| CTRI Number |
CTRI/2025/08/093263 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study focuses on understanding eye diseases caused by inherited genes in Indian people. It aims to use simple genetic tests and thorough eye check-ups to better identify and treat these conditions, helping patients get the care they need. |
|
Scientific Title of Study
|
Genetic Testing and Deep Phenotyping of Inherited Retinal Diseases (IRDs) in Indian population: A prospective, multicenter study |
| 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 Parveen Sen |
| Designation |
Senior Consultant, Head, Retina Services |
| Affiliation |
Dr. Agarwal Group of Eye Hospitals |
| Address |
Consultation Room-1, Retino Vitreo Services, First Floor
Chandigarh
CHANDIGARH
160022
India |
| Phone |
9884327629 |
| Fax |
|
| Email |
parveensen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parveen Sen |
| Designation |
Senior Consultant, Head, Retina Services |
| Affiliation |
Dr. Agarwal Group of Eye Hospitals |
| Address |
Consultation Room-1, Retino Vitreo Services, First Floor
Chandigarh
CHANDIGARH
160022
India |
| Phone |
9884327629 |
| Fax |
|
| Email |
parveensen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Riya Sharma |
| Designation |
Clinical Research Coordinator |
| Affiliation |
Dr. Agarwal Group of Eye Hospitals |
| Address |
Clinical Research Room, First Floor
Chandigarh
CHANDIGARH
160022
India |
| Phone |
8566019905 |
| Fax |
|
| Email |
riyabhardwaj2512@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vitreo Retinal Society of India, Dr. Shroffs Charity Eye Hospital, 5027, Ketar Nath Road, Daryaganj, New Delhi – 110002 |
|
|
Primary Sponsor
|
| Name |
Vitreo Retinla Socirty of India (VRSI) |
| Address |
5027, Ketar Nath Road, Daryaganj, NewDelhi – 110002. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Simar Rajan Singh |
Advanced Eye Center, PGIMER |
Room No. 126, Level 1
Advanced Eye Centre, PGIMER
Chandigarh
CHANDIGARH |
9914427851
simarrajansingh@gmail.com |
| Dr Vinod Kumar |
All India Institute of medical sciences |
Vitreoretina Services,
RPC, AIIMS
New Delhi
DELHI |
9868420620
drvinod_agg@yahoo.com |
| Dr Srikanta Kumar Padhy |
Anand Bajaj Retina Institute LVPrasad Eye Institute, Bhubaneswar |
1st floor, Retina clinic, Room number 7
Khordha
ORISSA |
9013232657
Srikanta.padhy@lvpei.org |
| Dr Subhadra Jalali |
Anant Bajaj Retina Institute, L V Prasad Eye Institute, Hyderabad |
Consultation room 230, Floor 2
Centre for vitreoretinal Diseases
Hyderabad
TELANGANA |
9848995088
subhadra@ lvpei.org |
| Dr Puja Maitra |
Aravind Eye Hospital, Chennai |
Department of Vitreoretina
Room R19 -202, Second floor
Chennai
TAMIL NADU |
9884541628
pujamaitra@gmail.com |
| Dr Poornachandra B |
Department of Retina and Ocular Genetics Narayana Nethralaya, Bengaluru |
Consultation room number 3
Floor: -1 level, B Block
Department of Retina
Bangalore
KARNATAKA |
9880016222
punith.poorna@gmail.com |
| Dr Padma Preetha |
Dr Agarwals Eye Hospital, Chennai |
Vitreo Retina department, Second floor,Room number 202
Chennai
TAMIL NADU |
9994954336
tgpreetha@gmail.com |
| Dr Parveen Sen |
Mirchias Laser Eye Clinic- a unit of Dr. Agarwal Eye hospitals, Chandigarh |
Consultation Room-1, Retino Vitreo services, First Floor
Chandigarh
CHANDIGARH |
09884327629
parveensen@gmail.com |
| Dr Chetan Rao |
Sankara Nethralaya,Chennai |
Room number 6302, JKCN campus, AS block
Chennai
TAMIL NADU |
9841157112
drss@snmail.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Aravind Eye Hospital High Road Tirunelveli Tamil Nadu India |
Submittted/Under Review |
| Dr. Agarwal Eye Hospital Institutional Ethics Committee |
Submittted/Under Review |
| Ethics Committee Situated at L V Prasad Eye Institute , Kallam Anji Reddy Campus, L V Prasad Marg, Road No.2, Banjara Hills, Hyderabad-500034, Andhra Pradesh, India |
Submittted/Under Review |
| Institutional Ethics Committe, PGIMERe |
Submittted/Under Review |
| Institutional Ethics committee,Stem Cell, Research & Therapy, AIIMS, Situated at Room No. 1081, Ist Floor Teaching Block Ansari Nagar New Delhi-110029 |
Submittted/Under Review |
| Institutional Ethics Committee- Dr. Agarwals Healthcare Mohali |
Approved |
| Institutional Review Board (Ethics Committee) |
Approved |
| L V Prasad Eye Institute Patia Bhubaneswar 751024 |
Submittted/Under Review |
| NARAYANA NETHRALAYA ETHICS COMMITTEE NARAYANA NETHRALAYA 121/C, CHORD ROAD, 1ST R BLOCK RAJAJINAGAR BANGALORE Bengaluru (Bangalore) Urban Karnataka |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Inherited Retinal Diseases (IRD) |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with RPwill be includedfrom 9 centres by experienced retina specialist with expertise in management of IRDs.
The diagnosis will be based on deep phenotyping including comprehensive ophthalmic examination, retinal multimodal imaging and electrophysiology wherever available.Patients presenting with nyctalopia, visual field loss and/or decreased vision, and having diffuse and/or widespread retinal pigment epithelial degeneration, arterial narrowing, disc pallor, and evidence of generalised rod and cone involvement will be diagnosed as RP
|
|
| ExclusionCriteria |
| Details |
a) Individuals with non-genetic retinal disorders will not be included.
b) Individuals with IRDs other than RP will not be included.
c) Participants who refuse to or are unable to provide informed consent for genetic testing will not be included.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)This study will provide a comprehensive, uniform and prospective phenotypic data using newer multimodal imaging techniques. This will depict the varied clinical presentation of RP in Indian population.
2)This study will provide the prevalence of disease causing genetic variants for RP in Indian population usinga uniform genetic testing method i.e Whole exome Sequencing or WES by a single certified service provider (Medgenome Labs Pvt. Ltd., Bengaluru, India).
|
36 week |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
15/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
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
|
N/A |