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Tiny eye implant offers hope for tough glaucoma cases

NCT ID NCT07350200

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a small implant called XEN in 150 people whose glaucoma was still out of control despite previous surgeries. The implant was placed in the eye to help drain fluid and lower pressure. Researchers tracked eye pressure, vision changes, and how many medications patients needed over the long term.

What this could mean

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

Active substance
XEN glaucoma implant (a tiny drainage device placed in the eye to lower pressure)
What this could lead to
If successful, this implant could help people with difficult-to-control glaucoma avoid further vision loss and reduce their need for daily eye drops.
What could go wrong
This is a completed observational study, not a controlled trial, so results may not apply to everyone. The implant carries risks like infection, inflammation, or scarring that can limit its effectiveness.

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

150 people

The number who actually took part.

Started

Dec 2014

Finished

Nov 2025

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

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: * presence of OUG, defined as prior treatment with surgical or cyclodestructive procedures * failure to achieve target IOP with maximally tolerated topical IOP-lowering treatment or intolerance to drugs * both primary and secondary open- and closed-angle glaucoma cases * presence of healthy mobile conjunctiva in at least one quadrant and bestcorrected visual acuity Exclusion Criteria: * presence of clinically significant inflammation or infection within 30 days before surgery, history of corneal refractive surgery, corneal deposits or haze preventing intraoperative viewing of the anterior chamber, presence of an anterior chamber lens, advanced age-related macular degeneration (AMD), known or suspected allergy or sensitivity to porcine products or glutaraldehyde, pregnant or nursing women, and lack of consent to participate in the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Military Institute of Medicine - National Research Institute

    Warsaw, 04-141, Poland

More trials for these conditions

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