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CTRI Number  CTRI/2025/08/093280 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 16/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How we use Eye Scans and Vision Tests to tell the difference between Glaucoma and Nearsightedness. 
Scientific Title of Study   Diagnostic Differentiation of Optic Disc Features in Glaucoma and Myopia via Angio-OCT and Visual Field Analysis - A Comparative 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  Shweta Chauhan 
Designation  Primary DNB Resident 
Affiliation  Centre For Sight Eye Hospital, Safdarjung Enclave, New Delhi 
Address  Centre For Sight, Department of Ophthalmology, B-5/24 Safdarjung Enclave, New Delhi
Centre For Sight, B-5/24 Safdarjung Enclave, New Delhi
South West
DELHI
110029
India 
Phone  8006185745  
Fax    
Email  shwetatashi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MAJ GEN (DR) J.K.S PARIHAR (RETD.) 
Designation  Senior Consultant 
Affiliation  Professor Of Ophthalmology, Head Education & Training Department of Ophthalmology 
Address  Department of Ophthalmology, Centre For Sight, Safdarjung Enclave, New Delhi 110029
Department of Ophthalmology, Centre For Sight, Safdarjung Enclave, New Delhi 110029
South West
DELHI
110029
India 
Phone  9818992191  
Fax    
Email  jksparihar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shweta Chauhan 
Designation  Primary DNB Resident 
Affiliation  Centre For Sight Eye Hospital, Safdarjung Enclave, New Delhi 
Address  Centre For Sight, B-5/24 Safdarjung Enclave, New Delhi
Centre For Sight, B-5/24 Safdarjung Enclave, New Delhi
South West
DELHI
110029
India 
Phone  8006185745  
Fax    
Email  shwetatashi@gmail.com  
 
Source of Monetary or Material Support  
Centre For Sight Eye Hospital, B - 5/24 Safdarjung Enclave, New Delhi - 110029 
 
Primary Sponsor  
Name  Maj Gen (Dr.) JKS Parihar (Retd.) 
Address  Centre For Sight, B-5/24 Safdarjung Enclave, New Delhi - 110029 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 Shweta Chauhan  Centre For Sight Eye Hospital  Centre For Sight Eye Hospital, B -5/24 Safdarjung Enclave, New Delhi - 110029
South West
DELHI 		 8006185745

shwetatashi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Centre For Sight Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia, (2) ICD-10 Condition: H401||Open-angle glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Patients with primary open angle glaucoma
2. Patients with axial myopia
3. Patients with myopic refraction ranging from -3D to -7D
4. Emmetropic patients taken as a control group 
 
ExclusionCriteria 
Details  1. Any media opacities like corneal opacity, vitreous haemorrhages
2. Patient with co-existing retinal pathologies
3. Non glaucomatous optic neuropathies
4. Ocular trauma
5. Nystagmus patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study aims to compare optic disc features in glaucoma and myopia using Angio-OCT. It will also compare these features with an emmetropic control group. Finally, the study will compare the visual field analysis of the control group with their respective optic disc features.  On the day of Consultation, follow up with test reports i.e., After One Week. 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   05/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
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 28-07-2025 and end date provided 28-07-2030?
    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   Glaucoma is big challenge worldwide. Patients with early glaucoma go undetected on visual field examination. By conducting this study, we aim to establish a corelation between the structural changes observed in the optic disc on Angio-OCT and the functional changes detected on visual field analysis. This will help us identify early glaucomatous changes in high myopia. 
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