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AI eye check in your Doctor's office could save your sight

NCT ID NCT06763952

Diagnosis Sponsor: University of Wisconsin, Madison 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This study tests whether using an AI program to screen for diabetic eye disease during regular primary care visits can get more people to follow up with an eye specialist. It will include 4,000 adults with diabetes who have Medicaid and haven't had an eye exam in the past year. The goal is to see if this approach improves screening rates and reduces racial and ethnic gaps in eye care.

What this could mean

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

Active substance
AI-based eye screening program
What this could lead to
If successful, this could make diabetic eye screening more accessible and reduce vision loss, especially among minority groups.
What could go wrong
This is an early-stage trial with no results yet. The AI screening may not improve follow-up rates as hoped, and real-world adoption could face barriers.

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

About 6,900 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2030

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Clinics Inclusion Criteria: * Clinic must be from a health system with at least two clinics that meet eligibility criteria and will agree to join. * Number of unique patients with diabetes should be \>550 over any continuous 15-month period prior to the clinic providing a letter of support to participate in the trial. * No point-of-care screening system in use for DR. * Have an electronic health record to track patient data and agree to share limited data set as requested. * Have a member of the clinical team who can commit to serving as the clinic champion for this study. * Have the IT infrastructure to deploy an artificial-intelligence-based eye camera in the clinic. Patient Inclusion Criteria: * Diagnosis of type 1 or 2 diabetes * No known diabetic retinopathy * No diabetic retinopathy screening in the past 12 months Patient Exclusion Criteria: * Have a documented DR screening in the electronic health record within 12 months of the date of the primary care visit * Contraindication includes diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion * Pregnant

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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.

Diabetes mellitus Diabetic retinopathy

How to take part

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

  1. The places running it

    1 site. 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

  • UW School of Medicine and Public Health

    Madison, Wisconsin, 53792, United States

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