Using AI to assess cardiovascular risk from eye images
CLAiR Pivotal Study
Toku Eyes Ltd · NCT06808334
This study is testing if a new AI tool can help identify people at risk for heart disease by looking at pictures of their eyes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 942 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Toku Eyes Ltd (industry) |
| Locations | 1 site (Canton, Ohio) |
| Trial ID | NCT06808334 on ClinicalTrials.gov |
What this trial studies
This observational clinical study aims to validate the CLAiR AI software's ability to identify elevated atherosclerotic cardiovascular disease (ASCVD) risk by analyzing retinal images from two different camera models. Participants aged 40-75 will have their retinal images and clinical biomarker data collected to compare the CLAiR algorithm's predictions against the established PCE risk score. The study seeks to determine the sensitivity and specificity of the CLAiR model in classifying individuals as having elevated or non-elevated ASCVD risk over the next decade.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-75 who are willing to participate and provide informed consent.
Not a fit: Patients with a known history of atherosclerotic cardiovascular disease or those currently on cholesterol-lowering medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for early identification of individuals at high risk for cardiovascular diseases.
How similar studies have performed: Other studies have shown promise in using AI for cardiovascular risk assessment, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Canton, Ohio
- Diabetes and Endocrine Associates of Stark County — Canton, Ohio, United States (RECRUITING)
Study contacts
- Study coordinator: Yariv Levinson
- Email: yariv.levin@tokueyes.com
- Phone: (240) 442 2479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: No Condition, retinal image, ASCVD, AI, cardiovascular risk, adults