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AI eye exam: could a computer spot diabetic retinopathy faster?

NCT ID NCT07404657

Diagnosis Sponsor: Centervue SpA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test a software that uses artificial intelligence to analyze photos of the retina and detect diabetic retinopathy, a common eye problem in people with diabetes. About 198 adults with diabetes will have their retinal images analyzed by the AI tool, and the results will be compared to expert human graders. The goal is to see if the AI can reliably identify cases that need referral to an eye specialist.

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 software tool (iCare RETCAD) for analyzing retinal images
What this could lead to
If successful, this AI tool could provide a fast, automated way to screen for diabetic retinopathy, helping catch the disease earlier in more people.
What could go wrong
This is a small, early-stage study (198 participants) and the AI may not match expert accuracy in all cases. The tool is only for screening, not a treatment.

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 198 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Apr 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

population attending a primary-care facility with diagnosis of diabetes mellitus and/or past diagnosis of diabetic retinopathy

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.

Inclusion Criteria: * 22 years old or older * diabetes or diabetic retinopathy * understand the study information and able to sign a consent form Exclusion Criteria: * cannot tolerate eye imaging tests * laser treatment or injections * eye surgery, except for simple cataract surgery * currently involved in another study * pregnant * cannot or do not want to have your eyes dilated * photodynamic therapy within the last 90 days

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Conditions

The condition(s) this trial relates to.

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 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 ↗

  2. 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.

More trials for these conditions

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