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Assessment of AI Program 'DRISTi' as a Screening Tool

NCT07222293 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2025-12-09

No results posted yet for this 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.

Conditions

  • Diabetic Retinopathy (DR)

Interventions

DIAGNOSTIC_TEST

Fundus Image Grading

The image is graded by a fully automated AI device

Sponsors & Collaborators

  • Artelus AI

    lead INDUSTRY

Principal Investigators

  • Vinod Jindal, MD · New Century Ophthalmology

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-23
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07222293 on ClinicalTrials.gov