目的:评估Xen®植入物治疗开角型青光眼的安全性和有效性。
方法:回顾性研究包括2019年1月至2020年12月在大学医院接受Xen®植入物的患者。使用DxCare®软件收集人口统计学和医疗数据。主要终点是12个月时眼内压(IOP)降低20%,根据法国格劳康公司(SFG)的建议。次要终点是青光眼药物的减少和不良事件的发生率。
结果:纳入53例患者(65只眼)(性别比0.65,年龄75.38±7.31岁)。眼压由17.86±4.22mmHg降至14.55±2.66mmHg,下降18.51%(P<0.05)。青光眼用药例数术前为2.16±1.01,术后为0.49±0.94(P<0.05)。不良事件包括8个错误,其中3个需要重新操作,1例眼压增高通过小梁切除术解决,1例光凝治疗静脉缺血,3个脉络膜脱离和3个角膜溃疡。18只眼睛需要针刺。
结论:在12个月时,IOP低于文献中先前报道的(14.55vs15.90mmHg,P<0.05),可能是由于术前IOP较低。术后用药数量与文献相似(0.49vs0.40,P=0.51),针刺频率也是如此(27.69%对32.00%,P=0.36)。错位的频率更高(12.31%vs7.70%,P<0.05),可能是由于复杂患者的管理。Xen®的疗效符合建议。比较Xen®与小梁切除术的疗效将是有趣的。
OBJECTIVE: To evaluate the safety and efficacy of the Xen® implant for the treatment of open-angle glaucoma.
METHODS: Retrospective study including patients who received the Xen® implant between January 2019 and December 2020 in a university hospital. Demographic and medical data were collected using DxCare® software. The primary endpoint was a 20% reduction in intraocular pressure (IOP) at 12 months according to Société Française du Glaucome (SFG) recommendations. The secondary endpoints were decrease in glaucoma medications and incidence of adverse events.
RESULTS: Fifty-three patients (65 eyes) were included (sex ratio 0.65, age 75.38±7.31 years). IOP decreased by 18.51% from 17.86±4.22mmHg to 14.55±2.66mmHg (P<0.05). The number of glaucoma medications was 2.16±1.01 preoperatively vs 0.49±0.94 postoperatively (P<0.05). Adverse events included 8 malpositionings, 3 of which required reoperation, 1 case of increased IOP resolved by trabeculectomy, 1 case of venous ischemia treated by photocoagulation, 3 choroidal detachments and 3 corneal ulcers. Needling was required for 18 eyes.
CONCLUSIONS: At 12 months, the IOP was lower than previously reported in the literature (14.55 vs 15.90mmHg, P<0.05), probably due to a lower preoperative IOP. The number of postoperative medications was similar to the literature (0.49 vs 0.40, P=0.51), as was the frequency of needling (27.69% vs 32.00%, P=0.36). The frequency of malpositioning was higher (12.31% vs 7.70%, P<0.05), probably due to the management of complicated patients. The efficacy of Xen® was in line with recommendations. It would be interesting to compare the efficacy of Xen® with trabeculectomy.