| 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
|
|
|
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
|
|
|
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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