Prcis: 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.
Purpose: 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.
Patients and methods: 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 ≤18 mm Hg and reduction of more than 20% from baseline, IOP ≥6 mm Hg. Secondary outcomes were mean IOP, visual acuity, the number of antiglaucoma medications, and the number and type of complications.
Results: 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±7.2 mm Hg before surgery to 11.9±4.4 mm Hg 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.
Conclusions: 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.
Trial registration: ClinicalTrials.gov NCT02554214.
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