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Assessment of AI Program 'DRISTi' as a Screening Tool
Sponsor: Artelus AI
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
Conditions
Interventions
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