University of Toronto, Toronto, Canada.
Dipartimento di Scienze Chirurgiche, Universita' di Torino, Torino, Italy.
Ophthalmology. 2020 Jan;127(1):52-61. doi: 10.1016/j.ophtha.2019.04.034. Epub 2019 Apr 26.
To compare the efficacy of different microinvasive glaucoma surgery (MIGS) devices for reducing intraocular pressure (IOP) and medications in open-angle glaucoma (OAG).
Prospective, multicenter, randomized clinical trial.
One hundred fifty-two eyes from 152 patients aged 45 to 84 years with OAG, Shaffer angle grade III-IV, best-corrected visual acuity (BCVA) 20/30 or better, and IOP 23 to 39 mmHg after washout of all hypotensive medications. Eyes with secondary glaucoma other than pseudoexfoliative or pigmentary glaucoma, angle closure, previous incisional glaucoma surgery, or any significant ocular pathology other than glaucoma were excluded.
Study eyes were randomized 1:1 to standalone MIGS consisting of either 1 Hydrus Microstent (Ivantis, Inc, Irvine, CA) or 2 iStent Trabecular Micro Bypass devices (Glaukos Inc, San Clemente, CA). Follow-up was performed 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively.
Within-group and between-group differences in IOP and medications at 12 months and complete surgical success defined as freedom from repeat glaucoma surgery, IOP 18 mmHg or less, and no glaucoma medications. Safety measures included the frequency of surgical complications, changes in visual acuity, slit-lamp findings, and adverse events.
Study groups were well matched for baseline demographics, glaucoma status, medication use, and baseline IOP. Twelve-month follow-up was completed in 148 of 152 randomized subjects (97.3%). At 12 months, the Hydrus had a greater rate of complete surgical success (P < 0.001) and reduced medication use (difference = -0.6 medications, P = 0.004). More Hydrus subjects were medication free at 12 months (difference = 22.6% P = 0.0057). Secondary glaucoma surgery was performed in 2 eyes in the 2-iStent group (3.9%) and in none of the Hydrus eyes. Two eyes in the Hydrus group and 1 in the 2-iStent group had BCVA loss of ≥2 lines.
Standalone MIGS in OAG with the Hydrus resulted in a higher surgical success rate and fewer medications compared with the 2-iStent procedure. The 2 MIGS devices have similar safety profiles.
比较不同微创青光眼手术（MIGS）装置降低开角型青光眼（OAG）眼内压（IOP）和药物的疗效。
前瞻性、多中心、随机临床试验。
152 名年龄在 45 至 84 岁的 OAG 患者的 152 只眼，Shaffer 角分级 III-IV，最佳矫正视力（BCVA）20/30 或更好，所有降压药物洗脱后 IOP 为 23 至 39mmHg。排除继发性青光眼（除假性剥脱或色素性青光眼外）、闭角型青光眼、既往切口性青光眼手术或除青光眼以外的任何显著眼部疾病的眼睛。
研究眼随机 1:1 接受单独的 MIGS 治疗，包括 1 个 Hydrus Microstent（Ivantis，Inc.，加利福尼亚州欧文）或 2 个 iStent Trabecular Micro Bypass 装置（Glaukos Inc.，加利福尼亚州圣克莱门特）。术后 1 天、1 周、1、3、6 和 12 个月进行随访。
12 个月内IOP 和药物的组内和组间差异以及定义为无需再次青光眼手术、IOP 18mmHg 或更低且无需使用青光眼药物的完全手术成功率。安全措施包括手术并发症的频率、视力变化、裂隙灯检查和不良事件。
研究组在基线人口统计学、青光眼状况、药物使用和基线 IOP 方面匹配良好。152 名随机受试者中有 148 名（97.3%）完成了 12 个月的随访。在 12 个月时，Hydrus 的完全手术成功率更高（P<0.001），药物使用减少（差异=-0.6 种药物，P=0.004）。12 个月时，更多的 Hydrus 患者无需药物治疗（差异=22.6%，P=0.0057）。2-iStent 组中有 2 只眼（3.9%）和 Hydrus 组中没有眼需要进行继发性青光眼手术。Hydrus 组中有 2 只眼和 2-iStent 组中有 1 只眼的 BCVA 损失≥2 行。
与 2-iStent 手术相比，OAG 中单独的 MIGS 治疗使用 Hydrus 可获得更高的手术成功率和更少的药物。两种 MIGS 装置具有相似的安全性。
