| NCT ID | NCT06808334 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Toku Eyes Ltd |
| Condition | No Condition |
| Study Type | OBSERVATIONAL |
| Enrollment | 942 participants |
| Start Date | 2025-02-27 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 942 participants in total. It began in 2025-02-27 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Michael McConnell, MD
STUDY DIRECTOR
Toku Inc.
Frequently Asked Questions
Who can join the NCT06808334 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying No Condition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06808334 currently recruiting?
Yes, NCT06808334 is actively recruiting participants. Contact the research team at yariv.levin@tokueyes.com for enrollment information.
Where is the NCT06808334 trial being conducted?
This trial is being conducted at Canton, United States.
Who is sponsoring the NCT06808334 clinical trial?
NCT06808334 is sponsored by Toku Eyes Ltd. The principal investigator is Michael McConnell, MD at Toku Inc.. The trial plans to enroll 942 participants.