飞秒激光辅助与传统超声乳化治疗硬核白内障的随机对照试验
Randomized Controlled Trial Comparing Femtosecond Laser-Assisted with Conventional Phacoemulsification on Dense Cataracts.
作者信息
Chee Soon-Phaik, Yang Younian, Wong Melissa H Y
机构信息
Singapore National Eye Centre, Singapore; Department of Ophthalmology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Cataract Research Team, Singapore Eye Research Institute, Singapore; Department of Ophthalmology & Visual Sciences Academic Clinical Program, Duke-NUS Medical School, Singapore.
Singapore National Eye Centre, Singapore.
出版信息
Am J Ophthalmol. 2021 Sep;229:1-7. doi: 10.1016/j.ajo.2020.12.024. Epub 2021 Mar 1.
PURPOSE
To compare the benefit of femtosecond laser-assisted cataract surgery (FLACS) versus phacoemulsification (PE) and 2 fragmentation patterns in managing dense cataracts.
DESIGN
Randomized controlled trial.
METHODS
Patients with nuclear opacity (NO) grade >5 (Lens Opacities Classification System III) were enrolled at the Singapore National Eye Centre. Patients who were unsuitable for FLACS, whose corneal endothelial cell count (ECC) was <1,500 cells/mm, or had cataracts with additional complexities were excluded from the study. Eyes were randomized to PE, 600 μm grid (FLACSg), or 16-segment fragmentation (FLACS16) in 2:1:1 ratio. The Victus (Bausch & Lomb) laser platform and in situ phacoemulsification chop technique was used. Data for patient demographics, preoperative, and 1 month postoperative best-corrected visual acuity (BCVA), ECC, effective phacoemulsification time (EPT), and perioperative complications were collected. Outcome measurements were the loss of ECC at 1 month and EPT.
RESULTS
Ninety-three patients were randomized to PE (48), FLACSg (22), and FLACS16 (23). Majority were Chinese (87; 93.5%). Mean age was 74.3 ± 8.8 years of age. Cataracts were mostly graded as NO 5-6 (49; 61.3%). EPT among treatment arms was not different (P = .097, one-way ANOVA) but was significantly higher for NO >6 than NO <6 (P < .001, general linear model). ECC loss was significantly less in FLACSg than in PE (P = .018, Bonferroni correction). Mean 1-month postoperative LogMAR BCVA (0.23 ± 0.20) was significantly better than preoperative BCVA (1.02 ± 0.85; P < .001, paired t test) but not different between PE and FLACS.
CONCLUSIONS
FLACSg but not FLACS16 significantly lowered the mean ECC loss during phacoemulsification in dense cataracts.
目的
比较飞秒激光辅助白内障手术（FLACS）与超声乳化白内障吸除术（PE）以及两种碎裂模式在处理硬核白内障中的益处。
设计
随机对照试验。
方法
新加坡国立眼科中心招募了核混浊（NO）分级>5（晶状体混浊分级系统III）的患者。不适合FLACS、角膜内皮细胞计数（ECC）<1500个细胞/mm²或患有复杂性白内障的患者被排除在研究之外。将眼睛以2:1:1的比例随机分为PE组、600μm网格组（FLACSg）或16段碎裂组（FLACS16）。使用Victus（博士伦）激光平台和原位超声乳化劈核技术。收集患者人口统计学数据、术前和术后1个月的最佳矫正视力（BCVA）、ECC、有效超声乳化时间（EPT）以及围手术期并发症的数据。结果测量指标为1个月时的ECC损失和EPT。
结果
93例患者被随机分为PE组（48例）、FLACSg组（22例）和FLACS16组（23例）。大多数为中国人（87例；93.5%）。平均年龄为74.3±8.8岁。白内障大多分级为NO 5 - 6级（49例；61.3%）。各治疗组之间的EPT无差异（P = 0.097，单因素方差分析），但NO>6级的EPT显著高于NO<6级（P < 0.001，一般线性模型）。FLACSg组的ECC损失显著低于PE组（P = 0.018，Bonferroni校正）。术后1个月的平均LogMAR BCVA（0.23±0.20）显著优于术前BCVA（1.02±0.85；P < 0.001，配对t检验），但PE组和FLACS组之间无差异。
结论
FLACSg组而非FLACS16组在硬核白内障超声乳化过程中显著降低了平均ECC损失。
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