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CTRI Number  CTRI/2025/04/085491 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparing the inner eye surface in people with cataracts with and without diabetes 
Scientific Title of Study   Specular microscopy in diabetic v/s non diabetic patients with cataract A cross sectional observational study 
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 Nikita Nupur 
Designation  Secondary DNB resident 
Affiliation  Centre for sight eye institute 
Address  Centre For Sight Eye Institute Plot No 9 Sector 9 Dwarka New Delhi 110075
Centre For Sight Eye Institute Plot No 9 Sector 9 Dwarka New Delhi 110075
South West
DELHI
110075
India 
Phone  8552867353  
Fax    
Email  nikitanupur19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nikita Nupur 
Designation  Secondary DNB resident 
Affiliation  Centre for sight Eye Institute 
Address  Centre for Sight Eye Institute Plot no 9 Sec 9 Dwarka New Delhi 110075
Centre for Sight Eye Institute Plot no 9 Sec 9 Dwarka New Delhi 110075
South West
DELHI
110075
India 
Phone  8552867353  
Fax    
Email  nikitanupur19@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tulika Chauhan 
Designation  Senior Consultant 
Affiliation  Centre for Sight Eye Institute 
Address  Centre For Sight Eye Institute Plot No 9 Sector 9 Dwarka New Delhi 110075
Centre For Sight Eye Institute Plot No 9 Sector 9 Dwarka New Delhi 110075
South West
DELHI
110075
India 
Phone  9535133800  
Fax    
Email  toolika.chauhan@gmail.com  
 
Source of Monetary or Material Support  
Centre For Sight Eye Institute Plot No 9 Sector 9 Dwarka New Delhi 110075 
 
Primary Sponsor  
Name  Dr Nikita Nupur 
Address  Centre For Sight Eye Institute Plot No 9 Sector 9 Dwarka New Delhi 110075 
Type of Sponsor  Other [Self] 
 
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 Nikita Nupur  Centre For Sight Eye Institute  Centre For Sight Eye Institute Plot No 9 Sector 9 Dwarka New Delhi 110075
South West
DELHI 		 8552867353

nikitanupur19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Centre for Sight Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H28||Cataract in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Males and females coming to our institution for cataract surgery

Patients will be categorized as diabetic or non-diabetic based on medical history and clinical history 
 
ExclusionCriteria 
Details  Patients with existing diseases such as
Corneal pathology
Lid pathology
Pterygium
Trichiasis
Previous refractive surgery
Previous glaucoma surgery
Contact lens wearer
Uveitis
Previous cataract surgery
Scleritis
Ptosis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the corneal endothelial changes in Diabetic and Non- diabetic patients presenting with cataract  1 week before cataract surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the association of corneal endothelial changes with laboratory data of diabetic patients including fasting blood sugar post prandial blood sugar levels HbA1c levels duration of diabetes   1 week before cataract surgery 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   12/05/2025 
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="1"
Months="0"
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 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) -  As I am a Diplomate of National board (DNB) resident in ophthalmology, I will be uploading the data on national board of examination site as part of the thesis submission

  6. For how long will this data be available start date provided 20-12-2025 and end date provided 19-12-2026?
    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   This study aims to evaluate and compare central corneal thickness and endothelial cell changes coefficient of variation between type 2 diabetes individual and non diabetic individuals presenting for cataract surgery. By analyzing these parameters this study will provide the impact of diabetes on corneal morphology 
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