Excisional goniotomy vs trabecular microbypass stent implantation: a prospective randomized clinical trial in eyes with mild to moderate open-angle glaucoma
Excisional goniotomy vs trabecular microbypass stent implantation: a prospective randomized clinical trial in eyes with mild to moderate open-angle glaucoma
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DOI：
10.1097/j.jcrs.0000000000000229
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发表时间：
2020-08-01
影响因子：
2.8
通讯作者：
Dorairaj, Syril
中科院分区：
文献类型：
--
作者：
Falkenberry, Suzanne;Singh, Inder Paul;Dorairaj, Syril
目的：在轻度至中度开角型青光眼（OAG）患者中，比较使用Kahook Dual Blade（KDB）与iStent微旁路植入术进行切除性房角切开术（均联合超声乳化）的眼的眼内压（IOP）降低和IOP降低药物。设置：美国的9个实践。设计：前瞻性、随机、活性对照、平行组临床试验。方法：将患眼随机分配至KDB-超乳或iStent-超乳组。在基线和术后第1天、第1周、第1个月、第3个月、第6个月和第12个月收集人口统计学资料、矫正远视力、IOP、降IOP药物和不良事件。主要结果的措施是眼睛的比例在12个月的IOP降低20%或更大或IOP药物减少1或更多与baseline.Results：在这项研究中，164眼164例患者进行了分析（每组82）。与基线相比，12个月时KDB-超乳组的平均IOP从18.5（标准误差0.4）降至15.4（0.4）mmHg，iStent-超乳组从18.5（0.3）降至16.1（0.4）mmHg（P = 0.24）。KDB-超乳组的平均降眼压药物从1.3（0.1）降至0.3（0.1），iStent-超乳组从1.4（0.1）降至0.4（0.1）（P = 0.17）。在研究完成者中，79例KDB-超乳患者中有74例（93.7%）获得了主要结局，78例iStent-Phaco患者中有65例（83.3%）获得了主要结局（P = 0.04）。两种手术的安全性相似。结论：两种手术都有效且安全地降低了轻度至中度OAG和白内障患者的IOP以及对降IOP药物的需求。值得注意的是，在12个月时，KDB-超乳术眼比iStent-超乳术眼更多地达到了IOP降低20%或以上或减少1次或多次药物治疗的主要结局。版权所有（C）2020由Wolters Kluwer代表ASCRS和ESCRS发布
Purpose: To compare reduction in intraocular pre-sure (IOP) and IOP-lowering medication in eyes undergoing excisional goniotomy with Kahook Dual Blade (KDB) vs iStent microbypass implantation, both combined with phacoemulsification, in eyes with mild to moderate open-angle glaucoma (OAG).Setting: Nine practices in the United States.Design: Prospective, randomized, active-controlled, parallel-group clinical trial.Methods: Eyes were randomized to KDB-Phaco or iStent-Phaco group. Demographics, corrected distance visual acuity, IOP, IOP-lowering medications, and adverse events were collected at baseline and at day 1, week 1, and months 1, 3, 6, and 12 postoperatively. The primary outcome measure was the proportion of eyes at 12 months with IOP reduction of 20% or greater or IOP medication reduction of 1 or more compared with baseline.Results: For this study, 164 eyes of 164 patients were analyzed (82 in each group). Mean IOP was reduced at 12 months compared with baseline from 18.5 (standard of error 0.4) to 15.4 (0.4) mm Hg in the KDB-Phaco group and from 18.5 (0.3) to 16.1 (0.4) mm Hg in the iStent-Phaco group (P = .24). Mean IOP-lowering medications were reduced from 1.3 (0.1) to 0.3 (0.1) in the KDB-Phaco group and from 1.4 (0.1) to 0.4 (0.1) in the iStent-Phaco group (P = .17). Among study completers, the primary outcome was attained in 74 (93.7%) of 79 patients of KDB-Phaco eyes and 65 (83.3%) of 78 patients of iStent-Phaco eyes (P = .04). Both procedures had similar safety profiles.Conclusions: Both procedures lowered both IOP and the need for IOP-lowering medications effectively and safely in eyes with mild to moderate OAG and cataract. Significantly, more KDB-Phaco eyes than iStent-Phaco eyes met the primary outcome of 20% or greater IOP reduction or 1 or more medication reduction at 12 months. Copyright (C) 2020 Published by Wolters Kluwer on behalf of ASCRS and ESCRS