LenSx飞秒激光辅助白内障手术安全性和有效性的临床研究

Clinical studies of the safety and effect of LenSx femtosecond laser-assisted cataract surgery

目的:对LenSx飞秒激光辅助的白内障手术的安全性和有效性进行临床评价及观察。方法:收集2014-07/2015-07于中国医科大学附属第四医院行飞秒激光辅助的白内障超声乳化摘除联合人工晶状体植入术的患者67例76眼进行临床研究,应用接触式LenSx飞秒激光白内障手术操作平台完成前囊膜截开、晶状体预劈核、主切口及辅助切口制作及角膜弧形切口制作,对激光截囊完成率、预劈核完成率、人工晶状体植入的完成率、角膜切口完成率、术前及术后1mo最佳矫正远视力(corrected distance visual acuity,CDVA)达到20/20、20/25、20/40的患者比例、不良事件及器械缺陷发生率进行记录,对影响角膜切口完成率的可能因素(眼别、年龄、切口位置、角膜直径、周边角膜厚度、术前角膜散光)进行回归分析。结果:所有患者均顺利完成Len Sx飞秒激光辅助的白内障超声乳化手术过程。其中截囊完成率97%,预劈核完成率100%,人工晶状体植入完成率100%,角膜切口完成率83%。无不良事件(晶状体囊破裂、角膜水肿、黄斑水肿、视网膜脱离)及器械缺陷发生。术后1mo CDVA较术前显著提高,差异存在统计学意义(P<0.05)。Logistic回归分析结果显示,切口位置是角膜切口是否完成的影响因素,而眼别、年龄、角膜直径、周边角膜厚度、术前角膜散光与角膜切口是否完成无相关性。结论:LenSx飞秒激光辅助的白内障手术具有临床安全性和有效性。

AIM： To report the safety and effectiveness of LenSx femtosecond laser-assisted cataract surgery. ● METHODS： Sixty - seven patients （ 76 eyes ） were included in the study. All the cases underwent LenSx femtosecond laser-assisted cataract surgery between Jul. 2014 and Jul. 2015. The completion rate of anterior capsulotomy, lens fragmentation, intraocular lens implantation and corneal incisions, the best corrected distance visual acuity （ CDVA ） before and 1mo after femtosecond laser-assisted cataract surgery, the adverse events and equipment defect rate were recorded. The regression analysis of possible factors affecting the completion rate of corneal incision （ eye, age, location of incision, corneal diameter, peripheral corneal thickness, preoperative corneal astigmatism） was taken. ● RESULTS： All surgeries were uneventful. The completion rate of anterior capsulotomy, lens fragmentation, intraocular lens implantation and corneal incisions was 97%, 100%, 100% and 83%, respectively. No adverse events （ posterior capsule rupture, corneal edema, macular edema and retinal detachment ） and device defect occurred. The CDVA was significantly improved 1mo after surgery. Logistic regression analysis showed that there was a correlation between location of corneal incision and completion rate of corneal incision, and no correlation was found between eye, age, corneal diameter, peripheral corneal thickness, preoperative corneal and completion rate of corneal incision. ●CONCLUSION： The LenSx femtosecond laser-assisted methodis efficient and safe for cataract surgery.