| 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
|
|
|
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
|
|
|
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.
|