Assessment of AI Program 'DRISTi' as a Screening Tool (NCT07222293)
Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: New Century Ophthalmology - Oxford — Oxford, North Carolina
Age range: 21 Years
🧪 Interventions in This Study
- Fundus Image Grading (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- New Century Ophthalmology - Oxford — Oxford, North Carolina
- New Century Ophthalmology - Raleigh — Raleigh, North Carolina
📞 Contact the Study Coordinator
Phone: (919) 234-7003
Email: Jeanne@ncophth.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diabetic Retinopathy (DR)
- Diabetic Retinopathy Screening Point-of-Care Artificial Intelligence — Chula Vista, California
- RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME) — Phoenix, Arizona
- Video Intervention to Improve Understanding of Diabetic Retinopathy at Zuckerberg San Francisco General Hospital and Trauma Center — San Francisco, California
- Using Implementation Science to Adapt a Targeted Transportation Intervention for Patients With Diabetic Retinopathy (PRONTO-EYE) — Chicago, Illinois
Explore by condition: All Diabetic Retinopathy (DR) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.