Recruiting

CLAiR

Sponsor:

Toku Eyes Ltd

Code:

NCT06808334

Conditions

No Condition

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

CLAIR

Study Details

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.

Conditions

No Condition

Study ID

NCT06808334

Start date

Feb 27, 2025

Status verified date

Mar, 2025

Completion date

Oct 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

942 participants

Anticipated

Interventions and Outcome Measures

Interventions

CLAIR

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.

Primary outcome measure

  • Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score. [ Time Frame: through study completion, an average of 6 months ]

Central Contacts and Locations

Central contacts

Locations

Diabetes and Endocrine Associates of Stark County

Recruiting

Canton, Ohio, United States, 44718

Contacts

Principal Investigator:

Arvind Krishna, MD

More Information

Sponsor

Toku Eyes Ltd

Last update posted

Mar 25, 2025

Last verified

Mar, 2025

Keywords

  • retinal image
  • ASCVD
  • AI
  • cardiovascular risk
  • adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Toku Eyes Ltd on 2025-03-25.