RECRUITING

CLAiR Pivotal Study

Conditions

No Condition retinal image ASCVD AI cardiovascular risk adults

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

CLAiR Pivotal Study

Quick Facts

Study Start:2025-02-27

Study Completion:2025-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06808334

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.

Ages Eligible for Study:40 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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)

Inclusion Criteria

Exclusion 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

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)

Contacts and Locations

Study Contact

Yariv Levinson

CONTACT

(240) 442 2479

yariv.levin@tokueyes.com

Principal Investigator

Michael McConnell, MD

STUDY_DIRECTOR

Toku Inc.

Study Locations (Sites)

Diabetes and Endocrine Associates of Stark County

Canton, Ohio, 44718

United States

Collaborators and Investigators

Sponsor: Toku Eyes Ltd

Michael McConnell, MD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2025-02-27

Study Completion Date2025-10-01

Study Record Updates

Study Start Date2025-02-27

Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

retinal image
ASCVD
AI
cardiovascular risk
adults

Additional Relevant MeSH Terms

No Condition