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Glaucoma implant under the microscope: 5-Year safety watch begins

NCT ID NCT04524416

Disease control Sponsor: iSTAR Medical Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 116 people with open-angle glaucoma who already have a MINIject implant in their eye. Researchers will track them for up to 5 years to see if any serious device-related problems occur. No new treatment is given—this is a safety check to see how well the implant holds up over time.

What this could mean

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

Active substance
MINIject implant (a tiny device placed in the eye to help drain fluid and lower pressure)
What this could lead to
If successful, this study could confirm that the MINIject implant is safe and effective for long-term use, offering a lasting option to control glaucoma without daily eye drops.
What could go wrong
This is an observational follow-up study, not a new treatment trial. It only monitors safety in people who already have the implant, so it cannot prove the implant works better than other options. There is a small risk of device-related eye problems over time.

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

116 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Dec 2026

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.

Who is studied

patients with open-angle glaucoma not-controlled with hypotensive medications and who, to treat this condition, already received MINIject in a previous study

Ages

18 to 99 years

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: * Patient who received a MINIject glaucoma implant within a prior clinical study * Patient continues to have MINIject implanted at the point of enrolment * Patient must provide written informed consent to participate Exclusion Criteria: * Individuals under tutorship or trusteeship * Patient who is unwilling to return to the study visits and undergo study assessments, as required by clinical study protocol

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Conditions

The condition(s) this trial relates to.

ocular hypertension open-angle glaucoma

As listed by the trial registrant

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

Ocular hypertension Open angle glaucoma

Contacts and locations

Locations

  • Center Hospotalier Universitaire Genoble Alpes

    Grenoble, 38043, France

  • Clinica Oftalmologica del Caribe

    Barranquilla, Colombia

  • Hopital de la Croix-Rousse

    Lyon, 69417, France

  • Hospital Clínico San Carlos

    Madrid, Spain

  • Klinikum der Universität München

    München, 81377, Germany

  • Maxivision Eye Hospital

    Hyderabad, Telangana, 500034, India

  • Panama Eye Center

    Panama City, Panama

  • Uniklinik Köln

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitätsklinikum Mainz

    Mainz, Rhineland-Palatinate, 55131, Germany

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