Trials / Recruiting
RecruitingNCT07222293
Assessment of AI Program 'DRISTi' as a Screening Tool
Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 900 (estimated)
- Sponsor
- Artelus AI · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Fundus Image Grading | The image is graded by a fully automated AI device |
Timeline
- Start date
- 2025-11-23
- Primary completion
- 2026-03-01
- Completion
- 2026-03-01
- First posted
- 2025-10-29
- Last updated
- 2025-12-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07222293. Inclusion in this directory is not an endorsement.