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CTRI Number  CTRI/2024/02/062281 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 04/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Different surgical techniques for managing corneal perforation of different sizes 
Scientific Title of Study   Management of corneal perforation and descemetocele by different techniques 
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 Shefali Mazumdar 
Designation  Associate Professor 
Affiliation  Sarojini Naidu Medical College,Agra 
Address  Department of Ophthalmology,Sarojini Naidu Medical College,Agra

Agra
UTTAR PRADESH
282003
India 
Phone  9457288925  
Fax    
Email  shefalimazumdar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shefali Mazumdar 
Designation  Associate Professor 
Affiliation  Sarojini Naidu Medical College,Agra 
Address  Department of Ophthalmology,Sarojini Naidu Medical College,Agra

Agra
UTTAR PRADESH
282003
India 
Phone  9457288925  
Fax    
Email  shefalimazumdar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shefali Mazumdar 
Designation  Associate Professor 
Affiliation  Sarojini Naidu Medical College,Agra 
Address  Department of Ophthalmology,Sarojini Naidu Medical College,Agra

Agra
UTTAR PRADESH
282003
India 
Phone  9457288925  
Fax    
Email  shefalimazumdar@gmail.com  
 
Source of Monetary or Material Support  
Sarojini Naidu Medical College,Agra,Uttar Pradesh,PIN 282002 
 
Primary Sponsor  
Name  Sarojini Naidu Medical College ,Agra 
Address  Sarojini Naidu Medical College ,Agra 
Type of Sponsor  Government medical college 
 
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 Shefali Mazumdar  S.N.Medical College  Department of ophthalmology
Agra
UTTAR PRADESH 		 9457288925

shefalimazumdar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sarojini Naidu Medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H188||Other specified disorders of cornea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  different surgical techniques to manage cases of corneal perforations and descemetocele of different sizes(1mm to 6mm)  different surgical techniques ( TABCL, Tenons patch grafting, lamellar corneal patch graft, full thickness corneal patch graft and Therapeutic keratoplasty to manage cases of corneal perforations and descemetocele of different sizes and assess their effectiveness by achieving globe integrityon day one as primary outcome and maintenance of globe integrity through out the follow up by that particular procedure(max 3years) for this study 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  cases of corneal perforation and descemetocele 
 
ExclusionCriteria 
Details  No perception of light 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Achievement of globe integrity Monday one post op.  Weekly follow up for a month then at 2weeks interval for next one month then once in a month for entire study period  
 
Secondary Outcome  
Outcome  TimePoints 
Visual recovery & post operative complications  Follow up schedule will be weekly for first month post op then at fortnight for next month then once in a month for rest of study period 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   08/02/2024 
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="5"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - 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 [shefalimazumdar@gmail.com].

  6. For how long will this data be available start date provided 15-01-2024 and end date provided 15-01-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Corneal perforation and descemetocele is a true ophthalmic emergency which requires prompt action to restore globe integrity and save the patient from becoming blind in that eye. As we are a Tertiary Centre in North India, we get many referrals from different places. We want to assess the outcome of different surgical techniques to manage these cases in terms of achievement of globe integrity as a primary outcome and visual recovery as a secondary outcome.  
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