RecruitingNCT07235592

PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

Post Market Clinical Follow-Up Study to Demonstrate the Safety and Performance of the PRESERFLO™ MicroShunt XI in Patients With Primary Open Angle Glaucoma

Sponsor

Santen SAS

Enrollment

112 participants

Start Date

Mar 19, 2026

Study Type

OBSERVATIONAL

Conditions

Primary Open Angle Glaucoma

Summary

The purpose of this study is to collect safety and performance data on the PRESERFLO™ MicroShunt XI in patients diagnosed with primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥18 mmHg and ≤35 mmHg and/or where glaucoma progression warrants surgery.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Microshunt XI for people with primary open angle glaucoma. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMicroshunt XI

The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device

Locations(11)

AKH Wien

Vienna, Austria

Glaucoma Clinic, UZ Leuven

Leuven, Belgium

Internationale Innovative Opthalmochirurgie GbR

Düsseldorf, Germany

Universitätsklinikum Tübingen, Department für Augenheilkunde

Tübingen, Germany

Irccs Fondazione G. B. Bietti

Rome, Italy

Policlinico Universitario Molinette

Turin, Italy

Universiteitskliniek voor Oogheelkunde Maastricht

Maastricht, Netherlands

ULS Santa Maria, Lisboa

Lisbon, Portugal

Hospital Clinico San Carlos

San Carlos, Spain

Guy's and St. Thomas' NHS Foundation Trust

London, United Kingdom

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07235592

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