RESEARCH PROPOSAL AJA September 8 SM

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RESEARCH PROPOSAL
OUTCOME OF AGE-RELATED CATARACT SURGERY IN
JUBA MEDICAL COMPLEX
DR. AJA PAUL KUOL
A THESIS PROPOSAL SUBMITTED IN PARTIAL
FULFILLMENT FOR THE AWARD OF DEGREE OF MASTERS
IN MEDICINE, (OPHTHALMOLOGY) AT THE UNIVERSITY OF
NAIROBI.
2014
DECLARATION
I declare that this research proposal is my original work and has never been published
or presented for a degree in any other University.
Dr Aja Paul
SIGNATURE ……………................
DATE………………..
PRINCIPAL INVESTIGATOR,
Dr. Aja Paul Kuol
Department of Ophthalmology,
University of Nairobi
H58/63241/2013
SIGNATURE ……………………………
DATE………………………………
ii
APPROVAL BY SUPERVISORS:
This proposal has been submitted with our approval as Supervisors:
1. Dr. Sheila Marco
MB.CHB, M.Med (Nairobi), FEACO, Ophthalmologist (Glaucoma specialist)
Signature. .………………………………………
Date …………………………
2. Prof. Jefitha Karimurio, MB.CHB, M.MED (Nairobi), MSC-CEH (London),
FEACO, PhD (Melbourne)
Department of Ophthalmology, University Of Nairobi
Signature…………………………………
Date ……………………………
3. Dr.Wani Gindalang Mena, MBChB, MMED (Harari) Msc, ClinEpi
Consultant Ophthalmologist, Head of Eye Unit, Juba Teaching Hospital-S.Sudan
Signature…………………………………
Date ……………………………
iii
TABLE OF CONTENTS
DECLARATION .......................................................................................................... ii
APPROVAL BY SUPERVISORS: ............................................................................. iii
LIST OF ABBREVIATIONS AND ACRONYMS ...................................................... v
ABSTRACT ..................................................................................................................vi
1.0 INTRODUCTION ................................................................................................... 1
1.1 Overview of cataract ............................................................................................ 1
1.2 Epidemiology ....................................................................................................... 2
1.3 Cataract Surgery in South Sudan ......................................................................... 3
2.0 LITERATURE REVIEW ........................................................................................ 5
2.1 Outcome of cataract surgery ................................................................................ 5
3.0 JUSTIFICATION .................................................................................................. 11
4.0 OBJECTIVES OF THE STUDY ........................................................................... 12
4.1 Main Objective................................................................................................... 12
4.2 Specific Objectives ............................................................................................ 12
5.0 MATERIAL AND METHODS ............................................................................. 13
5.1 Study Area ......................................................................................................... 13
5.2 Study Design ...................................................................................................... 14
5.3 Study Population: ............................................................................................... 14
5.4 Case Definition: ................................................................................................. 14
5.5 Target population ............................................................................................... 14
5.6 Sample Size........................................................................................................ 15
5.7 Study Period ....................................................................................................... 15
5.8 Inclusion Criteria ............................................................................................... 16
5.9 Exclusion Criteria .............................................................................................. 16
5.10 Data Collection ................................................................................................ 16
5.12 Data Management and Analysis ...................................................................... 17
5.12 Ethical Considerations ..................................................................................... 18
5.13 Study Limitations ............................................................................................. 18
6.0 REFERENCES ...................................................................................................... 19
7.0 APPENDICES ....................................................................................................... 23
7.1 APPENDIX I: QUESTIONNAIRE ................................................................... 23
7.2 APPENDIX II: W.H.O. CLASSIFICATION OF BLINDNESS ...................... 26
7.3 APPENDIX III: DEFINITION OF TERMS...................................................... 27
7.4 APPENDIX IV: WORK PLAN ......................................................................... 28
7.5 APPENDIX V: BUDGET.................................................................................. 29
iv
LIST OF ABBREVIATIONS AND ACRONYMS
BCVA
Best corrected visual acuity
ECCE
Extra-capsular cataract extraction
ICCE
Intra capsular cataract extraction
IOL
Intra ocular lens
JMC
Juba Medical Complex
VA
Visual Acuity
WHO
World Health Organization
v
ABSTRACT
Background: According to World Health Organization (WHO), cataract is the
leading cause of blindness and visual impairment throughout the world. WHO target
is to eliminate cataract as one of blinding disease by 2020. Most age related cataract
surgery outcomes are poor in sub-Saharan Africa due to patient selection, poor
surgical techniques or uncorrected refracted errors among others. In Juba, there are a
lot of cataract surgeries being done. As time goes, the number of patients waiting for
cataract surgery is predicted to increase. Further, there is no current published study
finding with regard to age related cataract surgery. It’s therefore necessary to conduct
a study on the outcome of age-related cataract.
Objective: To determine the outcome of age related cataract surgery at Juba Medical
Complex from March 2011 to March 2014.
Study design: A retrospective hospital based case series
Study population: Any patient 40 years of age and above who underwent age related
cataract surgery in Juba Medical Complex within the study period.
Materials and methods: Data will be extracted from theatre registers and from the
files of patients aged 40 years old and above who had age related cataract surgery. All
the necessary socio- demographic and clinical data of the patient will be captured
using a standardized structured questionnaire and analyzed using STATA Version 13.
Descriptive analysis will be used to determine means, frequencies and proportions of
the various variables. Proportionate test will be used to compare proportions. Chisquare will be used to test factors associated with poor outcome. Results will be
presented in form of tables and graphs.
vi
1.0 INTRODUCTION
According to World Health Organization (WHO), cataract is the leading cause of
blindness and visual impairment throughout the world with approximately 50% of the
world's blind suffer from cataract.1 Most cases of blindness in the world are avoidable
and preventable. WHO VISION 2020 targets elimination of cataract as one of
blinding diseases by 2020 since its preventable.2 Most age related cataract surgery
outcomes are poor in sub-Saharan Africa due to a number of factors such as poor
patient selection, poor surgical techniques among others.3 The number of people
undergoing cataract surgery of the past years has been increasing rapidly hence the
need to investigate the outcomes of the cataract surgeries being performed. It’s
therefore necessary to conduct a study on the outcome of age-related cataract.
1.1 Overview of cataract
Cataracts are cloudy patches that develop in the lens of your eye and can cause
blurred or misty vision.1,2,4 A cataract can occur in either or both eyes and cannot
spread from one eye to the other. Most cataracts are related to aging and are very
common in older people, but there are other types of cataract due to other factors and
they include traumatic cataract, congenital cataract, radiation cataract etc1,5,6
Cataract is usually detected through a comprehensive eye exam which includes visual
acuity test, dilated eye exam and tonometry.6,7 The symptoms of early cataract may be
treated or improved with new eyeglasses, brighter lighting, anti-glare sunglasses, or
magnifying lenses. However, when these measures do not help, surgery becomes the
only effective treatment.7,8. Cataract surgery is a procedure which involves removal of
cloudy natural lens and replacing it with a clear optical device such as an intraocular
lens (IOL) or contact lenses. This is a technique which prevents the blindness from
occurring.
Some of the cataract surgeries include: Phacoemulsification (phaco), Extracapsular
Cataract Extraction (ECCE), Intracapsular Cataract Extraction (ICCE) and Small
Incision Cataract Surgery (SICS) among others.7,8,9,10 Risk factors for age-related
cataract include diabetes, prolonged exposure to sunlight, tobacco use and alcohol
drinking among others.1,6,11
1.2 Epidemiology
The prevalence of age-related cataract varies from region to region. Globally, the
estimated number of blind people is about 39 million and approximately 82% of
people living with blindness are aged 50 years and above. Surgical removal of the
cataract is still the current effective treatment that is available to prevent the
blindness.12 There are an estimated 39 million blind people and 285 million visually
impaired people worldwide and about 90% of people who are visually impaired live
in developing countries.13 Unoperated cataract contributes to 33% of the global causes
of visual impairments. About 65% of all people who are visually impaired are aged 50
and older and this constitutes 20% of worlds population. In developed countries, for
each decade after the age of 40 there is an expected increase in the prevalence of
blindness and vision loss.13 According to WHO, life expectancy in South Sudan is low
(54/55 years) because of the long civil war that the country had and majority of the
patients develop cataract at younger age around 40 years.
2
In Sub-Saharan Africa the prevalence of blindness in people over the age of 50 is as
high as 9%, and cataract is responsible for more than 50% of this blindness.14 About
7.1 of the world's 38 million blind people live in sub-Saharan Africa with 60% of
Africa's blind being women and 50% of blindness in sub-Saharan Africa is due to
cataract.14 The prevalence of blinding cataract in sub-Saharan Africa is approximately
0.5%.14 Cataract is the leading cause of blindness in the world: in 1998, an estimated
20 million people were blind due to cataract.15 Globally, at least 100 million eyes
have visual acuity <6/60 due to cataract and the need for cataract operations is at
least 30 million per year, but only around 10 million cataract operations are
performed annually.16
1.3 Cataract Surgery in South Sudan
In South Sudan, access to cataract surgery may still be a challenge to many patients
due to factors such as lack of knowledge/ awareness, lack of funds or specialized
practitioners and the techniques. So far the private medical center in south Sudan
where cataract surgery is done is the Juba Medical Complex (JMC) which may not be
adequate to cover the larger population of 350,000 (Sudan 2008 census).17 The
cataract surgery is done by the consultant ophthalmology and the type of surgery done
is ECCE. And the center (JMC) is in operation with only one ophthalmologist, one
ophthalmic nurse and one nurse assistant
Juba Medical Complex is one of the main eye hospitals in South Sudan serving a
larger number of populations since so far there less than 10 ophthalmologists in the
region. Cataract surgery is increasingly being performed in the hospital with up to 350
cases of cataract surgeries have been done between 2011 and 2014. The number is
3
quite low because cataract surgery in the hospital is too expensive for the people to
afford. This study will review the outcome of age related cataract surgery in patients
aged 40 years and above at Juba Medical Complex for the period between March
2011 and March 2014. It will be the first such study in the hospital and will provide a
baseline for future comparisons, provide appropriate recommendations and guide
future training of Ophthalmologists in age-related cataract surgery.
4
2.0 LITERATURE REVIEW
2.1 Outcome of cataract surgery
Outcome of cataract surgery is an important factor to be looked at since complications
problems can arise after surgery. These problems can include infection, bleeding,
inflammation (pain, redness, swelling), loss of vision, double vision, and high or low
eye pressure.4,18,19 With prompt medical attention, these problems can usually be
treated successfully. In South Sudan, generally there are no reported studies on the
outcome of surgery and specifically outcome of age related cataract surgery.
However, there are other studies which have looked at outcomes of cataract surgery
and complications. WHO recommends that poor (best corrected visual acuity [BCVA]
<6/60) or borderline (BCVA <6/18) outcomes after cataract surgery should not be
more than 10% to 20%.
Several studies have attributed poor cataract surgery outcomes to late presentation,
poor surgical techniques and loss to follow up among others.18 Others have attributed
the poor cataract surgery outcomes due refractive errors, post-operative complications
and due to other diseases such as glaucoma or corneal scleral or even traumatic
cataract for age related cataract surgery.10,18,19,20 This study will also study age related
cataract surgery outcome for those aged 40 years and above. These complications
may occur in about 6% of cataract surgeries cases in the developing world.8 Poor
results due to surgical complications can be limited through continuous training and
visual outcome monitoring.11
Cook reviewed a study on how to improve the outcomes of cataract surgery in the
year 2000. In the study, they noted poor outcome may be due to ‘selection’ (other
5
pathology), ‘surgery’ (intra-operative complications), and ‘spectacles’ (uncorrected
refractive error), or ‘sequelae’ (post-operative complications).18 The study
recommended that in order to improve the outcome of cataract surgeries the
individual cataract surgeons should monitor their intra-operative complications and
the visual outcome of their surgery. In addition, the programme managers must ensure
that there is adequate training of cataract surgeons. In this study therefore we shall
also assess the possible causes of poor outcomes after cataract surgery.
Thulasiraj et al assessed the clinical outcomes of cataract surgery in rural southern
India of persons aged 50 years and above was conducted. The study found that within
the cataract-operated sample of 682 persons, 13.8% had presenting visual acuity
worse than 6/60 in both eyes, 25.2% better than or equal to 6/18 in both eye. For
aphakic eyes, 50.5% presented with visual acuity better than or equal to 6/18; 82.6%
with best-correction. The study noted that uncorrected aphakia and other refractive
error were the main causes of vision impairment.10 In this study we will also identify
for eyes with presenting visual acuity worse than 6/18 for principal cause of reduction
in eye vision.
Domple et al conducted a study on visual outcomes after cataract surgery with
intraocular lens implant at rural health training Centre in India. The study assessed the
visual outcomes of patients after cataract surgery with intraocular lens implants with
reference to visual acuity (VA) and visual function (VF) in order to assess patient
satisfaction with surgical outcome. 50% patients had VA in fair vision range of
<6/18-6/60 and 52% showed the VF in the range of 76-100. Of the 32 satisfied
patients, majority were in the age group 70-79 years.21 This study, however, did not
6
show the potential causes of poor visual outcomes after age-related cataract surgery
which we shall try and address in our study
Bourne et al conducted a study to evaluate the outcomes of cataract surgery in
Pakistan in the year 2007 among the adults aged 30 years and above. The study
assesse 1317 patients and found that more recent ICCE surgeries were associated with
a poorer outcome. The study noted that almost a third of cataract operations resulted
in a presenting VA of <6/60, which could be halved by appropriate refractive
correction. The study highlighted the need for an improvement in quality of surgery
with a more balanced distribution of services.22
Salomão et al conducted a study on prevalence and outcomes of cataract surgery in
Brazil. The study found out that among the 352 cataract-operated eyes, 41.2 %
presented with VA >6/12, 28.1% with VA 6/12 to 6/18, 14.2% with VA 6/18 to 6/60,
and 16.5% with VA <6/60. The study noted that with best correction, the percentages
were 79.5%, for vision better than 6/18, 8.2%, and 12.2% respectively. The main
cause of vision impairment or blindness in operated eyes were refractive error and
retinal disorders.23
Lai et al investigated clinical outcomes of cataract surgery in very elderly adults aged
90 years and above who underwent cataract surgery. The study found out that most
common complications were vitreous loss (8.2%), posterior capsular rupture (7.2%),
and zonular rupture (4.8%). Participants with Age-related macular degeneration
(AMRD) and vitreous loss were less likely to achieve postoperative visual
improvement. The study noted that despite a high prevalence of systemic and ocular
7
comorbidities in very elderly adults, good clinical outcomes of cataract surgery were
attainable.24 This study will investigate the clinical outcomes of age-related cataract
surgery in Juba.
Malik et al. conducted a study on visual outcomes after high volume cataract surgery
in Pakistan in 2002. In their study 181 patients aged 45–82 years who had undergone
cataract surgery were examined. The type of cataract operations examined were
extracapsular cataract extraction (ECCE), phacoemulsification (phaco), ECCE with
intraocular lens (IOL) and phaco with IOL. The study found out that functional vision
in eyes undergoing ECCE with IOL was good in 77% and phaco with IOL in 71.8%.
Uncorrected refractive error, present in 75.5%, was the commonest cause of poor
functional vision.20 The study noted that more attention should be directed towards
ensuring that successful outcomes are indeed being realized by continued visual
monitoring postoperatively. The study, however, was not able to access data on
preoperative visual acuity and ocular findings. In this study we will assess if good
visual results are possible due to the types of the surgical techniques and try access
data on preoperative visual acuity and ocular findings.
Bastawrous and Sherwin conducted systematic reviews of blindness and visual
impairment due to age-related cataract in sub-Saharan Africa. They reviewed
population-based studies published between 2000 and October 2012 for patients aged
50 years and above from 15 countries. The study found out that cataract was the
principal cause of blindness and visual impairment. There was a strong positive
correlation between good visual outcomes and IOL use. In this study, we shall assess
the relationship between the surgical techniques and the visual outcomes.25 The study
8
noted that there was no data that was available from countries such as South Sudan
when they were evaluating age-related cataract surgery in sub-Saharan Africa in 2013
Chirambo conducted initial study to develop monitoring systems for cataract outcome
in Malawi in the year 2000. The study found out that 19.5% poor visual outcome at
the time of discharge and that most cases of poor outcome were attributed to surgery,
particularly post-operative corneal oedema.26 This study will assess the outcomes
attributed to age-related cataract surgery in Juba, South Sudan.
Bejiga and Tadesee assessed cataract surgical coverage and outcome in Goro District,
Central Ethiopia. The study found out that presenting and corrected visual acuities of
6/18 or better were obtained in 23.7% and 47.4% of the operated eyes respectively.
The major cause of poor visual outcome found was surgery related complications in
61.1% of the cases.27 The visual outcome after cataract surgery was however lower
than the recommended WHO visual outcome.
Trivedy conducted a study on the Outcomes of high volume cataract surgeries at a
Lions Sight First Eye Hospital in Kenya. The study found out that there was no
significant association between pre-operative visual acuity, surgeon, time of surgery
and post-operative uncorrected visual acuity (UCVA) of 6/18 and better.
Postoperative examination done at day 30 did not reveal any anterior segment
complications in all the eyes operated. The study concluded that high quality cataract
surgery can be attained in a high volume setting.9
9
Bitok et al conducted a study on the outcome of age-related cataract surgery at
Sabatia Eye Hospital from the year 2011 to 2012. The study found that the main
causes of poor visual outcome included refractive errors, poor patient selection and
surgical complications and concluded that the visual outcome is below the WHO set
standard.28
Nganga et al conducted a study on the outcome of age-related cataract surgery at
Light House for Christ Eye Centre in Mombasa from the year 2009 to 2011. The
study found out that the post-operative BCVA at 7 weeks post-operative was found to
be slightly below the recommended WHO guidelines. The intra-operative surgical
complications were found to be within the recommended WHO guidelines. The study
concluded that Lack of surgical complications was shown to be statistically
significant in contributing to good visual outcome post-operative. (p-value= 0. 008).29
Monday et al conducted a study on patterns of ocular findings among patients aged 40
years and above attending eye clinic at Juba Teaching Hospital in South Sudan. The
study found that cataract was the second most causes of ocular morbidity in the
population aged 40 years and above (21%). The study didn’t not mention if the
cataract was age-related and not age-related, and did not investigate the outcomes of
the age-related cataract for patients aged 40 years and above.30
The review of literature shows no published findings for age-related cataract surgery
in south Sudan.
10
3.0 JUSTIFICATION
It is very important to carry out ongoing and continuous audits in eye hospital in order
to know both the visual and surgical outcomes of the surgeries that have been done.
This study will be able to establish the outcome of age related cataract surgery in the
center and consequently in the whole region of South Sudan. Studies have shown that
poor outcomes due to age-related cataract surgery are common in developing
countries. This will also assist the hospital and its management in monitoring its
performance towards improving the outcome of cataract surgery in the region. It will
provide the baseline information for the subsequent researchers that are done in the
same field of study
The study, which was conducted in south Sudan on the patterns of ocular morbidity
among the patients aged 40 years and above, found that cataract was the second most
cause of ocular disease. This study only mentioned cataract in general and didn’t
specify the type of cataract was found
11
4.0 OBJECTIVES OF THE STUDY
4.1 Main Objective
To assess the outcome of age related cataract surgery in patients aged 40 years and
above performed at Juba Medical Center between March 2011 and March 2014.
4.2 Specific Objectives
1. To assess the visual outcomes of age-related cataract surgery
2. To determine the complications of age-related cataract surgery
3. To determine the factors associated with poor surgical outcome.
12
5.0 MATERIAL AND METHODS
5.1 Study Area
Fig 1: A map showing Juba Medical Centre, Juba
The study will be carried out at the Juba Medical Complex in Juba, South Sudan. It is
located in the capital of South Sudan Juba; which is located in Central Equatorial
State, one of the ten states of the South Sudan, with a catchment area of about 150
km/s with population of 350,000 (Sudan 2008 census).
The eye unit operates once a week with frequency of patient ranging between 10 -20
per Day and ranging from 3600 to 7000 per Year in all age groups but frequency of
patients going for cataract surgery ranging between 2 to 10per day and to
approximately 700 to 3600 per year (JMC eye unit statistic-2014).
13
Juba Medical Complex (JMC) in Juba is a sixty bed Hospital established to plug a
yawning gap in the provision of high quality secondary and tertiary care in the
Southern Sudan. Juba Medical Complex has 5 separate blocks: pharmacy, theater,
maternity, wards, and the main block.
At JMC there is only one ophthalmologist consultant who does all the eye surgeries
and only one ophthalmic nurse.
5.2 Study Design
This will be a retrospective hospital based case series.
5.3 Study Population:
Records of all persons age 40 and above went for cataract surgery at JMC.
5.4 Case Definition:
Any patient aged 40 years and above who had under gone cataract surgery for age
related cataract between March 2011 to March 2014 at Juba Medical Center.
5.5 Target population
An estimated number of 350 patients have undergone age-related cataract surgery at
Juba Medical Complex between March 2011 and March 2014 (from the Juba Medical
Complex records).
14
5.6 Sample Size
The following sample size determination formula for finite population correction
(Lwanga & Lameshow, 1991)31 was used to estimate the proportion of population
study size.
n' 
NZ 2 P(1  P)
d 2 ( N  1)  Z 2 P(1  P)
Where
n' = sample size with finite population correction,
N = size of the target population = 350 (estimated number of patients who have
undergone age-related cataract surgery according to the Juba Medical Centre theatre
registry book between March 2011 to March 2014)
Z = statistic for 95% level of confidence
P = estimated proportion of patients with poor age-related surgical outcome – 4.2%3
d = margin of error = 2.1%
n
350 1.962  0.042  0.958
 175.38  175
(0.0212  349)  (1.962  0.042  0.958)
n' = 175 patients
5.7 Study Period
The study will be conducted from December 2013 to December 2014.
15
5.8 Inclusion Criteria
All the records of persons 40 years and older who had age related cataract surgery at
the centre will be eligible to be included in the study.
5.9 Exclusion Criteria
Missing or incomplete records (age ,VA)
Record of all persons less than 40 years at the time of surgery
Cataract secondary to trauma
Uveitic cataract
5.10 Data Collection
Structured questionnaires (Appendix I) will be used by the principal investigator
assisted by a research assistant to record/ collect patients’ data. The file/card number
of patients over 40 years who underwent cataract surgery between March 2011 and
March 2014 will be recorded from the theatre surgery record books, the files will then
be retrieved from the hospital registry with the assistance of the hospital records clerk
and the data recorded in the questionnaire. Information that will be collected will
include: Demographics, preoperative examination information (visual acuity,
refraction, visual complaints, other diseases that may affect the outcome), Surgery
(Date, time and surgeon qualifications, anaesthesia given, Surgical techniques, and
intra operative complications), Post-operative examination (discharge date, visual
acuity, possible cause of poor vision, examination at day 1, 1st follow up, 2nd follow
up, 3rd follow up and 4th follow-up, and complications after surgery.
Data collection period will be between December 2014 and January 2015
16
5.12 Data Management and Analysis
The collected data will be entered into the computer, cleaned, validated and coded
using STATA version 13 (Stata Corp, College Station, Texas). It will be checked for
any wrong entry and double entry and corrected. Back up will be created in an
external hard disk in case of damage and/or loss of original data and it will be
password protected. All data will be stored under lock and key and with password
protected files under the custody of the principal investigator to prevent any illicit
access to the data. Use of coded data will be done to ensure maximum confidentiality.
At the end of the study, the raw data will be destroyed and deleted from any existing
hard copies by paper shredding and formatting and deleting from any soft copy
storage devices including computers, flash discs and hard disks. \.\
Data analysis
Data analysis will be done using the STATA version 13 (Stata Corp, College Station,
Texas). Descriptive analysis will be done to determine means, frequencies and
proportions of the various variables and findings presented by means of graphs, tables
and charts where appropriate. Proportionate test will be used to compare proportions
of the categorical and continuous variables describing demographics, Preoperative
examination, surgery and post-operative examination. Chi-square will be used to test
factors associated with poor outcome. Confidence level will be taken as 95% (p
<0.05) where applicable.
17
5.12 Ethical Considerations
The identity of the patients will be keep anonymous during data collection. No record
of the identity of the patient or file number will be made. No photocopies of medical
records will be made. The questionnaires will only be available to the Biostatistician
and investigator for analysis only.
Written ethical approval to conduct the study will be sought from the Ethics and
Research Committee of University of Nairobi and Kenyatta National Hospital for
approval. Approval will also be sought from Juba Medical Complex and Ministry of
Health in South Sudan for approval
The raw data will be retain in confidentiality until the thesis has been accepted and
marked for any verification and/or study published and maximum of 1 year after
ethical approval. The questionnaires and other materials shall then be destroyed.
5.13 Study Limitations
The retrieved information from the private health facility (JMC) may not be sufficient
for the study to make inference about the whole of south Sudan.
18
6.0 REFERENCES
1. World Health Organization, Global initiative for the elimination of avoidable
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[Online],
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8. Gogate PM, Deshpande M, Wormald RP, et al. Extracapsular cataract surgery
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setting in western India: a randomised controlled trial. Br J Ophthalmol. 2003;
87(6): 667-672.
9. Trivedy J. Outcomes of high volume cataract surgeries at a Lions Sight First
Eye Hospital in Kenya. Nepal J Ophthalmol. 2011;3(1):31-38.
19
10. Thulasiraj RD, Reddy A, Selvaraj S, et al. The Sivaganga Eye Survey: II.
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11. Yorston D. Cataract Complications. Community Eye Health. 2008; 21(65).
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13. Taylor HR, Keeffe, JE. World blindness: a 21st century perspective. Br J
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needs. Br J Ophthalmol. 2001;85(8):897-903
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16. Foster A. Cataract-a global perspective: output, outcome and outlay. Eye.
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19. Lumme P, Laatikainen LT. Factors affecting Visual Outcome after cataract
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20. Malik AR, Qazi ZA, Gilbert C. Visual outcome after high volume cataract
surgery in Pakistan. Br. J. Ophthalmol. 2003;87(8):937–40.
21. Domple VK, Gaikwad AV, Khadilkar HA, et al. A study on visual outcomes
after cataract surgery with intraocular lens implants at the rural health training
center, Paithan, Maharashtra. Indian Journal of Public Health. 2011; 55( 1):
22-24
20
22. Bourne R, Dineen B, Jadoon Z, et al. Outcomes of cataract surgery in
Pakistan: results from The Pakistan National Blindness and Visual Impairment
Survey. Br J Ophthalmol. 2007;91(4):420-426.
23. Salomão SR, Soares FS, Berezovsky A, et al. Prevalence and Outcomes of
Cataract Surgery in Brazil: The São Paulo Eye Study. Am. J. Ophthalmol.
2009;148(2):199–206
24. Lai FH, Lok JY, Chow PP, et al. Clinical Outcomes of Cataract Surgery in
Very Elderly Adults. J Am Geriatr Soc. 2013
25. Bastawrous A, Dean WH, Sherwin JC. Blindness and visual impairment due
to age-related cataract in sub-Saharan Africa: a systematic review of recent
population-based studies. Br J Ophthalmol. 2013;97(10):1237-1243
26. Chirambo MC. Country-wide Monitoring of Cataract Surgical Outcomes.
Community Eye Health 2002;15(44):58–59.
27. Bejiga A, Tadesse S. Cataract surgical coverage and outcome in Goro District,
Central Ethiopia. Ethiop. Med. J. 2008;46(3):205–210.
28. Bitok MC, Kariuki MM, Karimurio J et al. Outcome of age-related cataract
surgery at Sabatia Eye Hospital, Western Kenya. Unpublished MMED Thesis,
University of Nairobi, 2013
29. Nganga MN, Kimani K, Njuguna MM et al. Outcome of age-realted cataract
surgery at Light House for Christ Eye Centre, Mombasa. Unpublished MMED
Thesis, University of Nairobi, 2014
30. Monday JL, Marco S, Maina N et al. Pattern of ocular findings among patients
aged 40 years and above attending eye clinic at Juba Teaching Hospital in
Southern Sudan. Unpublished MMED Thesis, University of Nairobi, 2014
21
31. Wanga SK, Lemeshow S. Sample size determination in health studies. A
practical manual. Ginebra: World Health Organization, 1991.
22
7.0 APPENDICES
7.1 APPENDIX I: QUESTIONNAIRE
TITLE OF STUDY: OUTCOME OF AGE-RELATED CATARACT SURGERY
IN JUBA MEDICAL COMPLEX
This questionnaire is for collecting information for the patients aged 40 years and
above
General Information
Questionnaire code _______________
Data collection date ______________
Socio-demographics
Home district/ region _____________
Gender:
1. Male
Age (years) ____________
2. Female
Clinical information
Operated eye
1. LE
2. RE
PRE-OP EXAMINATION
VA
Presenting
______
Biometry
Pinhole/BCVA ____
IOP
______________________
Eyelids
______________________
Conjunctiva
______________________
Cornea
______________________
NO
Anterior chamber______________________
Iris
_______________________
Pupil
____________________________
Yes
Type of cataract: Nuclear Cataract
Hypermature
Cortical cataract
Other
PSC
Vitreous _______________________________________
Fundus ________________________________________
23
SURGERY
Date _____________________________
Surgeon
Consultant
OCO/CS
Trainee
Anaesthesia
LA
GA
Surgical technique
Type
IOL
Suture
Incision
SICS
Bag
Yes ___
Scleral ___
ICCE
Sulcus
No ___
Corneal
Lensectomy
AC
Limbal ___
Phaco..
None
Superior __
___
Temporal __
COMPLICATIONS
Pre-op complications
Retrobulbar haemorrhage during aneasthesea ___________________________
Other _______________________________________________
Intra-op Complications
Complication
Yes
No
None
Posterior capsule tear
Iris prolapse
Iridodilysis
Vitreous loss
Suprachorodal haemorrhage
Hyphema
Zonular dialysis
Lens matter in vitreous
Other
24
Post-op Complications
Complication
Yes
No
Shallow/flat AC
Elevated IOP
Corneal oedema
Aqueous Misdirection
Cystoid macula edema
PCO
IOL dislocation
Endophthalmitis
Astigmatism
Retinal detachment
Uveitis
Pupillary capture
Other
POST-OP VA
Day of follow up
Findings
Presenting
BCVA/ Pinhole
Day 1
_________
_________
Follow-up 2 (___weeks)
_________
_________
Follow-up 3 ( ___weeks)
_________
_________
Follow-up 3 (____weeks)
_________
_________
Follow-up 4 (_____weeks)
_________
_________
___________________
_________
_________
Main cause of poor Outcome at last visit
Selection _______________________________________________
Surgery ________________________________________________
Refraction_______________________________________________
Sequelae _______________________________________________
25
7.2 APPENDIX II: W.H.O. CLASSIFICATION OF BLINDNESS
Category
Degree of visual impairment
Best corrected visual acuity in
the better eye
0
Normal vision
6/6 - <6/18
1
Visual impairment
6/18 –< 6/60
2
Severe visual impairment
6/60 -<3/60 or visual field < 10 ̊
3
Blind
3/60 –NPL or visual field <5 ̊
26
7.3 APPENDIX III: DEFINITION OF TERMS
Age related cataracts: Cataract occurring after 40 years of age.
Best corrected visual acuity – The best achievable visual acuity after correcting for
any refractive errors with spectacles, contact lenses or other corrective measures.
Biometry – Measurement of the size and lens power of the eye using ultrasound
measurements and formulas
Cataract - Is a clouding of the crystalline lens of the eye which impedes the passage
of light.
Extracapsular cataract extraction – A method of eye surgery used in which the lens
nucleus and cortex of the natural lens of the eye is extracted from the lens capsule in
parts, after opening the anterior lens capsule.
Intracapsular cataract extraction – A method of eye surgery used in which the
natural lens of the eye is extracted in total without disruption of the lens capsule.
Visual Acuity – The measure of vision for an eye.
Poor visual outcome: visual acuity 6/60 or less (as per WHO guidelines)
Moderate or Borderline visual outcome: visual acuity of <6/18 - 6/60 (as per WHO
guidelines)
Good visual outcome: visual acuity above or equal to 6/18 (as per WHO guidelines)
27
7.4 APPENDIX IV: WORK PLAN
TIME (YEAR &MONTH
2014
2015
J F MA MJ J A S O N D J F MA M
ACTIVITY
Concept and Preparation of Proposal
Presentation to Department
Ethical Approval
Budget Approval
Preparation of Study materials/Training of
Assistants
Data collection
Data Analysis and Results presentation
Preparation and Submission of Thesis
28
7.5 APPENDIX V: BUDGET
Item
Total (Ksh)
Printing and Packing
400
Photocopy of Proposal
240
Binding Proposal
360
Proposal Printing 2nd draft
400
Photocopy of proposal 2nd draft
240
Binding of proposal 2nd draft
450
Ethics: Kenya, South Sudan
5000
Sub-total
4,500
Contracted services
Statistician
50,000
Research assistants
30,000
Sub-total
80,000
Communication
Telephone
4,000
Miscellaneous
1,500
Subtotal
5,500
Results
Printing of questionnaire
100
Photocopy of questionnaire
6,500
Printing of results
6000
Copy of final book
5000
Binding of final paper
1,700
Transportation (T&T)
Nairobi-Juba-Nairobi
110,000
Juba-Juba Medical Complex- Juba
16,000
Grand total
237,890
29
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