CLAiR Pivotal Study for ASCVD Risk Identification

This study is looking at how well a special artificial intelligence (AI) software called CLAiR can identify your risk of developing atherosclerotic cardiovascular disease (ASCVD), which is a type of heart disease. CLAiR uses images of your retina (the back of your eye) to do this. You would have retinal images taken, which are then analyzed by the CLAiR software. There are no medical interventions involved. This study aims to see if CLAiR can accurately tell if you have an elevated ASCVD risk, compared to a standard risk score used by doctors. People aged 40 to 75 can join, as long as they can understand and agree to the study procedures. The study is considered successful if CLAiR can accurately identify elevated ASCVD risk. The current recruitment status is unclear.

Study design
This is an observational study involving 942 participants. It is designed to compare the CLAiR software's performance against a standard risk score.
What's involved
You would need to provide informed consent and have retinal images obtained. You would also need to be available for the duration of the study, which averages 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured through study completion, which averages 6 months.

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NCT06808334

CLAiR Pivotal Study

Recruiting
Not specifiedAges 40–75Observational
Toku Eyes Ltd
~942 participants
Updated 2025-03-25 on ClinicalTrials.gov
What's tested:CLAIR

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score.
Measured over through study completion, an average of 6 months
No Condition
1 sites across 1 states
Ohio1
  • Michael McConnell, MD · STUDY_DIRECTOR · Toku Inc.

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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

    Sensitivity and Specificity of CLAiR binary elevated risk classification (PCE ≥ 7.5% Y/N) against the reference standard of PCE ≥ 7.5%