Save Sight Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia; School of Clinical Medicine, Faculty of Medicine and Health, University of New South Wales, Kensington, New South Wales, Australia.
Save Sight Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Ophthalmol Glaucoma. 2024 Nov-Dec;7(6):539-550. doi: 10.1016/j.ogla.2024.07.002. Epub 2024 Jul 14.
To compare safety, effectiveness, and baseline predictors of failure in standalone primary Xen45 gel stent (Xen) versus trabeculectomy (Trab) in glaucoma.
Retrospective study.
Subjects that underwent primary Xen or Trab augmented by mitomycin-C with at least 12 months follow-up.
Multinational observational study of eyes in the Fight Glaucoma Blindness international registry MAIN OUTCOME MEASURES: The primary outcome was success at 12 months defined by intraocular pressure (IOP) reduction ≥ 20% from baseline and ≤ threshold IOPs of 15, 18, and 21 mmHg with (qualified) or without (complete) medications and without secondary glaucoma surgery. Multivariable mixed effects Cox regression models were used to identify risk factors for failure in each cohort.
A total of 701 eyes (Xen, 308; Trab, 393) of 596 subjects were included with baseline IOP being significantly higher (22.4 vs. 19.9 mmHg, P < 0.001) and baseline medications significantly lower in the Xen versus the Trab group (2.9 vs. 3.4, P < 0.001). Baseline visual field mean deviation was less severe in the Xen group (-9.47 vs. -13.04 dB, P < 0.001). The proportion of complete surgical success was significantly lower in the Xen versus Trab group across the 3 upper IOP limits at 12 months; 32% versus 52% at 15 mmHg, 37% versus 54% at 18 mmHg, and 39% versus 55% at 21 mmHg (P < 0.001). The incidence of postoperative numerical and symptomatic hypotony was lower in the Xen versus Trab group. In the Xen cohort, a higher failure rate was associated with Asian ethnicity (hazard ratio [HR], 1.97; 95% confidence interval (CI), 1.03-3.79) and use of oral acetazolamide at baseline (HR, 1.74; 95% CI, 1.13-2.70), whereas a lower failure rate was associated with diagnosis of ocular hypertension/open-angle glaucoma suspect (HR, 0.40; 95% CI, 0.20-0.82) and secondary open-angle glaucoma (HR, 0.46; 95% CI, 0.26-0.82). Exposure to prostaglandin analog was associated with greater failure in the Trab group (HR, 2.66; 95% CI, 1.18-6.01).
There was significantly greater complete success at 12 months across all complete success definitions for Trab compared with Xen, whereas the rate of postoperative hypotony was significantly lower in the Xen group. Asian ethnicity and use of oral acetazolamide at baseline were associated with greater failure in Xen, whereas exposure to prostaglandin analog was associated with greater failure in Trab patients. Such baseline predictors of success and failure may help guide patient selection for subconjunctival minimally invasive glaucoma surgery in patients undergoing surgical intervention.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
比较原发性 Xen45 凝胶支架（Xen）与小梁切除术（Trab）在青光眼治疗中的安全性、有效性和基线失败预测因素。
回顾性研究。
接受原发性 Xen 或 Trab 联合丝裂霉素 C 治疗且随访至少 12 个月的受试者。
国际 Fight Glaucoma Blindness 注册中心的多国观察性研究，主要结局指标是 12 个月时的成功率，定义为眼压（IOP）较基线降低≥20%，且眼压≤阈值 IOP 15、18 和 21mmHg，同时使用（合格）或不使用（完全）药物，且无继发性青光眼手术。采用多变量混合效应 Cox 回归模型，确定每个队列中失败的风险因素。
共纳入 596 例受试者的 701 只眼（Xen 组 308 只眼，Trab 组 393 只眼），Xen 组基线 IOP 显著更高（22.4mmHg 比 19.9mmHg，P＜0.001），基线药物使用显著更低（2.9 比 3.4，P＜0.001）。Xen 组基线视野平均偏差较小（-9.47dB 比-13.04dB，P＜0.001）。在 12 个月时，Xen 组在所有 3 个较高的 IOP 限制下的完全手术成功率明显低于 Trab 组；15mmHg 时分别为 32%比 52%，18mmHg 时分别为 37%比 54%，21mmHg 时分别为 39%比 55%（P＜0.001）。Xen 组术后发生数字性和症状性低眼压的发生率较低。在 Xen 队列中，较高的失败率与亚洲人种（风险比 [HR]，1.97；95%置信区间 [CI]，1.03-3.79）和基线时使用口服乙酰唑胺（HR，1.74；95%CI，1.13-2.70）相关，而较低的失败率与诊断为高眼压/开角型青光眼可疑（HR，0.40；95%CI，0.20-0.82）和继发性开角型青光眼（HR，0.46；95%CI，0.26-0.82）相关。在 Trab 组中，接触前列腺素类似物与较高的失败率相关（HR，2.66；95%CI，1.18-6.01）。
与 Xen 相比，Trab 在所有完全成功定义下的 12 个月完全成功率均显著更高，而 Xen 组术后发生低眼压的比率显著较低。亚洲人种和基线时使用口服乙酰唑胺与 Xen 失败率增加相关，而接触前列腺素类似物与 Trab 患者失败率增加相关。这些成功和失败的基线预测因素可能有助于指导接受手术干预的患者选择行结膜下微创青光眼手术。
在本文末尾的脚注和披露中可能存在专有或商业披露。
