Assessment of AI Program 'DRISTi' as a Screening Tool

Part of paid clinical trials in Oxford, North Carolina.

Sponsor
Artelus AI
Study ID
NCT07222293
Status
Recruiting
Apply to this trial

Conditions

  • Diabetic Retinopathy (DR)

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Fundus Image Grading — DIAGNOSTIC_TEST
    The image is graded by a fully automated AI device

Study Details

A study will be conducted to demonstrate that DRISTi will correctly diagnose Diabetic Retinopathy (e.g., mtmDR, PDR, DME) in eyes of patients with diabetes. Participants who have been diagnosed with diabetes mellitus and meet the other inclusion/exclusion criteria will be invited to participate and will consent to have ophthalmic images taken. These images will be analyzed by DRISTi AI software and evaluated by an ophthalmic reading center. The results will be compared, and a statistical analysis will be completed to ensure statistical significance in the outcomes thus proving DRISTi is an effective DR diagnosis tool.

Key Dates

Start date
Nov 23, 2025
Status verified
Dec 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
900 participants (estimated)

Primary Outcome Measure

Accuracy of AI Grade [ Time Frame: From time of arrival to completion of diagnostic tests, up to 8 hours ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
New Century Ophthalmology - OxfordOxfordNorth Carolina27565
Jeanne Champion, Site Coordinator Oxford
[email protected]
9192347003
Chaitan Walia, Study Coordinator, BA
[email protected]
3129738490
Vinod Jindal, MD (PRINCIPAL_INVESTIGATOR)
New Century Ophthalmology - RaleighRaleighNorth Carolina27617
Adriana Valencia, Site Coordinator Raleigh
[email protected]
9192347406
Chaitan Walia, Study Coordinator, BA
[email protected]
3129738490
Sumeet Jindal, MD (SUB_INVESTIGATOR)
Vinod Jindal, MD (PRINCIPAL_INVESTIGATOR)

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