Zhang Xiaobo, Yu Yinhui, Zhang Guangbin, Zhou Yanwen, Zhao Guangyu, Chen Maosheng, Wang Yong, Zhu Siquan, Zhang Hong, Yao Ke
Eye Center, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Cataract, Xiamen Eye Center, Xiamen, China.
BMC Ophthalmol. 2019 Mar 14;19(1):77. doi: 10.1186/s12886-019-1079-0.
This study aimed to investigate the completion rate, visual performance, and adverse outcomes of femtosecond laser-assisted cataract surgery (FLACS) in Chinese patients.
This is a prospective, single-arm, multicenter registry study of 19 cataract surgery clinics in China. Chinese patients with cataract who underwent FLACS using the Alcon LenSx® laser system in single eye (n = 1140) or both eyes (n = 201) were enrolled and data were collected between March 2015 and August 2016. Clinical characteristics were recorded before surgery, and on postoperative days 1, 7, and 30. For surgery on both eyes, the second eye was included in the analysis only if it was operated within 30 days after the first eye surgery. The primary outcome was the completion rate of circular anterior capsulotomy. Secondary outcomes for lens fragmentation, corneal incision, and intraocular lens (IOL) implantation included best corrected distance visual acuity (BCDVA) and completion rates. Adverse events (AEs) were recorded.
The completion rates of circular anterior capsulotomy, lens fragmentation, corneal incision, and IOL implantation were 98.6% (95% CI: 97.8-99.1%), 99.5% (95% CI: 99.1-99.8%), 97.6% (95% CI: 96.7-98.3%), and 100% (95% CI: 99.8-100%), respectively. BCDVA preoperatively and at postoperative day 30 were 1.134 ± 0.831 logMAR and 0.158 ± 0.291 logMAR, respectively. The proportion of eyes with BCDVA of 20/20 or better was 1.6% at baseline and 41.3% at postoperative day 30. AE incidence was 0.32%, with posterior capsule rupture present in 0.19% of eyes.
FLACS using the LenSx® laser system can achieve satisfactory results in a real-world setting.
本研究旨在调查中国患者中飞秒激光辅助白内障手术（FLACS）的完成率、视觉效果及不良结局。
这是一项针对中国19家白内障手术诊所的前瞻性、单臂、多中心注册研究。纳入使用爱尔康LenSx®激光系统单眼（n = 1140）或双眼（n = 201）接受FLACS的中国白内障患者，并于2015年3月至2016年8月收集数据。记录术前以及术后第1天、第7天和第30天的临床特征。对于双眼手术，仅当第二眼在第一眼手术后30天内进行手术时才纳入分析。主要结局是环形前囊切开术的完成率。晶状体粉碎、角膜切口和人工晶状体（IOL）植入的次要结局包括最佳矫正远视力（BCDVA）和完成率。记录不良事件（AE）。
环形前囊切开术、晶状体粉碎、角膜切口和IOL植入的完成率分别为98.6%（95%CI：97.8 - 99.1%）、99.5%（95%CI：99.1 - 99.8%）、97.6%（95%CI：96.7 - 98.3%）和100%（95%CI：99.8 - 100%）。术前和术后第30天的BCDVA分别为1.134±0.831 logMAR和0.158±0.291 logMAR。基线时BCDVA为≥20/20的眼比例为1.6%，术后第30天为41.3%。AE发生率为0.32%，0.19%的眼出现后囊破裂。
使用LenSx®激光系统的FLACS在实际临床环境中可取得满意结果。
