| CTRI Number |
CTRI/2025/09/094690 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of effectiveness of Fibrin Tissue Adhesive as an alternative to Silicon oil/gas in surgery for Retinal Detachment: A Clinical Study |
|
Scientific Title of Study
|
Study of Fibrin tissue adhesive use in management of rhegmatogenous retinal detachment |
| 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 Ajay Sharma |
| Designation |
Senior consultant- Retina |
| Affiliation |
Sankar Foundation Eye Hospital |
| Address |
Sankar Foundation Eye Hospital, Vepagunta, Sai Madhava Nagar - Prahaladapuram Road, Naidu Thota, Visakhapatnam, Andhra Pradesh
Visakhapatnam ANDHRA PRADESH 530047 India |
| Phone |
9959822688 |
| Fax |
|
| Email |
sharma.a@sfeye.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajay Sharma |
| Designation |
Senior consultant- Retina |
| Affiliation |
Sankar Foundation Eye Hospital |
| Address |
Sankar Foundation Eye Hospital, Vepagunta, Sai Madhava Nagar - Prahaladapuram Road, Naidu Thota, Visakhapatnam, Andhra Pradesh
Visakhapatnam ANDHRA PRADESH 530047 India |
| Phone |
9959822688 |
| Fax |
|
| Email |
sharma.a@sfeye.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajay Sharma |
| Designation |
Senior consultant- Retina |
| Affiliation |
Sankar Foundation Eye Hospital |
| Address |
Sankar Foundation Eye Hospital, Vepagunta, Sai Madhava Nagar - Prahaladapuram Road, Naidu Thota, Visakhapatnam, Andhra Pradesh
Visakhapatnam ANDHRA PRADESH 530047 India |
| Phone |
9959822688 |
| Fax |
|
| Email |
sharma.a@sfeye.org |
|
|
Source of Monetary or Material Support
|
| Sankar Foundation Eye Hospital,
19-50, Sri Sai Madhava Nagar, Naiduthota, Vepagunta, Visakhapatnam-530047, Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [Nil] |
|
|
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 Ajay Sharma |
Sankar Foundation Eye Hospital |
Room 102, First floor, Retina Department,
Sai Madhav Nagar, Naidu Thota, Vepagunta, Visakhapatnam-530047, Andhra Pradesh
Visakhapatnam ANDHRA PRADESH |
9959822688
sharma.a@sfeye.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution of ethics committee ,NRI medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H330||Retinal detachment with retinal break, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Surgery with application of glue at a specified step |
Application of fibrin glue for adhesion of rhegmatogenous retinal detachment.
Surgery will take for 1hour and follow up for 3months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subtotal or total RD with 1-3 breaks in a single quadrant.
2.Duration of symptoms – upto 60 days
|
|
| ExclusionCriteria |
| Details |
a)Children
b)Cases with: any previous retinal surgery, giant retinal tears, proliferative vitreoretinopathy (PVR) grade B or more, associated vitreous haemorrhage, associated choroidal detachment, associated with retinal breaks in multiple quadrants and macular holes
C)Patients who do not consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of the procedure defined as successful anatomical retinal reattachment. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative improvement in BCVA & complications
|
Visual Recovery time.
Post OP Day 1,
Post OP 1 Month,
Post OP 3 Months |
|
|
Target Sample Size
|
Total Sample Size="7" Sample Size from India="7"
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)
|
01/10/2025 |
| 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="5" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [research@sfeye.org].
- For how long will this data be available start date provided 12-08-2025 and end date provided 14-08-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
· The present study aims to evaluate the use of fibrin glue in rhegmatogenous retinal detachment surgery, potentially transforming current surgical practices and improving visual outcomes in patients. · Objectives · Primary Objective- · Efficacy of the procedure defined as successful anatomical retinal reattachment. · Secondary Objectives: · Postoperative improvement in BCVA and complications · Anticipated Findings: It is expected that fibrin glue will demonstrate early rehabilitation, higher retinal reattachment rates, improved visual outcomes, and fewer complications compared to traditional methods, it will eliminate the problems like use of tamponade ,second surgery requirement, post-op position on. · Implications: Positive results could lead to a shift in clinical practice, offering a more effective and patient-friendly treatment option for rhegmatogenous retinal detachment. |