Swiss Federal Institute of Technology.
Glaucoma Center, Montchoisi Clinic, Lausanne, Vaud.
J Glaucoma. 2019 May;28(5):452-458. doi: 10.1097/IJG.0000000000001209.
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.
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.
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.
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%.
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.
本研究旨在评估新型可调式青光眼引流装置 eyeWatch 联合 Baerveldt 青光眼植入物治疗难治性青光眼的安全性和有效性。
这是一项多中心、前瞻性、非对照的临床试验。纳入年龄大于 18 岁、经多次手术失败后患有难治性青光眼、IOP≥20mmHg、计划进一步采用房水分流术治疗的患者。主要结局是成功率，定义为 IOP≤18mmHg 且较基线降低≥20%，IOP≥6mmHg。次要结局为平均 IOP、视力、抗青光眼药物的数量、并发症的数量和类型。
共纳入 15 例患者。平均随访时间为 15.6±3.5 个月。平均基线 IOP 从术前的 26.2±6.8mmHg 下降至 12 个月时的 11.9±2.8mmHg（P<0.001）。平均抗青光眼药物的数量从术前的 3.0±0.7 降至末次随访时的 0.8±0.9（P<0.001）。末次随访时完全成功率为 40%，总体成功率为 93%。并发症发生率为 7%。
新型青光眼装置可在围手术期和术后对房水流出阻力进行非侵入性调整。这有助于在术后早期更好地控制 IOP，防止眼球压低，并消除阻塞性元素和再次干预的需要。并发症发生率低，IOP 得到充分控制和降低，抗青光眼药物的数量显著减少。
