| CTRI Number |
CTRI/2025/10/096073 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Artificial Intelligence ophthalmologist with in detecting Diabetic Retinopathy |
|
Scientific Title of Study
|
Comparison of the DRISTi -Artificial Intelligence System with Ophthalmologists’
Grading for Diabetic Retinopathy Detection |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyothsna Rajagopal |
| Designation |
Medical Head |
| Affiliation |
ARTELUS-Artificial Learning Systems India Private Limited, |
| Address |
No. 1665/A, II Floor, 14th Main Road, HSR Layout Sector 7, Bengaluru,
No. 1665/A, II Floor, 14th Main Road, HSR Layout Sector 7, Bengaluru, 560102
Bangalore
KARNATAKA
560102
India |
| Phone |
09980949289 |
| Fax |
|
| Email |
j.rajagopal@artelus.ai |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyothsna Rajagopal |
| Designation |
Medical Head |
| Affiliation |
ARTELUS-Artificial Learning Systems India Private Limited, |
| Address |
No. 1665/A, II Floor, 14th Main Road, HSR Layout Sector 7, Bengaluru,
No. 1665/A, II Floor, 14th Main Road, HSR Layout Sector 7, Bengaluru, 560102
Bangalore
KARNATAKA
560102
India |
| Phone |
09980949289 |
| Fax |
|
| Email |
j.rajagopal@artelus.ai |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep Walia |
| Designation |
Founder |
| Affiliation |
ARTELUS-Artificial Learning Systems India Private Limited, |
| Address |
No. 1665/A, II Floor, 14th Main Road, HSR Layout Sector 7, Bengaluru,
No. 1665/A, II Floor, 14th Main Road, HSR Layout Sector 7, Bengaluru, 560102
Bangalore
KARNATAKA
560102
India |
| Phone |
09980949289 |
| Fax |
|
| Email |
pwalia@artelus.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Artelus Pvt Ltd |
| Address |
1665/A 14t Main Rd, 7th Sector, HSR Layout,Bengaluru,Karnataka-560102 |
| Type of Sponsor |
Other [Med Tech company] |
|
|
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 |
| Dr Jyothsna Rajagopal |
ARTELUS-Artificial Learning Systems India Private Limited |
No. 1665/A, II Floor, 14th Main Road, HSR Layout Sector 7, Bengaluru,
No. 1665/A, II Floor, 14th Main Road, HSR Layout Sector 7, Bengaluru, 560102
Bangalore
KARNATAKA |
09980949289
j.rajagopal@artelus.ai |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patient visiting hospital for diabetic screening or retinal evaluation |
|
| ExclusionCriteria |
| Details |
Images of patients which are un-gradbale |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome measures
1.Sensitivity and specificity of the DRISTi algorithm for detecting more than Mild DR and vision threartening DR compared to the reference standard
|
only at baseline since this is a cross sectional single observation study |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="2500"
Sample Size from India="2500"
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)
|
01/11/2025 |
| 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="0"
Months="0"
Days="7" |
|
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
|
India currently has 101 million people with diabetes, expected to rise to 134 million by 2045. Diabetic retinopathy affects about 35 percent of people with diabetes for over five years. Due to limited eye care access and few ophthalmologists, only a small percentage of diabetics receive regular screening. AI-based tools can help scale DR detection. This study aims to compare the diagnostic performance of Artificial Intelligence System ( called DRISTi) with that of expert ophthalmologists. The primary objective of the study is compare the sensitivity and specificity of DRISTi in detecting Referable Diabetic Retinopathy from fundus images versus ophthalmologist grading.The study is designed as a Retrospective observational study to be done over maximum Three months for data collection, analysis, and reporting. An estimated 2500 images from different non-mydriatic cameras (Crystal Vue, ) will be de-identified and anonymided .This data set will be secure ly stored and garded by both AI and the Ophthalmologist . The opthalmologist will be blinded to AI results. Statistical anlaysis will include snsitivity and specificity in detecting referable DR awith 95 percent confidence intervals . |