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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  
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 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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [research@sfeye.org].

  6. 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.

  7. 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.

 
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