Glaucoma Research Centre, Montchoisi Clinic, Swiss Visio Network, Lausanne, Switzerland.
Narayana Nethralaya, Hulimavu, Bangalore, India.
J Glaucoma. 2023 Nov 1;32(11):909-917. doi: 10.1097/IJG.0000000000002302. Epub 2023 Sep 4.
XEN 45 Gel Stent is safe and effective for 3 years. The study results provide useful insight into the outcome of XEN 45 Gel Stent surgery over 5 years in daily clinical practice.
To evaluate 5-year outcomes of XEN 45 gel stent implantation (XEN) in patients with open angle glaucoma.
This is a prospective, single-center, interventional study. XEN implantation either alone (XEN) or combined with phacoemulsification (Phaco + XEN) was performed on 170 consecutive eyes (126 patients) with uncontrolled intraocular pressure (IOP) or disease progression despite medical treatment. "Complete" surgical success at 60 months was defined as unmedicated IOP ≤15 mm Hg and a relative IOP reduction ≥20% from medicated baseline, while "qualified" success allowed fewer ocular hypotensive medications than at baseline. Other definitions of success with various IOP targets were also analyzed. Secondary outcomes included mean IOP and IOP-lowering medication changes and rates of reoperations.
Mean age was 78.1±9.2 years, and 70.3% were female. Mean medicated IOP decreased from 19.8±7.7 mm Hg [19.6±7.1 (XEN) vs. 19.8±7.0 mm Hg (Phaco+XEN)] at baseline to 12.6±3.1 mm Hg [12.5± 3.1 (XEN) vs. 12.6±3.1 (Phaco+XEN)] at 5 years (-37.0%; P < 0.001). Medications decreased from 2.0±1.3 [2.0±1.3 (XEN) vs. 2.0±1.3 (Phaco+XEN)] to 0.8±1.1 [0.8±1.1 (XEN) vs. 0.8±1.1 (Phaco + XEN)] (-60%; P <0.001). Needling was performed in 84 eyes (49%), and 19.4% underwent a secondary surgical intervention. Complete success at 3 years was a strong predictor of success at 5 years (odds ratio: 3.06, P <0.01), while needling was associated with higher rates of failure (odds ratio: 3.6, P <0.01).
At 5 years, XEN gel stent implantation was a safe procedure and achieved clinically meaningful IOP and medication reduction. Success at 3 years is a predictor of success at 5 years. Needling correlates with higher failure rates.
XEN 45 凝胶支架 3 年安全有效。研究结果为 XEN 45 凝胶支架在日常临床实践中超过 5 年的手术结果提供了有用的见解。
评估 XEN 45 凝胶支架植入术（XEN）治疗开角型青光眼 5 年的结果。
这是一项前瞻性、单中心、干预性研究。对 170 只连续眼（126 例患者）进行 XEN 植入术（XEN）或联合超声乳化术（Phaco+XEN）治疗，这些患者的眼内压（IOP）控制不佳或尽管进行了药物治疗但疾病仍在进展。60 个月时“完全”手术成功定义为未用药 IOP≤15mmHg，与药物治疗基线相比相对 IOP 降低≥20%，而“合格”成功允许比基线更少的降眼压药物。还分析了不同 IOP 目标下其他成功定义。次要结局包括平均 IOP 和 IOP 降低药物变化以及再次手术率。
平均年龄为 78.1±9.2 岁，70.3%为女性。基线时，平均用药 IOP 从 19.8±7.7mmHg[19.6±7.1mmHg（XEN）与 19.8±7.0mmHg（Phaco+XEN）]下降至 12.6±3.1mmHg[12.5±3.1mmHg（XEN）与 12.6±3.1mmHg（Phaco+XEN）]，降幅为 37.0%（P<0.001）。药物从 2.0±1.3[2.0±1.3（XEN）与 2.0±1.3（Phaco+XEN）]降至 0.8±1.1[0.8±1.1（XEN）与 0.8±1.1（Phaco+XEN）]，降幅为 60%（P<0.001）。84 只眼（49%）行针刺治疗，19.4%行二次手术干预。3 年时完全成功是 5 年时成功的强烈预测因素（优势比：3.06，P<0.01），而针刺与更高的失败率相关（优势比：3.6，P<0.01）。
5 年时，XEN 凝胶支架植入术是一种安全的手术，可实现有临床意义的 IOP 和药物降低。3 年时的成功是 5 年时成功的预测因素。针刺与更高的失败率相关。
