Minnesota Eye Consultants, Minneapolis, Minnesota.
Dean McGee Eye Institute, Oklahoma City, Oklahoma.
Ophthalmology. 2019 Jun;126(6):811-821. doi: 10.1016/j.ophtha.2019.03.006. Epub 2019 Mar 14.
Evaluate the safety and effectiveness of an ab interno implanted (iStent inject) Trabecular Micro-Bypass System (Glaukos Corporation, San Clemente, CA) in combination with cataract surgery in subjects with mild to moderate primary open-angle glaucoma (POAG).
Prospective, randomized, single-masked, concurrently controlled, multicenter clinical trial.
Eyes with mild to moderate POAG and preoperative intraocular pressure (IOP) ≤24 mmHg on 1 to 3 medications, unmedicated diurnal IOP (DIOP) 21 to 36 mmHg, and cataract requiring surgery.
After uncomplicated cataract surgery, eyes were randomized 3:1 intraoperatively to ab interno implantation of iStent inject (Model G2-M-IS; treatment group, n = 387) or no stent implantation (control group, n = 118). Subjects were followed through 2 years postoperatively. Annual washout of ocular hypotensive medication was performed.
Effectiveness end points were ≥20% reduction from baseline in month 24 unmedicated DIOP and change in unmedicated month 24 DIOP from baseline. Safety measures included best spectacle-corrected visual acuity (BSCVA), slit-lamp and fundus examinations, gonioscopy, pachymetry, specular microscopy, visual fields, complications, and adverse events.
The groups were well balanced preoperatively, including medicated IOP (17.5 mmHg in both groups) and unmedicated DIOP (24.8±3.3 mmHg vs. 24.5±3.1 mmHg in the treatment and control groups, respectively, P = 0.33). At 24 months, 75.8% of treatment eyes versus 61.9% of control eyes experienced ≥20% reduction from baseline in unmedicated DIOP (P = 0.005), and mean reduction in unmedicated DIOP from baseline was greater in treatment eyes (7.0±4.0 mmHg) than in control eyes (5.4±3.7 mmHg; P < 0.001). Of the responders, 84% of treatment eyes and 67% of control eyes were not receiving ocular hypotensive medication at 23 months. Furthermore, 63.2% of treatment eyes versus 50.0% of control eyes had month 24 medication-free DIOP ≤18 mmHg (difference 13.2%; 95% confidence interval, 2.9-23.4). The overall safety profile of the treatment group was favorable and similar to that in the control group throughout the 2-year follow-up.
Clinically and statistically greater reductions in IOP without medication were achieved after iStent inject implantation with cataract surgery versus cataract surgery alone, with excellent safety through 2 years.
评估一种经内植入（iStent inject）小梁微旁路系统（Glaukos 公司，加利福尼亚州圣克莱门特）在伴有轻度至中度原发性开角型青光眼（POAG）的患者中行白内障手术后的安全性和有效性。
前瞻性、随机、单盲、同期对照、多中心临床试验。
患有轻度至中度 POAG 和术前眼压（IOP）≤24mmHg 的患者，使用 1 至 3 种药物治疗，未用药日间 IOP（DIOP）为 21 至 36mmHg，需要手术治疗白内障。
在白内障手术后，无并发症，术中随机将 3：1 分配至经内植入 iStent inject（Model G2-M-IS；治疗组，n=387）或不植入支架（对照组，n=118）。术后随访 2 年。每年行药物洗脱治疗。
有效性终点是 24 个月时未经药物治疗的 DIOP 较基线下降≥20%和未经药物治疗的 24 个月时 DIOP 较基线的变化。安全性测量指标包括最佳矫正视力（BSCVA）、裂隙灯和眼底检查、房角镜检查、角膜厚度测量、共焦显微镜、视野、并发症和不良事件。
两组患者术前情况均衡，包括药物治疗的 IOP（两组均为 17.5mmHg）和未经药物治疗的 DIOP（治疗组为 24.8±3.3mmHg，对照组为 24.5±3.1mmHg，P=0.33）。24 个月时，治疗组 75.8%的眼较对照组 61.9%的眼未经药物治疗的 DIOP 下降≥20%（P=0.005），治疗组未经药物治疗的 DIOP 较基线的平均下降幅度（7.0±4.0mmHg）大于对照组（5.4±3.7mmHg；P<0.001）。在应答者中，23 个月时，治疗组 84%的眼和对照组 67%的眼未使用降眼压药物。此外，治疗组 63.2%的眼与对照组 50.0%的眼在 24 个月时药物治疗的 DIOP 无≤18mmHg（差异 13.2%；95%置信区间，2.9-23.4）。治疗组的整体安全性状况良好，在 2 年随访期间与对照组相似。
与单纯白内障手术相比，iStent inject 植入联合白内障手术后可实现 IOP 更显著且无需药物治疗的降低，安全性良好，可持续 2 年。
