Clinical Trials in the USA / NCT06808334
Recruiting
Observational
CLAiR Pivotal Study
NCT06808334 · tracked via the Priya Life Science USA tracker
Condition(s) studied
No Condition
Investigational drug(s) / intervention(s)
CLAIR
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.
Study 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.
Eligibility
Inclusion Criteria:
1. Male or female, aged 40-75 years
2. 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.
3. Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Known history of atherosclerotic cardiovascular disease, including stroke, heart attack, coronary artery surgery, or stenting
2. Current use of cholesterol-lowering medication, such as a statin
3. Pregnancy
4. 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)
Primary outcome measure(s)
- Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score. — through study completion, an average of 6 months
Sensitivity and Specificity of CLAiR binary elevated risk classification (PCE ≥ 7.5% Y/N) against the reference standard of PCE ≥ 7.5%
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Diabetes and Endocrine Associates of Stark County | Canton | Ohio | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06808334 on ClinicalTrials.gov ↗ ← All trials in the USA