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AI eye check: could DRISTi replace human screenings for diabetic retinopathy?

NCT ID NCT07222293

Diagnosis Sponsor: Artelus AI Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study checks if an AI software named DRISTi can accurately detect diabetic retinopathy, a serious eye disease, in people with diabetes. About 900 participants will have their eye images analyzed by both DRISTi and a human reading center. The goal is to see if the AI matches human experts, potentially making screening faster and more accessible.

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.

Participants

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2026

An estimate. End dates often move.

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.

Who is studied

Patients will be referred from primary care clinics and ophthalmology clinics in North Carolina.

Ages

21 years and older

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: 1. Ability to sign and date the informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age (≥)21 years of age or older 4. Diagnosed with diabetes mellitus as per criteria established by the World Health Organization (WHO) or the American Diabetes Association (ADA) 1. Hemoglobin A1c (HbA1c) ≥ 6.5% 2. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) 3. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L) Exclusion Criteria: 1. Persistent visual impairment in one or both eyes; 2. History of macular edema or retinal vascular (vein or artery) occlusion; 3. History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications; 4. Subject is contraindicated for fundus photography (for example, has light sensitivity); 5. Subject has contraindications for mydriatic medications or is unwilling or unable to dilate; 6. Subject is currently enrolled in an interventional study of an investigational device or drug for the same condition; or 7. Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs 8. Subject falls into one of the below categories: * Adults unable to consent (individuals w/ impaired decision-making capacity) * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic retinopathy

As listed by the trial registrant

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

Diabetic retinopathy (DR)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • New Century Ophthalmology - Oxford

    RECRUITING

    Oxford, North Carolina, 27565, United States

  • New Century Ophthalmology - Raleigh

    RECRUITING

    Raleigh, North Carolina, 27617, United States

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