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CTRI Number  CTRI/2025/10/096627 [Registered on: 30/10/2025] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Visual Functions examination in various retinal conditions 
Scientific Title of Study   Changes in Visual Functions Beyond Acuity in Patients with Epiretinal Membrane, Diabetic Macular Edema with good vision, Vitreomacular Traction, and Retinal Detachment Requiring Surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Praneet Telukunta 
Designation  consultant, opthalmologist 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, VSPC Building, 2nd floor, Retina Department, Banjara Hills, Road No:02, Hyderabad 500034, Telangana,India

Hyderabad
TELANGANA
500034
India 
Phone  9030896002  
Fax    
Email  praneet.telukunta@lvpei.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Praneet Telukunta 
Designation  consultant, opthalmologist 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, VSPC Building, 2nd floor, Retina Department, Banjara Hills, Road No:02, Hyderabad 500034, Telangana,India


TELANGANA
500034
India 
Phone  9030896002  
Fax    
Email  praneet.telukunta@lvpei.org  
 
Details of Contact Person
Public Query
 
Name  Dr Praneet Telukunta 
Designation  consultant, opthalmologist 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, VSPC Building, 2nd floor, Retina Department, Banjara Hills, Road No:02, Hyderabad 500034, Telangana,India


TELANGANA
500034
India 
Phone  9030896002  
Fax    
Email  praneet.telukunta@lvpei.org  
 
Source of Monetary or Material Support  
L V Prasad Eye Institute, VSPC Building, 2nd floor, Retina Department,Banjara Hills, Road No:02, Hyderabad 500034, Telangana, India. 
 
Primary Sponsor  
Name  L V Prasad Eye Institute 
Address  Banjara Hills, Road No:02, Hyderabad 500034, Telangana, India 
Type of Sponsor  Other [Non Profitable Organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praneet Telukunta  L V Prasad Eye Institute  L V Prasad Marg, 2nd floor VSPC building, 2nd floor, Retina OPD,Banjara Hills, Road No:02, Hyderabad 500034, Telangana, India
Hyderabad
TELANGANA 
9030896002

praneet.telukunta@lvpei.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
L V Prasad Eye Institute, Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H358||Other specified retinal disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Age more than 18 years
2. Visual acuity of at least 20 by 30 in the affected eye
3. Patients who have Epiretinal membrane
Vitreomacular traction Diabetic macular edema
Post Retinal Detachment surgeries
 
 
ExclusionCriteria 
Details  1.Patient who does not consent
2.Patient with other co-existing retinal pathologies.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the visual functions in patients with Epiretinal membrane, Vitreomacular Traction, Diabetic Macular Edema with good visual acuity and rhegmatogenous retinal detachment requiring surgery using a series of visual function tests.
2.To correlate the visual function test in these eyes with clinical findings and imaging results.
 
Day 0, 1 month, 3 months, 6 months, 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1.To monitor longitudinal changes in visual functions over course of the disease.
2.To assess changes in quality of life with the L.V. Prasad Functional Vision Questionnaire-II.
 
Day 0, 1 month, 3 months, 6 months, 1 year 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The participants will undergo comprehensive eye examination which would include refraction, slit lamp bio - microscopy, intraocular pressure measurement.  The participants, then be undergoing visual function tests including visual acuity, reverse polarity, contrast sensitivity, colour vision, cone flicker and microperimetry. Apart from these, the patients would also be undergoing OCT, Fundus photographs.Colour vision, contrast sensitivity function, photoreceptor (cone flicker) sensitivity will be measured using simple psychophysical procedures, where participants will be required to identify the location of the coloured patch of light or flicker in the computer screen using a numeric key pad. There will be a total of five tests, which will be administered monocularly for each individual. The length of time for participation is approximately 60 minutes for each eye. The total testing time, excluding the comprehensive eye examination would be approximately 2 hrs.  The results of the tests are not provided to the participants, however if patient prefers, it would be provided after the study has been concluded.All these test procedures are done routinely in research. Instruments used will be Advanced Vision and Optometric Testing (AVOT) systems. This instrument has been previously used safely in human participants over large number of studies over the past decade.

 
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