Department of Ophthalmology and Optometry, Medical University of Innsbruck, Innsbruck, Austria.
Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Acta Ophthalmol. 2021 Jun;99(4):369-375. doi: 10.1111/aos.14627. Epub 2020 Sep 30.
The aim of this study was to evaluate the efficacy of XEN Gel Stent implantation in the treatment of primary open-angle glaucoma (POAG) and pseudoexfoliation glaucoma (XFG) regarding the reduction of intraocular pressure (IOP) and number of IOP-lowering medications over 2 years.
In this retrospective, observational, single-centre study, patients with POAG or XFG underwent implantation of the XEN Gel Stent with or without combined phacoemulsification. Changes in mean IOP, mean number of IOP-lowering medications, number of postoperative interventions, complete or qualified surgical success rate (defined as IOP < 18 mmHg without or with IOP-lowering medication, respectively) and complete surgical failure rate (defined as the necessity of a glaucoma-related secondary surgical intervention or loss of light perception) were assessed 12 months (12M) and 24 months (24M) postoperatively.
Seventy-nine eyes of 63 patients with open-angle glaucoma were included in the study (71% POAG, 29% XFG). Before surgery, mean IOP was 23.4 ± 7.9 mmHg. IOP was 14.6 ± 3.6 mmHg 12 months postoperatively (-31% from baseline, 95% CI -42% to -20%, n = 30, p < 0.001) and 14.8 ± 4.4 mmHg 24 months postoperatively (-29% from baseline, 95% CI -30% to -41%, n = 28, p < 0.001). Mean number of IOP-lowering medications was significantly reduced from 2.7 ± 1.1 before surgery to 1.0 ± 1.2 (-69%, 95% CI -89% to 46%, p < 0.001) 12 months after surgery and 1.0 ± 1.2 (-64%, 95% CI -91% to -36%, p < 0.001) at 24 months after surgery. Complete surgical success was achieved in 39% (12M) and 34% (24M) of patients and qualified success in 29% (12M) and 27% (24M). 13 (16%) eyes were classified as complete surgical failure. In 62% of the patients needling procedures had to be performed.
The XEN Gel Stent is an efficacious minimal invasive glaucoma surgery for primary open-angle and pseudoexfoliation glaucoma, resulting in significant reduction of IOP and a reduction in glaucoma medications from baseline in two-third of treated patients with 2-year follow-up. Frequent follow-up examinations were mandatory to identify early and late bleb failure and additional needling procedures were necessary to reestablish aqueous flow.
本研究旨在评估 XEN 凝胶支架植入术治疗原发性开角型青光眼（POAG）和假性剥脱性青光眼（XFG）的疗效，评估 2 年内眼压（IOP）降低和 IOP 降低药物数量。
在这项回顾性、观察性、单中心研究中，POAG 或 XFG 患者接受 XEN 凝胶支架植入术，联合或不联合超声乳化白内障吸除术。评估术后 12 个月（12M）和 24 个月（24M）时平均眼压（IOP）、平均 IOP 降低药物数量、术后干预次数、完全或合格的手术成功率（定义为 IOP<18mmHg 而无需或使用 IOP 降低药物，分别）和完全手术失败率（定义为需要与青光眼相关的二次手术干预或光感丧失）。
该研究纳入了 63 例开角型青光眼患者的 79 只眼（71%为 POAG，29%为 XFG）。术前平均 IOP 为 23.4±7.9mmHg。术后 12 个月 IOP 为 14.6±3.6mmHg（与基线相比降低 31%，95%CI-42%至-20%，n=30，p<0.001），术后 24 个月 IOP 为 14.8±4.4mmHg（与基线相比降低 29%，95%CI-30%至-41%，n=28，p<0.001）。术前 IOP 降低药物的平均数量为 2.7±1.1，术后 12 个月时降至 1.0±1.2（降低 69%，95%CI-89%至 46%，p<0.001），术后 24 个月时降至 1.0±1.2（降低 64%，95%CI-91%至 36%，p<0.001）。术后 12 个月时，39%（12M）的患者达到完全手术成功，29%（12M）的患者达到合格手术成功。术后 24 个月时，34%（24M）的患者达到完全手术成功，27%（24M）的患者达到合格手术成功。13 只（16%）眼被归类为完全手术失败。62%的患者需要进行针刺治疗。
XEN 凝胶支架是一种有效的原发性开角型和假性剥脱性青光眼微创性青光眼手术，可显著降低眼压，并使三分之二的治疗患者在 2 年随访期间从基线开始减少青光眼药物。需要定期进行随访检查，以发现早期和晚期滤泡失败，并进行额外的针刺治疗以重新建立房水流动。
