Precision Study of CLAiR AI Software

NCT07747233 | Completed FDA Device

• 1 other identifier: CPS-En02
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• 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.

  Single study visit (approximately 2 hours)

Study Arms (1)

CLAiR Imaging Cohort

EXPERIMENTAL

Participants underwent protocol-defined retinal fundus imaging using Topcon NW400 and NW500 cameras. Images were analyzed using the investigational CLAiR artificial intelligence software to evaluate performance and reproducibility. No clinical management decisions were made based on device outputs.

Device: CLAiR Artificial Intelligence Software

Interventions

CLAiR Artificial Intelligence Software DEVICE

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.

CLAiR Imaging Cohort

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Toku Eyes Ltd: lead

Study Sites (2)

Illinois Retina Associates

Homer Glen, Illinois, 60491, United States

Location

Diabetes and Endocrinology Associates of Stark County, Inc.

Canton, Ohio, 44718, United States

Location

Study Officials

• Michael Mcconnell, MD

  Toku Eyes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: August 5, 2026
• Study Start: December 5, 2025
• Primary Completion: January 9, 2026
• Study Completion: January 9, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)