Actively Recruiting
CLAiR Pivotal Study
Led by Toku Eyes Ltd · Updated on 2025-03-25
942
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
T
Toku Eyes Ltd
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
CLAiR Pivotal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 40-75 years
- Able to provide informed consent and understand study details
- Willing to comply with all study procedures and available for the study duration
You will not qualify if you...
- 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
- Persistent vision impairment in at least one eye (legally blind with current driving glasses or visual acuity worse than 20/400)
- Known pathological myopia
- Previous treatment or current care for retinal disease by a specialist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Diabetes and Endocrine Associates of Stark County
Canton, Ohio, United States, 44718
Actively Recruiting
Research Team
Y
Yariv Levinson
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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