Abstract:
Objective: To compare the medium-term therapeutic effects of Kahook Dual Blade (KDB) goniotomy and Trabectome surgery in the treatment of patients with primary open-angle glaucoma (POAG). Methods: This study was a non-randomized prospective interventional controlled clinical study. POAG patients who underwent KDB goniotomy or Trabectome surgery at Beijing Tongren Hospital from May 2017 to April 2022 were enrolled. The definition of successful surgery was postoperative average intraocular pressure (IOP)≤21 mmHg (1 mmHg=0.133 kPa) and IOP decrease≥20%. Follow-up visits were conducted on the 1st day, 1st week, 1st, 3rd and 6th month after surgery. The IOP value, the number of IOP-lowering medications, the proportion of surgical success (average IOP≤21 mmHg at 6 months), and complications were evaluated. Statistical methods included independent sample t-test, Mann-Whitney rank sum test, χ2 test, repeated measures two-factor analysis of variance, Bonferroni, Friedman M test, Wilcoxon, and Log-rank. The Kaplan-Meier method was used to calculate the cumulative success rate of each group. Results: Seventeen male patients (17 eyes) and 10 female patients (10 eyes) were included. The mean age was (39.9±17.7) years old. There were 11 patients in the KDB group and 16 patients in the Trabectome group. There was no significant difference in clinical baseline conditions between the two groups (P>0.05). The IOPs in the KDB and Trabectome groups at postoperative 1 week [(16.6±6.3) and (16.4±4.1) mmHg) and 6 months [(17.8±5.3) and (19.9±4.4) mmHg) were lower than those before surgery [(25.1±9.3) and (27.4±9.1) mmHg) (all P<0.05). There was no significant difference in the overall IOP between groups (P>0.05). The IOP reduction rates in the KDB and Trabectome groups were 23.4% and 19.0%, with no significant difference (P=0.674). The numbers of IOP-lowering medications used in the KDB and Trabectome groups at 3 months [2.0 (1.0, 4.0) and 2.0 (1.0, 2.3)] and 6 months [2.0 (0.0, 4.0) and 2.0 (1.0, 3.0)] after surgery were not significantly different from those before surgery [4.0 (2.0, 4.0) and 3.0 (2.0, 4.0)] (both P>0.05). There was no statistical significance in the overall number of IOP-lowering medications used between the two groups (P>0.05). There was also no statistically significant difference in the proportion of patients with an IOP decrease of≥20% and the proportion of patients whose mean postoperative IOP was≤21 mmHg (all P>0.05). The proportions of IOP≤21 mmHg in the KDB group and the Trabectome group at 6 months after surgery were 81.8% and 68.8% (P>0.05). Serious intraoperative or postoperative complications occurred in neither group. Conclusions: Both KDB trabeculotomy and Trabectome surgery can effectively reduce IOP and have a good safety profile in treating POAG, with the same number of IOP-lowering medications.
目的: 比较Kahook双刃刀(KDB)内路小梁切除术和小梁消融术治疗原发性开角型青光眼(POAG)的中期疗效和安全性。 方法: 前瞻性非随机临床对照研究。收集2017年5月至2022年4月在首都医科大学附属北京同仁医院北京同仁眼科中心拟接受KDB内路小梁切除术(KDB组)或小梁消融术(消融术组)的POAG患者,并分组进行手术。手术成功标准为术后眼压≤21 mmHg(1 mmHg=0.133 kPa)和眼压下降幅度≥20%。分别在术前和术后1 d、1周、1个月、3个月和6个月进行检查,记录眼压、降眼压药物使用数量以及术后的手术成功比例(主要为术后6个月眼压≤21 mmHg的比例)、手术相关并发症情况。采用独立样本t检验、Mann-Whitney秩和检验及χ2检验、重复测量两因素方差分析、Bonferroni检验、Friedman M检验、Wilcoxon符号秩检验、对数秩成对比较等统计学方法。采用Kaplan-Meier方法计算2个组的累积手术成功率。 结果: 纳入POAG患者27例(27只眼),男性17例(17只眼),女性10例(10只眼);年龄为(39.9±17.7)岁。KDB组11例(11只眼)、消融术组16例(16只眼)。2个组临床基线情况比较的差异均无统计学意义(均P>0.05)。KDB组和消融术组术后1周[(16.6±6.3)和(16.4±4.1)mmHg]、6个月[(17.8±5.3)和(19.9±4.4)mmHg]的眼压均低于术前[(25.1±9.3)和(27.4±9.1)mmHg],差异均有统计学意义(均P<0.05)。KDB组和消融术组组间眼压总体比较,差异无统计学意义(P>0.05)。术后6个月眼压下降幅度KDB组为23.4%,消融术组为19.0%,二者差异无统计学意义(P>0.05)。KDB组和消融术组术后3个月[2.0(1.0,4.0)和2.0(1.0,2.3)种]和6个月[2.0(0.0,4.0)和2.0(1.0,3.0)种]的降眼压药物使用数量与术前[4.0(2.0,4.0)和3.0(2.0,4.0)种]比较,差异均无统计学意义(均P>0.05)。2个组降眼压药物使用数量总体比较,差异无统计学意义(P>0.05)。2个组术后眼压下降幅度≥20%的比例总体比较,差异无统计学意义(P>0.05)。2个组术后眼压≤21 mmHg的比例总体比较,差异无统计学意义(P>0.05);术后6个月KDB组和消融术组眼压≤21 mmHg的比例分别为81.8%和68.8%,差异无统计学意义(P>0.05)。2个组均未出现严重手术相关并发症。 结论: KDB内路小梁切除术和小梁消融术治疗POAG均可有效降低眼压且具有较好的安全性,在使用相同数量降眼压药物基础上均可获得更佳的眼压控制效果,在眼压的下降幅度和减少术后降眼压药物使用数量方面无明显不同。.