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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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