A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma and Cataract The HORIZON Study
A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma and Cataract The HORIZON Study
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DOI：
10.1016/j.ophtha.2018.05.012
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发表时间：
2019-01-01
期刊：
影响因子：
13.7
通讯作者：
Singh, Kuldev
中科院分区：
文献类型：
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作者：
Samuelson, Thomas W.;Chang, David F.;Singh, Kuldev
目的：比较白内障手术与植入施累姆管微支架与单纯白内障手术在 24 个月后降低眼压 (IOP) 和药物使用的效果。设计：前瞻性、多中心、单盲、随机对照试验。参与者：同时患有原发性开角型青光眼 (POAG)、视觉上明显白内障和 22 至 22 岁之间的褪色改良日眼压 (MDIOP) 的受试者34 mmHg。方法：受试者以 2:1 的比例随机分配，在施累姆管内接受单个 Hydrus 微型支架（Ivantis, Inc, Irvine, CA），或在简单的超声乳化术后不接受支架。术后1天、1周、1、3、6、12、18、24个月进行全面眼部检查。在 12 个月和 24 个月时重复进行药物清除和 MDIOP 测量。 主要结果指标：主要和次要有效性终点分别是 24 个月时未用药 MDIOP 降低 20% 或以上以及平均 MDIOP 较基线变化的受试者比例。在整个随访过程中跟踪降压药物的使用情况。安全措施包括手术并发症和不良事件的发生率。结果：超声乳化术后共有 369 只眼睛被随机分配至 Hydrus 微型支架 (HMS)，187 只眼睛被随机分配至无微型支架 (NMS)。 24 个月时，HMS 组 77.3% 的眼睛和 NMS 组 57.8% 的眼睛中，未经药物治疗的 MDIOP 降低了≥ 20%（差异 = 19.5%，95% 置信区间 [CI] 11.2% -27.8%，P < 0.001）。 HMS 组 24 个月未用药 MDIOP 平均降低为 -7.6 +/- 4.1 mmHg（平均值 +/- 标准差），NMS 组为 -5.3 +/- 3.9 mmHg（差异 =-2.3 mmHg；95% CI，-3.0 至 -1.6；P < 0.001）。 HMS 组的平均药物数量从基线时的 1.7 +/- 0.9 减少到 24 个月时的 0.3 +/- 0.8，NMS 组的平均药物数量从 1.7 +/- 0.9 减少到 0.7 +/- 0.9（差异 =-0.4 药物；P < 0.001）。没有发生与微支架相关的严重眼部不良事件，两组之间的安全参数没有显着差异。结论：这项为期 24 个月的多中心随机对照试验表明，与单独超声乳化术相比，接受施累姆管微支架联合超声乳化术的轻至中度 POAG 受试者的 MDIOP 和药物使用明显减少。 (C) 2018 年美国眼科学会
Objective: To compare cataract surgery with implantation of a Schlemm canal microstent with cataract surgery alone for the reduction of intraocular pressure (IOP) and medication use after 24 months.Design: Prospective, multicenter, single-masked, randomized controlled trial.Participants: Subjects with concomitant primary open-angle glaucoma (POAG), visually significant cataract, and washed-out modified diurnal IOP (MDIOP) between 22 and 34 mmHg.Methods: Subjects were randomized 2: 1 to receive a single Hydrus Microstent (Ivantis, Inc, Irvine, CA) in the Schlemm canal or no stent after uncomplicated phacoemulsification. Comprehensive eye examinations were conducted 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months postoperatively. Medication washout and MDIOP measurement were repeated at 12 and 24 months.Main Outcome Measures: The primary and secondary effectiveness end points were the proportion of subjects demonstrating a 20% or greater reduction in unmedicated MDIOP and change in mean MDIOP from baseline at 24 months, respectively. Hypotensive medication use was tracked throughout the course of follow-up. Safety measures included the frequency of surgical complications and adverse events.Results: A total of 369 eyes were randomized after phacoemulsification to Hydrus Microstent (HMS) and 187 to no microstent (NMS). At 24 months, unmedicated MDIOP was reduced by >= 20% in 77.3% of HMS group eyes and in 57.8% of NMS group eyes (difference = 19.5%, 95% confidence interval [ CI] 11.2% -27.8%, P < 0.001). The mean reduction in 24-month unmedicated MDIOP was -7.6 +/- 4.1 mmHg (mean +/- standard deviation) in the HMS group and -5.3 +/- 3.9 mmHg in the NMS group (difference =-2.3 mmHg; 95% CI, -3.0 to -1.6; P < 0.001). The mean number of medications was reduced from 1.7 +/- 0.9 at baseline to 0.3 +/- 0.8 at 24 months in the HMS group and from 1.7 +/- 0.9 to 0.7 +/- 0.9 in the NMS group (difference =-0.4 medications; P < 0.001). There were no serious ocular adverse events related to the microstent, and no significant differences in safety parameters between the 2 groups.Conclusions: This 24-month multicenter randomized controlled trial demonstrated superior reduction in MDIOP and medication use among subjects with mild-to-moderate POAG who received a Schlemm canal microstent combined with phacoemulsification compared with phacoemulsification alone. (C) 2018 by the American Academy of Ophthalmology