Assessment of AI Program 'DRISTi' for Diabetic Retinopathy Screening

This study is testing an artificial intelligence (AI) program called 'DRISTi' to see how accurately it can screen for Diabetic Retinopathy (DR), an eye condition that can affect people with diabetes. We are looking for about 900 adults, aged 21 or older, who have been diagnosed with diabetes. If you join, ophthalmic images (pictures of your eyes) will be taken. These images will be analyzed by the DRISTi AI software and also by eye specialists. The goal is to compare these results to show that DRISTi can correctly identify different types of Diabetic Retinopathy. This study aims to prove DRISTi is an effective tool for diagnosing DR.

Study design
This is an observational study involving about 900 participants. It is designed to compare the results from an AI program with evaluations from eye specialists.
What's involved
You would need to sign a consent form and have ophthalmic images taken. The diagnostic tests, including image taking, are expected to be completed within 8 hours.
Compensation
Not stated in the trial record.
Follow-up
Your participation involves diagnostic tests completed within 8 hours from your arrival. No further follow-up is specified after this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07222293

Assessment of AI Program 'DRISTi' as a Screening Tool

Recruiting
Not specifiedAges 21+Observational
Artelus AI
~900 participants
Updated 2025-12-09 on ClinicalTrials.gov
What's tested:Fundus Image Grading

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of AI Grade
Measured over From time of arrival to completion of diagnostic tests, up to 8 hours
Diabetic Retinopathy (DR)
2 sites across 1 states
North Carolina2
  • Vinod Jindal, MD · PRINCIPAL_INVESTIGATOR · New Century Ophthalmology
Jeanne Champion, Primary Site Coordinator Oxford
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Eligibility criteria

Exclusion

Adults unable to consent (individuals w/ impaired decision-making capacity)
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
  • Accuracy of AI GradeFrom 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