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CTRI Number  CTRI/2025/07/092047 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Studying the Connection Between Macular Nerve Thickness and Vision Test Patterns in Glaucoma Suspects 
Scientific Title of Study   Correlation of Macular Ganglion Cell Complex (GCC) Thickness on Optical Coherence Tomography (OCT) With 24-2C SITA Faster and 10-2 SITA Standard on Humphrey Visual Fields in Glaucoma Suspects – 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 Jyoti Yadav 
Designation  Primary DNB Resident 
Affiliation  Centre For Sight Eye Hospital 
Address  Exam Room 4, First Floor, Department of Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi 110075
Exam Room 4, First Floor, Department of Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi 110075
South West
DELHI
110075
India 
Phone  7977917052  
Fax    
Email  Sanjujyot07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kiran Kirtani  
Designation  Senior Consultant 
Affiliation  Centre For Sight Eye Hospital 
Address  Exam Room 4, First Floor, Department of Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi 110075
Exam Room 4, First Floor, Department of Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi 110075
South West
DELHI
110075
India 
Phone  9953775085  
Fax    
Email  drkiranp2k@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kiran Kirtani  
Designation  Senior Consultant 
Affiliation  Centre For Sight Eye Hospital 
Address  Exam Room 4, First Floor, Department of Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi 110075
Exam Room 4, First Floor, Department of Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi 110075

DELHI
110075
India 
Phone  9953775085  
Fax    
Email  drkiranp2k@gmail.com  
 
Source of Monetary or Material Support  
Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi 110075 
 
Primary Sponsor  
Name  Centre For Sight Eye Hospital 
Address  Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi 110075 
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 Jyoti Yadav  Centre For Sight Eye Hospital  Exam Room 4, First Floor, Department of Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi 110075
South West
DELHI 		 7977917052

Sanjujyot07@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: H400||Glaucoma suspect,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age greater than or equal to 18 years to 60 years

Best-corrected visual acuity (BCVA) greater than or equal to 6/12

Ocular Hypertension

Risk factors for glaucoma suspicion:

· Ethnicity: African, Hispanic, or Asian

· Family history of glaucoma

· Elevated IOP greater than or equal to 21 mmHg

· Thin central corneas (less than 530-550µm thickness)

· High Myopia

· Long term steroid medications

· Comorbidities like DM, HTN and Cardiovascular Diseases

Open Angles on Gonioscopy

24-2C SITA Faster and 10-2 SITA Standard Humphrey Visual Field tests with: Reliable fields (Fixation losses less than 20 percent, False positives and False negatives less than 15 percent)

Optic nerve head changes suspicious of glaucoma:

· Increased cup-disc ratio greater than or equal to 0.6:1

· Asymmetrical discs greater than or equal to 0.2

· Neuro Retinal Rim notching and/or thinning

· Nasalization of retinal vessels

· Disc hemorrhages

· Retinal Nerve Fiber Layer Wedge defects 
 
ExclusionCriteria 
Details  · Established Glaucoma cases (early, moderate, advanced, POAG, Normal Tension Glaucoma, Secondary glaucoma due to Pseudo-exfoliation Syndrome or Pigment Dispersion Syndrome, etc.)

· Non-glaucomatous optic neuropathies

· Co- existing Vitreo-Retinal pathologies:

Retinal dystrophies, degeneration and detachments

Diabetic retinopathy with macular changes

Age-related macular degeneration

Epiretinal membrane

Associated CRVO, BRVO, CRAO and BRAO

· Unreliable visual field tests (fixation losses greater than 20 percent, false positives and false negatives greater than 15 percent)

· Media Opacities affecting OCT or HVF test results:

Corneal opacity

Significant cataract (greater than or equal to NS3)

Vitreous hemorrhage

Dense posterior capsular opacification

· Intraocular inflammation: anterior or posterior uveitis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the correlation between Macular GCC thickness measured by OCT and visual field sensitivity at the additional central test points in the 24-2C SITA Faster and 10-2 SITA Standard HVF in glaucoma suspects.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the sensitivity and efficacy of GCC analysis by quantifying macular GCC thickness using OCT in glaucoma suspects.

2.To assess the visual field sensitivity at additional central 10degree test points using the 24-2C SITA Faster and 10-2 SITA Standard HVF in glaucoma suspects.

3.To study and determine the utility of Macular GCC analysis and central 10degree cluster points on 24-2C SITA Faster and 10-2 SITA Standard by analyzing the statistical correlation between them in glaucoma suspects. 		 Baseline 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   15/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/08/2025 
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 Applicable 
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 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 28-01-2027?
    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   This study aims at assessing and studying structural functional correlation between 24-2C SITA Faster and 10-2 SITA Standard HVF defects and Macular GCC thickness. 24-2C SITA Faster and 10-2 SITA Standard, by targeting central test points, enhances the detection of functional correlates of early structural loss which is GCC thinning on OCT, together improving the diagnostic accuracy in glaucoma suspects, aiding early intervention. 
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