Purpose

To compare early postoperative intraocular pressure (IOP) in patients who underwent cataract surgery alone with those who underwent cataract surgery combined with implantation of a Hydrus Microstent (HMS) (Ivantis, Irvine, CA).

Design

Subanalysis of data from the randomized controlled HORIZON trial, a multicenter trial including 26 US and 12 international sites.

Participants

Participants with mild/moderate primary open-angle glaucoma (POAG) and visually significant cataract with mean modified diurnal IOP between 22 and 34 mmHg after washout of IOP-lowering medications.

Methods

A total of 556 subjects were randomized in a 2:1 ratio to undergo cataract surgery with placement of the HMS versus cataract surgery alone (no microstent [NMS]). All eyes were washed out of IOP-lowering medications before surgery and remained unmedicated until surgery. No IOP-lowering prophylaxis was used postoperatively. Comprehensive eye examination including measurement of intraocular pressure was conducted on postoperative day (POD) 1, week 1, and month 1.

Main Outcome Measures

Postoperative IOP >40 mmHg was analyzed as the primary outcome. Incidence of IOP increase >10 mmHg above baseline, unmedicated IOP, and mean IOP were analyzed as secondary outcomes.

Results

A total of 369 eyes were randomized to the HMS group, and 187 eyes were randomized to cataract surgery alone. The HMS and NMS groups did not differ with respect to baseline demographic or ocular characteristics. On POD1, the incidence of IOP spike >40 mmHg was significantly higher at 14.4% in the NMS group compared with 1.4% in the HMS group (P < 0.001). The incidence of IOP increase ≥10 mmHg relative to baseline on POD1 was also significantly higher in the NMS group than in the HMS group (22.5% vs. 3.0%, P < 0.001). IOP in the NMS group was significantly higher than in the HMS group (27.6 vs. 17.0 mmHg, P < 0.001). In multivariable logistic regression analysis, higher baseline IOP predicted higher odds of POD1 IOP spike >40 mmHg, whereas the presence of HMS was associated with a lower likelihood of postoperative IOP spike.

Conclusions

The addition of an HMS at the time of cataract surgery lowered the risk of markedly elevated IOP in the early postoperative period in patients with glaucoma.

中文翻译：

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白内障手术后Schlemm管微支架对术后早期眼内压的影响：HORIZON随机对照试验的分析。

目的

比较单独接受白内障手术的患者与接受白内障手术并植入Hydrus Microstent（HMS）的患者术后早期眼内压（IOP）（Ivantis，Irvine，CA）。

设计

来自随机对照HORIZON试验的数据的亚分析，HORIZON试验是一个多中心试验，包括26个美国和12个国际站点。

参加者

参与者患有轻度/中度原发性开角型青光眼（POAG）和视觉显着的白内障，冲洗降眼压药物后的平均眼压在22至34 mmHg之间。

方法

总共556名受试者以2：1的比例被随机分配接受HMS放置白内障手术与仅进行白内障手术（无微支架[NMS]）。手术前，所有眼睛均已从降低IOP的药物中冲洗出来，直到手术前仍未进行药物治疗。术后没有降低眼压的预防措施。在术后第1天（POD），第1周和第1个月进行全面的眼部检查，包括眼压测量。

主要观察指标

术后IOP> 40 mmHg被分析为主要结局。IOP的发生率比基线高出10 mmHg以上，未治疗的IOP和平均IOP被分析为次要结果。

结果

总共369眼被随机分为HMS组，而187眼被随机分为仅白内障手术。HMS和NMS组在基线人口统计学或眼部特征方面没有差异。在POD1上，NMS组IOP峰值> 40 mmHg的发生率显着更高，为14.4％，而HMS组为1.4％（P < 0.001）。NMS组的POD1相对于基线的IOP发生率相对于基线升高≥10 mmHg也显着高于HMS组（22.5％对3.0％，P < 0.001）。NMS组的IOP显着高于HMS组（27.6 vs. 17.0 mmHg，P <0.001）。在多变量logistic回归分析中，较高的基线IOP预测POD1 IOP峰值> 40 mmHg的可能性更高，而HMS的存在与术后IOP峰值降低的可能性相关。

结论

白内障手术时添加HMS可降低青光眼患者术后早期IOP明显升高的风险。