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CTRI Number  CTRI/2021/10/037477 [Registered on: 22/10/2021] Trial Registered Prospectively
Last Modified On: 26/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   To study the correlation of Corneal Parameters and visual acuity outcomes after Manual DSEK (Descemets stripping endothelial Keratoplasty ) in Pseudophakic Bullous Keratopathy . 
Scientific Title of Study   To study the correlation of corneal parameters and visual acuity outcomes after manual descemet stripping endothelial keratoplasty in pseudophakic bullous keratopathy . 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  shefali Mazumdar 
Designation  Assistant Professor 
Affiliation  S.N.Medical College Agra 
Address  Department of Ophthalmology S.N.Medical College,Moti Katra ,Mantola,Agra
Department of Ophthalmology S.N.Medical College,Moti Katra ,Mantola,Agra
Agra
UTTAR PRADESH
282003
India 
Phone  9457288925  
Fax    
Email  shefalimazumdar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  shefali Mazumdar 
Designation  Assistant Professor 
Affiliation  S.N.Medical College Agra 
Address  Department of Ophthalmology S.N.Medical College, Moti Katra ,Mantola, Agra
Department of Ophthalmology S.N.Medical College, Moti Katra ,Mantola, Agra
Agra
UTTAR PRADESH
282003
India 
Phone  9457288925  
Fax    
Email  shefalimazumdar@gmail.com  
 
Details of Contact Person
Public Query  
Name  shefali Mazumdar 
Designation  Assistant Professor 
Affiliation  S.N.Medical College Agra 
Address  Department of Ophthalmology S.N.Medical College, Moti Katra,Mantola,Agra
Department of Ophthalmology S.N.Medical College, Moti Katra,Mantola,Agra
Agra
UTTAR PRADESH
282003
India 
Phone  9457288925  
Fax    
Email  shefalimazumdar@gmail.com  
 
Source of Monetary or Material Support  
S.N.Medical College,Agra 
 
Primary Sponsor  
Name  S N Medical CollegeAgra 
Address  S.N.Medical College,Moti Ktra, Mantola ,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  Department of Ophthalmology  Department of Ophthalmology,S.N.Medical College Agra
Agra
UTTAR PRADESH 		 9457288925

shefalimazumdar@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: H181||Bullous keratopathy, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: H598||Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Manual DSEK(Descemets stripping Endothelial Keratoplasty)  DSEK(Descemets stripping Endothelial Keratoplasty) is a posterior lamellar keratoplasty ,in which we replace the patients abnormal descemets membrane and endothelium with donors healthy posterior lenticule. As pseudophakic bullous Keratopathy is most important cause of endothelial dysfunction and subsequent corneal edema and visual loss in India,we chose this subset of patients to do lamellar keratoplasty.In our study we will prepare graft manually. 
Comparator Agent  no comparison group  no comparison group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients of pseudophakic bullous keratopathy
Ready to give consent and participate in study
 
 
ExclusionCriteria 
Details  Other causes of Corneal edema
Dense central corneal scarring
uncontrolled Glaucoma
PL absent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Corneal Parameters and Visual acuity  F/U after surgery on day1 post op , day 7,day 15 post op then monthly till the completion of study 
 
Secondary Outcome  
Outcome  TimePoints 
intraoperative and post operative complication of Manual DSEK  F/U after surgery on day1 post op , day 7,day 15 post op then monthly till the completion of study 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   23/10/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  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 02-01-1970 and end date provided 02-01-1970?
    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
Modification(s)  		 Descemet’s Stripping Endothelial Keratoplasty (DSEK) is a form of Lamellar Keratoplasty that allows selective replacement of diseased endothelium .According to literature , as Pseudophakic Bullous Keratopathy is the main cause of endothelial dysfunction in our country ,the advantages of  doing DSEK over PKP in these cases include rapid visual rehabilitation, minimal induced astigmatism,less chances of infection ,no suture related complications and negligible chances of catastrophic intraoperative complications such asexpulsive haemorrhage and choroidal detachment. DSEK lenticular can be prepared by Automated Keratome or Manually. At our centre, we don’t have Automated Keratome .So we will prepare the lenticule  manually.
This study aims at to correlate the Corneal Parameters and Visual acuity outcome after Manual DSEK in Pseudophakic Bullous Keratopathy.
 
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