PreserFlo™ MicroShunt Versus Trabeculectomy in Patients With Moderate to Advanced Open-Angle Glaucoma: 12-Month Follow-Up of a Single-Center Prospective Study.

Purpose: The study compares the efficacy and safety of PreserFlo™ MicroShunt (Santen, Osaka, Japan) and trabeculectomy in eyes with moderate to advanced open-angle glaucoma.

Methods: In this prospective study, 300 patients (300 eyes) with moderate to advanced open-angle glaucoma were treated with either PreserFlo MicroShunt or trabeculectomy. The implantation of the PreserFlo MicroShunt was performed in 150 eyes (group A) and trabeculectomy was performed in 150 eyes (group B). The efficacy was evaluated by estimating the absolute and qualified success rates using the Kaplan-Meier survival analysis.  Results: During the 12-month follow-up period, 81.33% of eyes in group A and 94% in group B reduced intraocular pressure (IOP) >20% without glaucoma eye drops. The average IOP 12 months after surgery was 12.89±3.4 mmHg in group A and 11.39±4.5 mmHg in group B, which was significantly lower than the baseline intraocular pressure (group A: 23.47±8.36 mmHg, p=0.00053; group B: 22.03±5.2 mmHg, p= 0.0006). The number of topical medications administered 12 months after ocular surgery was 0.4±0.8 in group A and 0 in group B, compared to 2.5±1.2 in group A and 2.7±0.9 in group B at baseline (group A: p= 0.00091; group B: p= 0.00072). Ten eyes (6.67%) in group A and four eyes (2.67%) in group B were referred for bleb revision due to bleb fibrosis and consequent acute postoperative rise in IOP. Four eyes of group A and two eyes of group B were treated with transscleral cyclophotocoagulation. Five eyes in group B received re-trabeculectomy because of dysfunction of the primary bleb.

Conclusion: PreserFlo MicroShunt reduced the number of antiglaucoma agents compared to baseline, but was inferior to trabeculectomy at reducing IOP after 12 months. Additionally, trabeculectomy produced better absolute success rates after 12 months than PreserFlo MicroShunt in the treatment of moderate to advanced open-angle glaucoma.