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CTRI Number  CTRI/2024/09/073356 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 08/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   studying of patterns in retinal nerve fibre layer thickness and macular ganglion cell complex in offsprings of patients with proven primary open angle glaucoma 
Scientific Title of Study   Analysis of patterns in retinal nerve fibre layer thickness and macular ganglion cell complex in normal offsprings of patients with proven primary open angle glaucoma 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Manjunath Kagathi 
Designation  Primary DNB  
Affiliation  Sankara Eye Hospital Bangalore 
Address  DEPARTMENT OF GLAUCOMA Room 27 Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka
DEPARTMENT OF GLAUCOMA Room 27 Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka 560037
Bangalore
KARNATAKA
560037
India 
Phone  7022554075  
Fax    
Email  nehamanjunathkagathi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Meena G Menon  
Designation  Senior Consultant Glaucoma 
Affiliation  Sankara Eye Hospital Bangalore 
Address  DEPARTMENT OF GLAUCOMA Room 27 Sankara Eye Hospital Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru
DEPARTMENT OF GLAUCOMA Room 27 Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka 56003
Bangalore
KARNATAKA
560037
India 
Phone  9886283310  
Fax    
Email  meenagm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Meena G Menon  
Designation  Senior Consultant Glaucoma 
Affiliation  Sankara Eye Hospital Bangalore 
Address  DEPARTMENT OF GLAUCOMA Room 27 Sankara Eye Hospital Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru
DEPARTMENT OF GLAUCOMA Room 27 Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka 56003
Bangalore
KARNATAKA
560037
India 
Phone  9886283310  
Fax    
Email  meenagm@gmail.com  
 
Source of Monetary or Material Support  
Sankara Eye Hospital Bangalore Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka PIN code - 560037 INDIA  
 
Primary Sponsor  
Name  Neha Manjunath Kagathi 
Address  Sankara eye hospital Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka 560037 
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 Neha Manjunath Kagathi  Sankara eye hospital   Glaucoma services Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru
Bangalore
KARNATAKA 		 7022554075

nehamanjunathkagathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI KANCHI KAMAKOTI MEDICAL TRUST SANKARA EYE HOSPITAL   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HEALTHY VOLUNTEERS  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Undiagnosed offsprings of patients with POAG 
 
ExclusionCriteria 
Details  Offsprings of patients with POAG who have already been diagnosed with glaucoma

Angle closure glaucoma

Media opacities

Refractive errors more than 3D of myopia / hyperopia

Retinal and macular pathology

History of chronic steroid use

Amblyopia

Strabismus

Any neurological problems or developmental delays

Albinism 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Using swept source OCT to measure RNFL thickness and macular GCC.  at baseline only  
 
Secondary Outcome  
Outcome  TimePoints 
1. Diagnosing glaucoma among offsprings of patients with POAG using -
Evaluation of IOP using Goldmann’s applanation tonometry / iCare / tonopen
Slit lamp bio-microscopy of anterior segment
Gonioscopy
Pachymetry
Dilated stereoscopic disc evaluation using +78 D or +90D lens
Visual fields using HFA3 SITA Standard strategy 24-2 and/or SITA Faster strategy 24-2C test grid. 10-2 if needed. 
SS OCT - RNFL Thickness & macular GCC 		 at baseline 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/09/2024 
Date of Study Completion (India) 01/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/09/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study is to collect data regarding RNFL thickness and Macular GCC in normal offspring’s of patients with glaucoma for the purpose of developing a better understanding on indicators suggesting early onset glaucoma that can help design better screening techniques to identify glaucoma before it starts to damage the eye. 
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