Efficacy and Safety of an Adjustable Glaucoma Drainage Device (eyeWatch System) for Refractory Glaucoma: A 2-Year Prospective Study.
AI Summary
This 2-year study found the adjustable eyeWatch device effectively lowered IOP and medication use in refractory glaucoma, offering a safe, sustained treatment option.
Abstract
Précis: 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.
MeSH Terms
Shields Classification
Key Concepts5
Implantation of the eyeWatch (eW) system, an adjustable glaucoma drainage device combined with an orbital filtering plate, effectively lowered intraocular pressure (IOP) from a mean baseline of 23.2±7.2 mm Hg to 11.9±4.4 mm Hg at 12 months (P <0.001) and 11.5±3.0 mm Hg at 24 months in 42 eyes from 42 patients with refractory glaucoma.
The eyeWatch (eW) system significantly reduced the mean number of glaucoma medications 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 in 42 eyes from 42 patients with refractory glaucoma.
The qualified success rate (IOP ≤18 mm Hg and reduction of more than 20% from baseline, IOP ≥6 mm Hg) for the eyeWatch (eW) system was 93% at 12 months and 90% at 24 months in 42 eyes from 42 patients with refractory glaucoma.
The complete success rate for the eyeWatch (eW) system was 46% at 12 months and 40% at 24 months in 42 eyes from 42 patients with refractory glaucoma.
Complications occurred in 7 out of 42 patients (16.7%) after implantation of the eyeWatch (eW) system for refractory glaucoma, with persistent hypotony not observed, indicating a low number of complications.
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