PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

Recruiting Observational Study
Primary Open Angle Glaucoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 85
Sex
Any
Study type
Observational
Participants needed
112 (estimated)
Sponsor
Santen SAS · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female, age 18 to 85 years, inclusive 2. Patient diagnosed with primary open glaucoma where the IOP is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure ≥18 mmHg and ≤35 mmHg while on glaucoma medications 3. Patient willing to…
Contacts

Study Director / Medical Monitor Raymund Angeles

510-368-9861

raymund.angeles@santen.com

CONTACT

Santen SAS Clinical Operations

bianca.groenendijk@santen.com

CONTACT