Initial Clinical Results of the eyeWatch: a New Adjustable Glaucoma Drainage Device Used in Refractory Glaucoma Surgery.

Precis: In this study, we report clinical results after implantation of an adjustable glaucoma drainage device. The intraocular pressure (IOP) profile was efficiently controlled postoperatively as the resistance to aqueous humor outflow was finely adjusted. Purpose: The main purpose of this study was to evaluate the safety and efficacy of the new adjustable glaucoma drainage device eyeWatch used in conjunction with a Baerveldt glaucoma implant in refractory glaucoma. Patients and Methods: This was a multicentric, prospective, noncomparative clinical trial. Patients older than 18 years of age suffering from refractory glaucoma after failed surgeries, with IOP of >= 20 mm Hg, in whom a further glaucoma procedure using an aqueous shunt was planned, were enrolled in this study. The primary outcome was the success rate, defined as an IOP <= 18 mm Hg and reduction of >20% from baseline, IOP >= 6 mm Hg. Secondary outcomes were mean IOP, visual acuity, number of antiglaucoma medications, number, and type of complications. Results: Fifteen patients were included. The mean follow-up time was 15.6 +/- 3.5 months. The mean baseline IOP decreased from 26.2 +/- 6.8 mm Hg before surgery to 11.9 +/- 2.8 mm Hg at 12 months (P<0.001). The mean number of glaucoma medications decreased from 3.0 +/- 0.7 before surgery to 0.8 +/- 0.9 at last visit (P<0.001). The success rate was 40% for complete success and 93% for overall success at last follow-up. Complication rate was 7%. Conclusions: The novel glaucoma device allows for perioperative and postoperative noninvasive adjustments of the resistance to aqueous humor outflow. This leads to better management of IOP during the early postoperative period, preventing ocular hypotony and eliminating the need for obstructive elements and reinterventions. The rate of complications was low, IOP was adequately controlled and lowered, with a substantial reduction in the number of antiglaucoma medication.