CLAiR Pivotal Study

Description

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

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Study Overview

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Study Details

Study overview

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.

CLAiR Pivotal Study

CLAiR Pivotal Study

Condition
No Condition
Intervention / Treatment

-

Contacts and Locations

Canton

Diabetes and Endocrine Associates of Stark County, Canton, Ohio, United States, 44718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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)

Ages Eligible for Study

40 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Toku Eyes Ltd,

Michael McConnell, MD, STUDY_DIRECTOR, Toku Inc.

Study Record Dates

2025-10-01