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.

中文翻译：

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用于降低原发性开角型青光眼和白内障的眼内压的Schlemm管微支架：HORIZON研究。

目的比较24个月后白内障手术与Schlemm管微支架植入与白内障手术在降低眼内压（IOP）和药物使用方面的差异。设计前瞻性，多中心，单项，随机对照试验。研究对象患有伴发性原发性开角型青光眼（POAG），明显的白内障和冲洗后的昼夜IOP（MDIOP）在22至34 mmHg之间的受试者。方法受试者被随机以2：1的比例接受一次简单的超声乳化术，在Schlemm根管内接受单个Hydrus Microstent（Ivantis，Inc，Irvine，CA），或不使用支架。术后1天，1周和1、3、6、12、18和24个月进行了全面的眼科检查。在12和24个月时重复进行药物冲洗和MDIOP测量。主要观察指标主要和次要疗效终点分别是受试者的比例，分别表明24个月未用药的MDIOP降低20％或更多，平均MDIOP相对于基线水平有所变化。在整个随访过程中跟踪了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发生的频率。结果超声乳化后，共有369只眼被随机分为Hydrus Microstent（HMS）和187只至无Microstent（NMS）。在24个月时，HMS组眼的77.3％和NMS组眼的57.8％的未用药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的平均减少量为-7.6±4.1 mmHg（平均值±标准偏差），为-5.3±3。NMS组为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的1.7±0.9降至24个月的0.3±0.8，NMS组的平均药物数量从1.7±0.9降至0.7±0.9（差异= -0.4药物； P <0.001）。两组之间没有发生与微支架相关的严重眼部不良事件，安全性参数也无显着差异。结论这项为期24个月的多中心随机对照试验表明，与单独使用超声乳化术相比，接受Schlemm管微支架联合超声乳化术的轻度至中度POAG受试者的MDIOP和药物使用均明显降低。HMS组在24个月时为8，NMS组从1.7±0.9到0.7±0.9（差异= -0.4药物； P <0.001）。两组之间没有发生与微支架相关的严重眼部不良事件，安全性参数也无显着差异。结论这项为期24个月的多中心随机对照试验表明，与单独使用超声乳化术相比，接受Schlemm管微支架联合超声乳化术的轻度至中度POAG受试者的MDIOP和药物使用均明显降低。HMS组在24个月时为8，NMS组从1.7±0.9到0.7±0.9（差异= -0.4药物； P <0.001）。两组之间没有发生与微支架相关的严重眼部不良事件，安全性参数也无显着差异。结论这项为期24个月的多中心随机对照试验表明，与单独使用超声乳化术相比，接受Schlemm管微支架联合超声乳化术的轻度至中度POAG受试者的MDIOP和药物使用均明显降低。