CLAiR Pivotal Study

March 20, 2025 updated by: Toku Eyes Ltd
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

942

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Diabetes and Endocrine Associates of Stark County
        • Contact:
        • Principal Investigator:
          • Arvind Krishna, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Males and Females between the ages of 40-75 years of age.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score.
Time Frame: 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%
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toku Eyes Ltd

Collaborators

MCRA

Investigators

  • Study Director: Michael McConnell, MD, Toku Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CPS-En01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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