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CTRI Number  CTRI/2023/03/050317 [Registered on: 03/03/2023] Trial Registered Prospectively
Last Modified On: 27/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of outcomes between microkeratome assisted and femtosecond laser assisted sutureless anterior lamellar keratoplasty for superficial corneal opacities 
Scientific Title of Study   Microkeratome assisted vs femtosecond laser assisted sutureless anterior lamellar keratoplasty for superficial corneal opacities: A randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mrinalini Singh 
Designation  Ophthalmology Resident 
Affiliation  Army Hospital Research and Referral 
Address  Department of Ophthalmology Army Hospital Research and Referral Subroto Park, Dhaula Kuan, New Delhi

South West
DELHI
110010
India 
Phone  9149522150  
Fax    
Email  mrinalinisingh90@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alok Sati 
Designation  Professor  
Affiliation  Army Hospital Research and Referral 
Address  Department of Ophthalmology Army Hospital Research and Referral Subroto Park, Dhaula Kuan, New Delhi

South West
DELHI
110010
India 
Phone  8334892288  
Fax    
Email  aloksati_123@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mrinalini Singh 
Designation  Ophthalmology Resident 
Affiliation  Army Hospital Research and Referral 
Address  Department of Ophthalmology Army Hospital Research and Referral Subroto Park, Dhaula Kuan, New Delhi

South West
DELHI
110010
India 
Phone  9149522150  
Fax    
Email  mrinalinisingh90@gmail.com  
 
Source of Monetary or Material Support  
Army Hospital Research and Referral, New Delhi 
 
Primary Sponsor  
Name  Army Hospital Research and Referral 
Address  Subroto Park, Dhaula Kuan, New Delhi, Delhi 110010 
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 Mrinalini Singh  Room No 4, Cornea and anterior segment, Dept of Advanced Centre of Ophthalmic and Visual Sciences  Army Hospital Research and Referral Subroto Park, Dhaula Kuan, New Delhi, Delhi 110010
South West
DELHI 		 9149522150

mrinalinisingh90@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Army Hospital (R&R), Delhi Cantt  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Femtosecond laser assisted sutureless anterior lamellar keratoplasty  Donor cornea with same diameter and depth as the recipient eye will be mounted on artificial chamber and cut with femtosecond laser. The donor lenticule will be placed on recipient bed and secured with a glue. Approximate duration: 20-30 min 
Comparator Agent  Microkeratome assisted sutureless anterior lamellar keratoplasty  Donor cornea with same diameter and depth as the recipient eye and will be cut with a microkeratome. The donor lenticule will be placed on recipient bed and secured with a glue. Approximate duration: 45-60 min 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Corneal scar secondary to infection
Corneal scar secondary to trauma
Spheroidal degeneration
Band shaped keratopathy
Corneal dystrophy involving superficial 200 µm thickness
 
 
ExclusionCriteria 
Details  Corneal opacity involving more than 200 µm corneal thickness. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual acuity - measured using logMAR charts.
Contrast sensitivity.
Corneal aberrations using Sirius Tomogram.
 		 pre-operative
post-operative day-1
week 1
week 4
week 12
week 24
 
 
Secondary Outcome  
Outcome  TimePoints 
K-readings using Sirius Tomogram.
AS-OCT.
Complications, if any 		 pre-operative
post-operative day-1
week 1
week 4
week 12
week 24 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   09/03/2023 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Preoperatively, slit lamp examination/anterior segment OCT will be done to know the depth of the opacity and for the purpose of documentation. Patients will be divided into two groups by computer generated randomization. In the first treatment arm, patients will undergo microkeratome-assisted anterior lamellar keratoplasty in main OT. In the second treatment arm, patients will undergo femtosecond laser-assisted anterior lamellar keratoplasty in Femto OT. Patients will be followed postoperatively on the next day, after 1 week, after 1 month, after 3 months and after 6 months.  
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