🏛️ Verified NIH Record • Updated 2025-03-20
CLAiR Pivotal Study (NCT06808334)
🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Toku Eyes Ltd
🩺 Plain-English Summary (8th-Grade Level)
This is a multi-site, observational clinical study to validate the performance of the CLAiR AI software in identifying elevated atherosclerotic cardiovascular disease (ASCVD) risk from retinal (eye) images obtained from two different retinal image camera models.
Who can join: Review the eligibility criteria below.
Location: Diabetes and Endocrine Associates of Stark County — Canton, Ohio
Age range: 40 Years to 75 Years
🧪 Interventions in This Study
- CLAIR (OTHER)
📋 "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 (1 Sites)
- Diabetes and Endocrine Associates of Stark County — Canton, Ohio
📞 Contact the Study Coordinator
Phone: (240) 442-2479
Email: yariv.levin@tokueyes.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.
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💡 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.