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Evaluation of DRISTi AI Software for Automated Screening of Diabetic Retinopathy in Adults with Diabetes
Led by Artelus AI · Updated on 2025-12-09
900
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the DRISTi automated screening tool to diagnose Diabetic Retinopathy including mtmDR, PDR, and DME in patients with diabetes. The study invites adults diagnosed with diabetes mellitus to participate by having eye images taken. These images will be analyzed by the DRISTi AI software and an ophthalmic reading center to compare results and complete statistical analysis for validation. Participants will have ophthalmic images taken and graded by the fully automated DRISTi AI device. The study is observational and involves no study drug or treatment. The primary outcome measure is the accuracy of the AI grading, assessed from arrival to completion of diagnostic tests within a maximum of 8 hours. There is no randomization or placebo group. During the study, participants will consent and comply with study procedures including imaging and data collection. Researchers will evaluate the AIs diagnostic accuracy compared to the ophthalmic reading centers evaluation. Participants may be monitored for any safety concerns related to imaging procedures. The study allows for the inclusion of adults aged 21 years or older diagnosed with diabetes mellitus, and participation duration varies by individual.
CONDITIONS
Brief Title
Assessment of AI Program 'DRISTi' as a Screening Tool
Research Team
J
Jeanne Champion, Primary Site Coordinator Oxford
A
Adriana Valencia, Site Coordinator Raleigh
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