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RECRUITING
NCT07222293

Assessment of AI Program 'DRISTi' as a Screening Tool

Sponsor: Artelus AI

View on ClinicalTrials.gov

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.

Official title: Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

OBSERVATIONAL

Enrollment

900

Start Date

2025-11-23

Completion Date

2026-03

Last Updated

2025-12-09

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Fundus Image Grading

The image is graded by a fully automated AI device

Locations (2)

New Century Ophthalmology - Oxford

Oxford, North Carolina, United States

New Century Ophthalmology - Raleigh

Raleigh, North Carolina, United States