Healey Paul R, Clement Colin I, Kerr Nathan M, Tilden Dominic, Aghajanian Lara
Centre for Vision Research Westmead Institute for Medical Research & Save Sight Institute.
Sydney Eye Hospital, University of Sydney.
J Glaucoma. 2021 Jul 1;30(7):606-620. doi: 10.1097/IJG.0000000000001805.
Standalone trabecular micro-bypass glaucoma surgery with the iStent devices is associated with clinically relevant reductions in intraocular pressure (IOP) sustained over a reasonably long-term while simultaneously reducing medication burden and a relatively favorable safety profile.
While there is a relatively large body of evidence supporting the implantation of the iStent trabecular micro-bypass devices during phacoemulsification in patients with open-angle glaucoma (OAG), its efficacy as a standalone procedure has been less widely reported. The aims of this study were to systematically identify and quantitatively evaluate the efficacy of iStent devices (iStent and iStent inject) when performed independently of cataract surgery in patients with OAG.
A systematic review of the literature was undertaken in August 2019 to identify studies of standalone trabecular micro-bypass glaucoma surgery with iStent devices in patients with OAG. All randomized trials were considered and nonrandomized studies that included at least 6 months of follow-up or more than 10 eyes. Key efficacy analyses included postoperative IOP and medication use, which were used to evaluate weighted mean differences from baseline, and the proportion of eyes free of ocular medication. Postoperative adverse events were descriptively summarized.
A total of 13 studies were identified including 4 randomized controlled trials and 9 nonrandomized or single-arm studies providing data for 778 eyes. In eyes implanted with iStent devices, a weighted mean IOP reduction of 31.1% was observed at 6 to 12 months. In studies reporting longer-term outcomes (36 to 48 mo or 60 mo), the weighted mean IOP reduction was 30.4% and 32.9%, respectively. The pooled weighted mean reduction in IOP from baseline across all studies at 6 to 12 months and 36 to 60 months poststent implantation was 7.01 mm Hg (95% confidence interval: 5.91, 8.11) and 6.59 mm Hg (95% confidence interval: 5.55, 7.63), respectively. Medication burden was reduced by ~1.0 medication at 6 to 18 months and 1.2 medications at 36 to 60 months. Adverse events reported in more than 5% of participants were progression of pre-existing cataract/cataract surgery and loss of best-corrected visual acuity but these rates were no different to those reported in comparator medical therapy study arms.
The results from these studies support the independent effect of the iStent trabecular bypass devices on IOP and medication burden over a duration of follow-up of up to 5 years.
使用iStent装置进行单独的小梁微旁路青光眼手术与眼内压（IOP）在相当长的一段时间内持续出现具有临床意义的降低相关，同时减轻了药物负担，并且安全性相对良好。
虽然有大量证据支持在开角型青光眼（OAG）患者的白内障超声乳化手术期间植入iStent小梁微旁路装置，但其作为单独手术的疗效报道较少。本研究的目的是系统地识别和定量评估iStent装置（iStent和iStent inject）在独立于白内障手术的OAG患者中的疗效。
2019年8月对文献进行了系统回顾，以确定在OAG患者中使用iStent装置进行单独的小梁微旁路青光眼手术的研究。纳入所有随机试验以及随访至少6个月或超过10只眼的非随机研究。关键疗效分析包括术后眼压和药物使用情况，用于评估与基线相比的加权平均差异，以及无需使用眼部药物的眼的比例。对术后不良事件进行了描述性总结。
共确定了13项研究，包括4项随机对照试验和9项非随机或单臂研究，为778只眼提供了数据。在植入iStent装置的眼中，在6至12个月时观察到加权平均眼压降低31.1%。在报告长期结果（36至48个月或60个月）的研究中，加权平均眼压降低分别为30.4%和32.9%。在所有研究中，支架植入后6至12个月和36至60个月时，与基线相比，眼压的合并加权平均降低分别为7.01 mmHg（95%置信区间：5.91, 8.11）和6.59 mmHg（95%置信区间：5.55, 7.63）。在6至18个月时药物负担减少约1.0种药物，在36至60个月时减少1.2种药物。超过5%的参与者报告的不良事件为既往白内障进展/白内障手术和最佳矫正视力丧失，但这些发生率与对照药物治疗研究组报告的发生率无差异。
这些研究的结果支持iStent小梁旁路装置在长达5年的随访期间对眼压和药物负担的独立作用。
