Glaucoma Research Center, Montchoisi Clinic, Swiss Vision Network, Lausanne, Switzerland; Department of Ophthalmology, University of Colorado School of Medicine, Denver, Colorado.
Glaucoma Research Center, Montchoisi Clinic, Swiss Vision Network, Lausanne, Switzerland.
Ophthalmol Glaucoma. 2019 Sep-Oct;2(5):309-318. doi: 10.1016/j.ogla.2019.03.011. Epub 2019 Jun 8.
To evaluate the 2-year treatment outcomes of the XEN gel stent (Allergan, Inc, Irvine, CA) in glaucoma patients.
Prospective, single-center interventional study.
One hundred forty-nine eyes of 113 patients with open-angle glaucoma.
Consecutive eyes with uncontrolled intraocular pressure (IOP) or signs of disease progression despite medical treatment were included to undergo either standalone XEN implantation or combined XEN implantation plus phacoemulsification surgery, both with mitomycin C injections.
Primary efficacy outcome was success, defined as complete when the unmedicated IOP was 12 mmHg or less, 15 mmHg or less, or 18 mmHg or less and 20% lower than at baseline over the 2-year period and defined as qualified when the IOP fulfilled the same conditions with fewer medications than at baseline. Secondary measures were mean reduction in IOP and in the number of medications and the rates of reoperations.
One hundred nine eyes (84 patients; mean age, 74.3 years) underwent XEN plus phacoemulsification surgery and 40 eyes (29 patients; mean age, 74.7 years) underwent standalone XEN surgery. Overall, 129 eyes (86.6%; 96 eyes of 75 XEN plus phacoemulsification patients and 33 eyes of 24 XEN standalone surgery patients) completed the study. Mean medicated IOP was 20.0±7.5 mmHg at baseline and 14.1±3.7 mmHg at 2 years (P < 0.01), a 29.3% IOP reduction. Mean number of medications dropped from 2.0±1.3 before surgery to 0.6±0.9 at 2 years (P < 0.001). Complete success was achieved in 18.2% of eyes using the 12 mmHg or less and 20% reduction criteria and in 44.4% using the 15 mmHg or less threshold. Needling with mitomycin C was performed in 58 eyes (45%). In all, 11.4% underwent reoperations.
After 2 years, XEN gel stent surgery achieved a clinically and statistically significant reduction both in IOP and the number of antiglaucoma medications, while requiring a high rate of needling interventions.
评估 XEN 凝胶支架（Allergan，Inc，加利福尼亚州欧文）在青光眼患者中的 2 年治疗效果。
前瞻性、单中心干预性研究。
113 例患者的 149 只眼，患有开角型青光眼。
连续纳入眼压（IOP）控制不佳或有疾病进展迹象的患者，进行单纯 XEN 植入或联合 XEN 植入加超声乳化白内障吸除术，均联合丝裂霉素 C 注射。
主要疗效指标为成功，定义为 2 年内未用药的 IOP 完全控制在 12mmHg 或以下、15mmHg 或以下或 18mmHg 或以下且较基线降低 20%，定义为合格，即 IOP 满足相同条件，用药量较基线减少。次要观察指标为 IOP 平均降低量、用药量减少数和再手术率。
109 只眼（84 例患者；平均年龄 74.3 岁）接受 XEN 联合超声乳化白内障吸除术，40 只眼（29 例患者；平均年龄 74.7 岁）接受单纯 XEN 手术。共有 129 只眼（86.6%；75 例 XEN 联合超声乳化白内障吸除术患者中 96 只眼和 24 例单纯 XEN 手术患者中 33 只眼）完成研究。基线时平均用药 IOP 为 20.0±7.5mmHg，2 年时为 14.1±3.7mmHg（P<0.01），IOP 降低 29.3%。术前平均用药量为 2.0±1.3 种，2 年时为 0.6±0.9 种（P<0.001）。采用 12mmHg 或以下和 20%降低标准的完全成功率为 18.2%，采用 15mmHg 或以下阈值的完全成功率为 44.4%。58 只眼（45%）行丝裂霉素 C 针刺术。共有 11.4%的患者行再手术。
XEN 凝胶支架手术后 2 年，IOP 和抗青光眼药物的使用数量均显著降低，需要进行高频率的针刺干预。
