RecruitingNCT06808334

CLAiR Pivotal Study

Sponsor

Toku Eyes Ltd

Enrollment

942 participants

Start Date

Feb 27, 2025

Study Type

OBSERVATIONAL

Conditions

No Condition

Summary

This is a multi-site, observational clinical study to validate the performance of the CLAiR AI software in identifying elevated atherosclerotic cardiovascular disease (ASCVD) risk from retinal (eye) images obtained from two different retinal image camera models.

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria3

Male or female, aged 40-75 years
Participants must be capable of providing informed consent, demonstrating understanding of the study details, and willingly sign a consent form or verbally confirm their consent in the presence of a witness.
Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria8

An individual who meets any of the following criteria will be excluded from participation in this study:
Known history of atherosclerotic cardiovascular disease, including stroke, heart attack, coronary artery surgery, or stenting
Current use of cholesterol-lowering medication, such as a statin
Pregnancy
A person who has (in at least one eye):
Persistent vision impairment: legally blind when wearing current driving glasses or known VA\<20/400
Known pathological myopia
Previous treatment or currently under the care for a retinal disease by a specialist (e.g., ophthalmologist)

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Interventions

OTHERCLAIR

Subject will have retinal images obtained and uploaded to CLAiR Software. Subjects are not directly in contact with CLAiR software. There is no medical intervention.