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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Sponsor: Santen SAS
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
Conditions
Interventions
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