Background: The aim of the study was to evaluate the long-term safety and efficacy of the Trabectome for Chinese glaucoma patients.
Methods: This was a multicenter, retrospective, observational study. Glaucoma patients, except those with neovascular glaucoma, with/without a visually significant cataract were enrolled. The patients received Trabectome or a combined surgery with phacoemulsification and intraocular lens implantation. The primary outcome evaluation was a reduction in intraocular pressure (IOP), and the secondary outcomes were a reduction in glaucoma medication, the 2-year success percentages, and complications. Success was defined as an IOP <21 mmHg and at least a 20% IOP reduction from baseline after 3 months for any two consecutive visits, without additional glaucoma surgery. The data were processed using the R Stats Package version 3.0.0. The Wilcoxon test was used to compare the postoperative IOP and the number of glaucoma medications with baselines. The Kaplan-Meier test was used to calculate the 2-year success percentage. The risk factors related to Trabectome failure were determined by logistic regression.
Results: A total of 120 glaucoma patients were enrolled. The Trabectome efficiently reduced the IOP from a baseline of 22.8 ± 1.34 mmHg to 17.6 ± 0.96 mmHg, and the use of glaucoma medications from 2.2 ± 0.17 mmHg to 1.4 ± 0.21 in a 2-year follow-up (both, P < 0.01). The overall success percentage was 80%. No risk factor related to Trabectome failure was identified. No vision-threatening complication was observed. Ten patients, who required secondary glaucoma surgery, all reached the target IOP.
Conclusions: In a 2-year follow-up, Trabectome was an efficient and safe procedure for Chinese glaucoma patients.
微创小梁消融术对中国青光眼患者安全性及有效性的多中心、回顾性研究 摘要 目的: 探讨微创小梁消融术对中国青光眼患者的长期安全性及有效性。 方法: 多中心、回顾性队列研究. 采集北京大学第三医院、北京同仁医院等国内六家眼科中心自2013年12月至2017年5月接受微创小梁消融术并随访超过2年的青光眼患者120例。 合并白内障的患者同时接受超声乳化及人工晶状体植入术。 手术效果评价的主要标准是眼压的下降。 次要评价标准包括: 青光眼用药的减少、2年的手术成功率及并发症。 手术成功的判定标准：(1) 术后3个月后的任意连续2次随访的眼压低于21mmHg; (2) 与术前眼压相比, 20%的眼压下降；(3) 无二次青光眼手术。术前与术后眼压和青光眼用药数量的比较采用Wilcoxon检验，术后2年成功率分析采用Kaplan Meier检验。我们还尝试使用回归分析寻找手术失败的危险因素。 结果: 经过2年随访, 接受微创小梁消融术的青光眼患者的眼压从术前的22.8 ± 1.34 mmHg下降到17.6 ± 0.96 mmHg (P < 0.01)。 青光眼用药数量也从术前的2.2 ± 0.17降低到1.4 ± 0.21 (P < 0.01). 小梁消融术的2年总体成功率为80%, 合并白内障手术的小梁消融术患者的手术成功率高于单独接受小梁消融术的患者(100% vs. 77%). 由于样本量有限，导致小梁消融术失败的危险因素未被找到. 在安全性方面, 未发现术中及术后威胁视力的并发症. 10例患者接受了二次青光眼手术, 术后眼压均控制良好. 结论: 微创小梁消融术能够长期、安全、显著地降低青光眼患者的眼压和用药数量, 因此是一种有效的青光眼手术方法.
Keywords: Glaucoma; Intraocular Pressure; Minimally Invasive Surgical Procedures; Trabecular Meshwork.