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Eye surgery showdown: which drainage device placement saves more vision cells?

NCT ID NCT05924477

Disease control Sponsor: University of Pennsylvania 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This clinical trial compares two ways to place a glaucoma drainage device during surgery: one in the front chamber of the eye and one in a small space behind it. The goal is to see which method causes less loss of important cells on the inner surface of the cornea. The study involves 226 adults with glaucoma that is not well controlled by medication.

What this could mean

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

Active substance
glaucoma drainage device implantation surgery with tube placement in either the ciliary sulcus or the anterior chamber
What this could lead to
If successful, this could identify a surgical technique that better preserves the eye's inner lining cells, potentially improving long-term vision outcomes for glaucoma patients.
What could go wrong
This is a surgical technique comparison, not a new drug or cure. Results may show no significant difference between placements, and individual outcomes can vary based on patient anatomy and surgeon skill.

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 226 people

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

Started

Jul 2023

Expected to finish

Dec 2027

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

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: * Medically uncontrolled glaucoma requiring GDD or GDD combined with phacoemulsification as the planned surgical procedure * Candidate for GDD implantation for ciliary sulcus and AC tube * Age greater than or equal to 18 years old Exclusion Criteria: * Preexisting corneal condition that would affect the corneal endothelium or previous corneal transplant * Presence or history of Cypass Micro-Stent * Previous GDD, Xen Gel Stent or Preserflo MicroShunt removed less than 6 months before surgery * Presence of GDD implantation, Xen Gel Stent, of Preserflo MicroShunt * Previous trabeculectomy and/or minimally invasive glaucoma surgery within the past 6 months * AC intraocular lens * Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure * Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits * No light perception vision in the study eye or fellow eye visual acuity \< 20/200 * Need for glaucoma surgery combined with other ocular procedures (i.e. corneal transplant, or retinal surgery) or anticipated need for additional ocular surgery

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Conditions

The condition(s) this trial relates to.

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 places running it

    8 sites in 2 countries. 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

  • Bascom Palmer Eye Institute

    RECRUITING

    Miami, Florida, 33136, United States

  • Diablo Eye Associates

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Massachusetts Eye and Ear

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Prism Eye Institute, University of Toronto

    RECRUITING

    Toronto, Canada

  • University of Buffalo/State University of New York

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27517, United States

  • Wilmer Eye Institute, Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

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