Precision Study of CLAiR AI Software

Toku Eyes Ltd56 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cardiovascular Risk

Interventions

CLAiR Artificial Intelligence SoftwareDEVICE

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Illinois Retina Associates

Homer Glen, Illinois, United States

Diabetes and Endocrinology Associates of Stark County, Inc.

Canton, Ohio, United States

Outcomes

Primary Outcomes

Overall inter-operator reproducibility of the CLAiR ASCVD risk classification

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.

Time frame: Single study visit (approximately 2 hours)

Data from ClinicalTrials.gov

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