CLAiR Pivotal Study

NCT ID: NCT06808334

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 942 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-27
• Study Completion Date: 2025-10-01

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.

Conditions

No Condition

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MCRA

INDUSTRY

Sponsor Role: collaborator

Toku Eyes Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael McConnell, MD

Role: STUDY_DIRECTOR

Toku Inc.

Locations

Diabetes and Endocrine Associates of Stark County

Canton, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yariv Levinson

Role: CONTACT

yariv.levin@tokueyes.com

(240) 442 2479

Facility Contacts

Brandi Kerr

Role: primary

brandik@go2endo.com

Other Identifiers

CPS-En01

Identifier Type: -

Identifier Source: org_study_id