Clinical Trial

Assessment of AI Program 'DRISTi' as a Screening Tool

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated December 9, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-10-27.
Status change: Not Yet Recruiting → Recruiting 2025-12-05
Trial Details
NCT Number NCT07222293
Lead Sponsor Artelus AI
Conditions Diabetic Retinopathy (DR)
Enrollment 900 participants
Start Date 2025-11-23
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-12-09