Department of Surgery, Division of Ophthalmology, Kobe University Graduate School of Medicine, Kobe, Japan.
Department of Ophthalmology, Faculty of Medicine, Shimane University, Izumo, Japan.
Ophthalmol Glaucoma. 2022 Jul-Aug;5(4):452-461. doi: 10.1016/j.ogla.2021.11.005. Epub 2021 Nov 25.
To elucidate the noninferiority of ab interno microhook trabeculotomy (μTLO) using a recently developed reusable stainless spatula-type microhook device to incise the trabecular meshwork to Trabectome (Neomeix, Inc) surgery in terms of the 1-year postoperative outcomes of Japanese patients with glaucoma by means of propensity score analyses.
Multicenter, retrospective cohort study.
We enrolled 553 and 392 patients who underwent Trabectome surgery and μTLO, respectively, between January 2014 and March 2020 at 10 facilities.
Logistic regression analysis was conducted to calculate the propensity score, which indicates the likelihood of treatment assignment (Trabectome or μTLO). We set the following factors as outcome-related covariates: age, sex, facility, glaucoma disease types, preoperative intraocular pressure (IOP), glaucoma drug score, mean deviation of Humphrey visual field test results, antithrombotic drug use, the presence or absence of combined cataract surgery, and incision range of the trabecular meshwork (1 or 2 quadrants). We analyzed 4 different methods (matching, inverse probability of treatment weighting [IPTW], stratification, and regression adjustment) using the propensity score. We set 15% as the noninferiority margin based on previous Trabectome meta-analysis results.
The primary outcome was surgical success at 1 year after surgery. We defined surgical success as satisfying all 3 criteria: (1) IOP within 5 to 21 mmHg, (2) IOP reduction of 20% or more from preoperative IOP, and (3) no additional glaucoma surgery.
The 95% confidence interval of risk difference of surgical failure in μTLO in reference to Trabectome surgery was -12.1% to +9.5% in matching, -12.7% to +11.1% in IPTW, -12.2 to +7.0 in stratification, and -9.7% to +8.1% in regression adjustment, all of which fell within the predetermined noninferiority margin of 15%.
Surgical success of μTLO at 1 year after was not inferior to that of Trabectome surgery.
通过倾向评分分析，阐明使用最近开发的可重复使用的不锈钢匙形微钩装置对内直肌微钩小梁切开术（μTLO）治疗日本青光眼患者的非劣效性，该装置用于切开小梁网至 Trabectome（Neomeix，Inc）手术，评估术后 1 年的结果。
多中心回顾性队列研究。
我们纳入了 2014 年 1 月至 2020 年 3 月在 10 家机构接受 Trabectome 手术和 μTLO 的 553 例和 392 例患者。
采用逻辑回归分析计算倾向评分，该评分表示治疗分配（Trabectome 或 μTLO）的可能性。我们将以下因素作为与结果相关的协变量：年龄、性别、机构、青光眼疾病类型、术前眼内压（IOP）、青光眼药物评分、Humphrey 视野测试结果的平均偏差、抗血栓药物使用、是否合并白内障手术以及小梁网切开范围（1 象限或 2 象限）。我们使用倾向评分分析了 4 种不同的方法（匹配、逆概率治疗加权[IPTW]、分层和回归调整）。我们根据之前 Trabectome 荟萃分析的结果将 15%作为非劣效性边界。
主要结局为术后 1 年的手术成功率。我们将手术成功定义为满足所有 3 个标准：（1）IOP 为 5 至 21mmHg，（2）IOP 较术前降低 20%或更多，（3）无需进行额外的青光眼手术。
在匹配中，μTLO 手术失败的风险差异 95%置信区间为 Trabectome 手术的-12.1%至+9.5%；在 IPTW 中为-12.7%至+11.1%；在分层中为-12.2%至+7.0%；在回归调整中为-9.7%至+8.1%，所有这些都在预定的 15%非劣效性边界内。
μTLO 术后 1 年的手术成功率不劣于 Trabectome 手术。
