PURPOSE To compare the efficacy of different microinvasive glaucoma surgery (MIGS) devices for reducing intraocular pressure (IOP) and medications in open-angle glaucoma (OAG). DESIGN Prospective, multicenter, randomized clinical trial. PARTICIPANTS One hundred fifty-two eyes from 152 patients aged 45 to 84 years with OAG, Shaffer angle grade III-IV, best-corrected visual acuity (BCVA) 20/30 or better, and IOP 23 to 39 mmHg after washout of all hypotensive medications. Eyes with secondary glaucoma other than pseudoexfoliative or pigmentary glaucoma, angle closure, previous incisional glaucoma surgery, or any significant ocular pathology other than glaucoma were excluded. INTERVENTION Study eyes were randomized 1:1 to standalone MIGS consisting of either 1 Hydrus Microstent (Ivantis, Inc, Irvine, CA) or 2 iStent Trabecular Micro Bypass devices (Glaukos Inc, San Clemente, CA). Follow-up was performed 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. MAIN OUTCOME MEASURES Within-group and between-group differences in IOP and medications at 12 months and complete surgical success defined as freedom from repeat glaucoma surgery, IOP 18 mmHg or less, and no glaucoma medications. Safety measures included the frequency of surgical complications, changes in visual acuity, slit-lamp findings, and adverse events. RESULTS Study groups were well matched for baseline demographics, glaucoma status, medication use, and baseline IOP. Twelve-month follow-up was completed in 148 of 152 randomized subjects (97.3%). At 12 months, the Hydrus had a greater rate of complete surgical success (P < 0.001) and reduced medication use (difference = -0.6 medications, P = 0.004). More Hydrus subjects were medication free at 12 months (difference = 22.6% P = 0.0057). Secondary glaucoma surgery was performed in 2 eyes in the 2-iStent group (3.9%) and in none of the Hydrus eyes. Two eyes in the Hydrus group and 1 in the 2-iStent group had BCVA loss of ≥2 lines. CONCLUSION Standalone MIGS in OAG with the Hydrus resulted in a higher surgical success rate and fewer medications compared with the 2-iStent procedure. The 2 MIGS devices have similar safety profiles.

中文翻译：

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比较水Hy和iStent微创青光眼手术植入物单独治疗开角型青光眼的前瞻性随机试验：COMPARE研究。

目的比较不同的微创青光眼手术（MIGS）设备在开角型青光眼（OAG）中降低眼压（IOP）和药物的功效。设计前瞻性，多中心，随机临床试验。参与者来自152名年龄在45至84岁之间的OAG，Shaffer角为III-IV级，最佳矫正视力（BCVA）为20/30或更高，IOP为23至39 mmHg的患者的152眼药物。排除患有假性剥脱性或色素性青光眼以外的继发性青光眼，角膜闭合，先前的切开性青光眼手术或除青光眼以外的任何重要眼部病理的眼睛。干预研究的眼睛以1：1的比例随机分配到由1个Hydrus Microstent（Ivantis，Inc，Irvine，CA）或2个iStent骨小梁微旁路设备（Glaukos Inc，加利福尼亚州圣克莱门特）。术后1天，1周以及1、3、6和12个月进行随访。主要观察指标：在12个月时，眼内压和药物治疗的组内和组间差异以及完全手术成功的定义为无重复青光眼手术，眼压18 mmHg或更低，且无青光眼药物。安全措施包括手术并发症发生的频率，视敏度的变化，裂隙灯的发现以及不良事件。结果研究组在基线人口统计学，青光眼状态，药物使用和基线眼压方面非常匹配。在152名随机受试者中的148名中完成了12个月的随访（97.3％）。在12个月时，Hydrus的完全手术成功率更高（P <0.001），药物使用减少了（差异= -0）。6种药物，P = 0.004）。更多Hydrus受试者在12个月时没有药物治疗（差异= 22.6％P = 0.0057）。2-iStent组（3.9％）的两只眼睛进行了继发性青光眼手术，Hydrus的一只眼睛均未进行。Hydrus组中的两只眼睛和2-iStent组中的1只眼睛的BCVA损失≥2行。结论与2-iStent手术相比，在OAG中使用Hydrus的独立MIGS可以提高手术成功率，减少用药。2个MIGS设备具有相似的安全性。结论与2-iStent手术相比，在OAG中使用Hydrus的独立MIGS可以提高手术成功率，减少用药。2个MIGS设备具有相似的安全性。结论与2-iStent手术相比，在OAG中使用Hydrus的独立MIGS可以提高手术成功率，减少用药。2个MIGS设备具有相似的安全性。