| CTRI Number |
CTRI/2026/02/103000 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Detecting Early Signs of Diabetic Eye Disease in Diabetic Patients Through Advanced Eye Scanning |
|
Scientific Title of Study
|
Standardization of Optical Coherence Tomography Angiography Biomarkers for Early Diabetic Retinopathy Correlation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Brajesh Kumar |
| Designation |
Ph.D. Scholar, Senior Faculty- Optometry |
| Affiliation |
Dr. Shroffs Charity Eye Hospital |
| Address |
Vitreo Retina Department, Dr. Shroffs Charity Eye Hospital, 5027, Kedarnath Road, Daryaganj, New Delhi
Central DELHI 110002 India |
| Phone |
9718056557 |
| Fax |
|
| Email |
brajeshoptm@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Partha Chowdhury |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No. E-002, Department of Optometry, Galgotias University, Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9456771714 |
| Fax |
|
| Email |
partha.chowdhury@galgotiasuniversity.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Partha Chowdhury |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room No. E-002, Department of Optometry, Galgotias University, Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9456771714 |
| Fax |
|
| Email |
partha.chowdhury@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr Shroffs Charity Eye Hospital, Daryaganj, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Shroffs Charity Eye Hospital, New Delhi |
| Address |
Dr Shroffs Charity Eye Hospital, 5027, Kedarnath Road, Daryaganj, New Delhi-110002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Brajesh Kumar |
Dr Shroffs Charity Eye Hospital |
Vitreo Retina Department, Dr. Shroffs Charity Eye Hospital, 5027, Kedarnath Road, Daryaganj, New Delhi Central DELHI |
09718056557
brajeshoptm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Type 2 diabetic patients with or without clinically diagnosed DR.
2. Non-diabetic control subjects of similar age for baseline OCTA biomarker comparisons.
3. Clear ocular media allowing high-quality OCTA imaging.
4. Informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Retinal diseases such as age-related macular degeneration AMD, retinitis pigmentosa RP, retinal vein occlusion RVO, or central serous retinopathy CSR.
2. Recent intraocular surgeries less than 6 months or trauma.
3. Ocular media opacities like dense cataracts causing poor imaging quality.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Establishment of OCTA biomarker thresholds predictive of early diabetic retinopathy (DR).
• Measurement: Quantitative analysis of vessel density, foveal avascular zone (FAZ) area, and perfusion density using OCTA.
|
Single assessment at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Correlation of OCTA biomarkers with systemic and visual parameters, including HbA1c, best-corrected visual acuity (BCVA), Contrast, and duration of diabetes.
• Comparison of the diagnostic accuracy of OCTA with fundus photography and fluorescein angiography (FA).
|
Single assessment at baseline. |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
14/02/2026 |
| 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
|
This study aims to evaluate the role of Optical Coherence Tomography Angiography in the early detection of diabetic retinopathy by identifying and standardizing retinal microvascular biomarkers. Diabetic retinopathy is a major cause of preventable vision loss, and early diagnosis before the appearance of clinical signs is critical for timely intervention.
The study will be a prospective cross sectional observational study involving type 2 diabetic patients with no or mild to moderate non proliferative diabetic retinopathy and age matched non diabetic controls. OCTA will be used to assess key biomarkers such as vessel density, foveal avascular zone area, perfusion density, and other microvascular and structural retinal parameters. These findings will be correlated with systemic diabetic control markers including HbA1c and functional visual outcomes such as best corrected visual acuity and contrast sensitivity.
The diagnostic performance of OCTA will be compared with conventional imaging techniques like fundus photography and fluorescein angiography. Statistical analysis will be used to establish standardized threshold values for OCTA biomarkers that can reliably differentiate early diabetic retinopathy from normal retinal findings.
The expected outcome is to validate OCTA as a sensitive and non invasive tool for early detection and monitoring of diabetic retinopathy, enabling earlier diagnosis, better risk stratification, and improved personalized management for patients at risk of diabetic vision loss. |