Precision Study of CLAiR AI Software

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.

Inclusion Criteria: Previously participated in the CLAiR pivotal study with blood pressure and blood test measurements completed. Continues to meet the original pivotal study eligibility criteria. Male or female, 40 to 75 years of age. Able and willing to provide written informed consent. Willing and able to comply with all study procedures and complete the single study visit. Exclusion Criteria: Known history of atherosclerotic cardiovascular disease (ASCVD), including stroke, myocardial infarction, coronary artery bypass surgery, or coronary stenting. Current use of cholesterol-lowering medication (e.g., statins). Pregnancy. Persistent vision impairment in at least one eye (legally blind with current corrective lenses or visual acuity \