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CTRI Number  CTRI/2025/11/097061 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 06/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Comparative Study 
Study Design  Other 
Public Title of Study   A Comparison of Eye Pressures measured Using Three Different Devices in People having different visual defects and Corneal Thickness. 
Scientific Title of Study   A COMPARATIVE STUDY OF INTRAOCULAR PRESSURE USING GOLDMANN APPLANATION, ICARE AND CORVIS ST AMONG DIFFERENT REFRACTIVE GROUPS WITH CORRELATION TO CENTRAL CORNEAL THICKNESS. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khoirom Yaifabi Chanu 
Designation  Secondary DNB Resident 
Affiliation  Centre For Sight Eye Hospital, Safdarjung Enclave, New Delhi 
Address  Centre For Sight Eyehospital, Safdarjung Enclave, New Delhi 110029
Centre For Sight Eye hospital , Safdarjung Enclave, New Delhi 110029
South West
DELHI
110029
India 
Phone  9856976164  
Fax    
Email  yaifabikhoirom@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Maj Gen Dr JKS Parihar Retd 
Designation  Senior Consultant 
Affiliation  Centre For Sight Eye Hospital, Safdarjung Enclave, New Delhi 
Address  Centre For Sight Eye hospital, Safdarjung Enclave, New Delhi 110029
Centre For Sight Eye hospital, Safdarjung Enclave, New Delhi 110029
South West
DELHI
110029
India 
Phone  9818992191  
Fax    
Email  jksparihar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Maj Gen Dr JKS Parihar Retd 
Designation  Senior Consultant 
Affiliation  Centre For Sight Eye Hospital, Safdarjung Enclave, New Delhi 
Address  Centre For Sight Eye hospital Safdarjung Enclave, New Delhi 110029
Centre For Sight Eye hospital Safdarjung Enclave, New Delhi 110029

DELHI
110029
India 
Phone  9818992191  
Fax    
Email  jksparihar@gmail.com  
 
Source of Monetary or Material Support  
Centre For Sight Eye Hospital, Safdarjung Enclave, New Delhi 110029 
 
Primary Sponsor  
Name  Centre For Sight Eye Hospital 
Address  Centre For Sight Eye Hospital, B - 5/24, Safdarjung Enclave, New Delhi 
Type of Sponsor  Private hospital/clinic 
 
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 Khoirom Yaifabi Chanu  Centre For Sight Eye Hospital  Centre For Sight Eye Hospital, Safdarjung Enclave, New Delhi 110029
South West
DELHI 		 9856976164

yaifabikhoirom@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: H578||Other specified disorders of eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects consenting for the study.
2.Age of subject 45 years to 60 years
3.Subjects having
Emmetropia: Error within the range of plus minus 0.25 D.
Hypermetropia: Error within the range of plus 3D to plus 5 D
Myopia: Error within the range of minus 3D to minus 5D
Astigmatism: Error less than plus minus 0.50 D
 
 
ExclusionCriteria 
Details  1.Subjects unwilling to participate.
2.Age is equal to and less than 45 years, more than 60 years
3.Patients with any significant systemic diseases.
4.Patients taking any systemic medications that may affect vision or are on steroids for any autoimmune diseases or organ transplants.
5.Patients with dry eyes, ocular surface pathologies (OSSN , SJS ,and OCP) glaucoma and corneal microtrauma.
6.Anxious patients / Type A personalities to avoid any anxiety issues and fear issues
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study aims to examine the agreement among the three devices(GAT, Icare and Corvis ST) and to investigate potential factors that might account for the difference between the IOP values. It is expected to correlate IOP values with various refractive statuses such as emmetropia, hypermetropia and myopia.  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
• Correlate the influence of corneal biomechanism on the values of IOP evaluated by the use of Goldmann Applanation Tonometer (GAT), Icare Tonometer, and Corvis ST in Emmetropia, Hypermetropia and Myopia.  One Time 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   18/11/2025 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 15-11-2025 and end date provided 15-12-2027?
    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  

Comparison and correlation of the efficacy and accuracy of intraocular pressure (IOP) readings taken with Goldmann Applanation Tonometer (GAT), Icare Tonometer, and Corvis ST in subjects having different refractive errors.

Correlate the influence of corneal biomechanism on the values of IOP evaluated by the use of Goldmann Applanation Tonometer (GAT), Icare Tonometer, and Corvis ST in Emmetropia, Hypermetropia and Myopia. 
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