Mou D P, Zhang C, Wang H Z, Wang J, Sang Q, Zhang Y H, Wang Y, Wang N L
Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Institute of Ophthalmology, Beijing Key Laboratory of Ophthalmology & Visual Sciences, Beijing 100730, China.
Department of Ophthalmology, Peking University Third Hospital, Beijing Key Laboratory of Restoration of Damaged Ocular Nerve, Beijing 100191, China.
Zhonghua Yan Ke Za Zhi. 2024 May 11;60(5):408-415. doi: 10.3760/cma.j.cn112142-20231203-00268.
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). 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 -test, Mann-Whitney rank sum test, test, repeated measures two-factor analysis of variance, Bonferroni, Friedman test, Wilcoxon, and Log-rank. The Kaplan-Meier method was used to calculate the cumulative success rate of each group. 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 (>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 <0.05). There was no significant difference in the overall IOP between groups (>0.05). The IOP reduction rates in the KDB and Trabectome groups were 23.4% and 19.0%, with no significant difference (=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 >0.05). There was no statistical significance in the overall number of IOP-lowering medications used between the two groups (>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 >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% (>0.05). Serious intraoperative or postoperative complications occurred in neither group. 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.
比较卡胡克双刀(KDB)前房角切开术和 Trabectome 手术治疗原发性开角型青光眼(POAG)患者的中期治疗效果。本研究为非随机前瞻性干预对照临床研究。纳入 2017 年 5 月至 2022 年 4 月在北京同仁医院接受 KDB 前房角切开术或 Trabectome 手术的 POAG 患者。手术成功的定义为术后平均眼压(IOP)≤21 mmHg(1 mmHg = 0.133 kPa)且眼压降低≥20%。术后第 1 天、第 1 周、第 1、3 和 6 个月进行随访。评估眼压值、降低眼压药物的数量、手术成功率(6 个月时平均眼压≤21 mmHg)和并发症。统计方法包括独立样本 t 检验、曼 - 惠特尼秩和检验、χ²检验、重复测量双因素方差分析、Bonferroni 检验、Friedman 检验、Wilcoxon 检验和 Log - rank 检验。采用 Kaplan - Meier 方法计算每组的累积成功率。纳入男性患者 17 例(17 眼),女性患者 10 例(10 眼)。平均年龄为(39.9±17.7)岁。KDB 组 11 例患者,Trabectome 组 16 例患者。两组临床基线情况无显著差异(P>0.05)。KDB 组和 Trabectome 组术后 1 周[(16.6±6.3)和(16.4±4.1)mmHg]及 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](均 P<0.05)。两组总体眼压无显著差异(P>0.05)。KDB 组和 Trabectome 组的眼压降低率分别为 23.4%和 19.0%,无显著差异(P = 0.674)。KDB 组和 Trabectome 组术后 3 个月[2.0(1.0,4.0)和 2.0(1.0,2.3)]及 6 个月[2.0(0.0,4.0)和 2.0(1.0,3.0)]使用的降低眼压药物数量与术前[4.0(2.0,4.0)和 3.0(2.0,4.0)]相比无显著差异(均 P>0.05)。两组降低眼压药物使用总数无统计学意义(P>0.05)。眼压降低≥20%的患者比例及术后平均眼压≤21 mmHg 的患者比例也无统计学差异(均 P>0.05)。术后 6 个月 KDB 组和 Trabectome 组眼压≤21 mmHg 的比例分别为 81.8%和 68.8%(P>0.05)。两组均未发生严重的术中或术后并发症。KDB 小梁切开术和 Trabectome 手术均可有效降低眼压,在治疗 POAG 方面安全性良好,且降低眼压药物数量相同。