Cardiovascular Risk
Conditions
Brief 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.
Detailed description
This prospective, multi-site precision study was designed to evaluate the analytical performance and reproducibility of the CLAiR AI software, a software as a medical device (SaMD) intended to identify individuals with elevated risk of atherosclerotic cardiovascular disease (ASCVD) using retinal fundus images. Participants were enrolled at U.S. clinical sites and underwent protocol-defined retinal imaging procedures using Topcon NW400 and NW500 non-mydriatic fundus cameras. Imaging was performed under controlled conditions, including predefined operator sequencing and repeated image acquisition, to assess reproducibility across operators and devices. The primary objective was to evaluate agreement of device outputs across repeated imaging sessions and camera models. Secondary objectives included assessment of intra- and inter-operator variability. The device under investigation was not FDA cleared or approved at the time of the study and was evaluated under institutional review board (IRB) oversight as a non-significant risk (NSR) device study. No therapeutic interventions were administered, and no clinical management decisions were made based on device outputs.
Interventions
DEVICECLAiR 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.
Sponsors
Toku Eyes Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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 \<20/400). Known pathological myopia in at least one eye. Previous treatment for, or current care by, a retinal specialist for retinal disease in at least one eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall inter-operator reproducibility of the CLAiR ASCVD risk classification | Single study visit (approximately 2 hours) | Inter-operator reproducibility will be assessed as the overall percent agreement between paired binary CLAiR outputs (Elevated Risk, Not Elevated Risk, or No Result) generated from retinal images acquired by different operators. Agreement will be calculated across all paired comparisons according to the predefined statistical analysis plan. |
Countries
United States
Contacts
STUDY_DIRECTORMichael Mcconnell, MD
Toku Eyes
Outcome results
None listed