Complication Management in Refractive Lens Exchange
Mark Packer, MD, FACS
Financial Disclosure
1.
Advanced Medical Optics
C,R
2.
Advanced Vision Science
C, R
3.
Bausch & Lomb
C
4.
Carl Zeiss Inc
C
5.
Carl Zeiss Meditec
C
6.
Celgene Corporation
C
7.
Ista Pharmacuticals
C, R
8.
Gerson Lehman Group, Inc
C
9.
iTherapeutix, Inc.
C
10.
Vistakon
C, R
11.
Leerink Swann & Company
C
12.
Transcend Medical, Inc.
C
13.
Visiogen, Inc.
C, R, O
14.
Vision Care Inc.
C
15.
WaveTec Vision Systems
C, R, O
16.
Endo Optiks, Inc.
L
17.
TrueVision, Inc.
C,O
C = Consultant / Advisor
R = Research Funding
O = Equity Owner (Stock Options)
L = Lecture Fees
This case includes the discussion of off-label uses of FDA approved devices.
Brief Author Biographies – please provide photos as well.
Mark Packer, MD, FACS
Dr. Packer grew up in Los Angeles and graduated cum laude from Harvard University, receiving
both an Honorary National Scholarship and a Harvard Scholarship. He received his medical
degree from the University of California at Davis and completed his residency training in
Ophthalmology at Boston University Medical Center; he achieved American Board of
Ophthalmology Certification in 1997. He currently serves as Clinical Associate Professor of
Ophthalmology at Oregon Health & Science University.
Dr. Packer focuses on refractive surgery and intraocular lens technology. He serves as Principal
Investigator for the Carl Zeiss Meditec MEL-80 Excimer Laser, and was Coordinating
Investigator for the US FDA monitored study of the aspheric Tecnis Intraocular Lens. He is
Medical Monitor for the investigation of the AMO Tecnis Multifocal Intraocular Lens, and
serves as Principal Investigator for the Visiogen Synchrony Dual Optic Accommodative Lens.
He has also participated in FDA monitored studies of the Eyeonics accommodative Crystalens,
VisionCare’s Implantable Miniaturized Telescope and Rayner’s C-flex IOL. Dr. Packer works
extensively with leaders in the ophthalmic industry on the development of new technology for
cataract and refractive surgery. He is a consultant to Advanced Medical Optics, Bausch &
Lomb, Advanced Vision Science and WaveTec Vision Systems.
Dr. Packer’s recent peer-reviewed publications include “Immersion A Scan Compared to Partial
Coherence Interferometry,” “The Physics of Phaco: A Review,” and “Intraocular Lens Power
Calculation Following Incisional or Thermal Keratorefractive Surgery,” appearing in The
Journal of Cataract and Refractive Surgery; “Initial Clinical Experience with an Anterior
Surface Modified Prolate Intraocular Lens” appeared in the Journal of Refractive Surgery. He
authored “Wavefront Technology in Cataract Surgery” in Current Opinion in Ophthalmology
and edited the textbook Refractive Lens Surgery published by Springer. He also served as editor
for the “Functional Vision” issue of International Ophthalmology Clinics and has edited the
annual Cataract and IOL issue of Current Opinion in Ophthalmology since 2005.
Dr. Packer has delivered hundreds of presentations at scientific meetings around the world and
demonstrated cataract surgery on four continents. He serves on the Cataract Clinical Committee
of the American Society of Cataract and Refractive Surgery (ASCRS) and represents ASCRS on
the Council of the American Academy of Ophthalmology. He also chairs the Cataract
Subcommittee of the American Academy of Ophthalmology Annual Meeting Program
Committee. In 2005 he was elected to membership in The International Intra-Ocular Implant
Club and named one of 50 Top Opinion Leaders by Cataract & Refractive Surgery Today.
I.
History (Slide 5)
A 48 year old woman presented for a Refractive Screening. She stated that she likes to
garden & quilt, and doesn’t want to wear bifocals or contact lenses.
II.
Examination
Her refraction, best-corrected visual acuity, central corneal pachymetry, axial length and
keratometry are shown below. The remainder of the exam was remarkable only for
complete posterior vitreous detachment OU.
-8.50 + 2.50 X 108
Pach 521
AL 26.66
43.04 X 44.88 @ 85
20/30 OD
-7.00 + 1.25 X 90
Pach 534
AL 26.35
43.60 X 45.24 @ 67
20/20 OS
III.
Refractive Options (Slides 6 – 13)
The refractive options for this woman with moderate to high myopia, astigmatism,
presbyopia OU and mild refractive amblyopia OD included LASIK, phakic refractive
lenses and refractive lens exchange with an accommodative or multifocal IOL. The
primary limitation of LASIK would be continued worsening presbyopia or decreased
stereopsis due to monovision; implantation of ICLs did not offer any significant
advantages over LASIK. Refractive lens exchange combined with limbal relaxing
incisions offered the potential to treat the myopia, astigmatism and presbyopia. The data
from FDA clinical investigations of the various IOLs were discussed with the patient,
including the percentage of spectacle independence and the potential for dysphotopsia.
Additionally the possibility of an enhancement procedure (LASIK or piggyback IOL) to
correct residual refractive error was discussed. The chance of her needing an
enhancement was described by a review of data from our practice (11 & 12). The risks of
refractive surgery in general and refractive lens exchange in particular were thoroughly
discussed, with particular attention to the risk of retinal detachment following lens
surgery in high myopia. In this case the patient already had bilateral PVDs; a careful
peripheral fundus exam demonstrated the absence of any predisposing lesions.
IV.
Surgical Decision and Early Postoperative Course (Slides 14 – 22)
Given the patient’s desire to be free of glasses and contacts for quilting and gardening,
which are intermediate range visual activities, we selected the crystalens. Her corneal
topography demonstrated significant astigmatism which required correction with limbal
relaxing incisions. These were cut to 90% depth at the 10mm zone based on the
Nichamin nomogram. The surgery was uncomplicated and her immediate postoperative
course was unremarkable; however, she developed regression of her astigmatism by 2
weeks. The probable need for a LASIK enhancement following refractive stability was
discussed.
V.
Postoperative Course and Complication Management (Slides 23 – 41)
At the six week post op visit the best-corrected acuity had declined and slit lamp
examination revealed anterior capsular phimosis with a thickened, fibrotic rim of capsule
within the pupil. Anterior chamber optical coherence tomography demonstrated the
phimotic ridge in both eyes. The YAG laser was used to gently dissect and lyse the
tissue. Subsequent slit lamp exam showed complete resolution of the phimosis. AC
OCT demonstrated a shift in the IOL position in both eyes (but in opposite directions)
and refraction demonstrated the expected changes due to these shifts. The best-corrected
acuity returned to normal. Once the refraction stabilized LASIK was performed to
correct the residual astigmatism.
VI.
Final Postoperative Course and Discussion (Slides 42 – 47)
Following LASIK the uncorrected distance acuity stabilized at 20/25 OD and 20/20 OS.
The patient was happy that she could garden and quilt without correction, as she had
desired. She did need reading glasses, however.
The regression of her astigmatism was likely related to her relatively thick corneas. The
capsular phimosis was effectively treated with YAG photolysis. LASIK provided a
spectacular solution for her residual refractive error.
VII.
Remediation Treatment Paths
Had the patient chosen LASIK in the first place she would have had continued
progression of her presbyopia but avoided additional surgical procedures If she had
chosen multifocal IOLs she might have achieved better uncorrected near visual acuity,
but she would have likely experienced some level of dysphotopsia. In the case, she did
not at any time complain of unwanted visual phenomena other than blurred vision due to
the capsular phimosis. Dysphotopsia related to multifocal IOLs often improves over
time. Treatments include the use of brimonidine to limit mydriasis and low minus
spectacles for night driving.
IX.
References
Packer M, Fine IH, Hoffman RS. “Refractive Lens Exchange With the Array Multifocal Lens.”
J Cataract Refract Surg. 2002; 28:421-424.
Hoffman RS, Fine IH, Packer M. "Refractive lens exchange with a multifocal IOL." Current
Opinion in Ophthalmology 2003;14:24-30.
Cumming JS, Colvard DM, Dell SJ, Doane J, Fine IH, Hoffman RS, Packer M, Slade SG.
Clinical evaluation of the Crystalens AT-45 accommodating intraocular lens: Results of the U.S.
Food and Drug Administration clinical trial. J Cataract Refract Surg May 2006; 32(5):812-825.
Fine IH, Hoffman RS, Packer M. “Avoiding complications with refractive lens exchange.”
Cataract and Refractive Surgery Today, July 2004; 4(7): 24-27.
Hoffman RS, Fine IH, Packer M. Refractive lens exchange as a refractive surgery modality.
Current Opinion in Ophthalmology 2004; 15: 22-28.
Packer M. Editorial overview: the age of refractive lens surgery, in Packer M (editor). Cataract
surgery and lens implantation, Current Opinion in Ophthalmology February 2005; 16 (1): 1.
Fine IH, Hoffman RS, Packer M. The new challenge for cataract surgeons. Editorial review,
Current Opinion in Ophthalmology February 2007; 18:1-3.