CLAiR Pivotal Study
ConditionNo Condition
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorToku Eyes Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Persistent vision impairment: legally blind when wearing current driving glasses or known VA<20/400
Trial population
Males and Females between the ages of 40-75 years of age.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CLAIR
Other interventionSubject will have retinal images obtained and uploaded to CLAiR Software. Subjects are not directly in contact with CLAiR software. There is no medical intervention.
Treatment groups
No treatment groups listed
Trial outcomes
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%
Time frame
through study completion, an average of 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Toku Eyes Ltd
Lead sponsor
MCRA
Collaborator
Source ClinicalTrials.gov