Department of Ophthalmology, Peking University Third Hospital, Beijing 100191, China.
Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Beijing 100005, China.
Chin Med J (Engl). 2018 Feb 20;131(4):420-425. doi: 10.4103/0366-6999.225050.
The aim of the study was to evaluate the long-term safety and efficacy of the Trabectome for Chinese glaucoma patients.
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.
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.
In a 2-year follow-up, Trabectome was an efficient and safe procedure for Chinese glaucoma patients.
本研究旨在评估 Trabectome 在中国青光眼患者中的长期安全性和有效性。
这是一项多中心、回顾性、观察性研究。纳入了除新生血管性青光眼以外的青光眼患者,无论是否存在视力显著下降的白内障,均接受 Trabectome 或联合白内障超声乳化吸除术及人工晶状体植入术治疗。主要结局评估指标为眼压降低,次要结局评估指标为降眼压药物减少、2 年成功率和并发症。成功定义为术后 3 个月内任意 2 次连续就诊时眼压<21mmHg,且与基线相比降低≥20%,且无需行额外的青光眼手术。数据使用 R Stats 包版本 3.0.0 进行处理。术后眼压和降眼压药物数量与基线相比的比较采用 Wilcoxon 检验。2 年成功率采用 Kaplan-Meier 检验进行计算。采用逻辑回归分析确定与 Trabectome 失败相关的危险因素。
共纳入 120 例青光眼患者。Trabectome 可有效降低眼压,从基线的 22.8±1.34mmHg 降至 17.6±0.96mmHg,在 2 年随访期间,降眼压药物的使用量从 2.2±0.17mmHg 降至 1.4±0.21mmHg(均 P<0.01)。总体成功率为 80%。未发现与 Trabectome 失败相关的危险因素。未观察到威胁视力的并发症。10 例需要行二次青光眼手术的患者眼压均达到目标值。
在 2 年随访期间,Trabectome 是中国青光眼患者一种有效且安全的治疗方法。