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CLAiR Pivotal Study

RecruitingObservational studyHealthy volunteers welcome

Who can join

Ages 40 to 75 · All sexes · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

1. Male or female, aged 40-75 years
2. 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.
3. Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Known history of atherosclerotic cardiovascular disease, including stroke, heart attack, coronary artery surgery, or stenting
2. Current use of cholesterol-lowering medication, such as a statin
3. Pregnancy
4. 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)

About the study

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.

What is being tested

Sponsor: Toku Eyes Ltd · Participants: 942 · Started: Feb 27, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06808334

Locations in the U.S.

OhioDiabetes and Endocrine Associates of Stark County, Canton

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.