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8-Year check: does the hydrus implant keep glaucoma in check?

NCT ID NCT07460791

Disease control Sponsor: Johannes Gutenberg University Mainz 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study follows 200 glaucoma patients who received a tiny eye implant called Hydrus along with cataract surgery. Researchers want to see if the implant still helps control eye pressure after 8 to 14 years. The goal is to understand how well the implant works over the long term and whether it reduces the need for eye drops.

What this could mean

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

Active substance
Hydrus implant (a tiny stent placed in the eye to help drain fluid) plus cataract surgery (phacoemulsification)
What this could lead to
If successful, this could show that the Hydrus implant provides long-lasting eye pressure control for glaucoma patients, reducing the need for daily eye drops.
What could go wrong
This is an observational follow-up study, not a new treatment test. It only looks back at past results, so it cannot prove the implant works better than other options. Some patients may still need additional treatments.

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.

Participants

About 200 people

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

Started

Apr 2025

Expected to finish

Aug 2026

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.

Who is studied

Up to 202 eyes will be examined in this long-term follow-up trial. Patients from the Hydrus I, II, IV trials and the Spectrum Data Collection will be invited for participation in this trial.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1\. Patient participated in one of the following trials in the clinical trial site in Mainz: 1. the Ivantis, Inc. HYDRUS I trial (NCT03065036), 2. the Ivantis, Inc. HYDRUS II trial (NCT01818115), 3. the Ivantis, Inc. HYDRUS IV trial (NCT01539239), 4. or in the retrospective SPECTRUM data collection. 2. Patient received either concomitant implantation of the Hydrus implant and phacoemulsification or the Hydrus implant alone or participated in the control group (phacoemusification alone) 3. Patient has a minimum follow-up period after surgery of 8 years at the study visit 4. Willingness to participate in the study, the subject's signed and dated informed consent must be submitted before the start of the study 5. Ability of subject to give consent \- Exclusion Criteria: 1\. Simultaneous participation in another interventional study or past interventions whose effect may still be ongoing (30 days) \-

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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

    1 site. 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

  • Department of Opthalmology

    RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

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