CLAiR Pivotal Study
1 other identifier
observational
942
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2025
CompletedFirst Posted
Study publicly available on registry
February 5, 2025
CompletedStudy Start
First participant enrolled
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedMarch 25, 2025
March 1, 2025
3 months
January 27, 2025
March 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score.
Sensitivity and Specificity of CLAiR binary elevated risk classification (PCE ≥ 7.5% Y/N) against the reference standard of PCE ≥ 7.5%
through study completion, an average of 6 months
Interventions
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.
Eligibility Criteria
Males and Females between the ages of 40-75 years of age.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Toku Eyes Ltdlead
- MCRAcollaborator
Study Sites (1)
Diabetes and Endocrine Associates of Stark County
Canton, Ohio, 44718, United States
Study Officials
- STUDY DIRECTOR
Michael McConnell, MD
Toku Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2025
First Posted
February 5, 2025
Study Start
February 27, 2025
Primary Completion
June 1, 2025
Study Completion
October 1, 2025
Last Updated
March 25, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share