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AI could spot diabetic eye disease in minutes

NCT ID NCT06721351

Diagnosis Sponsor: Centro De Salud La Comunidad De San Ysidro Inc DBA: San Ysidro Health Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using artificial intelligence (AI) to screen for diabetic retinopathy is faster and more accessible than the usual method with an eye doctor. About 548 adults with diabetes will be randomly assigned to either standard screening or AI-based screening using a special camera and EyeArt® system. Researchers will compare completion rates, time spent, and patient satisfaction over one year.

What this could mean

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

Active substance
EyeArt® AI system for diabetic retinopathy screening
What this could lead to
If successful, this could make diabetic eye screenings quicker and more widely available, especially in community clinics, helping catch vision-threatening problems earlier.
What could go wrong
This is a single-site study with 548 participants, so results may not apply everywhere. The AI may not work as well in all real-world settings or for all patients.

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

548 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

22 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. Capacity to provide informed consent. Individuals must have the capacity to understand the study information, risks, and benefits and voluntarily provide informed consent. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Established and active patient of SYHealth-CV and KC (having a medical appointment in the last 18 months). 4. Person aged 22 and older. 5. Established diagnosis of DM. 6. Medical appointment(s) (in-person or telehealth) scheduled during the intervention period. 7. Has not completed a dilated eye exam or retinal exam in the last 11months. Exclusion Criteria: 1. have a prior diagnosis of DR, macular edema, or retinal vascular occlusion; 2. have persistent visual Impairment in one or both eyes; 3. history of ocular injections, laser treatment of the retina, or intraocular surgery (excluding cataract surgery); 4. pregnant women; and 5. diagnosis of mental or degenerative disease that prevents self-consent for the study.

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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)

Contacts and locations

Locations

  • San Ysidro Health - Comprehensive Health Center - Ocean View

    San Diego, California, 92113, United States

  • San Ysidro Health Chula Vista

    Chula Vista, California, 91910, United States

  • San Ysidro Health King-Chavez Health Center

    San Diego, California, 92114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.