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AI eye scans could spot glaucoma hidden in routine diabetic screenings

NCT ID NCT06882356

Diagnosis Sponsor: Massachusetts Eye and Ear Infirmary Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether adding an AI analysis of eye photos, an eye pressure check, and a virtual reality visual field test to standard diabetic eye screening can help detect glaucoma. About 2,000 people with diabetes who are already getting AI-based screening for diabetic eye disease will take part. Researchers will compare how many glaucoma cases are found in the group that gets the extra screening versus the group that only gets the standard diabetic eye screening. The goal is to see if this combined approach is a practical and effective way to catch glaucoma earlier.

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 analysis of fundus photographs, intraocular pressure measurement, and virtual reality visual field testing
What this could lead to
If it works, this approach could make glaucoma screening more common and catch the disease earlier, potentially saving sight for many people with diabetes.
What could go wrong
The trial is still in early testing, and the AI may not be accurate enough in real-world settings. Some participants may find the extra tests uncomfortable or inconvenient.

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 2,000 people

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

Started

Jul 2025

Expected to finish

Sep 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

40 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.

* Individuals with diabetes undergoing AI-based screening for diabetic retinopathy using the LumineticsCore (Digital Diagnostics) system at primary care centers. * Individuals who are able and willing to provide informed consent for participation in the study.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus glaucoma prevention target

As listed by the trial registrant

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

Glaucoma

How to take part

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

  1. The places running it

    7 sites. 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

  • Brigham and Women's Primary Care Associates of Longwood

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • MGH Chelsea HealthCare Center

    RECRUITING

    Chelsea, Massachusetts, 02150, United States

  • Massachusetts General Hospital Broadway Primary Care-Revere

    RECRUITING

    Boston, Massachusetts, 02151, United States

  • Massachusetts General Hospital Internal Medicine Associates

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • NSPG Lynn

    RECRUITING

    Lynn, Massachusetts, 01904, United States

  • NSPG Salem

    NOT_YET_RECRUITING

    Salem, Massachusetts, 01970, United States

  • NSPG Saugus

    RECRUITING

    Saugus, Massachusetts, 01906, United States

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