Not Yet RecruitingNot Applicable

PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

Austria, Belgium, Germany112 participantsStarted 2026-03

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Male or female, age 18 to 85 years, inclusive
✓. 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
✓. Patient willing to comply with study requirements
✓. Patient who has signed an approved informed consent form

Exclusion criteria

✕. Angle closure glaucoma
✕. Presence of conjunctival scarring, previous incisional ophthalmic surgery involving the conjunctiva or conjunctival pathologies (e.g., thin conjunctiva, pterygium)
✕. Active iris neovascularization
✕. Active inflammation (e.g., blepharitis, conjunctivitis, scleritis, keratitis, uveitis)
✕. Vitreous in the anterior chamber
✕. Presence of an anterior chamber intraocular lens (ACIOL)
✕. Intraocular silicone oil
✕. Need for glaucoma surgery combined with other ocular procedures (e.g., cataract surgery with IOL implantation) or anticipated need for additional ocular surgery during the investigational period

What they're measuring

Primary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure

Timeframe: Screening to 12 months

Trial details

NCT IDNCT07235592

SponsorSanten SAS

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-04

Contact for this trial

Study Director / Medical Monitor Raymund Angeles

510-368-9861 raymund.angeles@santen.com

View on ClinicalTrials.gov More Primary Open Angle Glaucoma trials