New eye implant could rival standard glaucoma surgery

NCT ID NCT07496957

Disease control Sponsor: Medical University of Bialystok Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a tiny drainage device called the Preserflo MicroShunt can lower eye pressure as well as the standard trabeculectomy surgery in adults with open-angle glaucoma. One hundred participants will be randomly assigned to receive one of the two procedures and will be followed for 12 months. The goal is to see if the MicroShunt is a safe and effective alternative that may be less invasive.

What this could mean

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

Active substance: Preserflo MicroShunt (a tiny drainage device) and trabeculectomy (a surgical procedure)
What this could lead to: If the Preserflo MicroShunt works as well as trabeculectomy, it could offer a less invasive surgical option for controlling eye pressure in glaucoma patients.
What could go wrong: This is a relatively small, early-stage comparison study (100 participants) and the device may not prove as effective or safe as the standard surgery. Complications like scarring or infection are possible with both procedures.

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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 100 people

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

Started

Mar 2026

Expected to finish

Dec 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

21 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: -\>21 years of age * An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEXG) * Inadequately controlled on maximum tolerated medical therapy * Mean Deviation (MD) \</= -3 * Intraocular pressure of 14-28 mmHg * Endothelial Cell Count ≥1000 cells/mm2 Exclusion Criteria: * An established diagnosis of: Closed-angle glaucoma or Secondary open-angle glaucoma (besides PDG and PEX) * Lens status: Aphakic patients or Anterior chamber intraocular lens * Previous procedures: Glaucoma shunt/valve/ surgery or cyclodestructive procedure, Selective laser trabeculoplasty within the past 3 months, Incisional ophthalmic surgery involving the conjunctiva within the past 3 months, Clear corneal cataract or trabecular meshwork surgery conducted within the past 6 months * Presence of intraocular silicone oil * No light perception vision * Current corticosteroid use (ocular or oral) * Conjunctival pathologies (e.g., pterygium) * Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) * Vitreous present in the anterior chamber * Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date * Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits

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Conditions

The condition(s) this trial relates to.

exfoliation syndrome glaucoma 1, open angle, l low tension glaucoma open-angle glaucoma pigment dispersion syndrome

As listed by the trial registrant

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

Glaucoma 1, open angle, D (disorder)

How to take part

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

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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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.

New eye implant could rival standard glaucoma surgery

What the study statuses mean