- PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group — Recruiting • NCT07235592.
- This study tracks safety and effectiveness of a tiny glaucoma drainage device in patients whose eye pressure remains too high despite maximum medication.
Verify eligibility, endpoints and current status on the original ClinicalTrials.gov registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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. Conditions: Primary Open Angle Glaucoma Interventions: Microshunt XI Lead Sponsor: Santen SAS Planned Enrollment: 112 participants