Oka Yoshitaka, Sasaki Noriyuki, Injev Valentine P
Senshinkai Eye Institute, Iizuka-shi, Japan.
Alcon Japan Ltd., Tokyo, Japan.
Clin Ophthalmol. 2021 Oct 20;15:4227-4237. doi: 10.2147/OPTH.S329935. eCollection 2021.
To compare the effects of femtosecond laser assisted cataract surgery (FLACS) and manual phacoemulsification on cumulative dissipated energy (CDE), torsional amplitude, and endothelial cell density (ECD).
This prospective, randomized study was conducted at Oka Eye Clinic (Fukuoka, Japan). Surgeries were performed using FLACS (with LenSx) or conventional technique in adults ≥20 years with grade 2-4 cataracts. Visits included preoperative, surgery day, and 5 postoperative visits (days 1, 4-10, 20-40, 60-120, and 150-210). Primary endpoint was CDE. Secondary endpoints included ECD percent change at day 150-210 versus preoperative visit and average torsional amplitude on surgery day. Exploratory endpoints included central corneal thickness and corrected distance visual acuity (CDVA). Superiority of FLACS to conventional technique was evaluated using t-tests based on a mixed model for repeated measures.
Full analysis set included 53 eyes per group. Mean cataract grade was 2.92±0.58 in FLACS and 2.94±0.57 in conventional group. FLACS versus conventional method had significantly lower mean CDE (0.213±0.334 versus 1.718±0.898%-seconds, respectively; <0.0001), demonstrating superiority of FLACS. Low endothelial cell loss (ECL) was achieved with both FLACS and conventional methods (1.5±5.6% and 2.7±5.2%; =0.260). Torsional amplitude was significantly lower for FLACS versus conventional method (19.6±16.0% versus 31.1±6.6%; <0.0001). Central corneal thickness was comparable for both methods at all visits except day 1; CDVA was comparable for both methods at all postoperative visits.
FLACS achieved significantly lower CDE compared with the conventional surgical method (<0.0001). Low ECL was achieved with both FLACS (1.5%) and conventional (2.7%) methods.
比较飞秒激光辅助白内障手术（FLACS）与手法超声乳化术对累积能量消散（CDE）、扭转幅度和内皮细胞密度（ECD）的影响。
本前瞻性随机研究在冈眼科诊所（日本福冈）进行。对年龄≥20岁、白内障分级为2 - 4级的成年人采用FLACS（使用LenSx）或传统技术进行手术。随访包括术前、手术日以及术后5次随访（第1天、第4 - 10天、第20 - 40天、第60 - 120天和第150 - 210天）。主要终点是CDE。次要终点包括第150 - 210天与术前随访相比ECD的百分比变化以及手术日的平均扭转幅度。探索性终点包括中央角膜厚度和矫正远视力（CDVA）。基于重复测量的混合模型，使用t检验评估FLACS相对于传统技术的优越性。
每组的完整分析集包括53只眼。FLACS组白内障平均分级为2.92±0.58，传统组为2.94±0.57。与传统方法相比，FLACS的平均CDE显著更低（分别为0.213±0.334与1.718±0.898%-秒；<0.0001），表明FLACS具有优越性。FLACS和传统方法均实现了低内皮细胞损失（ECL）（分别为1.5±5.6%和2.7±5.2%；P = 0.260）。与传统方法相比，FLACS的扭转幅度显著更低（19.6±16.0%与31.1±6.6%；<0.0001）。除第1天外，两种方法在所有随访时的中央角膜厚度相当；两种方法在所有术后随访时的CDVA相当。
与传统手术方法相比，FLACS的CDE显著更低（<0.0001）。FLACS（1.5%）和传统方法（2.7%）均实现了低ECL。
