Purpose

To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS).

Design

Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).

Participants

Seven hundred eighty-five patients with age-related cataract.

Methods

This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616.

Main Outcome Measures

We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was −0.01 logMAR (−0.05 to 0.03), and mean corrected distance visual acuity difference was −0.01 logMAR (95% confidence interval [CI], −0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome.

Conclusions

Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.

中文翻译：

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飞秒激光辅助白内障手术与超声乳化白内障手术（FACT）：一项随机性非劣效性试验。

目的

为了报告一项为期3个月的随机试验（飞秒激光辅助白内障试验[FACT]）的结果，该试验比较了飞秒激光辅助白内障手术（FLACS）与标准超声乳化白内障手术（PCS）。

设计

多中心，随机对照试验由英国国立卫生研究院（HTA 13/04/46 /）资助。

参加者

785例年龄相关性白内障患者。

方法

该试验在英国国家卫生局（NHS）的3家医院中进行。使用安全的基于网络的系统，按部位，外科医生和符合条件的一只眼睛或两只眼睛进行随机分组（1：1）。术后评估掩盖了分配的干预措施。主要结果是研究眼在3个月时的独立视力（UDVA）。次要结局包括矫正远视力，并发症和患者报告的结局指标。非劣效性边缘是最小分辨角（logMAR）的0.1对数。ISRCTN.com注册表，编号ISRCTN77602616。

主要观察指标

我们在2015年5月至2017年9月期间招募了785名参与者，并随机分配了392名参与者到FLACS和393名参与者给PCS。术后3个月，治疗组之间的平均UDVA差异为-0.01 logMAR（-0.05至0.03），平均矫正远视力差异为-0.01 logMAR（95％置信区间[CI]，-0.05至0.02）。FLACS和PCS病例中有71％处于屈光目标的±0.5屈光度（D）以内，FLACS和PCS病例的93％处于屈光目标的±1.0 D以内。PCS臂中有2个后囊撕裂而FLACS臂中没有一个。对于任何次要结果，两组之间无明显差异。

结论

飞秒激光辅助性白内障手术在术后3个月并不逊于常规PCS手术。两种方法在视力，患者报告的健康状况和3个月的安全性方面均良好。等待临床效果和成本效益的长期结果。