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A Comparison of Clinical Outcomes After XEN Gel Stent and EX-PRESS Glaucoma Drainage Device Implantation

机译:Xen Gel支架和前压青光眼引流装置植入临床结果比较

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Supplemental Digital Content is available in the text. Precis: Although the XEN stent offers a lower risk of hypotony and choroidal effusions with fewer clinic visits postoperatively, its surgical success rate was inferior to the EX-PRESS shunt. Purpose: To compare the clinical efficacy and safety outcomes of the XEN stent and EX-PRESS glaucoma drainage device in glaucomatous eyes. Materials and Methods: One hundred eyes from 88 patients underwent ab interno XEN stent or EX-PRESS shunt implantation (52 XEN and 48 EX-PRESS) for uncontrolled glaucoma at the University of Colorado Eye Center. The primary outcome was surgical success defined as intraocular pressure (IOP) ≥6 and ≤18?mm?Hg, without reoperation for uncontrolled glaucoma, loss of light perception, or use of glaucoma medications (complete success). Secondary outcomes were the same requirements allowing for medications (qualified success), mean IOP, medication use, adverse events, and number of postoperative clinic visits in the first 3 months. Results: Baseline characteristics including glaucoma type and severity were similar between groups, with the exception of XEN patients having fewer men (17% vs. 46%), older patients (median age, 78 vs. 68), and a higher percentage of white patients (89% vs. 69%). Adjusted hazard ratio of failure of XEN relative to EX-PRESS was 3.94 (95% confidence interval, 1.73-9.00, P =0.001) for complete success and 1.61 (95% confidence interval, 0.40-6.38, P =0.501) for qualified success. There were significantly fewer postoperative clinic visits during the first 3 months in the XEN group (5.3 vs. 9.1 visits, P <0.001). The incidence of serous choroidal effusions and hypotony was significantly less after XEN compared with EX-PRESS (1 vs. 9, P =0.02 and 15 vs. 25, P =0.023, respectively). Three XEN stents (5.8%) required removal. Conclusions: In this population, although the XEN stent offers a better safety profile and fewer postoperative clinic visits, complete surgical success was inferior to the EX-PRESS shunt.
机译:文本中提供了补充数字内容。精确:尽管XEN支架术后临床访视较少,但其低眼压和脉络膜积液的风险较低,但其手术成功率低于EX-PRESS分流术。目的:比较XEN支架和EX-PRESS青光眼引流装置治疗青光眼的临床疗效和安全性。材料与方法:88例患者在科罗拉多大学眼科中心接受不带控制的青光眼一百例(AxNO Xen支架)或EX-Press分流植入(52 Xen和48 EXPress)。主要结果是手术成功,定义为眼压(IOP)≥6和≤18?嗯?Hg,无需因青光眼失控、光感丧失或使用青光眼药物而再次手术(完全成功)。次要结果是考虑到药物(合格成功率)、平均眼压、药物使用、不良事件和前3个月术后临床就诊次数的相同要求。结果:两组患者的基线特征(包括青光眼类型和严重程度)相似,但XEN患者的男性较少(17%对46%),年龄较大(中位年龄78对68),白人患者的比例较高(89%对69%)。XEN相对于EX-PRESS的校正失败风险比为3.94(95%置信区间,1.73-9.00,P=0.001),为完全成功,为1.61(95%置信区间,0.40-6.38,P=0.501),为合格成功。XEN组术后前3个月的临床访视次数明显减少(5.3次与9.1次,P<0.001)。XEN术后浆液性脉络膜积液和低眼压的发生率明显低于EX-PRESS(分别为1对9,P=0.02和15对25,P=0.023)。三个XEN支架(5.8%)需要移除。结论:在该人群中,尽管XEN支架提供了更好的安全性,术后临床访视较少,但完全手术成功率低于EX-PRESS分流术。

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