Effectiveness of MicroShunt in Patients with Primary Open-Angle and Pseudoexfoliative Glaucoma: A Retrospective European Multicenter Study.
Antonio Maria Fea, Gian Luca Laffi, Enrico Martini, Mario A Economou, Paolo Caselgrandi, Matteo Sacchi, Leon Au
Summary
In this retrospective study, the MicroShunt effectively lowered IOP and the need for IOP-lowering medications.
Abstract
PURPOSE
To evaluate the effectiveness and safety of the Preserflo MicroShunt implant (Santen) in patients with primary open-angle glaucoma (POAG) and pseudoexfoliation glaucoma (PXG).
DESIGN
Retrospective, open-label, multicenter study.
PARTICIPANTS
Patients with insufficiently controlled primary POAG or PXG who underwent a standalone MicroShunt implantation procedure.
METHODS
Consecutive patients with POAG and PXG who underwent surgery with the ab externo minimally invasive glaucoma surgery device Preserflo MicroShunt with mitomycin C.
MAIN OUTCOME MEASURES
Primary end points were mean change in intraocular pressure (IOP) and number of hypotensive medications from baseline through month 12. Success was defined as an IOP of 18 mmHg or less and an IOP reduction of 20% or more, with (qualified) or without (complete) any hypotensive medication.
RESULTS
Among the 130 patients who underwent MicroShunt implantation, 104 fulfilled the inclusion and exclusion criteria and were included in the analysis. Eighty-one eyes (77.9%) were diagnosed with POAG and 23 eyes (22.1%) were diagnosed with PXG. The mean age was 71.4 ± 12.6 years, and 45 patients (43.3%) were women. Mean IOP was lowered significantly from 25.1 ± 6.5 mmHg at baseline to 14.1 ± 3.4 mmHg at month 12 (P < 0.0001). At month 12, 27 eyes (26.0%) were categorized as complete successes and 61 eyes (58.7%) were categorized as qualified successes. The mean number of hypotensive medications was reduced significantly from 3.0 ± 1.0 medications at the preoperative visit to 0.77 ± 0.95 medication at month 12 (P < 0.001). Throughout the study, 19 eyes (18.3%) required needling and 14 eyes (13.5%) underwent surgical revision. Eight eyes (7.7%) showed hyphema and 5 eyes (4.8%) showed choroidal detachment. These were resolved with medical therapy without sequelae. Four patients underwent subsequent surgeries, and 2 patients underwent trabeculectomy (at months 3 and 6): One patient underwent transscleral cyclophotocoagulation at month 3 and 1 patient underwent MicroPulse cyclophotocoagulation at month 4.
CONCLUSIONS
In this retrospective study, the MicroShunt effectively lowered IOP and the need for IOP-lowering medications.
Keywords
More by Antonio Maria Fea
View full profile →Long-term outcomes after acute primary angle closure of Caucasian chronic angle closure glaucoma patients.
The quality of reporting on Glaucoma Surgical Innovations during Early Development Stages using IDEAL Guidelines: a Systematic Review.
Preserflo MicroShunt in refractory glaucoma: multicentre european results with up to three years of follow-up.
Top Research in Glaucoma Surgery
Browse all →Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up.
Efficacy, Safety, and Risk Factors for Failure of Standalone Ab Interno Gelatin Microstent Implantation versus Standalone Trabeculectomy.
Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract: Two-Year Results.
In the Knowledge Library
Discussion
Comments and discussion will appear here in a future update.