THESIS TITLE:

“A CLINICAL STUDY OF MACULAR EDEMA AFTER CATARACT SURGERY IN

DIABETIC PATIENTS”.

(FOR MS OPHTHALMOLOGY)

STUDY PERIOD: 1.5years

(2023- 2024)

DR. SHIVNA PANDYA

1ST-YEAR RESIDENT

DEPARTMENT OF
OPHTHALMOLOGY B.J.MEDICAL
COLLEGE AHMEDABAD
Contact number: 9824215051

Date of submission:
PROPOSAL DR. SHIVNA PANDYA
1st YEAR
RESIDENT,
M & J INSTITUTE OF
OPHTHALMOLOGY (GOVERNMENT
EYE HOSPITAL)
B. J. MEDICAL
COLLEGE
AHMEDABAD
Date:
Mob. No-9824215051
EMAIL ID: shivnapandya@gmail.com

To,
The Chairperson of the Ethics Committee,
Dissertation Review Board,
B. J. Medical College,
New Civil Hospital, Ahmedabad.

Subject: -To grant ethical approval to conduct the study for the dissertation entitled-
“A CLINICAL STUDY OF MACULAR EDEMA AFTER CATARACT SURGERY IN
DIABETIC PATIENTS”.

Respected Ma’am,
I, Dr. Shivna Pandya first year resident in M and J Western Regional Institute of
Ophthalmology (Government Eye Hospital) have been assigned the thesis topic:
“A CLINICAL STUDY OF MACULAR EDEMA AFTER CATARACT SURGERY IN
DIABETIC PATIENTS” under the guidance of my P.G. Teacher, Dr. Sonali Shah (MS),
Associate Professor at M and J Institute of Ophthalmology.
A synopsis of my dissertation has been attached overleaf. Kindly grant me ethical approval to
conduct the dissertation.

Guided by; Yours faithfully Approved By

Dr. Sonali Shah, Dr. Shivna Pandya Dissertation Screening
Associate Professor, 1st-year resident, Committee,
M & J Institute M & J Institute Ophthalmology
Department
of Ophthalmology, of Ophthalmology, M & J Institute
B. J. Medical B. J. Medical of Ophthalmology
College, College, B. J. Medical
Civil Hospital, Civil Hospital, College,
Ahmedabad. Ahmedabad Civil Hospital,
Ahmedabad
 DISSERTATION PROTOCOL

(I) PROTOCOL TITLE – “A CLINICAL STUDY OF MACULAR EDEMA AFTER

CATARACT SURGERY IN DIABETIC PATIENTS”.

Name of principal investigator- Dr. Shivna Pandya

1st-year Resident,
M & J Institute of
Ophthalmology,
B. J. Medical College,
Civil Hospital,Ahmedabad

Study period: 2023 to 2024

(II) INTRODUCTION: -

Diabetes Mellitus is a metabolic disorder caused by chronic hyperglycemia that results in a number of
pathologies including microvascular and macrovascular complications such as retinopathy, neuropathy,
nephropathy, ischemic heart disease, cerebrovascular disease and peripheral vascular diseases [1],[2].

Diabetic retinopathy (DR) is the most feared ocular manifestation of diabetes. It is characterized by
progressive damage to the retinal microvasculature, which leads to ischemia, retinal edema and
neovascularization, manifesting as microaneurysms, retinal hemorrhages, hard exudates, cotton wool
spots, retinal venular abnormalities (venous beading and tortuosity), intraretinal microvascular
abnormalities, and new blood vessels[3],[4]. Retinopathy is associated with both type 1 and type 2 diabetes.
Despite this strong association with diabetes, it must be noted that the development of retinopathy lesions
is multifactorial metabolic parameters including central obesity, hypertriglyceridemia, dyslipidemia,
hypertension, fasting hyperglycemia, and poor long term hyperglycemic control.

Macular edema (ME) is one of the most common causes of visual loss after uncomplicated cataract
surgery nowadays [5],[6],[7] . The effect of cataract surgery on the progression of retinopathy is not fully
defined, although cataract surgery is associated with an increased risk of postsurgical edema or
worsening of the preexisting edema due to postsurgical inflammation that is increased by
preexisting diabetic retinopathy [8],[9]

Hyperglycemia-induced elevation of intracellular glucose levels generates chronic oxidative stress

through the flux of glucose through the polyol pathway, leading to the release of proinflammatory
cytokines, recruitment of leukocytes, loss of endothelial cells, breakdown of tight junctions, and an
increase in vascular endothelial growth factor.5 All of these phenomena result in a significant increase in
cell permeability, with the consequent formation of edema within the macula.[10]

Several studies made attempts to identify the risk factors of post-operative ME in diabetic eyes, though
the exact cause of this phenomenon is still undetermined. However, with the availability of the optical
coherence tomography (OCT), we can obtain qualitative and quantitative parameters of macula better
than ever and explore the relationship of macular status before and after cataract surgery in diabetic
patients[11],[12],[13],[14]
OCT provides detailed information about retinal microstructure, and measures retinal thickness with high
precision and reproducibility. Any abnormal pooling of extracellular fluid may result in displacement of
the spatial relationships between retinal neuronal components. Small amounts of fluid may lead to an
increase in overall retinal thickness, whereas larger amounts may give rise to cell-free spaces, as seen in
CME. On OCT images, cystoid cavities appear as black non-reflective spaces, surrounded by medium-to-
low reflective septa.[15]

(III) STUDY HYPOTHESIS: To assess the quantitative changes of the macula in diabetic
eyes after cataract surgery using optical coherence tomography (OCT) and to study the effect of
metabolic parameters affecting the development of CME in diabetic patients post cataract
surgery.

(IV) AIMS AND OBJECTIVES:

1. To estimate the incidence of CME development or worsening post cataract surgery in
diabetic patients in population of western India
2. To study the metabolic factors associated with development of CME in patients with DM
after cataract surgery.
3. To study the visual prognosis of patients developing CME post-surgery at 1 month and 3
months.
(V) STUDY DESIGN:-

• Study type: - Prospective Observational study

• Study site: - M and J Institute of Ophthalmology, Civil Hospital,Ahmedabad.
• Study duration: - 2023 to 2024

(VI) Medical devices/drugs/vaccines/alternative medicine/new technique/diagnostic kit

to be used in the study:
1. Slit Lamp Biomicroscope (Zeiss)

2. OCT

3.Visual acuity with standard ETDRS vision chart

4. Dilatation drops – Tropicamide 0.8% and phenylephrine 5%

5. Indirect Ophthalmoscope and 20D lens

(VII) All above mentioned medical devices are available in the government supply
 (VIII) STUDY SELECTION:
Sample size: 250 patients having DM undergoing cataract surgery.

1) Inclusion criteria
1. Age above 18 years.
2. Patients willing to give consent
3. Patients diagnosed with Diabetes Mellitus
4. Patient diagnosed with cataract undergoing cataract surgery
5. Visual acuity (VA) of light perception or better
6. The patient is compliant with his/her medication

2) Exclusion criteria
1. The patient cannot give consent or is unwilling to come for a follow-up.
2. Pregnant and lactating women.
3. Patient having a previous history of intraocular surgery.
4. Patients having any other preexisting ocular disease.

(IX) MATERIALS AND METHOD:

Prior approval will be obtained from the dissertation screening board and dissertation review
board. Study participants consisting of cohort of diabetic patients above the age of 18 years with
varying levels of retinopathy, including the absence of retinopathy, scheduled for routine cataract
surgery with intraocular lens implantation at M & J Institute of Ophthalmology and consenting for
the study shall be consecutively enrolled for this study between the period of 2023 to 2024.

Participants will undergo all routine blood investigations including HbA1C levels, hsCRP levels and
Lipid profile and Serum Homocysteine levels preoperatively.

Fundus examination and Optical coherence tomography testing will be performed within 4 weeks
before surgery and at 1- and 3-month at postoperative visits.

Best-corrected visual acuity (BCVA) will be recorded at each visit at 15 days, 1 month and 3 month
postoperative follow up.

Primary outcome: Estimating the effect of metabolic syndrome on the development of CME
post cataract surgery in patients with DM.

Secondary outcomes will be:

1. To estimate the incidence of CME development or worsening post cataract surgery in
diabetic patients in population of western India
2. To study the metabolic factors associated with development of CME in patients with DM
after cataract surgery.
3. To study the visual prognosis of patients developing CME post-surgery at 1 month and 3
months.
(X) DATA ANALYSIS:
All data regarding primary and secondary outcomes will be collected, entered in IBM SPSS
statistics for windows, and analyzed using appropriate tests.

(XI) STUDY ENDPOINT

1. To estimate the incidence of CME development or worsening post cataract surgery in
diabetic patients in population of western India
2. To study the metabolic factors associated with development of CME in patients with DM
after cataract surgery.
3. To study the visual prognosis of patients developing CME post-surgery at 1 month and 3
months.

(XII) NAME OF PRINCIPAL INVESTIGATORS:

Dr.Shivna Pandya
1st- year resident, M.S. Ophthalmology

Dr.Sonali Shah,
Associate Professor,
M and J Institute of
Ophthalmology, Civil hospital,
Ahmedabad.

(XIII) BIBLIOGRAPHY
1. Herman WH. Diabetes epidemiology: guiding clinical and public health practice: the Kelly West
Award Lecture, 2006. Diabetes Care. 2007;30:1912–1919.
2. Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk
Manag. 2007;3:853–876.
3. van Leiden HA, Dekker JM, Moll AC, Nijpels G, Heine RJ, Bouter LM, Stehouwer CD, Polak BC.
Risk factors for incident retinopathy in a diabetic and nondiabetic population: the Hoorn study. Arch
Ophthalmol. 2003;121:245–251.
4. Venkatramani J, Mitchell P. Ocular and systemic causes of retinopathy in patients without diabetes
mellitus. BMJ. 2004;328:625–629.
5. Kim SJ, Equi R, Bressler NM. Analysis of macular edema after cataract surgery in patients with
diabetes using optical coherence tomography. Ophthalmology. 2007;114(5):881–889.

6. Diabetic retinopathy clinical research network. Browning DJ, Glassman AR, Aiello LP, et al.
Relationship between optical coherence tomography-measured central retinal thickness and visual acuity
in diabetic macular edema. Ophthalmology. 2007;114(3):525–536.

7. Mentes J, Erakgun T, Afrashi F, Kerci G. Incidence of cystoid macular edema after uncomplicated
phacoemulsification. Ophthalmologica. 2003;217(6):408–412.

8. Solomon SD, Chew E, Duh EJ, et al. Diabetic retinopathy: a position statement by the American
diabetes association. Diabetes Care 2017;40:412–418.

9. Dowler JG, Hykin PG, Hamilton AM. Phacoemulsification versus extracapsular cataract extraction in
patients with diabetes. Ophthalmology 2000;107:457–462.

10. Zhang X, Zeng H, Bao S, et al. Diabetic macular edema: new concepts in patho-physiology and
treatment. Cell Biosci 2014;4:27.

11. Browning DJ, McOwen MD, Bowen RM, Jr, O'Marah TL. Comparison of the clinical diagnosis of
diabetic macular edema with diagnosis by optical coherence
tomography. Ophthalmology. 2004;111(4):712–715.

12. Romero-Aroca P, Fernandez-Ballart J, Almena-Garcia M, Mendez-Marín I, Salvat-Serra M, Buil-

Calvo JA. Nonproliferative diabetic retinopathy and macular edema progression after
phacoemulsification: prospective study. J Cataract Refract Surg. 2006;32(9):1438–1444.

13. Virgili G, Menchini F, Murro V, Peluso E, Rosa F, Casazza G. Optical coherence tomography (OCT)
for detection of macular oedema in patients with diabetic retinopathy. Cochrane Database Syst
Rev. 2011;7:CD008081.

14. Otani T, Kishi S, Maruyama Y. Patterns of diabetic macular edema with optical coherence
tomography. Am J Ophthalmol. 1999;127(6):688–693.

15. Antcliff R, Marshall J. The pathogenesis of edema in diabetic maculopathy. Semin

Ophthalmol. 1999;14:223–232.

PROFORMA:
“A CLINICAL STUDY OF MACULAR EDEMA AFTER CATARACT SURGERY IN
DIABETIC PATIENTS”.

PRELIMINARY DATA:

1. Registration number:
2. Age:
3. Sex:
4. Binocular corrected visual acuity:
5. Slit Lamp Biomicroscopy
Lid/Lac
Cornea
Conj./Sclera
AC
I/P
Lens
Eom
6. Applanation IOP:
7. Fundus
8. Visual Field Testing:
9. OCT
10. Blood investigations:
a. LDL
b. VLDL
c. HDL
d. HbA1C
e. hsCRP
f. Serum Homocysteine

Guided by; Yours faithfully,

Dr. Sonali Shah, Dr. Shivna Pandya
Associate Professor, 1st-year resident,
M and J Institute of Ophthalmology, M and J institute of Ophthalmology,
B. J. Medical College, B. J. Medical College,
Civil Hospital, Civil Hospital,
Ahmedabad. Ahmedabad.
Annexure:

[1] Informed consent form

Consent form

I, enroll myself in the research project by Dr. Shivna Pandya who is resident in the
ophthalmology department at M and J Institute of Ophthalmology, B.J. Medical College,
Ahmedabad. I have been informed about the procedure of this study. I know that my
identity and the results will be kept confidential throughout the study and the result will be
used for research purposes only. I am not provided any remuneration for participation in
the study, I also know that I am free to withdraw my consent at any time during the study.
I give consent of my own free will.
Signature of the patient:
Name:
Date:
Investigator’s name and mobile number:
(II)Participant Information Sheet

I am Dr Shivna Pandya doing my training for MS in Ophthalmology at M & J Institute of

Ophthalmology, Ahmedabad. I am conducting research on the above-mentioned topic under the guidance
of Dr Sonali Shah, who is an Associate Professor of Ophthalmology in the Department of Ophthalmology
at M & J Institute of Ophthalmology, Ahmedabad.
I am going to give you information and invite you to be a part of this research. You do not have to decide
today whether or not you will participate in the research. Before you decide you can talk to anyone you
feel comfortable with about the research.
There may be some words that you do not understand. Please ask me to stop as we go through the
information and I will take time to explain. If you have questions later, you can clarify those with me.

1.“What is the purpose of this study?”

Diabetes is a common disease that affects a lot of people. It has many vision affecting
complication in the eye, especially a type of swelling in the eye called Macular edema. We want to study
the factors that affect the development of this swelling in patients undergoing cataract surgery.

2. “Why have I been invited to participate in this study?”

You are being requested to volunteer for this research because you have been seeking
treatment/studying/working at the tertiary care centre and closely interacting with staff
members/service users (patients) at the centre. Your experience on side effects encountered by you can
help in determining the prevalence of these side effects and the morbidity caused by them.

3. “What if I don’t want to participate in this study, or I want to withdraw later?”

Your participation in this study is entirely voluntary. If you choose not to participate, your choice would
be respected. Even if you agree to participate, you may withdraw from this study at any time without any
explanation.

4. “What will happen to me if I take part in this study?”

If you agree to join the study, you will undergo some investigation pre and post operatively and will need
to come for a follow up examination at 15 days, 1 month and 3 month follow up.

5. “What investigations will be conducted in this study?”

Pre operatively you will undergo slit lamp examination, blood investigations, fundus examination and
OCT testing
Post operatively you’ll undergo slit lamp examination, fundus examination and OCT testing
6. “Will I benefit from this study?”

You will not benefit directly from this study. By participating in the study, you will help to assess the risk
of developing macular edema post cataract surgery in diabetic patients such as yourself and any
additional factors aiding it and the morbidity caused by it and in turn, help in providing feedback
regarding additional research and interventions needed to prevent it effects as much as possible.

7.. Are there any risks?

There are no major risks of participating in the study.

8. “How will my confidentiality be protected?”

All the information obtained in this study will be kept confidential. The data will be stored
anonymously using codes. You are being requested to volunteer for this research because you have been
seeking treatment/studying/working at the tertiary care centre and closely interacting with staff
members/service users (patients) at the centre. Your perspective is valuable and would help in shaping the
approach towards further management and prevention of side effects.

9. “What happens with the results and how long will the data be stored?”
In the event that any reports or publications result from this study, no information will be revealed that
will permit readers to identify you. If you would like to know the results of the study or your individual
results on any of the measures, we would be happy to reveal them to you.

10. “What should I do if I want to discuss this study further before I decide?”

You can take your time to decide on participating in the study. You may clarify with us or with your
family member or any other competent researcher/ person regarding the research or your participation

11. “Who is organizing and funding the study?”

The study is organized by the Department of Ophthalmology at M and J Institute of

Ophthalmology, Ahmedabad and it is an unfunded project

12. “Who has reviewed the ethical aspects of the study?”

The ethical aspects of this study have been reviewed by the Departmental Dissertation screening
committee of the Department of Ophthalmology at M & J Institute of Ophthalmology, Ahmedabad
and approved by the Institute Ethics Committee of B. J. Medical College, Ahmedabad.

Thank you for taking time to consider this study. If you wish to take part in it, please sign the attached
consent form
This information sheet is for you to keep
The Consent Form will be read and explained to the participant before receiving the participant’s consent,
and it would be ensured that the participant has knowledge of the research project and seemingly has
understood it. The consent form will be read out and the participants response will be recorded Through
audio recording during the interview.