PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Condition(s) studied
Investigational drug(s) / intervention(s)
Microshunt XI: The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device
Study 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
Primary outcome measure(s)
- Primary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure — Screening to 12 months
This is a primary performance outcome to determine the proportion of eyes with ≥20% change and 6 mmHg to \<21 mmHg intraocular pressure from screening to 12 months
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| AKH Wien | Vienna | Austria | Recruiting |
| Glaucoma Clinic, UZ Leuven | Leuven | Belgium | Recruiting |
| Internationale Innovative Opthalmochirurgie GbR | Düsseldorf | Germany | Recruiting |
| Universitätsklinikum Tübingen, Department für Augenheilkunde | Tübingen | Germany | Not Yet Recruiting |
| Irccs Fondazione G. B. Bietti | Rome | Italy | Recruiting |
| Policlinico Universitario Molinette | Turin | Italy | Not Yet Recruiting |
| Universiteitskliniek voor Oogheelkunde Maastricht | Maastricht | Netherlands | Not Yet Recruiting |
| ULS Santa Maria, Lisboa | Lisbon | Portugal | Not Yet Recruiting |
| Hospital Clinico San Carlos | San Carlos | Spain | Not Yet Recruiting |
| Guy's and St. Thomas' NHS Foundation Trust | London | United Kingdom | Recruiting |
| Moorfields Eye Hospital NHS Foundation Trust | London | United Kingdom | Not Yet Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07235592 on ClinicalTrials.gov ↗ ← All trials in Italy