CLAiR Pivotal Study

Part of paid clinical trials in Canton, Ohio.

Sponsor
Toku Eyes Ltd
Study ID
NCT06808334
Status
Recruiting
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Conditions

  • No Condition

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • CLAIR — OTHER
    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.

Study Details

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.

Key Dates

Start date
Feb 27, 2025
Status verified
Mar 2025
Primary completion
Jun 1, 2025
Completion
Oct 1, 2025

Study Design

Enrollment
942 participants (estimated)

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

Locations (1)

FacilityCityStateZIPSite coordinators
Diabetes and Endocrine Associates of Stark CountyCantonOhio44718
Arvind Krishna, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Diabetes and Endocrine Associates of Stark County· Canton, OH

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