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CLAiR Pivotal Study

Toku Eyes Ltd · with MCRA · NCT06808334

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–75 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
942
US sites recruiting
1
Study start
February 27, 2025
Record last updated
March 25, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: CLAIR

Conditions: No Condition

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Male or female, aged 40-75 years
  • 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.
  • 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:

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

Recruiting US locations

  • Diabetes and Endocrine Associates of Stark County

    Canton, OH 44718

    Site contact: Brandi Kerr · brandik@go2endo.com

Study contacts (from the official record)

  • Yariv Levinson · (240) 442 2479 · yariv.levin@tokueyes.com
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CLAiR Pivotal Study (NCT06808334) | Bored Studies