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

Abstract

Précis: 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.

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

“…In that sense, obtaining comparable results after implantation of either a Baerveldt or an eyePlate indicates that these devices are functioning in a very comparable way to ensure a functioning filtering surgery. In other words, the efficacy and safety of the eyePlate are likely to be comparable to that of a Baerveldt device when connected to an eW 8 …”

Eyewatch adjustable drainage device in vitrectomized eyes with refractory glaucoma

“…16 Roy et al have al-ready shown, in non-vitrectomized eyes, that the use of the eyeWatch device combined to a Baerveldt tube resulted in a significant reduction in IOP in association with low complications in comparison to the Ahmed glaucoma valve. 20 The advantage of implanting a BGI instead of an AVG are also related to a higher bleb encapsulation rate reported in the AVG group. The early conjunctival exposure to the proinflammatory me-diators from the aqueous can be a reason for this high encapsulation rate.…”

“…The eyeWatch encompasses a mechanism allowing for selective compression of its internal elastic tube, thus altering its fluidic resistance, which is performed noninvasively using the eyeWatch Pen single use during the surgery or the eyeWatch Pen (office) post-operatively. 20,21 In this small case series we assess the efficacy and safety of eyeWatch device in vitrectomized refractory glaucomatous eyes.…”

Microfluidics in the eye: a review of glaucoma implants from an engineering perspective

“…172 Additionally, initial clinical results of the eyeWatch have reported an extremely low complication rate (7%). 173 It is believed that the device will prevent IOP spikes and promote smooth transitions of IOP through fine-tuning the flow resistance in a continuous manner, and hence may mitigate the tissue response and FC formation. The eyeWatch allows for non-invasive adjustments of the flow resistance, leading to patient-specific management of IOP and eliminating the need for surgical reinterventions.…”

“…Since the flow resistance can be tuned gradually, the IOP spikes observed in the 2nd wave implants can be reduced, thus the relevant tissue response could be mitigated because the IOP varies in smooth means. 39,173 However, the eyeWatch™ implant doesn't come with an integrated IOP sensor, making it inconvenient for the clinicians to use. Typically, operators need to measure the IOP after each adjustment of the flow resistance to confirm that the desired IOP is reached.…”