Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts
Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts
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DOI：
10.1016/j.ophtha.2016.06.032
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发表时间：
2016-10-01
期刊：
影响因子：
13.7
通讯作者：
Ianchulev, Tsontcho
中科院分区：
文献类型：
--
作者：
Vold, Steven;Ahmed, Iqbal Ike K.;Ianchulev, Tsontcho
目的：我们评估了睫状上微支架（CyPass Micro-Stent；Transcend Medical, Inc., Menlo Park, CA）治疗接受白内障手术的轻至中度原发性开角型青光眼 (POAG) 的 2 年安全性和有效性。设计：多中心（美国 24 个站点）、介入性随机临床试验 (RCT)（ClinicalTrials.gov 标识符， NCT01085357）。参与者：受试者于 2011 年 7 月开始入组，研究于 2015 年 3 月完成。受试者患有 POAG，平均每日未用药眼压（IOP）为 21-33 mmHg，并正在接受超声乳化白内障手术。方法：完成白内障手术后，受试者在术中随机分为仅超声乳化术（对照）或上辅助超声乳化术。微支架植入术与超声乳化（微支架）组（1:3 比例）。通过睫状体上腔经腹腔入路植入微支架，可以同时进行白内障和青光眼手术。主要结果指标：结果指标包括与基线相比，未接受药物治疗的每日眼压降低≥20%的受试者百分比、平均眼压变化和青光眼药物使用情况，以及 24 个月内眼部不良事件 (AE) 发生率。结果：在 505 名受试者中，131 名被随机分配至对照组组和 374 人被随机分配到微支架组。对照组和微支架组的基线平均 IOP 相似：分别为 24.5 +/- 3.0 和 24.4 +/- 2.8 mmHg（P > 0.05）；平均用药次数分别为 1.3 +/- 1.0 和 1.4 +/- 0.9 (P > 0.05)。眼压出现早期且持续的降低，24 个月时，60% 的对照组和 77% 的微支架受试者相比基线，未用药的 IOP 降低≥20%（P - 0.001；符合方案分析）。微支架组的平均 IOP 降低幅度为 7.4 mmHg，而对照组为 5.4 mmHg（P < 0.001），其中 85% 的微支架受试者在 24 个月时不需要 IOP 药物。微型支架受试者的平均 24 个月药物使用量降低了 67% (P < 0.001)； 59% 的对照组和 85% 的微支架受试者没有接受药物治疗。对照组的平均药物使用量在 12 个月和 24 个月时分别从基线时的 1.3 +/- 1.0 种药物减少到 0.7 +/- 0.9 种药物和 0.6 +/- 0.8 种药物，而在微支架组中，在 12 个月和 24 个月时平均药物使用量从 1.4 +/- 0.9 种药物减少到 0.2 +/- 0.6 种药物（两组随访时的减少量与对照组相比，P < 0.001）。基线）。没有发生威胁视力的微支架相关 AE。 24 个月内，两组的视力都很高； > 98% 的受试者达到 20/40 最佳矫正视力或更好。结论：这项随机对照试验证明，对轻中度 POAG 进行微介入手术治疗后，眼压和青光眼药物使用量可安全持续减少 2 年。 (C) 2016 年由美国眼科学会颁发。
Purpose: We evaluated 2-year safety and efficacy of supraciliary microstenting (CyPass Micro-Stent; Transcend Medical, Inc., Menlo Park, CA) for treating mild-to-moderate primary open-angle glaucoma (POAG) in patients undergoing cataract surgery.Design: Multicenter (24 US sites), interventional randomized clinical trial (RCT) (ClinicalTrials.gov identifier, NCT01085357).Participants: Subjects were enrolled beginning July 2011, with study completion in March 2015. Subjects had POAG with mean diurnal unmedicated intraocular pressure (IOP) 21-33 mmHg and were undergoing phacoemulsification cataract surgery.Methods: After completing cataract surgery, subjects were intraoperatively randomized to phacoemulsification only (control) or supraciliary microstenting with phacoemulsification (microstent) groups (1: 3 ratio). Microstent implantation via an ab interno approach to the supraciliary space allowed concomitant cataract and glaucoma surgery.Main Outcome Measures: Outcome measures included percentage of subjects achieving >= 20% unmedicated diurnal IOP lowering versus baseline, mean IOP change and glaucoma medication use, and ocular adverse event (AE) incidence through 24 months.Results: Of 505 subjects, 131 were randomized to the control group and 374 were randomized to the microstent group. Baseline mean IOPs in the control and microstent groups were similar: 24.5 +/- 3.0 and 24.4 +/- 2.8 mmHg, respectively (P > 0.05); mean medications were 1.3 +/- 1.0 and 1.4 +/- 0.9, respectively (P > 0.05). There was early and sustained IOP reduction, with 60% of controls versus 77% of microstent subjects achieving >= 20% unmedicated IOP lowering versus baseline at 24 months (P - 0.001; per-protocol analysis). Mean IOP reduction was down arrow 7.4 mmHg for the microstent group versus down arrow 5.4 mmHg in controls (P < 0.001), with 85% of microstent subjects not requiring IOP medications at 24 months. Mean 24-month medication use was 67% lower in microstent subjects (P < 0.001); 59% of control versus 85% of microstent subjects were medication free. Mean medication use in controls decreased from 1.3 +/- 1.0 drugs at baseline to 0.7 +/- 0.9 and 0.6 +/- 0.8 drugs at 12 and 24 months, respectively, and in the microstent group from 1.4 +/- 0.9 to 0.2 +/- 0.6 drugs at both 12 and 24 months (P < 0.001 for reductions in both groups at both follow-ups vs. baseline). No vision-threatening microstent-related AEs occurred. Visual acuity was high in both groups through 24 months; >98% of all subjects achieved 20/40 best-corrected visual acuity or better.Conclusions: This RCT demonstrated safe and sustained 2-year reduction in IOP and glaucoma medication use after microinterventional surgical treatment for mild-to-moderate POAG. (C) 2016 by the American Academy of Ophthalmology.