飞秒激光辅助白内障手术与超声乳化白内障手术的比较：一项 1 年结局的随机非劣效性试验。
Femtosecond laser-assisted cataract surgery compared with phacoemulsification cataract surgery: randomized noninferiority trial with 1-year outcomes.
机构信息
From the NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust (Day, Wilkins), London, Moorfields Eye Hospital (Day, Wilkins), London, UCL Institute of Ophthalmology (Day), London, School of Medicine, University of St. Andrews (Burr), St. Andrews, UCL Comprehensive Clinical Trials Unit (Bennett, Dore, Hunter), London, Department of Primary Care & Public Health Sciences, King's College London (Bunce), London, Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust (Nanavaty), Brighton, Wolverhampton and Midlands Eye Infirmary, New Cross Hospital, Royal Wolverhampton NHS Trust (Balaggan), Wolverhampton, United Kingdom.
出版信息
J Cataract Refract Surg. 2020 Oct;46(10):1360-1367. doi: 10.1097/j.jcrs.0000000000000257.
PURPOSE
To report the 1-year outcomes of a randomized trial comparing femtosecond laser-assisted cataract surgery (FLACS) and phacoemulsification cataract surgery (PCS).
SETTING
Moorfields Eye Hospital, New Cross Hospital, and Sussex Eye Hospital, United Kingdom.
DESIGN
Multicenter, randomized controlled noninferiority trial.
METHODS
Patients undergoing cataract surgery were randomized to FLACS or PCS. Postoperative assessments were masked. Outcomes included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), complications, corneal endothelial cell count, and patient-reported outcomes measures.
RESULTS
The study enrolled 785 participants. A total of 311 of 392 (79%) participants were allocated to FLACS and 292 of 393 (74%) participants were allocated to PCS attended follow-up at 1 year. Mean UDVA was 0.14 (SD = 0.22) for FLACS and 0.17 (0.25) for PCS with difference of -0.03 logarithm of the minimum angle of resolution (logMAR) (95%, -0.06 to 0.01, P = .17). Mean CDVA was 0.003 (0.18) for FLACS and 0.03 (0.23) for PCS with difference of -0.03 logMAR (95% CI, -0.06 to 0.01, P = .11); 75% of both FLACS (230/307) and PCS (218/290) cases were within ±0.5 diopters (D) refractive target, and 292 (95%) of 307 eyes of FLACS and 279 (96%) of 290 eyes of PCS groups were within ±1.0 D. There were no significant differences between arms for all other outcomes with the exception of binocular CDVA mean difference -0.02 (-0.05 to 0.002) logMAR (P = .036) favoring FLACS. Mean cost difference was £167.62 per patient greater for FLACS (95% iterations between -£14.12 and £341.67).
CONCLUSIONS
PCS is not inferior to FLACS regarding vision, patient-reported health, and safety outcomes after 1-year follow-up. A difference was found for binocular CDVA, which, although statistically significant, was not clinically important. FLACS was not cost-effective.
目的
报告一项比较飞秒激光辅助白内障手术（FLACS）和超声乳化白内障手术（PCS）的随机试验的 1 年结果。
背景
英国摩尔菲尔德眼科医院、新十字医院和苏塞克斯眼科医院。
设计
多中心、随机对照非劣效性试验。
方法
接受白内障手术的患者被随机分配至 FLACS 或 PCS 组。术后评估设盲。主要结局包括未矫正远视力（UDVA）、矫正远视力（CDVA）、并发症、角膜内皮细胞计数和患者报告的结局测量。
结果
该研究共纳入 785 例患者。共有 392 例患者中的 311 例（79%）被分配至 FLACS 组，393 例患者中的 292 例（74%）被分配至 PCS 组在 1 年时接受随访。FLACS 的平均 UDVA 为 0.14（标准差=0.22），PCS 为 0.17（0.25），差异为-0.03 最小角分辨对数视力（logMAR）（95%置信区间：-0.06 至 0.01，P=0.17）。FLACS 的平均 CDVA 为 0.003（0.18），PCS 为 0.03（0.23），差异为-0.03 logMAR（95%置信区间：-0.06 至 0.01，P=0.11）；FLACS（230/307）和 PCS（218/290）组的 75%患者均在±0.5 屈光度（D）屈光目标范围内，FLACS 组的 307 只眼中有 292 只（95%）和 PCS 组的 290 只眼中有 279 只（96%）在±1.0 D 范围内。除双眼 CDVA 平均差值（优势比为 0.02；95%置信区间：-0.05 至 0.002；P=0.036）有利于 FLACS 外，两组在其他所有结局上均无显著差异。FLACS 组每位患者的平均成本差异为£167.62（95%迭代值在-£14.12 和 £341.67 之间）。
结论
在 1 年随访时，PCS 在视力、患者报告的健康和安全性结局方面并不劣于 FLACS。虽然双眼 CDVA 存在差异，但尽管统计学上有意义，但无临床意义。FLACS 并不具有成本效益。
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