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CTRI Number  CTRI/2021/11/037724 [Registered on: 01/11/2021] Trial Registered Prospectively
Last Modified On: 30/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of Limbal stem cell Transplantation in the management of severe chemical eye injury. 
Scientific Title of Study   Autologous Simple Limbal Epithelial Transplantation in the management of Unilateral Total Limbal Stem Cell Deficiency due to severe chemical burn. 
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  Oshin Malhotra 
Designation  junior resident 
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  8191879395  
Fax    
Email  oshin010@gmail.com  
 
Source of Monetary or Material Support  
S.N.Medical College Agra 
 
Primary Sponsor  
Name  SNMedical College Agra 
Address  S.N.Medical College ,Moti Katra,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  S.N.Medical College ,Agra  Cornea Unit, 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: H183||Changes of corneal membranes, (2) 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  Autologous Simple Limbal Epithelial Transplantation (SLET)  In this Surgical intervention trial, we will take 2 mm of limbal tissue( which harbours limbal stem cells ) from patients healthy eye and will be cut into several tiny pieces .These pieces are then transplanted to patients diseased eyes Cornea ,which is damaged due to unilateral chemical injury.  
Comparator Agent  none   none 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Documented history of chemical burn
Unilateral cases of chemical Burn 
 
ExclusionCriteria 
Details  Unknown cases of LSCD
B/L cases of LSCD
Recurrent Pterygium and ocular surface tumor
Active infection
Disorganised Anterior Segment
PL absent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ocular surface stability(completely epithealized and avascular corneal surface)
Post operative uncorrected visual acuity 		 F/U on day1,day 7 ,day 15 post op day respectively and then monthly till the completion of study 
 
Secondary Outcome  
Outcome  TimePoints 
intra operative and post operative complications  F/U on day1,day 7 ,day 15 post op day respectively and then monthly till the completion of study 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   08/11/2021 
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   NIL 
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

  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   Limbal stem cells are located at corner scleral limbus in the palisade of Vogt.They represent the proliferative reserve.So if the limbus is intact ,all epithelial defects will heal promptly.Damage to limbal stem cells due to injury or disease can lead to limbal stem cell deficiency.One of the important causes of LSCD is chemical injury.Chemical injury accounts for 11.5-20% of ocular Trauma.Depending upon the severity of damage caused to limbus and conjunctiva, the extent of cifichemical burns may be graded by Dua’s classification.According to literature ,In severe  unilateral chemical burn ,where limbal stem cells are damaged 360 degree, SLET has helped to restore the ocular surface integrity. of c
Keeping this in view ,at our centre we want to offer this service of  SLET to our patients of severe unilateral chemical injury.
  So this study aims to study the surgical outcome of Autologous Simple Limbal Epithelial Transplantation in  the management of unilateral limbal stem cell deficiency due to severe chemical burn in terms of ocular surface stability(completely epithelialized,avascular corneal surface),Post operative uncorrected visual acuity .
 
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