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RECRUITING
NCT06808334

CLAiR Pivotal Study

Sponsor: Toku Eyes Ltd

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

942

Start Date

2025-02-27

Completion Date

2025-10-01

Last Updated

2025-03-25

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

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.

Locations (1)

Diabetes and Endocrine Associates of Stark County

Canton, Ohio, United States