Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Tiny tube could tame glaucoma without daily drops

NCT ID NCT07235592

Disease control Sponsor: Santen SAS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study tests a small implant called the PRESERFLO™ MicroShunt XI in people with primary open-angle glaucoma whose eye pressure remains high despite maximum medication. The implant is placed under the eye's surface to drain fluid and lower pressure. Researchers will check if it safely reduces pressure by at least 20% and keeps it in a healthy range for 12 months.

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 XI implant (a tiny tube placed in the eye to drain fluid and lower pressure)
What this could lead to
If it works, this could offer a safe, long-term way to control eye pressure in glaucoma patients, possibly reducing the need for daily eye drops.
What could go wrong
This is a mid-stage study with only 112 participants, so results may not apply to everyone. The implant is a surgical device, so risks include infection, scarring, or the device not working as expected.

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 112 people

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

Started

Mar 2026

Expected to finish

Sep 2027

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

This study will include adult patients with primary open angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery. At the time of a scheduled clinic visit, eligible patients will be invited to participate in the study and willing patients will be requested to sign an informed consent form. Once informed consent is obtained, the subject is included in the study and relevant data will be recorded during scheduled clinical visits. Participation in this study is entirely voluntary;

Ages

18 to 85 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: 1. Male or female, age 18 to 85 years, inclusive 2. Patient diagnosed with primary open glaucoma where the IOP is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure ≥18 mmHg and ≤35 mmHg while on glaucoma medications 3. Patient willing to comply with study requirements 4. Patient who has signed an approved informed consent form Exclusion Criteria: 1. Angle closure glaucoma 2. Presence of conjunctival scarring, previous incisional ophthalmic surgery involving the conjunctiva or conjunctival pathologies (e.g., thin conjunctiva, pterygium) 3. Active iris neovascularization 4. Active inflammation (e.g., blepharitis, conjunctivitis, scleritis, keratitis, uveitis) 5. Vitreous in the anterior chamber 6. Presence of an anterior chamber intraocular lens (ACIOL) 7. Intraocular silicone oil 8. Need for glaucoma surgery combined with other ocular procedures (e.g., cataract surgery with IOL implantation) or anticipated need for additional ocular surgery during the investigational period 9. Central corneal thickness that is less than 450 microns or greater than 620 microns 10. Previous cilioablative procedure 11. Neovascular glaucoma 12. Uveitic Glaucoma 13. Pseudoexfoliative or pigmentary glaucoma 14. Chronic inflammation 15. Previous incisional ophthalmic surgery within 6 months prior to study 16. Enrolled in this or another study (only one eye can participate in this study) or completed their participation in another study within 30 calendar days of the screening exam 17. Ocular pathology or medical condition for which, in the investigator's judgment, the following factors would either place the patient at increased risk of complications or contraindicate device implantation or interfere with compliance to elements of the Protocol

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Primary open-angle glaucoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

    11 sites in 8 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

  • AKH Wien

    RECRUITING

    Vienna, Austria

  • Glaucoma Clinic, UZ Leuven

    RECRUITING

    Leuven, Belgium

  • Guy's and St. Thomas' NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • Hospital Clinico San Carlos

    NOT_YET_RECRUITING

    San Carlos, Spain

  • Internationale Innovative Opthalmochirurgie GbR

    RECRUITING

    Düsseldorf, Germany

  • Irccs Fondazione G. B. Bietti

    RECRUITING

    Rome, Italy

  • Moorfields Eye Hospital NHS Foundation Trust

    NOT_YET_RECRUITING

    London, United Kingdom

  • Policlinico Universitario Molinette

    NOT_YET_RECRUITING

    Turin, Italy

  • ULS Santa Maria, Lisboa

    NOT_YET_RECRUITING

    Lisbon, Portugal

  • Universiteitskliniek voor Oogheelkunde Maastricht

    NOT_YET_RECRUITING

    Maastricht, Netherlands

  • Universitätsklinikum Tübingen, Department für Augenheilkunde

    NOT_YET_RECRUITING

    Tübingen, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.