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AI eye exam could spot glaucoma in seconds

NCT ID NCT07668193

Diagnosis Sponsor: Fondazione G.B. Bietti, IRCCS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study tests an artificial intelligence (AI) system called GlaukomAI that analyzes standard eye photos to detect glaucoma, a leading cause of blindness. Researchers will enroll 1,200 participants to see how accurately the AI identifies glaucoma compared to expert doctors. If it works well, this tool could make glaucoma screening faster and more accessible, helping people get treatment sooner.

What this could mean

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

Active substance
GlaukomAI (Sens-vue GlaukomAI) - an AI-based diagnostic software
What this could lead to
If successful, this AI tool could help doctors find glaucoma earlier, potentially preventing blindness by speeding up referrals.
What could go wrong
This is an early validation study, not a treatment trial. The AI may not perform as well in real-world settings, and it only analyzes eye photos, not other tests.

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 1,200 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 2028

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 for all patients: * Age \>18 years * Freely given informed consent obtained prior to study initiation * The participant has the capacity to understand and the willingness to follow study instructions and is likely to complete all required visits and procedures Inclusion Criteria for glaucoma patients: Patients affected by any type of glaucoma (primary open-angle, primary angle-closure, secondary glaucoma) on pharmacological therapy Inclusion Criteria for healthy controls: * Absence of ocular pathologies * IOP \<21 mmHg * Visual field and OCT within normal limits * Optic disc of normal appearance on clinical evaluation Exclusion Criteria: * Presence of media opacities preventing the acquisition of adequate quality fundus imaging (e.g., advanced cataract, vitreous hemorrhage, severe corneal opacities) * Retinal or optic nerve pathologies that could confound the diagnosis (e.g., non-glaucomatous optic neuropathies (ischemic, inflammatory, compressive), moderate-to-severe diabetic retinopathy, advanced macular degeneration, retinal vascular occlusions) * Having undergone any ocular surgery in the past 3 months * Inability to cooperate with perimetric examination

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Conditions

The condition(s) this trial relates to.

disease glaucoma

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 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

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