World Glaucoma Association publications. www.worldglaucoma.org/
• SEAGIG (Southeast Asian Glaucoma Interest Group) guidelines. www.seagig.org/
Retinal services
• American Academy of Ophthalmology: Posterior Vitreous Detachment, Retinal Breaks, and
Lattice Degeneration – Preferred Practice Pattern (September 2008). Access from
http://one.aao.org/CE/PracticeGuidelines/PPP.aspx?p=1
Macular degeneration
• American Academy of Ophthalmology: Age-Related Macular Degeneration – Preferred Practice
Pattern (September 2008). Access from
http://one.aao.org/CE/PracticeGuidelines/PPP.aspx?p=1
• RANZCO: Medications for Age-Related Macular Degeneration (AMD) (undated). Access from
http://www.ranzco.edu/aboutus/ranzco-policies-andprocedures/policy/Additional%20information%20on%20PBS%20access%20to%20AMD%20the
rapies%20-%20August%202007.pdf
Cataracts
• American Academy of Ophthalmology: Cataract in the Adult Eye – Preferred Practice Pattern
(September 2006). Access from http://one.aao.org/CE/PracticeGuidelines/PPP.aspx?p=1
Page 359
• Canadian Ophthalmological Society evidence-based clinical practice guidelines for cataract
surgery in the adult eye (October 2008). Access from http://eyesite.ca/english/program-andservices/policy-statements-guidelines/index.htm
• RANZCO: Cataract and Intraocular Lens Surgery (March 2006). Access from
http://www.ranzco.edu/aboutus/ranzco-policies-and-procedures/policy/Cataract_Surgery.pdf
Electroretinography
• Standard for clinical electroretinography (2008 update). Access from
http://www.iscev.org/standards/index.html
• Standard for clinical electrooculography (2006). Access from
http://www.iscev.org/standards/index.html
• Standard for clinical pattern electroretinography (2007 update). Access from
http://www.iscev.org/standards/index.html
• Guidelines for clinical multifocal electroretinography (2007). Access from
http://www.iscev.org/standards/index.html
Page 360
APPENDIX G: CRITICAL APPRAISAL OF
GUIDELINES (AGREE SCORES)
Guideline
(AAO 2008)
(AAO 2008)
(AAO 2006)
(AAO 2005)
COG 2009
(Rafuse P.E.,
Buys Y.M. et al.
2009)
COG (2008)
(COS 2008)
ISCEV 2008
(Hood, Bach et al.
2008)
ISCEV (2007)
(Holder, Brigell et
al. 2007)
(NHMRC 2009)
(NICE 2009)
(RANZCO 2006)
(RANZCO 2009)
(RCO 2009)
(RCO 2007)
Indications covered by
guidelines
Strongly
recommended
Age-related macular
degeneration
Posterior vitreous detachment,
retinal breaks and lattice
degeneration
Cataract
Primary Angle Closure
Glaucoma
AGREE scorea
Recommended
(with provision /
alteration)
Would not
recommend
X
X
X
X
Glaucoma
X
Cataract
X
Clinical multifocal
electroretinography
X
Clinical pattern
electroretinography
X
Glaucoma
Chronic open angle glaucoma
and ocular hypertension
Cataract
Glaucoma
Age-related macular
degeneration
Cataract
X
X
X
X
X
X
Overall assessment of guideline. For simplicity, guidelines have been assigned a good, moderate or poor quality
rating for use in the review. Good quality implies the guideline has been assessed as strongly recommended,
moderate quality implies that the guideline has been recommended, but with some provision or alteration and poor
quality implies that the guideline would not be recommended.
a
Page 361
APPENDIX H: CLINICAL PRACTICE GUIDELINE
RECOMMENDATIONS
MBS items
Service
Glaucoma
11200
Guidelines
11203
Guidelines
PROVOCATIVE TEST OR TESTS FOR GLAUCOMA, including water drinking
American Academy of Ophthalmology (AAO) 2005†
 Meticulous ophthalmological examination including gonioscopy has almost superseded the need for use of provocative tests in order to manage
the patients at the risk of primary angle closure.
† This guideline has been considered for this item number only – in all other cases, recommendations from the AAO 2005 Primary Angle Closure guideline
were incorporated into the NHMRC 2009 Glaucoma guideline findings.
TONOGRAPHY in the investigation or management of glaucoma, 1 or both eyes using an electrical tonography machine producing a directly recorded
tracing
Tonography is non-invasive method which continuously measures intra-ocular pressure (IOP) by determining the outflow of aqueous humour. It is
measured by placing Schiötz tonometer on the surface of the eye for 4 minutes. The measurement are taken with the help of electronic Schiötz tonometer
taking into consideration the initial IOP and change in scale reading of IOP over 4 minutes time. The outflow of aqueous humour in µL / min / mmHg is
expressed as C value. None of the guidelines reported on the use of tonography for the screening or management of glaucoma; however, seem to address
the measurement of IOP for the diagnosis and management of glaucoma by tonometry; and indicated that Goldmann applanation tonometry is preferred
over Schiötz tonometer
NHMRC (Glaucoma) 2009:
 Goldmann applanation tonometry remains the gold standard for measurement of IOP for diagnosis and monitoring of glaucoma. However,
measurements of IOP by applanation tonometry can be discernibly affected by many factors such as corneal thickness, diurnal variations,
advancing age or exercise. Measuring IOP with applanation tonometry also increases risk of eye infections. Therefore, the guidelines underpin
the need for maximum infection control and advocate the minimum standards: disinfecting equipment before each patient, or using disposable
covers/prisms with each patient, and between eyes for the same patient [ High Quality].
National Institute for Health and Clinical Excellence (NICE) (Glaucoma) 2009:
 Guidelines suggest that all patients with chronic open angle glaucoma (COAG), or presumptively diagnosed COAG or who have ocular
hypertension (OHT) should have Goldmann applanation tonometry (slit lamp mounted) at each monitoring assessment [Low Quality].
Page 362
Canadian Ophthalmological guidelines (COG) (Glaucoma) 2009:
 The guidelines recommend the Goldmann applanation tonometry, as it is more accurate, for IOP measurement in patients with healthy corneas
[Level 335].
 In children, and in those unable to come easily to the slit lamp (e.g. obese, bedridden, with postural difficulties), hand-held devices such as
Perkins/Kowa, Tono-Pen, and hand-held noncontact tonometers are recommended [Consensus].
11221
11224
11225
Guidelines
35
FULL QUANTITATIVE COMPUTERISED PERIMETRY - (automated absolute static threshold) not being a service involving multifocal multichannel
objective perimetry, performed by or on behalf of a specialist in the practice of his or her specialty, where indicated by the presence of relevant ocular
disease or suspected pathology of the visual pathways or brain with assessment and report, bilateral - to a maximum of 2 examinations (including
examinations to which item 11224 applies) in any 12 month period
FULL QUANTITATIVE COMPUTERISED PERIMETRY - (automated absolute static threshold) bilateral, where it can be demonstrated that a further
examination is indicated in the same 12 month period to which Item 11221 applies due to presence of one of the following conditions: established glaucoma (where surgery may be required within a six month period) where there has been definite progression of damage
over a 12 month period;
 established neurological disease which may be progressive and where a visual field is necessary for the management of the patient; or
 monitoring for ocular disease or disease of the visual pathways which may be caused by systemic drug toxicity, where there may also be
other disease such as glaucoma or neurological disease.
- each additional examination
FULL QUANTITATIVE COMPUTERISED PERIMETRY - (automated absolute static threshold) unilateral, where it can be demonstrated that a further
examination is indicated in the same 12 month period to which item 11224 applies due to presence of one of the following conditions: established glaucoma (where surgery may be required within a 6 month period) where there has been definite progression of damage over a 12
month period;
 established neurological disease which may be progressive and where a visual field is necessary for the management of the patient; or
monitoring for ocular disease or disease of the visual pathways which may be caused by systemic drug toxicity, where there may also be other
disease such as glaucoma or neurological disease
- each additional examination
NHMRC (Glaucoma) 2009:
 The guidelines recommend performing visual field (VF) testing with automated perimetry on multiple occasions at diagnosis, in order to set a
reliable baseline. An accurate estimation of probable rate of progression will necessitate two to three field tests per year in the first two years
[ moderate quality].
 The guidelines recommend that VF testing is mandatory for glaucoma diagnosis [Consensus].
NICE (Glaucoma) 2009:
 All patients who have COAG or presumptively diagnosed COAG or who have OHT should be offered visual field measurement using standard
automated perimetry (SAP: central thresholding test). Patients with established OHT or suspected COAG who previously had normal VF
recorded by SAP can be monitored with supra-threshold perimetry. Guidelines recommend threshold testing by 24-2 SITA Standard Humphrey
Field Analyzers [Consensus];
 The guidelines suggest that it can take several measurements to get an accurate assessment of progression. Therefore it is important to minimise
inter-test variability by using the same VF measurement strategy for each VF test, thereby optimising detection of changes in visual field when a
defect has occurred [Consensus].
COG (Glaucoma) 2009:
 The recommendations suggest using SAP as the standard for VF testing for glaucoma diagnosis and monitoring. In patients who have glaucoma a
Phelps CD, Phelps GK. (1976). ‘Measurement of intraocular pressure: a study of its reproducibility’. Albrecht Von Graefes Arch Klin Exp Ophthalmol; 16, 198:39–43.
Page 363


42746
42749
Guidelines
testing strategy such as SITA standard is recommended, while SITA Fast could be preferred for screening and diagnosis [Level III 36]
The evidence shows that SAP, a standard investigation for detecting VF defects indicative of functional glaucomatous damage, is likely to miss
some visual field loss at early stage37. The newer VF testing techniques such as short wavelength automated perimetry (SWAP) and frequency
doubling technology (FDT) perimetry appear to be effective in identifying the glaucomatous changes earlier than SAP in some cases [level III38];
however, their role in detection of visual field defects is yet be substantiated in larger trials.
Several VFs should be performed at regular intervals in the first 2 years in order to establish a good baseline and to identify potential rapid
progression [Consensus].
GLAUCOMA, filtering operation for
Multiple operation rule T8.3
GLAUCOMA, filtering operation for, where previous filtering operation has been performed
Multiple operation rule T8.3
NHMRC (Glaucoma) 2009:
 High quality evidence reported in the guidelines underpins that surgical treatment can effectively reduce the IOP in patients with open angle
glaucoma and is almost equally effective as conservative treatment [ High Quality];
 There is compelling evidence that advocates using surgery in open angle glaucoma patients if two or more medications fail to attain desirable
IOP, or poor compliance with medications, and when laser has been unsuccessful or unlikely to succeed [ High Quality];
 Evidence recommends using filtering surgery in the third instance among patients with glaucoma when conservative and laser therapies have
been ineffectual due to the innate risks associated with any penetrating surgery [ Moderate Quality];
 There is sufficient evidence that supports the effectiveness of filtration surgery in reducing IOP successfully in patients with moderate or
advanced glaucoma, particularly when patients have continual IOP over 30mmHg or are unresponsive to other forms of therapy [ Moderate
Quality];
 The guidelines recommend using intra-operative and post-operative anti-fibrotics (MMC or 5-FU) to decrease the risk of failure for patients
undergoing penetrating surgery [ Moderate Quality];
 Evidence suggests that the risk of complications due to subsequent drainage surgery can be reduced by initially employing cataract surgery to
open the angle in most patients with primary angle closure, when laser treatments have been ineffectual [ Moderate Quality];
NICE (Glaucoma) 2009:
 Guidelines advocate the provision of pharmacological augmentation (MMC or 5FU) to patients with advanced COAG or COAG patients who are at
risk of progressing to sight loss despite treatment filtering surgery (trabeculectomy). Information on the risks and benefits associated with
surgery should be provided for these patients. Trabeculectomy is cost-effective in patients who are at high risk of progression to vision loss
despite topical treatment [Low Quality];
 A consensus based recommendation suggests that surgery with pharmacological augmentation (MMC or 5FU) or laser-trabeculoplasty should be
considered after failed conservative treatment with two pharmacological drugs;
 Compared with pharmacological treatment, trabeculectomy appears to provide more benefits in decreasing IOP from baseline to follow up >5
years but the effect size is clinically inconspicuous [Low Quality]however, no statistically significant difference in the number of patients with an
unacceptable IOP is found at 12 months follow up [Low Quality]. Evidence that trabeculectomy is more cost-effective than pharmacological
therapy has minor limitations and direct applicability [Low Quality].
 Patients should be offered re-treatment with pharmacological drugs if surgery fails to reduce IOP satisfactorily to stave off the risk of
progression to vision loss. Repeat surgery or laser trabeculoplasty may be required and if so should be offered.
 There is no statistically significant difference between viscocanalostomy and deep sclerectomy in reducing IOP from baseline to 6 months follow
36
37
38
Artes, P. H., Iwase, A. et al (2002). 'Properties of Perimetric Threshold Estimates from Full Threshold, SITA Standard, and SITA Fast Strategies', Invest. Ophthalmol. Vis. Sci., 43 (8), 2654-2659.
Kerrigan-Baumrind, L. A., Quigley, H. A. et al (2000). 'Number of Ganglion Cells in Glaucoma Eyes Compared with Threshold Visual Field Tests in the Same Persons', Invest. Ophthalmol. Vis. Sci., 41 (3), 741-748.
Artes, P. H., Hutchison, D. M. et al (2005). 'Threshold and Variability Properties of Matrix Frequency-Doubling Technology and Standard Automated Perimetry in Glaucoma', Invest. Ophthalmol. Vis. Sci., 46 (7), 2451-2457.
Page 364

up [Low Quality]. The evidence did not mention any specific valve to be used;
Guidelines report that no statistically significant difference is found between non-penetrating surgery (deep sclerectomy or viscocanalostomy) +
pharmacological augmentation and non-penetrating surgery (deep sclerectomy or viscocanalostomy) alone in reducing the number of patients
with unacceptable IOP at 12 and 24 months follow up [Low Quality]. Differences in persistent hypotony and wound leaks at 24 months follow up
are not statistically significant [Low Quality].
COG (Glaucoma) 2009:
 The evidence indicates trabeculectomy as a widely practiced surgical method for lowering IOP and is usually offered when conservative therapy
and laser trabeculoplasty fail to attain desirable IOP, or arenot likely to attain it. The Advanced Glaucoma Intervention Study (AGIS) 39 included in
the guidelines demonstrates that the success rate for trabeculectomy differs among people of differenent race, suggesting a 10-year success rate
of 70% in African-American patients and 80% in Caucasian Americans. Success rate is low in patients with previous surgical conjuctival
manipulation and with inflammation of the eyes;
 The studies included in the guidelines also describe that pharmacological augmentation (Intra-operative or post-operative) with antimetabolites
(MMC more potent and convenient in application than 5-FU 355) can increase the success rate of trabeculoectomy40 41. Although antimetabolites
do increase the success of trabeculectomy, they may also increase the risk of postoperative complications including wound leak, hypotony
suprachoroidal haemorrhage, and bleb-related endophthalmitis42 43 44 45 46 47 48.
 The evidence indicates that in most instances non-penetrating filtration surgery (viscocanalostomy or deep sclerectomy) does not seem to
reduce IOP to the same extent as trabeculectomy,49 50 51 52 53 54 55 56 making trabeculoectomy the better option, especially when a low IOP is
targeted.
42752
Guidelines
GLAUCOMA, insertion of Molteno valve for, 1 or more stages.
Multiple operation rule T8.3
NHMRC (Glaucoma) 2009:
There is convincing evidence that tube surgery for long term management of IOP. It can be employed as a first choice surgery in patients:

with eyes at higher risk of failure from trabeculectomy

who have failed trabeculectomy
Ederer, F., Gaasterland, D. A. et al (2004). 'The Advanced Glaucoma Intervention Study (AGIS): 13. Comparison of treatment outcomes within race: 10-year results', Ophthalmology, 111 (4), 651-664.
The Fluorouracil Filtering Surgery Study Group (1989). 'Fluorouracil Filtering Surgery Study one-year follow-up'., Am J Ophthalmol, 108 (6), 625-635.
41 Wormald, R., Wilkins, M. R. & Bunce, C. (2001). 'Post-operative 5-Fluorouracil for glaucoma surgery', Cochrane Database Syst Rev, 3 (3), CD001132.
42 Costa, V. P., Wilson, R. P. et al (1993). 'Hypotony maculopathy following the use of topical mitomycin C in glaucoma filtration surgery', Ophthalmic Surg, 24 (6), 389-394.
43 Zacharia, P. T., Deppermann, S. R. & Schuman, J. S. (1993). 'Ocular hypotony after trabeculectomy with mitomycin C', Am J Ophthalmol, 116 (3), 314-326.
44 Greenfield, D. S., Liebmann, J. M. et al (1998). 'Late-onset bleb leaks after glaucoma filtering surgery', Arch Ophthalmol, 116 (4), 443-447.
45 Soltau, J. B., Rothman, R. F. et al (2000). 'Risk factors for glaucoma filtering bleb infections', Arch Ophthalmol, 118 (3), 338-342.
46 Jampel, H. D., Quigley, H. A. et al (2001). 'Risk factors for late-onset infection following glaucoma filtration surgery', Arch Ophthalmol, 119 (7), 1001-1008
47 Whiteside-Michel J, Liebmann JM, Ritch R (1992). ‘Initial 5-fluorouracil trabeculectomy in young patients’. Ophthalmology; 99:7–13
48 Suñer IJ, Greenfield DS. et al (1997). ‘Hypotony maculopathy after filtering surgery with mitomycin C’. Incidence and treatment. Ophthalmology; 104:207–14.
49 Yarangumeli, A., Gureser, S. et al (2004). 'Viscocanalostomy versus trabeculectomy in patients with bilateral high-tension glaucoma', Int Ophthalmol, 25 (4), 207-213.
50 Yalvac IS, Sahin M. et al (2004). ‘Primary viscocanalostomy versus trabeculectomy for primary open-angle glaucoma: three-year prospective randomized clinical trial’. J Cataract Refract Surg; 30:2050–7.
51 Lüke C, Dietlein TS. et al (2002). ‘A prospective randomized trial of viscocanalostomy versus trabeculectomy in open-angle glaucoma: a 1-year follow-up study’. J Glaucoma; 11:294–9.
52 Kobayashi H, Kobayashi K, Okinami S. (2003). ‘A comparison of the intraocular pressure-lowering effect and safety of viscocanalostomy and trabeculectomy with mitomycin C in bilateral open-angle glaucoma’. Graefes
Arch Clin Exp Ophthalmol ;241:359–66.
53 Carassa RG, Bettin P. et al (2003). ‘Viscocanalostomy versus trabeculectomy in white adults affected by open-angle glaucoma: a 2-year randomized, controlled trial’. Ophthalmology;110:882–7.
54 El Sayyad F, Helal M. et al (2000). ‘Nonpenetrating deep sclerectomy versus trabeculectomy in bilateral primary open-angle glaucoma’. Ophthalmology;107:1671–4.
55 Jonescu-Cuypers C, Jacobi P. et al (2001). ‘Primary viscocanalostomy versus trabeculectomy in white patients with open-angle glaucoma: A randomized clinical trial’. Ophthalmology; 108:254–8.
56 Netland, P. A. (2001). 'Nonpenetrating glaucoma surgery', Ophthalmology, 108 (2), 416-421.
39
40
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


with iridocorneal endothelial syndrome
with various forms of uveitic (inflammatory) glaucoma, or
with aphakic glaucoma [ High Quality].
COG (Glaucoma) 2009:
 Initially tube shunt surgery was exercised in patients with several failed previous trabeculectomies or in patients at very high risk for failure of
trabeculectomy, such as those patients with aggressive neovascular glaucoma or extensive conjunctival scarring. The Trabeculectomy versus
Tube study373 reported in these guidelines advocates consideration of tube shunt surgery earlier in the treatment algorithm, particularly
following failure of a single previous mitomycin trabeculectomy, although further studies with longer follow-up in this area are warranted.
 The guidelines also reported studies that compared various designs of tube shunts, includingMolteno, Krupin, Ahmed or Baerveldt implants, and
describe no clear long-term benefits of using one implant over another57 58.
42770
42771
Guidelines
42782
42783
Guidelines
CYCLODESTRUCTIVE procedures for the treatment of intractable glaucoma, treatment to 1 eye, to a maximum of 2 treatments to that eye in a 2 year
period
Multiple operation rule T8.3
CYCLODESTRUCTIVE PROCEDURES for the treatment of intractable glaucoma, treatment to one eye - where it can be demonstrated that a 3rd or
subsequent treatment to that eye (including any treatments to which 42770 applies) is indicated in a 2 year period (Anaes.)
Multiple operation rule T8.3
NHMRC (Glaucoma) 2009:
 Patients with advanced open angle glaucoma, who are not suitable candidates for penetrating surgery, should be treated with cyclodestructive
surgery where conservative and laser treatments remain ineffectual [ High Quality].
COG (Glaucoma) 2009:
 This type of surgery is usually performed with the use of a contact trans-scleral laser delivery system and can be easily carried out in the
outpatient setting. Cyclodestructive surgery is mainly employed to the patients with poor vision in the operative eye in whom other surgical
interventions have failed and few options remain for obtaining IOP control. Likewise, other surgical methods are associated with procedure
related complications such as postoperative hypotony, significant visual acuity reduction of ≥2 lines after treatment, and phthisis bulbi59.
 Alternatively, endoscopic delivery of laser energy directly to the ciliary processes for cytodestruction has been suggested; however, the clinical
efficacy of this method in glaucoma patients is yet to be proved in large randomised controlled trials 60.
LASER TRABECULOPLASTY - each treatment to 1 eye, to a maximum of 4 treatments to that eye in a 2 year period
Multiple operation rule T8.3
LASER TRABECULOPLASTY - each treatment to 1 eye - where it can be demonstrated that a 5th or subsequent treatment to that eye (including any
treatments to which item 42782 applies) is indicated in a 2 year period
Multiple operation rule T8.3
NHMRC (Glaucoma) 2009:
 The guidelines recommend using argon laser trabeculoplasty as treatment of choice for elderly patients with open angle glaucoma who are at
greater risk of progression to sight loss, especially where the following apply: poor drug compliance, disease not amenable to medications, and
poor candidates for incisional surgery [ High Quality].
Hong CH, Arosemena A. et al (2005). ‘Glaucoma drainage devices: a systematic literature review and current controversies’. Surv Ophthalmol;50:48–60.
Aung T, Nolan WP, Machin D. et al (2005). ‘Anterior chamber depth and the risk of primary angle closure in 2 East Indian populations’. Arch Ophthalmol;123:527–32
59 Pastor SA, Singh K, Lee DA, et al (2001). ‘Cyclophotocoagulation: a report by the American Academy of Ophthalmology’. Ophthalmology; 108:2130–8.
60 ibid
57
58
Page 366

Patients receiving laser treatment necessitate continual comprehensive glaucoma monitoring owing to the wearing off effect over time [
Consensus].
NICE (Glaucoma) 2009:
 The laser treatments that were considered in these guidelines were argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT).
In ALT, argon laser beam is focused onto trabeculo-meshwork (TM) with the help of a contact lens and half of the TM (180 degrees) is treated at
one setting. It may take up to six weeks for treatment to have the full effect and after this, if further IOP lowering is needed, the second 180
degrees of the TM is treated. Re-treatments in the same area can cause scarring of the TM and raised IOP. On the other hand, SLT is similar to
ALT but uses a different laser with much larger spot size and discharge of a very short duration; therefore accurate identification of the TM is not
as critical and the procedure is technically simpler. The re-treatments with SLT are reported to be less likely to cause raised IOP because there is
less photo-coagulative damage to adjacent tissue. However, there was no statistically significant difference noted between SLT and ALT in
outcomes of reducing IOP from baseline at 12 months follow up [Moderate Quality], number of patients with an unacceptable IOP at 12 months
follow up [Low Quality], and peripheral anterior synechiae formation [Low Quality].
 Laser trabeculoplasty or cyclodiode laser treatment should be recommended to patients who choose not to have surgery or who are not suitable
for surgery. However, laser treatment may be less effective than surgery for the prevention of risk of progression to sight loss but has a lower
risk of immediate loss of sight, and some patients may choose a higher long term risk of sight loss to a low risk of immediate sight loss
[Consensus].
COG (Glaucoma) 2009:
 These guidelines suggest that laser trabeculoplasty is an effective procedure in lowering IOP and commonly used as an adjunctive treatment
with medications. This procedure should include the following measures: Preoperative evaluation by the treating surgeon; postoperative
evaluation by the surgeon including IOP measurement within 2 hours after the laser treatment; and IOP measurement up to 4–6 weeks later to
determine treatment effect. However, no recommendations were reported about the frequency of repetitions of this procedure [Consensus].
 Patients with mild glaucoma controlled with medications and/ or with laser trabeculoplasty, in the presence of clinically evident cataract should
be treated with phacoemulsification/ IOL implantation alone [Level 2]. Patients with moderate to advanced glaucoma + clinically evident
cataract should be treated with combined phacoemulsification / IOL implantation and trabeculectomy [Level 3]; and uncontrolled glaucoma +
cataract patients should undergo trabeculectomy first, followed by phacoemulsification/IOL implantation several months later, in order to
diminish the risk of intra-operative complications such as suprachoroidal hemorrhage [Consensus].
Retina
11215
11218
Guidelines
RETINAL PHOTOGRAPHY, multiple exposures of 1 eye with intravenous dye injection
RETINAL PHOTOGRAPHY, multiple exposures of both eyes with intravenous dye injection
The Royal College of Ophthalmologists (RCO) 2009 and American Academy of Ophthalmology (AAO) 2008 guidelines for AMD:
Fluorescein angiography (FA) examines the changes in vasculature of the retina and choroid produced by various eye disorders and sequentially captures
images of the fundus over a 10 minute period after injection of the non toxic dye, fluorescein isothiocyanate, into a suitable peripheral vein.
Alternatively, indocyanine green (ICG) dye is used to visualise the choroidal circulation. ICG does not bind to plasma protein and hence does not exit
through the fenestrae of the choroidal vessels, instead remaining within the vascular compartment. Therefore, it can provide better information about
choroidal vessel morphology. The RCO guidelines suggested using ICG in atients with suspected macular haemorrhage or retinal angiomatous
proliferative lesions, idiopathic polypoidal choroidopathy, or non-vascularised vs. vascularised pigment epithelial detachments (PEDs).
However, the guidelines mandate the use of good resolution ocular coherence tomography (OCT) for diagnosis and monitoring response to therapy; OCT
may also provide better diagnostic results in patients allergic to fluorescein dye or have poor venous access.
These guidelines described FA as the gold standard in diagnosing choroidal neovascularisation (CNV) in age related macular degeneration (AMD) and
recommended its use to determine the extent, type, size and location of CNV. It is also a useful diagnostic measure for atypical forms of AMD including
idiopathic polypoidal choroidopathy (IPC) and retinal angiomatous proliferation (RAP) as well as in other eye disorders such as diabetic retinopathy,
Page 367
cystoid macular oedema, vascular occlusions, macular telangiectasia., central serous retinopathy, and Eales’ disease.
FA can also be beneficial in steering verteporfin PDT or laser photocoagulation surgery in CNV or to identify the recurrence of CNV following treatment
and to assist in determining the cause of visual loss that is not explained by the clinical examination [A: I in AAO and Practical points in RCO guidelines].
42728
42818
42809
42773
42776
42779
42812
Guidelines
CRYOTHERAPY OF RETINA or other intraocular structures with an internal probe, being a service associated with a service to which item 42725
(VITRECTOMY by posterior chamber sclerotomy including the removal of vitreous, division of bands or removal of preretinal membranes where
performed, by cutting and suction and infusion) applies
Multiple operation rule T8.3
RETINA, CRYOTHERAPY TO, as an independent procedure, with external probe
Multiple operation rule T8.3
RETINA, photocoagulation of, not being a service associated with photodynamic therapy with verteporfin
Multiple operation rule T8.3
DETACHED RETINA, diathermy or cryotherapy for, not being a service associated with a service to which item 42776 applies
Multiple operation rule T8.3
DETACHED RETINA, buckling or resection operation
Multiple operation rule T8.3
DETACHED RETINA, revision operation
Multiple operation rule T8.3
DETACHED RETINA, removal of encircling silicone band from
Multiple operation rule T8.3
AAO (Retinal tears) 2008:
 The guidelines suggest using cryotherapy or laser photocoagulation aiming to create a firm chorioretinal adhesion in the attached retina
immediately adjacent to and surrounding the retinal tear and/or the focal accumulation of subretinal fluid associated with the break. Evidence
suggests extending treatment of peripheral horseshoe tears well into the vitreous base, even to the ora serrata. Failure to treat horseshoe tears
far enough anteriorly will most commonly result in treatment failure [A: II].
 These guidelines report that there is scarcity of data to assemble evidence-based recommendations for other vitreoretinal abnormalities,
including lattice degeneration and asymptomatic retinal breaks.
 Early intervention with cryotherapy or laser photocoagulation for small retinal breaks and / or predisposing lesions such as lattice degeneration
can prevent the occurrence of retinal detachment; however literature provides no guidance (No randomised controlled trial done).
 No recommendations regarding diathermy or others items descriptors 42812, 42776 and 42779 were given in any guidelines.
The mainstay of treatment of retinal detachment involves closure of retinal breaks or maintenance of chorioretinal apposition. Cryotherapy , diathermy or
laser photocoagulation can be employed to seal the retinal breaks; cryotherapy is the most widely used method. In order to maintain chorioretinal
apposition the following methods are used: scleral buckling (inward indentation of sclera providing external tamponade), pneumatic retinopexy
(outpatient procedure that involves closure of the breaks with cryopexy and then administering an expanding balloon in the vitreous) pars plana
vitrectomy, or endolaser photocoagulation and internal tamponade (with gas bubble or silicon oil)61
RCO (AMD) 2009 and AAO (AMD) 2008:
 The guidelines do not recommend treatment with laser photocoagulation for patients with subfoveal or juxtafoveal CNV owing to the immediate
visual loss resulting from foveal photoreceptor and RPE damage, or later impingement of the scar on the fovea [A: I in AAO and Practical points
in RCO guidelines].
61
A.K Khurana (2007), ‘Comprehensive ophthalmology’, 4th edit., text book pg 277-279.
Page 368

The guidelines indicate that laser photocoagulation has some role in treatment of small extrafoveal CNV and IPC lesions [A: I in AAO and
Practical points in RCO guidelines].
Macular degeneration
42740
Guidelines
PARACENTESIS OF ANTERIOR OR POSTERIOR SEGMENT (including the vitreous) OR BOTH, for the injection of therapeutic substances, or the removal of
aqueous or vitreous for diagnostic purposes, 1 or more of
Multiple operation rule T8.3
AAO (AMD) 2008:
 Ranibizumab is a recombinant humanised immunoglobulin G1 kappa isotype antibody fragment developed for therapeutic intraocular use.
Ranibizumab binds to and inhibits the biological activity of all isoforms of human anti-vascular endothelial growth factor A (VEGF-A). It is
recommended to administer as a 0.5mg intravitreal injection once a month in patients with subfoveal CNV [A: I]. These patients should be
advised to report immediately any symptoms suggestive of endophthalmitis, including eye pain or increased discomfort, worsening eye redness,
blurred or decreased vision, increased sensitivity to light, or increased number of floaters [A: III]. Patients should be followed up after treatment
at approximately 4 weeks and subsequent follow up depends on the clinical findings and judgment of the treating ophthalmologist [A: III].
 Pegaptanib sodium is a selective VEGF antagonist that binds only to the 165 isoform of VEGF-A. Two higher level of studies reported in this
guidelines suggested using Pegaptanib with a recommended dosage of 0.3 mg injected every 6 weeks into the vitreous for the treatment of
following subtypes of neovascular AMD:

Subfoveal CNV, new or recurrent, for predominantly classic lesions ≤12 MPS disc areas in size

Minimally classic or occult with no classic lesions where the entire lesion is ≤12 disc areas in size, subretinal haemorrhage associated
with CNV comprises ≤50% of lesion, and/or there is lipid present, and/or the patient has lost 15 or more letters of visual acuity during
the previous 12 weeks [2 level A: I].
Patients should be instructed to report immediately any symptoms suggestive of therapy related complications (aforementioned); and review
with retreatments every 6 weeks as indicated [A: III].
The guidelines also recommend using Bevacizumab as an intravitreal injection for subfoveal CNV and advocate that patients should be provided
informed consent about its off-label status[A:III].
RCO (AMD) 2009:
Practical points
 These guidelines recommend using Pegaptanib and Ranibizumab to treat all subfoveal CNV and favour to use Ranibizumab, although there are
no direct comparisons. It is admissible to simultaneously treat both affected eyes;
 Treatment with intravitreal injection of anti-VEGF agents in patients with large extrafoveal classic CNV or occult CNV with progression, or
scotoma interfering with vision following previous laser treatment is recommended. This therapy is also indicated in patients with classic CNV
lesions or other lesion types who did not respond well to photodynamic therapy or laser photocoagulation;
 The guidelines emphasise the need for frequent monitoring when commencing a course of anti-VEGF therapy for AMD and patients should be
advised accordingly (every 4-6 weeks depending on the anti-VEGF used). Treatment and follow-up may need to be continued for up to and
beyond 2 years;
 Bevacizumab has also been recommended by the guidelines to treat subfoveal CNV; although, there are no long-term results on safety and
effectiveness of intravitreal bevacizumab. The treating ophthalmologists are advised to clearly explain the off-label status of this drug to the
patients before its administration.

Cataract
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42698
42701
42702
42703
42704
42707
42710
42713
42716
Guidelines
62
LENS EXTRACTION, excluding surgery performed for the correction of refractive error except for anisometropia greater than 3 dioptres following the
removal of cataract in the first eye
Multiple operation rule T8.3
ARTIFICIAL LENS, insertion of, excluding surgery performed for the correction of refractive error except for anisometropia greater than 3 dioptres
following the removal of cataract in the first eye
Multiple operation rule T8.3
LENS EXTRACTION AND INSERTION OF ARTIFICIAL LENS, excluding surgery performed for the correction of refractive error except for anisometropia
greater than 3 dioptres following the removal of cataract in the first eye
Multiple operation rule T8.3
ARTIFICIAL LENS, insertion of, into the posterior chamber and suture to the iris and sclera
Multiple operation rule T8.3
ARTIFICIAL LENS, REMOVAL or REPOSITIONING of by open operation, not being a service associated with a service to which item 42701 applies
Multiple operation rule T8.3
ARTIFICIAL LENS, REMOVAL of and REPLACEMENT with a different lens, excluding surgery performed for the correction of refractive error except for
anisometropia greater than 3 dioptres following the removal of cataract in the first eye
Multiple operation rule T8.3
ARTIFICIAL LENS, removal of, and replacement with a lens inserted into the posterior chamber and sutured to the iris or sclera
Multiple operation rule T8.3
INTRAOCULAR LENSES, repositioning of, by the use of a McCannell suture or similar
Multiple operation rule T8.3
CATARACT, JUVENILE, removal of, including subsequent needlings
Multiple operation rule T8.3
COG (Cataract) 200862:
 Evidence recommends using cataract surgery primarily for correction of visual impairment owing to presence of lens opacity unresponsive to
nonsurgical measures. [Level III].
 The guidelines suggest to carry out cataract surgery within 4 [Consensus] to 6 [2 Level III] months of specialist consultation to lower the risks of
falls, fractures, and motor vehicle accidents. In clinical settings where this cannot be achieved, even after attempting to shorten wait times by
acquiring more resources, patients who are at great risk should be triaged for priority [Consensus].
 Expert/consensus based recommendations propose that it is admissible to perform cataract surgery for ocular conditions such as phacomorphic
glaucoma, lens-induced uveitis, or treatable posterior segment pathology, when they are difficult to manage due to lens opacity.
 Expert/ consensus recommends using posterior chamber IOL (PCIOL) implants within the capsular bag. If there is no support posteriorly, e.g. in
cases of posterior capsule tear, then a PCIOL should be placed in the cilliary sulcus. The evidence suggests that an anterior chamber IOL (ACIOL),
iris-fixated or sclera-fixated PCIOL are reasonable options to employ when there is no capsular support [Level II].
 The guidelines endorse using foldable IOLs as compared to polymethyl-meth-acrylate (PMMA) IOLs because they require small incision for
placement, promptly resulting in fast and better vision after surgery with minimal postoperative complications and surgery induced astigmatism
[Level IA]. Administering foldable IOLs using an injectable catridge system in comparison to forcep-folded IOLs is recommended as this
minimises the potential risk of bacterial endophthalmitis [Level III].
 Provided the benefits in monocular patients outweigh the risks, it is suggested to employ cataract surgery in these patients and should not be
delayed because of monocular status, as this may lead to increased surgical risk due to progressively increasing lens opacity [3 Level III].
 Expert/ consensus based recommendations suggest simultaneous bilateral cataract surgery should not be performed in the wake of increased
possibility of bilateral endophthalmitis [2 Level IV] and bilateral toxic anterior segment syndrome (TASS) [Consensus].
 Simultaneous bilateral cataract surgery can only be admissible in patients for whom the benefits outweigh the risks, in the opinion of the
Canadian guidelines for cataract incorporated all the relevant recommendations from AAO 2006, RANZCO 2006 and RCO 2007 guidelines for cataract.
Page 370


treating ophthalmologists and patients [Consensus]. Evidence suggests employing two separate procedures for simultaneous bilateral surgery
(re-prep, re-gown, new instruments, different lot numbers for all drugs, solutions, and instrumentation when possible) [level III]. It is necessary
to sure that no obvious complications such as posterior capsule rupture have occured after the first procedure [Level III]. Surgery in the second
eye should be postponed, if any significant complications with first eye occur [Level III].
The guidelines advocate small-incision phacoemulsification as compared to ECCE because it bestows patients with quick, better and more stable
visual acuity [Level IA]. Expert/consensus opinion recommends using planned ECCE in select cases, such as in the instance of extremely
advanced opacity or hard lenses.
To help prevent posterior capsular opacification (PCO), a continuous curvilinear capsulorhexis completely overlapping the IOL edges, is
suggested in the guidelines [Level IA]; and it is suggested that hydrodissection is routinely performed in order to lower zonular stress and
expedite cortical removal with reduction of PCO [Level III].
Electroretinography
ELECTRORETINOGRAPHY of one or both eyes by computerised averaging techniques, including 3 or more studies performed according to current
11204
11205
11210
11211
Guidelines
professional guidelines or standards
ELECTROOCULOGRAPHY of one or both eyes performed according to current professional guidelines or standards
PATTERN ELECTRORETINOGRAPHY of one or both eyes by computerised averaging techniques, including 3 or more studies performed according to
current professional guidelines or standards
DARK ADAPTOMETRY of one or both eyes with a quantitative (log cd/m2) estimation of threshold in log lumens at 45 minutes of dark adaptations
No clinical guidelines pertaining to electroretinography (ERG) providing patient-oriented recommendations were identified in the searches. The main aim
of the International Society for Clinical Electrophysiology of Vision (ISCEV) guidelines was to improve quality of testing and reporting of the results, and
also to provide guidance on technical or practical issues.
ISCEV guidelines recommended that the standard ERG should incorporate at least six ERG responses to distinctly make the clinical diagnosis. The five
basic responses with respect to conditions of adaption and the stimulus (flash strength in cd s m - 2) are: dark-adapted 0.01 ERG (formerly ‘‘rod
response’’); dark-adapted 3.0 ERG (formerly ‘‘maximal or standard combined rod–cone response’’); dark-adapted 3.0 oscillatory potentials (formerly
‘‘oscillatory potentials’’); light-adapted 3.0 ERG (formerly ‘‘single-flash cone response’’); light-adapted 3.0 flicker ERG (formerly ‘‘30 Hz flicker’’); and
recommended additional response is either dark adapted 10.0 ERG or dark-adapted 30.0 ERG 63
The electrophysiological testing bestows clinicians with the tangible evaluation of retinal functions at different levels of the visual system with the
intention to precisely localise and characterise the visual impairment in different patients. For example, night blindness could be a manifestation of
disorders of the photoreceptors or may arise from post-phototransduction in the retina where fundus or ophthalmoscopic examination may not be
helpful in localising the lesion. The electro-oculogram (EOG) gives information regarding the function of the retinal pigment epithelium (RPE) and its
interaction with the photoreceptors; whereas, the response from photoreceptors and inner nuclear layers of retina are measured by ERG. To identify
abnormalities in macula where full-field ERG would be normal, multi-focal ERG (mfERG) or pattern ERG (pERG) are required to investigate the macular
dysfunction. Both tests are done in specialist centers.64
A systematic review by Lai et al (2007) suggested that mfERG can provide objective assessment of the spatial aspects of the central retinal function within
a reasonably short duration of time. The assessment of retinal function with mfERG can distinctly identify the localised lesions particularly those confined
to the central retina where full-field ERG is normal, caused by various retinal diseases. Its use also enabled clinicians to objectively monitor the
electrophysiological response to surgical or non-surgical treatments employed for various retinal diseases.65
63
Marmor MF, Fulton AB, et al. ‘Standard for clinical electroretinography (2008 update)’. Doc Opthalmol 118: 69-77.
Holder, G. E., Celesia, G. G. et al (2010). 'International Federation of Clinical Neurophysiology: Recommendations for visual system testing', Clinical Neurophysiology, 121 (9), 1393-1409
65
Lai, T. Y. Y., Chan, W.-M. et al 'The Clinical Applications of Multifocal Electroretinography: A Systematic Review', Survey of Ophthalmology, 52 (1), 61-96.
64
Page 371
The evidence described that pERG can not only objectively assess the macular function but also can differentiate electrophysiologically between optic
nerve and macular dysfunction. The retinal ganglion dysfunction can also be identified easily by pERG 66 67
Dark adaptometry or dark-adapted ERG is done in total darkness and is preferably done prior to light adapted ERG. Fluorescein angiography or ocular
coherence tomography should be avoided prior to dark adapted ERG; if possible, patients should be given at least 30 min recovery time in normally lit
room before commencing dark adapted ERG.68
Following are the main types of eye disorders in which ERG can be provide significant clinical benefits69 70:
 Neurological conditions not involving the visual system; possible demyelinating disease e.g. multiple sclerosis, Friedreich ataxia, other
hereditary ataxias, familial spastic paraplegia, adrenoleukodystrophy (ALD), or hereditary motor and sensory neuropathies;
 Sudden onset of visual acuity loss/blurred vision e.g. non-arteritic anterior ischaemic optic neuropathy (NAION), Leber hereditary optic
neuropathy (LHON), posterior scleritis (PS), central serous chorioretinopathy (CSR), acute idiopathic blind spot enlargement syndrome (AIBSE),
and acute zonal occult outer retinopathy (AZOOR);
 Progressive visual acuity loss e.g. AMD, diabetic retinopathy, ethambutol induced optic neuropathy, alcohol or tobacco induced or carcinoma
associated retinopathy in patients with paraneoplastic disorder;
 Inexplicable visual field defect
 Nyctalopia (night blindness) and photophobia
 Nystagmus
66
Holder, G. E., Brigell, M. G. et al (2007). 'ISCEV standard for clinical pattern electroretinography – 2007 update', Doc Ophthalmol, 114 (9), 111-116
Holder, G. E., Celesia, G. G. et al (2010). 'International Federation of Clinical Neurophysiology: Recommendations for visual system testing', Clinical Neurophysiology, 121 (9), 1393-1409
68
ibid, pg 1399-1400
69ibid pg 1405
70
Lai, T. Y. Y., Chan, W.-M. et al 'The Clinical Applications of Multifocal Electroretinography: A Systematic Review', Survey of Ophthalmology, 52 (1), 61-96.
67
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APPENDIX I: COLLATED SUMMARY OF
FINDINGS
Glaucoma services
Item 11200 Provocative test/s
MODIFICATION OF ITEM TO CLARIFY INDICATION
It is suggested that the item descriptor be modified to indicate that the provocative test
should only be used for the management of open angle glaucoma.
Item 11203 Tonography
DELETION OF ITEM FROM SCHEDULE
Data analysis indicates that tonography is decreasingly utilised and is considered part of
a standard ophthalmic examination. This suggests the service does not need a separate
item number and should be removed from the MBS.
Items 42746 and
42749 - Glaucoma
filtering operation
MODIFICATION OF ITEM TO CLARIFY INTERVENTION
It is suggested that the item descriptor for 42746 be modified to indicate this operation
should be performed once conservative therapies have failed or are likely to fail or are
contraindicated.
Item 42752 Insertion of valve
for glaucoma
MODIFICATION OF ITEM TO CLARIFY PATIENT GROUP AND INTERVENTION
It is suggested that the item descriptor be modified to provide for the insertion of a
device draining to an external plate or extraocular reservoir, such as a Molteno device,
and that the item is restricted to certain patient subgroups such as patients who are at
high risk of failure of, or who failed, trabeculectomy; or who have iridocorneal
endothelial syndrome, or inflammatory (uveitic) glaucoma, or aphakic glaucoma.
Item 42771 Cyclodestructive
procedures
DELETION OF ITEM FROM SCHEDULE
Data analysis indicates item 42771 is an outmoded practice, suggesting this item should
be removed from the MBS.
Electroretinography services
Items 11204,
11205, 11210 and
11211 Electretinography,
electrooculography,
and dark
adaptometry
NO CHANGE
No evidence-based guidelines provided recommendations regarding the use of the
various forms of electroretinography.
Examination of optic fundi
Item 11212 Examination of
optic fundi
DELETION OF ITEM FROM SCHEDULE
Analysis suggests the removal of this item is unlikely to impact upon the quality of patient
care or their health outcomes.
Retinal photography services
Items 11215 and
11218 Retinal
photography
NO CHANGE
The current wording of the descriptor for ‘retinal photography’ appears to adequately
serve for both fluorescein and indocyanine green angiography.
Perimetry services
Items 11221,
11222, 11224 and
11225 Computerised
perimetry
NO CHANGE
The frequency of perimetry testing as specified in the descriptors is sufficient for patients
with glaucoma. Currently, only automated threshold perimetry can be billed to Medicare
and it is unclear whether Medicare can be billed for supra-threshold perimetry which
may have a role in monitoring certain types of patients.
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Orbital echography/ocular biometry services
Items 11237,
11240, 11241,
11242 and 11243 Ultrasonic
echography or
partial coherence
interferometry
SUGGESTION TO MODIFY ITEM TO CLARIFY PATIENT GROUP
It is suggested that the relevant patient indications (or exclusions) for partial coherence
interferometry are outlined in the Schedule.
Removal of foreign body
Items 42551,
42554, 42557 Repair of a
perforating wound
MINOR CHANGES TO REFLECT CURRENT TERMINOLOGY
Minor wording changes were suggested for these items as part of stakeholder negotiation
with RANZCO.
Items 42560,
42563, 42566,
42569 Removal of a
foreign body
DELETION OF SOME ITEMS AND MINOR TERMINOLOGY CHANGES
Use of either the internal or external approach for the removal of an intraocular foreign
body appears to be related to clinical preference and size of intraocular foreign body. Due
to low use, item numbers 42560 and 42566 should be removed and the wording of
42563 and 42569 should be modified with the removal of the word ‘nonmagnetic’.
Item 42644 Removal of an
imbedded foreign
body
MINOR CHANGES TO REFLECT CURRENT TERMINOLOGY
Minor wording changes were suggested for this item as part of stakeholder negotiation
with RANZCO.
Extirpation of tarsal cyst
Item 42575 Expiration of a
tarsal cyst
NO CHANGE
The current wording of the descriptor for extirpation of tarsal cysts appears to be
adequate and should remain unchanged.
Lacrimal passage services
Items 42610,
42611, 42614,
42615 Nasolacrimal tube
NO CHANGE
The evidence from non-comparative studies suggests that high rates of lacrimal passage
patency and reduced epiphora are achievable using probing procedures, and that
younger children may experience better clinical outcomes than older children with
congenital nasolacrimal duct obstruction. No studies concerning probing in adult
populations or nasolacrimal tube removal or replacement were identified; and therefore,
an assessment of the safety or effectiveness of these procedures in adults was not
possible.
Cataract surgery services
Items 42698, 42701
- Extraction of
insertion of
artificial lens
NO CHANGE
These items are rarely accessed and have mostly been replaced by claims made under
item 42702, which combines claims for the extraction and insertion of a lens. Certain
select circumstances still require their use, hence the retention of these items on the
Schedule.
Items 42702,
42703, 42704,
42707, 42710,
42713 and 42716 Lens extraction and
insertion of an
artificial lens,
repositioning of a
lens and removal of
a juvenile cataract
MINOR CHANGES TO REFLECT CURRENT TERMINOLOGY
Stakeholder negotiation suggested rewording to replace ‘artificial lens’ with ‘intraocular
lens’ in the descriptors of 42702, 42703, 42704, 42707 and 4710, which was agreed to by
the Department. In addition, it was also agreed to change the descriptor wording to
better describe iris suturing for fixation of an intraocular lens.
Descriptors of MBS item numbers that describe the lens insertion technique should be
clarified to include not only anterior chamber IOL insertion (for 42703 and 42710), but to
explicitly specify the IOL placement relevant to 42701, 42702, 42704 and 42707. No
evidence for the use of needling in juvenile cataracts (42716) or the use of a McCannell
suture technique (42713) was found in the Guidelines, thus no comment can be made
regarding the appropriateness of the relevant MBS item descriptors.
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Capsulectomy and lensectomy services
Items 42719, 42722
- Capsulectomy or
removal of vitreous
MINOR CHANGES TO REFLECT CURRENT TERMINOLOGY AND DELETION OF ITEM
Choice of lens removal technique appears to be by surgeon preference. It is suggested
that modification of the descriptor of MBS item number 42719 should reflect the current
terminology regarding ‘limbal lensectomy’ or ‘pars plana lensectomy’ and should be
informed by clinical consensus. The rewording of item 42731 (see below) would appear
to make the use of item 42722, as currently worded, redundant.
Item 42731 Capsulectomy or
lensectomy
MINOR CHANGES TO REFLECT CURRENT TERMINOLOGY
Minor wording changes were suggested for this item as part of stakeholder negotiation
with RANZCO. It was suggested that modification of the descriptor of MBS item number
42731 should reflect the current terminology regarding ‘limbal lensectomy’ or ‘pars
plana lensectomy’ and should be informed by clinical consensus.
Vitrectomy services
Item 42725 Vitrectomy
MINOR CHANGES TO REFLECT CURRENT TERMINOLOGY
Minor wording changes were suggested for this item as part of stakeholder negotiation
with RANZCO.
Intra-vitreal injection services
Item 42740 Paracentesis of
anterior or
posterior segment
or injection of
therapeutic
substance
SEPARATION OF CURRENT ITEM TO REFLECT DIFFERENT PROCEDURES
Injection of pharmaceutical agents, tamponade agents and removal of fluid from the eye
are likely to be undertaken for different indications. Separation of some of these
procedures into distinct MBS item numbers appears warranted. It is suggested also that
there is a distinct item for the injection of other tamponade substances such as gas,
silicone oil and perfluorocarbons, which is to be used in association with the vitrectomy
item (42725).
Cryotherapy of retina
Item 42728 Cryotherapy of
retina
DELETION OF ITEM
The changes to the intervention and indications for item 42818 (see below) will make
this service redundant.
Item 42818 Cryotherapy of
retina
MODIFICATION OF ITEM TO CLARIFY INTERVENTION AND INDICATIONS
Both cryotherapy procedures in 42728 and 42818 are uncommon and appear to have
been largely superseded by other procedures including laser photocoagulation. There is
considerable regional variation in the usage of item 42728. Item 42728 may be used in
conjunction with vitrectomy (item 42725) whereas item 42818 is to be used as a
procedure not associated with vitrectomy, for example cryotherapy for retinal tears,
proliferative retinopathies, and some tumours. The RANZCO initially suggested removing
"as an independent procedure" from the item descriptor of 42818 to allow for situations
where additional treatment such as laser photocoagulation is required, but where the
procedure is still not done in association with vitrectomy. However, the treatment of
retinal tears or holes with cryotherapy during scleral buckling surgery, given the
preparation already done for the surgery, would be far simpler and thus may not require
reimbursement at the same rate as delivering cryotherapy for retinal tears not in
conjunction with the surgery.
As a consequence, the descriptor for item 42818 was agreed to be re-worded so that it
does not specify the type of cryotherapy probe and, rather than removing “as an
independent procedure” from the descriptor, a list of items was formulated that can be
"co-billed" with item 42818 (items 42809, 42770 and 42771). It was suggested that item
42728 could be made redundant.
Retinal services
Item 42773 Diathermy or
cryotherapy for
detached retina
MODIFICATION OF ITEM TO CLARIFY INDICATION
Clarification of the descriptor for 42773 may be warranted to indicate that it is meant to
describe pneumatic retinopexy.
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Item 42776 Buckling or
resection operation
for detached retina
NO CHANGE
The evidence suggested that scleral buckling or resection procedures are similarly
effective, therefore this item number should remain unchanged.
Item 42779 Revision operation
for detached retina
MODIFICATION OF ITEM TO CLARIFY INTERVENTION AND INDICATION
Given that pars plana vitrectomy (PPV) for revision of primary retinal reattachment
results in better patient outcomes, PPV is generally the preferred method of revision for
retinal re-detachment, and can be billed using item 42725. Clinical advice suggests that
revision of scleral buckling, rather than vitrectomy, is preferred in a small number of
cases. The adoption of RANZCO's recommendation that the wording of 42779 be
amended to: "DETACHED RETINA, revision of scleral buckling operation for (Anaes.)
(Assist.) ", would clarify the original intent of 42779, which is that it should be used only
for a buckle revision.
Item 42812 Removal of
encircling band
from detached
retina
NO CHANGE
No evidence was found with respect to removal of a silicone band in patients who have
had a detached retina. The procedure appears to be uncommon.
Laser trabeculoplasty services
Item 42782 Laser
trabeculoplasty
MODIFICATION OF ITEM TO REFLECT INDICATION
It is suggested that the item descriptor be altered to indicate glaucoma as the appropriate
patient indication. Clinical advice suggests that four treatments per 2 year period would
not commonly be done using current protocols. Therapy is usually given as a 180 degree
treatment to the filtration angle followed by the second 180 degrees at a future date if
needed. Thus two treatments in a 2 year period would be reasonable, reduced from the
currently allowable 4 treatments. In the event of requiring a greater number of
treatments, MBS item 42783 may be used.
Retinal photocoagulation services
Item 42809 Photocoagulation of
retina
NO CHANGE
This item is commonly used for a number of indications - retinal detachment, diabetic
retinopathy, choroidal neovascularisation associated with pathologic myopia, macular
oedema, age-related macular degeneration, macular holes, and retinoblastoma. The
evidence for which was generally disappointing and insufficient to suggest a change to
the wording of the descriptor.
Removal of silicone oil
Item 42815 Removal of silicone
oil from posterior
chamber
MODIFICATION OF ITEM TO CLARIFY INTERVENTION
The modification of the descriptor for item 42815 suggested by RANZCO appears
reasonable based on the range of liquid vitreous substitutes in current use i.e.
"VITREOUS CAVITY, removal of silicone oil or other liquid vitreous substitute from,
during a procedure other than that in which the vitreous substitute is inserted (Anaes.)
(Assist.)".
Surgical assistance
Item 51315 Assistance at
cataract and
intraocular lens
surgery
EXPANSION OF SERVICES FOR CLAIMING ASSISTANCE
Stakeholder negotiation regarding minor wording amendments to the MBS descriptor
for item 51315 was undertaken.
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APPENDIX J: MINOR ITEM AMENDMENTS
Negotiations between the Department of Health and Ageing and the Royal Australian and New
Zealand College of Ophthalmologists resulted in the following minor item amendments:
42551
EYEBALL, PERFORATING PENETRATING WOUND OR RUPTURE OF, not involving intraocular
structures repair involving suture of cornea or sclera, or both, not being a service to which
item 42632 applies (Anaes.) (Assist.)
42554
EYEBALL, PERFORATING PENETRATING WOUND OR RUPTURE OF, with incarceration or
prolapse of uveal tissue repair (Anaes.) (Assist.)
42557
EYEBALL, PERFORATING PENETRATING WOUND OR RUPTURE OF, with incarceration of
lens or vitreous repair (Anaes.) (Assist.)
42644
CORNEA OR SCLERA, complete removal of imbedded foreign body from - not more than
once on the same day by the same practitioner (excluding aftercare) (Anaes.)
42703
INTRAOCULAR LENS or IRIS PROSTHESIS ARTIFICIAL LENS, insertion of, into the posterior
chamber and suture with fixation to the iris and or sclera (Anaes.) (Assist.)
42704
ARTIFICIAL INTRAOCULAR LENS, REMOVAL or REPOSITIONING of by open operation, not
being a service associated with a service to which item 42701 applies (Anaes.)
42707
ARTIFICIAL INTRAOCULAR LENS, REMOVAL of and REPLACEMENT with a different lens,
excluding surgery performed for the correction of refractive error except for
anisometropia greater than 3 dioptres following the removal of cataract in the first eye
(Anaes.)
42710
ARTIFICIAL INTRAOCULAR LENS, removal of, and replacement with a lens inserted into the
posterior chamber and sutured fixated to the iris or sclera (Anaes.) (Assist.)
42713
INTRAOCULAR LENSES , repositioning of, by the use of a McCannell suture or similar
(Anaes.) (Assist.) IRIS SUTURING, McCannell technique or similar, for fixation of intraocular
lens or repair of iris defect (Anaes.) (Assist)
42725
VITRECTOMY by via pars plana posterior chamber sclerotomiesy including the removal of
vitreous, division of bands or removal of preretinal epiretinal membranes where
performed, by cutting and suction and infusion.(Anaes.) (Assist.)
42731
CAPSULECTOMY or LENSECTOMY, or both, by posterior chamber sclerotomy in conjunction
with the removal of vitreous or division of vitreous bands or removal of preretinal
membrane from the posterior chamber by cutting and suction and infusion, not being a
service associated with any other intraocular operation (Anaes.) (Assist.) LIMBAL OR PARS
PLANA LENSECTOMY combined with vitrectomy, not being a service associated with items
42698, 42702, 42719, 42722, or 42725 (Anaes.) (Assist.)
51315
Assistance at cataract and intraocular lens surgery covered by item 42698, 42701, 42702,
42704 or 42707, when performed in association with services covered by item 42551 to
42569, 42653, 42656, 42725, 42746, 42749, 42752, 42776 or 42779
Page 377