Inatani Masaru, Kohama Ichiro, Chu Alice
Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Department of Clinical Affairs, Glaukos Japan, Tokyo, Japan.
Clin Ophthalmol. 2025 Jun 12;19:1863-1876. doi: 10.2147/OPTH.S524956. eCollection 2025.
To evaluate 2-year safety and effectiveness of iStent W implantation with phacoemulsification in adult Japanese open-angle glaucoma (OAG) patients.
Multicenter, prospective, post-market surveillance.
Eyes were evaluated preoperatively and at Day 1, Week 1, and Months (M) 1, 3, 6, 12, and 24. Primary outcome was M24 cumulative probability of success defined as no additional glaucoma surgery and intraocular pressure (IOP) < preoperative value and number of glaucoma medications ≤ preoperative value or IOP ≤ preoperative value and number of glaucoma medications < preoperative value. Other endpoints included cumulative probability of achieving American Academy of Ophthalmology Glaucoma (AAO) success criteria for minimally invasive glaucoma surgery with phacoemulsification, and changes in mean IOP, number of glaucoma medications, and medication costs over time. Subanalysis was based on OAG subtype [primary open-angle glaucoma (POAG), normal tension glaucoma (NTG), and exfoliative glaucoma (XFG)]. Adverse events were recorded.
Cumulative probability of success at M24 was 91.7%, 98.8%, 88.9%, and 85.0% for cohort (N = 214), NTG, XFG, and POAG, respectively. The AAO M24 success was 80.7%. Statistically significant reductions in mean IOP and number of medications were observed through M24 in cohort and OAG subtypes. At M24, the estimated reductions in mean (standard error) IOP and number of medications were 2.0 (0.5) mmHg and 1.9 (0.4), respectively, in the cohort. Adverse events were minimal. At M24, the average monthly glaucoma medication costs decreased by 49.7%.
Japanese OAG eyes treated with iStent W combined with phacoemulsification experienced reduced IOP and medication burden with minimal adverse events and high success rates over postoperative 2 years.
评估iStent W植入联合超声乳化术在成年日本开角型青光眼（OAG）患者中的2年安全性和有效性。
多中心、前瞻性、上市后监测。
在术前、术后第1天、第1周以及第1、3、6、12和24个月对眼睛进行评估。主要结局是第24个月成功的累积概率，定义为无需额外的青光眼手术且眼压（IOP）<术前值且青光眼药物数量≤术前值，或IOP≤术前值且青光眼药物数量<术前值。其他终点包括达到美国眼科学会青光眼（AAO）超声乳化微创青光眼手术成功标准的累积概率，以及平均IOP、青光眼药物数量和药物成本随时间的变化。亚分析基于OAG亚型[原发性开角型青光眼（POAG）、正常眼压性青光眼（NTG）和剥脱性青光眼（XFG）]。记录不良事件。
队列（N = 214）、NTG、XFG和POAG在第24个月成功的累积概率分别为91.7%、98.8%、88.9%和85.0%。AAO第24个月的成功率为80.7%。在队列和OAG亚型中，直至第24个月均观察到平均IOP和药物数量有统计学意义的降低。在第24个月，队列中平均（标准误）IOP和药物数量的估计降低值分别为2.0（0.5）mmHg和1.9（0.4）。不良事件极少。在第24个月，平均每月青光眼药物成本降低了49.7%。
接受iStent W联合超声乳化术治疗的日本OAG患眼在术后2年眼压降低、药物负担减轻，不良事件极少，成功率高。
