Assessment of AI Program 'DRISTi' as a Screening Tool
Condition(s) studied
Investigational drug(s) / intervention(s)
Fundus Image Grading: The image is graded by a fully automated AI device
Study 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.
Eligibility
Primary outcome measure(s)
- Accuracy of AI Grade — From time of arrival to completion of diagnostic tests, up to 8 hours
AI generated image grades are directly compared to a Human generated image grade
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| New Century Ophthalmology - Oxford | Oxford | North Carolina | Recruiting |
| New Century Ophthalmology - Raleigh | Raleigh | North Carolina | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07222293 on ClinicalTrials.gov ↗ ← All trials in the USA