Early Results of PRESERFLO TM MicroShunt for Primary Open-angle Glaucoma in Caucasian Patients.

Abstract

Precis: The PRESERFLO MicroShunt effectively lowered intraocular pressure in primary high and normal pressure open-angle glaucoma.

Purpose: To evaluate the efficacy and safety of the PRESERFLOTM MicroShunt in patients with primary open-angle glaucoma (POAG) and the two variants high (HPG) and normal pressure glaucoma (NPG) after one year.

Methods: Single-center prospective interventional case series consecutively including eyes of White/European patients with POAG, who received the PRESERFLOTM MicroShunt as a primary and stand-alone glaucoma intervention. Primary outcome measures: change in mean 24-h IOP (mdIOP, mean of 6 measurements), peak IOP, IOP fluctuations, anti-glaucoma medications, and success rates. Secondary outcome measures: visual acuity, visual fields, complications, surgical interventions, and adverse events.

Results: Forty-two eyes of 42 POAG patients, 29 in the HPG and 13 in the NPG group, were analyzed after 1-year follow-ups. Median [Q25, Q75] mdIOP (mmHg) dropped by 30% from 16.5 [13.7-27.3] to 12.8 [10.2-14.5] in the HPG and by 40% from 14.3 [13.3-16.0] to 9.5 [8.3-11.1] in the NPG group, with a median postoperative medication use of 0 [0-0] in both groups. At one year, 92.5% of eyes were medication-free versus 0% preoperatively. The reduction of mdIOP (P=1.0), peak IOP (P=0.932), IOP fluctuations (P=0.142) and the rate of interventions (P=0.298) were not statistically significantly different between the HPG and NPG group. None of the patients experienced severe adverse events or loss of vision.

Conclusions: Effective and safe intraocular pressure lowering was observed one year following MicroShunt implantation for primary HPG and NPG in white patients of European descent.