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CTRI Number  CTRI/2024/10/075127 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 25/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   Vision improvement and retinal reatachment outcome in a complex RRD ( Rhegmatogenous Retinal Detachments)patients managed by retaining a heavy PFCL (perfluoro carbon liquid)as tamponade for two weeks. 
Scientific Title of Study   Functional and Anatomical outcomes in a complex Rhegmatogenous retinal detachments (RRD) managed by retaining perfluorocarbon liquid (PFCL) tamponade for 2 weeks. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manapadi Yogitha 
Designation  PG STUDENT-MBBS DOMS (DNB) 
Affiliation  SANKARA EYE HOSPITAL , PEDDAKAKANI,GUNTUR.  
Address  Retina department, Room no 106, Sankara eye hospital, Pedhakakani, Guntur.

Guntur
ANDHRA PRADESH
522509
India 
Phone  8328342249  
Fax    
Email  yogithamanupadi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.MADHUKUMAR.R  
Designation  CONSULTANT -Vitreoretinal surgeon, M.S., F.I.C.O., F.V.R. 
Affiliation  SANKARA EYE HOSPITAL,PEDDAKAKANI, GUNTUR.  
Address  Room no 106 , DEPARTMENT OF RETINA, Sankara eye hospital, Pedhakakani.

Guntur
ANDHRA PRADESH
522509
India 
Phone  8328342249  
Fax    
Email  madhukumar@sankaraeye.com  
 
Details of Contact Person
Public Query  
Name  Manapadi Yogitha 
Designation  postgraduate student at Sankara eye hospital  
Affiliation  SANKARA EYE HOSPITAL,PEDDAKAKANI, GUNTUR  
Address  Room no 106, Department of Retina, Sankara eye hospital, Pedhakakani, Guntur.

Guntur
ANDHRA PRADESH
522509
India 
Phone  8328342249  
Fax    
Email  yogithamanupadi@gmail.com  
 
Source of Monetary or Material Support  
Sankara eye hospital,peddakakani, GUNTUR-Andhra Pradesh. 522509 
 
Primary Sponsor  
Name  Sankara eye hospital 
Address  Pedhakakani, GUNTUR, AndhraPradesh-522509. 
Type of Sponsor  Research institution and hospital 
 
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 MANAPADI YOGITHA   SANKARA EYE HOSPITAL   ROOM NO 106 ,DEPARTMENT OF RETINA, PEDAKAKANI, GUNTUR,ANDHRA PRADESH, PINCODE 522509.
Guntur
ANDHRA PRADESH 		 8328342249

yogithamanupadi@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H338||Other retinal detachments,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable   Not applicable  
Intervention  Vitrectomy is done and perfluorocarbon liquid tamponade is used   Tamponade is retained for 2 weeks and observed for reattachment of retina.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1)Rhegmatogenous RD (RRD) with PVR grade C and above.

2)Complex Rhegmatogenous retinal detachments ie RRD with intrinsic retinal contractions/extensive retinal shortening/proliferative vitreoretinopathies secondary to Trauma, Block perforations.




 
 
ExclusionCriteria 
Details  Any concomitant ocular diseases, such as choroidal neovascularization.

Advanced or uncontrolled ocular disease (e.g., glaucoma, uveitis, uncontrolled systemic disease).

Tractional or combined retinal detachments.

Rhegmatogenous RD with PVR less than grade C
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Functional and Anatomical outcomes in a complex Rhegmatogenous retinal detachments RRD.  1week,1month,3months,6months  
 
Secondary Outcome  
Outcome  TimePoints 
Vision improvement and complications during follow-up period   6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/10/2024 
Date of Study Completion (India) 24/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="10" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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-identiļ¬cation.

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [yogithamanupadi@gmail.com].

  6. For how long will this data be available start date provided 18-01-2024 and end date provided 18-01-2040?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  		 Functional and Anatomical outcomes in a complex Rhegmatogenous retinal detachments (RRD) managed by retaining perfluorocarbon liquid (PFCL) tamponade for 2 weeks.
It is an interventional study. 
 
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