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CTRI Number  CTRI/2025/08/093610 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two types of cataract surgery (phacoemulsification and small incision cataract surgery) by counting the loss of cells in the cornea in eyes with pseudoexfoliation 
Scientific Title of Study   Comparison of endothelial cell count after phacoemulsification and small incision cataract surgery in eyes with pseudoexfoliation: A randomized controlled trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sowndharya 
Designation  Post graduate 
Affiliation  Sri Manakula Vinayagar Medical college and hospital  
Address  Department of Ophthalmology Sri Manakula Vinayagar Medical college and hospital Kalitheerthalkuppam Madagadipet

Pondicherry
PONDICHERRY
605107
India 
Phone  9486712969  
Fax    
Email  sowndjayaraman@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhagwati Wadwekar 
Designation  Post graduate 
Affiliation  Sri Manakula Vinayagar Medical college and hospital  
Address  Department of Ophthalmology Sri Manakula Vinayagar Medical college and hospital Kalitheerthalkuppam Madagadipet

Pondicherry
PONDICHERRY
605107
India 
Phone  9626249484  
Fax    
Email  bwadwekar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Sowndharya 
Designation  Post graduate 
Affiliation  Sri Manakula Vinayagar Medical college and hospital  
Address  Department of Ophthalmology Sri Manakula Vinayagar Medical college and hospital Kalitheerthalkuppam Madagadipet

Pondicherry
PONDICHERRY
605107
India 
Phone  9486712969  
Fax    
Email  sowndjayaraman@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Sowndharya  
Address  Sri Manakula Vinayagar Medical college and hospital Kalitheerthalkuppam Madagadipet Puducherry-605107 
Type of Sponsor  Other [Principal investigator] 
 
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 Sowndharya  Sri Manakula Vinayagar Medical college and hospital  Department of Ophthalmology Sri Manakula Vinayagar Medical college and hospital Kalitheerthalkuppam Madagadipet 605107
Pondicherry
PONDICHERRY 		 09486712969

sowndjayaraman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cataract surgery   Endothelial cell count after phacoemulsification and small incision cataract surgery in eyes with pseudoexfoliation 
Comparator Agent  Endothelial cell count  Comparison of endothelial cell count after phacoemulsification and small incision cataract surgery in eyes with pseudoexfoliatio  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with mild to moderate grade PXF
Nuclear sclerosis 1 to grade 3
Endothelial cell counts between 2000 and 3000 cells per mm square
40 to 80 years age group
Both gender 
 
ExclusionCriteria 
Details  Zonular weakness.
Posterior polar cataract
Grade IV nuclear sclerosis
Mature cataract
Hypermature cataract
Traumatic cataract
Corneal pathology
Corneal opacity
Corneal endothelial dystrophy
Uveitis
Shallow anterior chamber
Contact lens wearers
Glaucoma
Diabetes mellitus
Previous history of intra-ocular surgery
Trabeculectomy
Retinal surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Endothelial Cell Density
 		 4weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Number of cells counted
Average cell area
Coefficient of variation
Standard Deviation of mean cell
Maximum area
Minimum area
Hexagonality
Central corneal thickness 		 4weeks 
 
Target Sample Size   Total Sample Size="146"
Sample Size from India="146" 
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)   03/09/2025 
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="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - All of the individual participant data collected during the trial, after de-identification.

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Will be submitted to ethics committee

  6. For how long will this data be available start date provided 28-08-2025 and end date provided 28-08-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   The results of this study will help the ophthalmic surgeon to know endothelial cell loss is more after phacoemulsification or small incision cataract surgery and will provide a base to refine the technique of cataract surgery in patients with pseudoexfoliation and this will help to prevent the corneal endothelial damage in the pseudoexfoliation patients and vision loss
 
 
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