Effectiveness of MicroShunt in primary open-angle and pseudoexfoliative glaucoma patients: A retrospective European multicenter study.

Abstract Purpose To evaluate the effectiveness and safety of the PRESERFLO™ MicroShunt in patients with primary open-angle (POAG) and pseudoexfoliative (PXG) glaucoma. Design Retrospective, open-label, and multicenter study. Participants Patients with insufficiently controlled primary POAG or PXG who underwent a stand-alone MicroShunt implantation procedure. Methods Consecutive POAG and PXG patients who underwent surgery with the ab-externo minimally invasive glaucoma surgery device Preserflo™ MicroShunt with mitomycin-C (MMC). Main Outcome Measures Primary end-points were mean change in intraocular pressure (IOP) and number of hypotensive medications from baseline to month-12. Success was defined as an IOP ≤ 18 mm Hg and an IOP reduction ≥ 20%, with (qualified) or without (complete) any hypotensive medication. Results Among the 130 subjects who underwent MicroShunt implantation, 104 fulfilled the inclusion and exclusion criteria and were included in the analysis. Eighty-one (77.9%) eyes were diagnosed with POAG and 23 (22.1%) ones with PXG. The mean age was 71.4±12.6 years, and 45 (43.3%) were women. Mean IOP was significantly lowered from 25.1± 6.5 mmHg at baseline to 14.1±3.4 mmHg at month-12 (p Conclusions MicroShunt seems to be a safe and effective device for lowering IOP and the need for IOP‐lowering medications.