Department of Ophthalmology, Johannes Gutenberg-University, Mainz, Germany.
Servicio de Oftalmología, Hospital Clinico San Carlos, Madrid, Spain.
Ophthalmology. 2015 Jul;122(7):1283-93. doi: 10.1016/j.ophtha.2015.03.031. Epub 2015 May 9.
To assess the safety and effectiveness of the Hydrus Microstent (Ivantis, Inc, Irvine, CA) with concurrent cataract surgery (CS) for reducing intraocular pressure (IOP) in open-angle glaucoma (OAG).
Prospective, multicenter, randomized, single-masked, controlled clinical trial.
One hundred eyes from 100 patients 21 to 80 years of age with OAG and cataract with IOP of 24 mmHg or less with 4 or fewer hypotensive medications and a washed-out diurnal IOP (DIOP) of 21 to 36 mmHg.
On the day of surgery, patients were randomized 1:1 to undergo CS with the microstent or CS alone. Postoperative follow-up was at 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months. Washout of hypotensive medications was repeated at 12 and 24 months.
Response to treatment was defined as a 20% or more decrease in washed out DIOP at 12 and 24 months of follow-up compared with baseline. Mean DIOP at 12 and 24 months, the proportion of subjects requiring medications at follow-up, and the mean number of medications were analyzed. Safety measures included change in visual acuity, slit-lamp observations, and adverse events.
The proportion of patients with a 20% reduction in washed out DIOP was significantly higher in the Hydrus plus CS group at 24 months compared with the CS group (80% vs. 46%; P = 0.0008). Washed out mean DIOP in the Hydrus plus CS group was significantly lower at 24 months compared with the CS group (16.9±3.3 mmHg vs. 19.2±4.7 mmHg; P = 0.0093), and the proportion of patients using no hypotensive medications was significantly higher at 24 months in the Hydrus plus CS group (73% vs. 38%; P = 0.0008). There were no differences in follow-up visual acuity between groups. The only notable device-related adverse event was focal peripheral anterior synechiae (1-2 mm in length). Otherwise, adverse event frequency was similar in the 2 groups.
Intraocular pressure was clinically and statistically significantly lower at 2 years in the Hydrus plus CS group compared with the CS alone group, with no differences in safety.
评估 Hydrus Microstent（Ivantis，Inc，加利福尼亚州欧文）联合白内障手术（CS）降低开角型青光眼（OAG）眼内压（IOP）的安全性和有效性。
前瞻性、多中心、随机、单盲、对照临床试验。
100 例年龄在 21 至 80 岁之间的 OAG 合并白内障患者，IOP 为 24mmHg 或更低，使用 4 种或更少的降压药物，日间眼压（DIOP）冲洗为 21 至 36mmHg。
手术当天，患者随机 1:1 分为接受 Microstent 联合 CS 或单纯 CS。术后随访 1 天、1 周、1、3、6、12、18 和 24 个月。12 个月和 24 个月时重复降压药物冲洗。
治疗反应定义为与基线相比，12 个月和 24 个月随访时冲洗后 DIOP 降低 20%或更多。分析 12 个月和 24 个月时的平均 DIOP、随访时需要药物的患者比例以及平均用药数量。安全性措施包括视力变化、裂隙灯观察和不良事件。
与单纯 CS 组相比，Hydrus 联合 CS 组在 24 个月时冲洗后 DIOP 降低 20%的患者比例显著更高（80% vs. 46%；P = 0.0008）。24 个月时，Hydrus 联合 CS 组的冲洗平均 DIOP 明显低于单纯 CS 组（16.9±3.3mmHg vs. 19.2±4.7mmHg；P = 0.0093），24 个月时，Hydrus 联合 CS 组无需使用降压药物的患者比例显著更高（73% vs. 38%；P = 0.0008）。两组间随访视力无差异。唯一明显的器械相关不良事件是局限性周边前粘连（长 1-2mm）。否则，两组的不良事件发生率相似。
与单纯 CS 组相比，Hydrus 联合 CS 组在 2 年时眼内压在临床和统计学上均显著降低，且安全性无差异。
