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Glaucoma implant under the microscope: will it stay put?

NCT ID NCT04553523

Disease control Sponsor: Alcon Research 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This study is checking whether a small metal implant called the Hydrus Microstent stays in the right place after being placed during cataract surgery. The implant is designed to help drain fluid from the eye and lower pressure in people with open-angle glaucoma. Researchers will follow 545 adults for two years to see if the implant moves or causes problems like inflammation, vision loss, or the need for another surgery.

What this could mean

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

Active substance
Hydrus Microstent (a tiny, crescent-shaped metal implant placed in the eye to help drain fluid and lower pressure)
What this could lead to
If successful, this study will confirm that the Hydrus Microstent is a safe and reliable option for managing glaucoma during cataract surgery, helping to control eye pressure long-term.
What could go wrong
This is a post-approval study focused on safety, not a new treatment. The implant could move out of place, causing inflammation, vision loss, or the need for more surgery. Results may not apply to all glaucoma patients.

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 545 people

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

Started

Aug 2020

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 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: * An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse; * Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications; * Optic nerve appearance characteristic of glaucoma; * Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Closed angle forms of glaucoma; * Congenital or developmental glaucoma; * Secondary glaucoma; * Use of more than 4 ocular hypotensive medications; * Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery; * Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal; * Other protocol-defined exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

open-angle glaucoma

As listed by the trial registrant

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

Primary open-angle glaucoma

How to take part

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

  1. The places running it

    20 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

  • Carolina Eye Associates PA

    RECRUITING

    Southern Pines, North Carolina, 28387, United States

  • Center for Sight

    RECRUITING

    Las Vegas, Nevada, 89145, United States

  • Cincinnati Eye / Apex Eye

    NOT_YET_RECRUITING

    Mason, Ohio, 45040, United States

  • Cincinnati Eye Institute

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Cleveland Eye Clinic

    COMPLETED

    Brecksville, Ohio, 44141, United States

  • Coastal Vision

    COMPLETED

    Irvine, California, 92618, United States

  • El Paso Eye Surgeons

    RECRUITING

    El Paso, Texas, 79902, United States

  • Eye Center of Northern Colorado

    RECRUITING

    Loveland, Colorado, 80538, United States

  • Eye Centers Of Racine And Kenosha

    RECRUITING

    Kenosha, Wisconsin, 53142, United States

  • Fraser Eye Care Center

    RECRUITING

    Fraser, Michigan, 48026, United States

  • Glaucoma Associates Of Texas

    NOT_YET_RECRUITING

    Dallas, Texas, 75231, United States

  • Jones Eye Center PC

    RECRUITING

    Sioux City, Iowa, 51104, United States

  • Midwest Vision Research Foundation

    RECRUITING

    Chesterfield, Missouri, 63017, United States

  • Moyes Eye Center

    NOT_YET_RECRUITING

    Kansas City, Missouri, 64154, United States

  • Sacramento Eye Consultants

    RECRUITING

    Sacramento, California, 95815, United States

  • Scott & Christie and Associates, PC

    NOT_YET_RECRUITING

    Cranberry Township, Pennsylvania, 16066, United States

  • Stiles Eyecare Excellence Cataracts and Glaucoma

    NOT_YET_RECRUITING

    Overland Park, Kansas, 66213, United States

  • Texan Eye / Keystone Research

    RECRUITING

    Austin, Texas, 78731, United States

  • Texas Eye Research Center

    RECRUITING

    Hurst, Texas, 76054, United States

  • The Eye Institute of Utah

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84107, United States

  • Twin Cities Eye Consultants

    RECRUITING

    Coon Rapids, Minnesota, 55433, United States

  • Visionary Eye Doctors

    NOT_YET_RECRUITING

    Rockville, Maryland, 20852, United States

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