The PRESERFLO MicroShunt effectively lowered intraocular pressure in primary high and normal pressure open-angle glaucoma. 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. 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. 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. Effective and safe intraocular pressure lowering was observed one year following MicroShunt implantation for primary HPG and NPG in white patients of European descent.
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