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CTRI Number  CTRI/2026/01/102182 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 27/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of Macular Nerve Cell Layer in Patients with Glaucoma Using Optical Eye Scans 
Scientific Title of Study   Macular Ganglion cell layer imaging in glaucoma using Spectralis Optical Coherence Tomography 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSamra wahaj Fatima  
Designation  glaucoma fellow 
Affiliation  Nethradhama Super Speciality Eye Hospital  
Address  256/14, KANAKAPURA MAIN ROAD, JAYANAGAR 7TH BLOCK, BENGALURU, KARNATAKA

Bangalore
KARNATAKA
560070
India 
Phone  8374016816  
Fax    
Email  wjsam19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSamra wahaj Fatima  
Designation  glaucoma fellow 
Affiliation  Nethradhama Super Speciality Eye Hospital  
Address  256/14, KANAKAPURA MAIN ROAD, JAYANAGAR 7TH BLOCK, BENGALURU, KARNATAKA

Bangalore
KARNATAKA
560070
India 
Phone  8374016816  
Fax    
Email  wjsam19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSamra wahaj Fatima  
Designation  glaucoma fellow 
Affiliation  Nethradhama Super Speciality Eye Hospital  
Address  256/14, KANAKAPURA MAIN ROAD, JAYANAGAR 7TH BLOCK, BENGALURU, KARNATAKA

Bangalore
KARNATAKA
560070
India 
Phone  8374016816  
Fax    
Email  wjsam19@gmail.com  
 
Source of Monetary or Material Support  
256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore  
 
Primary Sponsor  
Name  Nethradhama Super Speciality Eye Hospital  
Address  256/14, Nethradhama Super Speciality Eye Hospital, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore  
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 
DrSamra wahaj Fatima   Nethradhama Super Speciality Eye Hospital   256/14, Department of Phacorefractive surgery, Kanakapura main road, Jayanagar 7th block, Bengaluru Bangalore KARNATAKA Bangalore KARNATAKA Bangalore KARNATAKA Bangalore KARNATAKA
Bangalore
KARNATAKA 
8374016816

wjsam19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H408||Other glaucoma, (2) ICD-10 Condition: H188||Other specified disorders of cornea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  Patients with a clinical diagnosis of primary open-angle glaucoma, primary angle-closure glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma 
 
ExclusionCriteria 
Details  Patients with media opacity interfering with good-quality OCT scans such as corneal opacity, cataracts,etc.; history of intraocular diseases; complicated intraocular surgery; nonglaucomatous secondary causes of elevated IOP (e.g. iridocyclitis and trauma); coexisting retinal disease (e.g. diabetic retinopathy); other diseases affecting visual field (e.g.pituitary lesions); taking medications known to affect visual field sensitivity; or with problems other than glaucoma affecting color vision were excluded from this study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome -To evaluate correlation between macular GCL thinning and visual field indices (MD, PSD).  Follow up - day 1, 1 week, 6 weeks ,6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the sensitivity of macular imaging for early detection of glaucomatous damage.  Follow up - day 1, 1 week, 6 weeks ,6 months 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   12/02/2026 
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 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 - NO
Brief Summary  

Study objectives -

To evaluate macular ganglion cell layer (GCL) changes in patients with glaucoma using Spectralis Optical Coherence Tomography (HRA-OCT) and to assess its utility as an early structural biomarker for disease detection and progression.

This cross sectional observational study will be approved by the Institutional Ethics Committee of Nethradhama Eye Hospital and will adhere to the tenets of the Declaration of Helsinki. Verbal and written informed consent will be obtained from all participants enrolled in the study.

All subjects will undergo a complete ophthalmic examination including best corrected visual acuity assessed using the Snellen chart refraction slit lamp biomicroscopy intraocular pressure measurement using applanation tonometry gonioscopy using a Sussman goniolens and dilated fundus examination using a ninety diopter lens and indirect ophthalmoscopy after obtaining a complete clinical history.

Visual field testing will be performed using the SITA standard thirty two program of the Humphrey Field Analyzer model two seven hundred fifty. Glaucomatous visual field loss will be defined by the consistent presence of a cluster of three or more non edge points on the pattern deviation plot with a probability of occurring in less than five percent of the normal population with at least one point having a probability of less than one percent. Additional criteria include a pattern standard deviation probability of less than five percent or a glaucoma hemifield test result outside normal limits. Visual field defects must be repeatable on at least two consecutive tests.

Patients will be categorized into three glaucoma severity subgroups using the Hodapp Parrish Anderson classification based on the mean deviation index of the visual field. Early glaucoma will be defined as mean deviation less than or equal to minus six decibels moderate glaucoma as mean deviation between minus six and minus twelve decibels and severe glaucoma as mean deviation worse than minus twelve decibels.

Optical coherence tomography is a non invasive non contact imaging technique based on the principle of optical reflectometry which allows precise anatomical localization of ocular structures. It functions on the principle of low coherence interferometry using broadband light. Infrared light of approximately eight hundred thirty nanometers is scanned across ocular tissue and focused using an internal lens. In spectral domain optical coherence tomography a broad spectrum light source such as a super luminescent diode is used and a spectrometer in the detector arm separates the reflected light into a spectrum which is detected by a line scan camera. Optical coherence tomography is currently the preferred method for measuring retinal thickness and retinal nerve fiber layer thickness.

All recruited eyes will undergo macular imaging using the Spectralis HRA optical coherence tomography system manufactured by Heidelberg Engineering Germany. The Spectralis volume scan consists of sixty one B scans each containing seven hundred sixty eight A scans acquired along the fovea disc centroid axis. Each scan will be repeated nine to eleven times to reduce speckle noise and improve image quality.

The following ganglion cell inner plexiform layer thickness parameters will be analyzed including average minimum and sectoral thickness values comprising superonasal superior superotemporal inferotemporal inferior and inferonasal sectors. The inbuilt software will analyze the data compare it with the internal normative database and generate thickness and deviation maps.

 


 
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