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Can AI catch the leading cause of blindness before It's too late?

NCT ID NCT05704491

Diagnosis Sponsor: West German Center of Diabetes and Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial is testing whether an artificial intelligence (AI) model, called MONA DR, can accurately detect diabetic retinopathy—a common eye complication of diabetes that can lead to blindness—from retinal photographs. The study will enroll 100 adults with diabetes and compare the AI's readings against standard assessments to measure its accuracy. If the AI proves reliable, it could offer a faster, more accessible screening option for the millions of people who need annual eye exams.

What this could mean

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

Active substance
An artificial intelligence (AI) algorithm called the MONA DR model, which analyzes retinal images to detect diabetic retinopathy.
What this could lead to
If successful, this AI could provide a reliable, fast, and accessible screening tool for diabetic retinopathy, potentially preventing vision loss in millions.
What could go wrong
The trial is relatively small (100 participants) and focuses on diagnostic accuracy, not long-term outcomes. The AI's performance in this specific group may not generalize to all populations or 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.

Participants

About 100 people

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

Started

Jan 2023

Expected to finish

Dec 2027

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.

Who is studied

Patients of the West German Centre of Diabetes and Health with Type 2 Diabetes

Ages

18 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: * Diagnosis of diabetes mellitus * Diabetes duration ≥ 5 years * Age \> 18 years old * Patient is able to give informed consent * Fluent in written and spoken German, or interpreter present Exclusion Criteria: * History of laser treatment * Contraindication to the fundus imaging systems used in the study

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Conditions

The condition(s) this trial relates to.

diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus

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

  • West German Center of Diabetes and Health

    RECRUITING

    Düsseldorf, 40591, Germany

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