Intermediate-term impact on corneal endothelial cells and efficacy of Preserflo MicroShunt implantation in patients with open-angle glaucoma - a prospective study over two years.

Abstract

Preserflo MicroShunt is a novel microinvasive bleb forming device for the treatment of primary open-angle glaucoma. The intermediate- and long-term success and the impact of this procedure on corneal endothelial cell density remain to be investigated. In this prospective observational study, 62 eyes of 55 glaucoma patients (mean age ± SD: 67.0 ± 15.0years) receiving a Preserflo MicroShunt were included. Corneal endothelial cell density, intraocular pressure and best corrected visual acuity were assessed preoperatively and at 3, 6, 9, 12, 18 and 24months postoperatively. Success rates, bleb revision rates and complications were analysed. Complete success was defined as an intraocular pressure reduction of ≥ 20% and achieving a target pressure of ≤ 18, ≤ 15 or ≤ 12mmHg without antiglaucoma medication. Qualified success indicated that the criteria were reached with or without medication. Corneal endothelial cells showed no significant decline over 24months (p > 0.05). Intraocular pressure showed a substantial reduction postoperatively (p < 0.001), decreasing from 29.6 ± 8,3mmHg to 13.0 ± 4.3mmHg after 24months (p < 0.001). Complete and qualified success with a target pressure ≤ 15mmHg was achieved in 52.9% and 54.6% of cases after 24months, respectively. Best corrected visual acuity did not change after 24months. Preserflo MicroShunt had no negative side effects on corneal endothelial cells and showed favourable success rates after 2years in patients with open-angle glaucoma.