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
Qualifiers
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 design
Treatments tested in this trial
- CLAIR
Treatment groups
No treatment groups listed
Sponsors and collaborators
Toku Eyes Ltd
Lead sponsor
MCRA
Collaborator
Source ClinicalTrials.gov