CLAiR Pivotal Study

Recruiting now

Conditions studied: No Condition

In brief

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.

Key facts

Study ID

NCT06808334

Run by

Toku Eyes Ltd

People needed

942

Starts

2025-02-27

Expected to finish

2025-10-01

Last updated by the study team

2025-03-25

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Diabetes and Endocrine Associates of Stark County — Canton, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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