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AI eye scan could catch diabetes blindness early

NCT ID NCT07378956

Diagnosis Sponsor: VUNO Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether an AI software can help doctors spot diabetic retinopathy (an eye disease caused by diabetes) earlier. About 340 adults with type 2 diabetes who have not been diagnosed with eye disease will be randomly assigned to get either standard care or standard care plus the AI analysis of their eye photos. The goal is to see if the AI leads to more correct referrals to eye specialists.

Why investors are watching

VUNO Inc. is running a 340-patient randomized trial testing its AI software, VUNO Med-Fundus AI, as a tool to help doctors detect diabetic retinopathy in routine care. For a small company, this trial is a direct test of whether its main product works in real-world settings, not just in a lab. A clear result could shape how clinics adopt the software and how the company positions its product.

If it works: A positive result could support wider use of the software in diabetes care, which might lead to more clinics buying or subscribing to it. That could strengthen VUNO's revenue base and its standing among eye-care and diabetes providers.

If it fails: The trial could fail to show that the AI improves detection in practice, or the company could face delays in completing or reporting the study. Trials often fail, and for a small company, a negative result could hurt confidence in the product and slow its commercial progress.

AI-written from the trial record. Speculative, and not investment advice.

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 340 people

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

Started

Apr 2026

Expected to finish

Aug 2027

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.

Ages

19 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: * Adults aged 19 years or older. * A documented diagnosis of type 2 diabetes mellitus. * Ability to communicate adequately and provide written informed consent for participation in the study. Exclusion Criteria: * A prior diagnosis of diabetic retinopathy at the time of screening. * A history of ophthalmic surgery within 6 months prior to the screening date. * A diagnosis of type 1 diabetes mellitus. * Pregnancy at the time of screening. * Any condition that, in the opinion of the investigator, would make participation in the study infeasible or inappropriate.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic retinopathy type 2 diabetes mellitus

As listed by the trial registrant

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

Diabete mellitus Diabetic retinopathy (DR) Fundus photography

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

  • Inha University Hospital

    RECRUITING

    Incheon, Gyeonggi-do, 22332, South Korea

More trials for these conditions

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