Clinical trial NCT06808334: CLAiR Pivotal Study
Official title: CLAiR Pivotal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: No Condition
Keywords: retinal image
ASCVD
AI
cardiovascular risk
adults
Lead sponsor: Toku Eyes Ltd
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2025-02-05
Enrollment: 942
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males and Females between the ages of 40-75 years of age.

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.

Detailed description: This is a prospective observational clinical study to collect retinal images and clinical biomarker data in order to analyze the performance of the CLAiR SaMD compared to the reference PCE risk score. CLAiR is a deep learning (DL) model that uses retinal photographs and limited demographic data to classify an individual's risk of developing ASCVD over the next 10 years as elevated (≥7.5%) or non-elevated (\<7.5%). For validation, the output of the algorithm can be directly compared to the PCE output, a widely accepted algorithm used by Healthcare Providers to predict ASCVD risk in patients.

The primary hypothesis is that the CLAiR SaMD can achieve high sensitivity and specificity in the binary determination of Yes/No elevated ASCVD risk with PCE risk score ≥7.5% as the reference standard.

Eligibility criteria: 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 outcomes:
measure: Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score.
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Canton
country: United States
facility: Diabetes and Endocrine Associates of Stark County
state: Ohio
Study officials:
affiliation: Toku Inc.
name: Michael McConnell, MD
role: STUDY_DIRECTOR
References: