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

Abstract

Précis: In this study, we report a two-year follow-up after implantation of an adjustable glaucoma drainage device combined to a novel orbital filtering plate. The IOP was efficiently controlled post-operatively with limited complications and an excellent safety profile. Purpose: To report the clinical results at two years after implantation of an eyeWatch system, which comprises of an adjustable glaucoma drainage device (eyeWatch implant) combined with a novel orbital filtering plate (eyePlate), in refractory glaucoma. Patients and Methods: Monocentric, prospective, non-comparative clinical trial. Patients suffering from refractory glaucoma after several failed surgeries were operated using the eyeWatch system. The primary outcome was the success rate, defined as an IOP ≤18 mmHg and reduction of more than 20% from baseline, IOP ≥6 mmHg. Secondary outcomes were mean IOP, visual acuity, number of anti-glaucoma medications, 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 mmHg before surgery to 11.9±4.4 mmHg at 12 months (P<0.001) and to 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 to 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 on 7 patients. Conclusions: Implantation of the eyeWatch system effectively lowered IOP and reduced glaucoma medications for a 2-year period in patients who had previous failed glaucoma surgery. Persistent hypotony was not observed and the number of complications was low.

A new self-adjustable glaucoma valve

“…The readout of the magnetic disk rotational position and the rotation of the disk is achieved with the eyeWatch Pen, an external hand-held device that is used as a control unit. Despite the desirable efficacy demonstrated in clinical trials ( Roy and Mermoud, 2024 ), including total avoidance of hypotony-related issues, the eyeWatch has two major shortcomings: first, it is not a self-adjustable valve, needing human intervention to adjust the valve resistance and, second, because of its complicated mechanism, it is very costly to manufacture, making the end-user price is quite expensive in comparison to all other GDDs in the market.…”