| CTRI Number |
CTRI/2025/10/095544 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Finding Out Subtle Changes in the Back of the Eye After Detachment Surgery Using a Safe Eye Scan |
|
Scientific Title of Study
|
Retinal Displacement Detection Using Fundus Autofluorescence Post Retinal Detachment 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 Khushi RanjeetKumar Mishra |
| Designation |
Primary DNB |
| Affiliation |
Sankara Eye Hospital Coimbatore |
| Address |
Sankara Eye Hospital, formerly known as Shri Kanchi Kamakoti Medical Trust Hospital, Shivanandapuram, Sathy Road, COIMBATORE, Tamil Nadu-641035
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9712980019 |
| Fax |
|
| Email |
km1152012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhu Shankar M |
| Designation |
Senior Consultant Of Vitreo Retinal Surgery |
| Affiliation |
Sankara Eye Hospital Coimbatore |
| Address |
Sankara Eye Hospital formerly known as Shri Kanchi Kamakoti Medical Trust Hospital Shivanandapuram Sathy Road COIMBATORE Tamil Nadu-641035
Coimbatore
TAMIL NADU
641035
India |
| Phone |
919443186568 |
| Fax |
|
| Email |
prabhushanker@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khushi RanjeetKumar Mishra |
| Designation |
Primary DNB |
| Affiliation |
Sankara Eye Hospital Coimbatore |
| Address |
Sankara Eye Hospital, formerly known as Shri Kanchi Kamakoti Medical Trust Hospital, Shivanandapuram, Sathy Road, COIMBATORE, Tamil Nadu-641035
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9712980019 |
| Fax |
|
| Email |
km1152012@gmail.com |
|
|
Source of Monetary or Material Support
|
| SANKARA EYE HOSPITAL COIMBATORE |
|
|
Primary Sponsor
|
| Name |
Dr. Khushi RanjeetKumar Mishra |
| Address |
Sankara Eye Hospital Coimbatore |
| Type of Sponsor |
Other [Self ] |
|
|
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 Khushi Mishra |
Sankara Eye Hospital Coimbatore |
Sankara Eye Hospital Coimbatore 16-A Sathy Rd , Near Prozone Mall , Sarvanampatti, Siranandha Puram , Coimbatore Tamil Nadu 641035
Coimbatore
TAMIL NADU |
9712980019
km1152012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H338||Other retinal detachments, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 years and above
2.Undergoing retinal detachment surgery (rhegmatogenous RD) with successful anatomical reattachment
3.Willing to undergo FAF imaging postoperatively (at 1 month and/or 3 months) |
|
| ExclusionCriteria |
| Details |
1. Proliferative vitreoretinopathy (PVR) grade C or higher
2. Poor-quality FAF images due to media opacities for example dense cataract, corneal opacity)
3. Previous vitreoretinal surgery in the same eye
4. Retinal diseases interfering with FAF interpretation for example widespread geographic atrophy, advanced AMD
5.Non-compliance with follow-up schedule or imaging protocols
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of retinal displacement on Fundus Autofluorescence ( FAF ) |
18-20 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| : Association of displacement (LIRA/HIRA) with subjective visual symptoms (metamorphopsia) |
18-20 months |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
10/10/2025 |
| 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="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
|
Background & Purpose: Some patients continue to experience distortion or double vision even after successful retinal detachment surgery. One reason could be that the retina reattaches in a slightly different position (retinal displacement). This study will use a safe, non-contact imaging method called Fundus Autofluorescence (FAF) to find out how often this happens and whether it relates to vision problems like distortion or double vision.
Study Design:
Adults undergoing surgery for retinal detachment will be included.
No additional or invasive procedure will be done apart from routine care.
Ethics and Scientific Committee approval will be obtained.
Written informed consent will be taken.
Procedures:
Routine eye examination with slit lamp before surgery.
Post-surgery follow-up at 1 month and 3 months including:
FAF scan (safe, non-invasive)
Vision test (Best Corrected Visual Acuity - BCVA)
Amsler grid test for visual distortion
No blood tests or extra hospital visits required.
|