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AI eye scans could reveal hidden heart risk

NCT ID NCT07747233

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study is testing whether an artificial intelligence software called CLAiR can reliably identify people at elevated risk for heart disease by analyzing images of the back of the eye (retina). The software looks for patterns in retinal images that may correlate with cardiovascular risk. Participants, who are adults aged 40 to 75 without known heart disease, will have retinal images taken with specific cameras. The main goal is to see if the software gives consistent results when different operators take the images, which is a key step toward using it as a screening tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CLAiR artificial intelligence software (a medical device that analyzes retinal images)
What this could lead to
If successful, this could lead to a quick, non-invasive way to screen for heart disease risk during routine eye exams, potentially catching problems earlier.
What could go wrong
This is a small, early-stage study focused on accuracy and consistency, not on patient outcomes. The software may not perform as well in broader populations or real-world settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

56 people

The number who actually took part.

Started

Dec 2025

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Previously participated in the CLAiR pivotal study with blood pressure and blood test measurements completed. Continues to meet the original pivotal study eligibility criteria. Male or female, 40 to 75 years of age. Able and willing to provide written informed consent. Willing and able to comply with all study procedures and complete the single study visit. Exclusion Criteria: Known history of atherosclerotic cardiovascular disease (ASCVD), including stroke, myocardial infarction, coronary artery bypass surgery, or coronary stenting. Current use of cholesterol-lowering medication (e.g., statins). Pregnancy. Persistent vision impairment in at least one eye (legally blind with current corrective lenses or visual acuity \<20/400). Known pathological myopia in at least one eye. Previous treatment for, or current care by, a retinal specialist for retinal disease in at least one eye.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Diabetes and Endocrinology Associates of Stark County, Inc.

    Canton, Ohio, 44718, United States

  • Illinois Retina Associates

    Homer Glen, Illinois, 60491, United States

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