Randomized Evaluation of the Trabecular Micro-Bypass Stent with Phacoemulsification in Patients with Glaucoma and Cataract
Randomized Evaluation of the Trabecular Micro-Bypass Stent with Phacoemulsification in Patients with Glaucoma and Cataract
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DOI：
10.1016/j.ophtha.2010.07.007
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发表时间：
2011-03-01
期刊：
影响因子：
13.7
通讯作者：
Giamporcaro, Jane Ellen
中科院分区：
文献类型：
--
作者：
Samuelson, Thomas W.;Katz, L. Jay;Giamporcaro, Jane Ellen
目的：评价iStent小梁微旁路支架(加利福尼亚州拉古纳山Glaukos公司)联合白内障手术治疗轻、中度开角型青光眼的安全性和有效性。设计：前瞻性、随机、开放标签、对照、多中心临床试验。不良事件的总体发生率在没有意外不良装置影响的组之间是相似的。结论：支架加白内障手术后1年，使用较少药物的降压效果在临床和统计学上显著优于单纯白内障手术，总体安全性与单纯白内障手术相似。
Objective: To assess the safety and efficacy of the iStent trabecular micro-bypass stent (Glaukos Corporation, Laguna Hills, CA) in combination with cataract surgery in subjects with mild to moderate open-angle glaucoma.Design: Prospective, randomized, open-label, controlled, multicenter clinical trial.Participants: A total of 240 eyes with mild to moderate open-angle glaucoma with intraocular pressure (IOP) = 20% IOP reduction without medication (P = 0.003). The overall incidence of adverse events was similar between groups with no unanticipated adverse device effects.Conclusions: Pressure reduction on fewer medications was clinically and statistically significantly better 1 year after stent plus cataract surgery versus cataract surgery alone, with an overall safety profile similar to that of cataract surgery alone.