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NOT YET RECRUITING
NCT07235592

PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

Sponsor: Santen SAS

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

112

Start Date

2026-03

Completion Date

2027-04

Last Updated

2026-01-16

Healthy Volunteers

No

Interventions

DEVICE

Microshunt 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