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Precision Study of CLAiR AI Software
Sponsor: Toku Eyes Ltd
Summary
This multi-site precision study evaluated the performance and reproducibility of the CLAiR artificial intelligence (AI) software in identifying elevated risk of atherosclerotic cardiovascular disease (ASCVD) from retinal fundus images. Participants underwent protocol-defined retinal imaging using Topcon NW400 and NW500 cameras. The study assessed agreement and consistency of device outputs across operators and imaging conditions. No medical management decisions were made based on device results.
Official title: A Multi-Site Precision Study to Validate the Performance of CLAiR AI Software in Identifying Elevated Atherosclerotic Cardiovascular Disease Risk From Retinal Images.
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2025-12-05
Completion Date
2026-01-09
Last Updated
2026-08-05
Healthy Volunteers
Yes
Conditions
Interventions
CLAiR Artificial Intelligence Software
CLAiR is an investigational software as a medical device (SaMD) designed to analyze retinal fundus images and classify individuals as having elevated or not elevated risk of atherosclerotic cardiovascular disease. The software was evaluated for performance and reproducibility under protocol-defined imaging conditions.
Locations (2)
Illinois Retina Associates
Homer Glen, Illinois, United States
Diabetes and Endocrinology Associates of Stark County, Inc.
Canton, Ohio, United States