Department of Ophthalmology, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt- Universität Zu Berlin and Berlin Institute of Health, Campus Virchow Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany.
Graefes Arch Clin Exp Ophthalmol. 2023 Apr;261(4):1063-1072. doi: 10.1007/s00417-022-05872-7. Epub 2022 Oct 28.
The aim of this study was to evaluate whether XEN® implantation is a reasonable and safe method to lower the intraocular pressure (IOP) and amount of medication for adult primary open-angle glaucoma (POAG) over a 3-year period. The influence of the type of anesthesia, previous glaucoma surgery, and postoperative interventions on the outcome were examined.
In this retrospective study, 96 eyes were included. XEN® implantation was performed as sole procedure under general (n = 86) or local anesthesia (n = 10). IOP and number of glaucoma medication were assessed preoperatively: day 1, week 6, month 3, 6, 12, 24, and 36. Further outcome parameters were Kaplan-Meier success rates, secondary intervention, and complication rates.
IOP decreased from 20.7 ± 5.1 to 12.8 ± 2.5 mmHg at the 36-month follow-up (p < 0.001) and glaucoma therapy was reduced from 3.3 ± 0.8 to 1.2 ± 1.6 (36 months, p < 0.001). Transient postoperative hypotony was documented in 26 eyes (27.1%). General anesthesia resulted in a significant improvement of the survival rate compared to local anesthesia (77% vs. 50%, p = 0.044). Prior iStent inject®, Trabectome®, or SLT laser had no significant impact, such as filter bleb revision. The number of postoperative needlings had a significantly negative influence (p = 0.012).
XEN® implantation effectively and significantly lowers the IOP and number of glaucoma therapy in POAG in the 36-month follow-up with a favorable profile of side effects and few complications. In case of IOP, general anesthesia has a significant positive influence on the survival rate, whereas prior SLT or MIGS does not have significant impact.
本研究旨在评估 XEN®植入术是否为治疗成人原发性开角型青光眼(POAG)的合理且安全的方法,以降低眼压(IOP)和药物用量。研究考察了麻醉类型、既往青光眼手术以及术后干预对结果的影响。
在这项回顾性研究中,纳入了 96 只眼。XEN®植入术在全身麻醉下(n=86)或局部麻醉下(n=10)作为单一手术进行。在术前、术后第 1 天、第 6 周、第 3、6、12、24 和 36 个月评估 IOP 和青光眼药物使用数量。进一步的结果参数包括 Kaplan-Meier 成功率、二次干预和并发症发生率。
IOP 从术前的 20.7±5.1mmHg 下降至 36 个月时的 12.8±2.5mmHg(p<0.001),青光眼治疗药物从术前的 3.3±0.8 降至 36 个月时的 1.2±1.6(p<0.001)。术后发生短暂性低眼压的有 26 只眼(27.1%)。与局部麻醉相比,全身麻醉显著提高了生存率(77% vs. 50%,p=0.044)。既往 iStent inject®、Trabectome®或 SLT 激光治疗对结果无显著影响,如滤过泡修复。术后需要进行的针刺次数对结果有显著的负面影响(p=0.012)。
XEN®植入术在 36 个月的随访中,有效且显著地降低了 POAG 的 IOP 和青光眼治疗药物的使用量,其副作用和并发症发生率较低。在眼压方面,全身麻醉对生存率有显著的积极影响,而既往的 SLT 或 MIGS 治疗则无显著影响。