Efficacy and Safety of an Adjustable Glaucoma Drainage Device (eyeWatch System) for Refractory Glaucoma: A 2-Year Prospective Study.

Abstract

In this study, we report a 2-year follow-up after implantation of an adjustable glaucoma drainage device combined with a novel orbital filtering plate. The IOP was efficiently controlled postoperatively with limited complications and an excellent safety profile. To report the clinical results at 2 years after implantation of an eyeWatch (eW) system, which comprises an adjustable glaucoma drainage device (eW implant) combined with a novel orbital filtering plate (eyePlate), in refractory glaucoma. Monocentric, prospective, noncomparative clinical trial. Patients suffering from refractory glaucoma after several failed surgeries were operated using the eW system. The primary outcome was the success rate, defined as an IOP ≤18mmHg and reduction of more than 20% from baseline, IOP ≥6mmHg. Secondary outcomes were mean IOP, visual acuity, the number of antiglaucoma medications, and the number and type of complications. Forty-two eyes from 42 patients were included. The mean follow-up time was 22.0±4.0 months. The mean baseline IOP decreased from 23.2±7.2mmHg before surgery to 11.9±4.4mmHg at 12 months ( P <0.001) and 11.5±3.0 at 24 months. The mean number of glaucoma medications decreased from 2.9±0.9 before surgery to 0.7±0.9 at 12 months ( P <0.001) and 1.0±0.9 at 24 months. The qualified success rate was 93% at 12 months and 90% at 24 months whereas the complete success rate was 46% and 40% at 12 and 24 months, respectively. Complications occurred in 7 patients. Implantation of the eW system effectively lowered IOP and reduced glaucoma medications for a 2-year period in patients who had previously failed glaucoma surgery. Persistent hypotony was not observed and the number of complications was low.