Laboratory of Hemodynamics and Cardiovascular Technology, Swiss Federal Institute of Technology.
Glaucoma Center, SwissVisio, Montchoisi Clinic, Lausanne, Switzerland.
J Glaucoma. 2024 Feb 1;33(2):132-138. doi: 10.1097/IJG.0000000000002334. Epub 2023 Nov 3.
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.
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.
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.
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.
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.
本研究报告了一种可调节青光眼引流装置与新型眼眶滤过板联合植入后的 2 年随访结果。术后眼压得到有效控制，并发症有限，安全性良好。
报告在难治性青光眼患者中植入 EyeWatch（eW）系统（包括可调节青光眼引流装置[ eW 植入物]和新型眼眶滤过板[ EyePlate]）后的 2 年临床结果。
单中心、前瞻性、非对照临床试验。对多次手术失败后患有难治性青光眼的患者使用 eW 系统进行手术。主要结局是成功率，定义为眼压（IOP）≤18mmHg，且较基线降低≥20%，IOP≥6mmHg。次要结局为平均 IOP、视力、抗青光眼药物数量，以及并发症的数量和类型。
42 例患者的 42 只眼纳入研究。平均随访时间为 22.0±4.0 个月。平均基线 IOP 从术前的 23.2±7.2mmHg 降至术后 12 个月时的 11.9±4.4mmHg（P<0.001）和 24 个月时的 11.5±3.0mmHg。术前平均抗青光眼药物数量为 2.9±0.9 种，术后 12 个月时降至 0.7±0.9 种（P<0.001）和 24 个月时降至 1.0±0.9 种。12 个月时的合格成功率为 93%，24 个月时为 90%，而 12 个月和 24 个月时的完全成功率分别为 46%和 40%。7 例患者出现并发症。
对于先前青光眼手术失败的患者，植入 eW 系统可在 2 年内有效降低眼压并减少抗青光眼药物的使用。未观察到持续低眼压，并发症数量较少。
