Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Ophthalmology. 2017 Nov;124(11):1579-1588. doi: 10.1016/j.ophtha.2017.05.004. Epub 2017 Jun 7.
To compare the efficacy, safety, and risk factors for failure of standalone ab interno gelatin microstent implantation with mitomycin C (MMC) versus trabeculectomy with MMC.
International, multicenter, retrospective interventional cohort study.
Three hundred fifty-four eyes of 293 patients (185 microstent and 169 trabeculectomy) with no prior incisional surgery.
Consecutive eyes with uncontrolled glaucoma underwent microstent or trabeculectomy surgery from January 1, 2011 through July 31, 2015 at 4 academic ophthalmology centers: Toronto, Canada; Frankfurt, Germany; Salzburg, Austria; and Leuven, Belgium.
Primary outcome measure was hazard ratio (HR) of failure, with failure defined as 2 consecutive intraocular pressure (IOP) readings of <6 mmHg with vision loss or >17 mmHg without glaucoma medications (complete success) at least 1 month after surgery despite in-clinic interventions (including needling). Secondary outcome measures included IOP thresholds of 6 to 14 mmHg and 6 to 21 mmHg and same thresholds allowing for medications (qualified success), interventions, complications, and reoperations.
Baseline characteristics were similar, except more men (56% vs. 43%), younger patients (average, by 3 years), better preoperative visual acuity (22% vs. 32% with 0.4 logarithm of the minimum angle of resolution vision or worse), and more trabeculoplasty (52% vs. 30%) among microstent eyes. The adjusted HR of failure of the microstent relative to trabeculectomy was 1.2 (95% confidence interval [CI], 0.7-2.0) for complete success and 1.3 (95% CI, 0.6-2.8) for qualified success, and similar for other outcomes. Time to 25% failure was 11.2 months (95% CI, 6.9-16.1 months) and 10.6 months (95% CI, 6.8-16.2 months) for complete success and 30.3 months (95% CI, 19.0-∞ months) and 33.3 months (95% CI, 25.7-46.2 months) for qualified success. Overall, white ethnicity was associated with decreased risk of failure (adjusted HR, 0.49; 95% CI, 0.25-0.96), and diabetes was associated with increased risk of failure (adjusted HR, 4.21; 95% CI, 2.10-8.45). There were 117 and 165 distinct interventions: 43% and 31% underwent needling, respectively, and 50% of trabeculectomy eyes underwent laser suture lysis. There were 22 and 30 distinct complications, although most were transient. Ten percent and 5% underwent reoperation (P = 0.11).
There was no detectable difference in risk of failure and safety profiles between standalone ab interno microstent with MMC and trabeculectomy with MMC.
比较单独使用 ab 内微支架植入联合丝裂霉素 C（MMC）与小梁切除术联合 MMC 治疗开角型青光眼的疗效、安全性和失败风险因素。
国际多中心回顾性队列研究。
354 只眼 293 例患者（185 例微支架，169 例小梁切除术），均无既往手术史。
2011 年 1 月 1 日至 2015 年 7 月 31 日，在多伦多、加拿大；法兰克福、德国；萨尔茨堡、奥地利；和鲁汶、比利时的 4 个学术眼科中心，对青光眼控制不佳的连续眼行微支架或小梁切除术。
主要观察指标为失败的风险比（HR），失败定义为术后至少 1 个月内连续 2 次眼压（IOP）<6mmHg，视力下降或>17mmHg，无青光眼药物（完全成功），尽管在门诊干预（包括针刺）后。次要观察指标包括 6 至 14mmHg 和 6 至 21mmHg 的 IOP 阈值，以及允许药物（合格成功）的相同阈值，干预、并发症和再手术。
基线特征相似，微支架眼的男性（56% vs. 43%）更多，患者年龄更小（平均 3 岁），术前视力更好（22% vs. 32%，视力矫正最小角分辨率为 0.4 对数或更差），以及更多的小梁成形术（52% vs. 30%）。微支架与小梁切除术相比，完全成功的失败 HR 为 1.2（95%置信区间[CI]，0.7-2.0），合格成功的失败 HR 为 1.3（95% CI，0.6-2.8），其他结果相似。25%失败的时间为 11.2 个月（95% CI，6.9-16.1 个月）和 10.6 个月（95% CI，6.8-16.2 个月）为完全成功，30.3 个月（95% CI，19.0-∞个月）和 33.3 个月（95% CI，25.7-46.2 个月）为合格成功。总的来说，白种人种族与降低失败风险相关（调整后的 HR，0.49；95%置信区间，0.25-0.96），糖尿病与失败风险增加相关（调整后的 HR，4.21；95%置信区间，2.10-8.45）。分别有 117 次和 165 次不同的干预措施：分别有 43%和 31%接受了针刺，50%的小梁切除术眼接受了激光缝线松解。有 22 次和 30 次不同的并发症，尽管大多数是短暂的。10%和 5%的患者接受了再手术（P=0.11）。
单独使用 ab 内微支架植入联合 MMC 与小梁切除术联合 MMC 治疗开角型青光眼的失败风险和安全性无明显差异。
