Last reviewed · How we verify
Post Market Clinical Follow-Up Study to Demonstrate the Safety and Performance of the PRESERFLO™ MicroShunt XI in Patients With Primary Open Angle Glaucoma
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.
Details
| Lead sponsor | Santen SAS |
|---|---|
| Status | NOT_YET_RECRUITING |
| Enrolment | 112 |
| Start date | 2026-03 |
| Completion | 2027-04 |
Conditions
- Primary Open Angle Glaucoma
Interventions
- Microshunt XI
Primary outcomes
- 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
Countries
Austria, Belgium, Germany, Italy, Netherlands, Portugal, Spain, United Kingdom