三维光学相干断层成像飞秒激光辅助白内障手术在真实世界证据研究中的应用

3D OCT Femtosecond Laser-Assisted Cataract Surgery in a Real-World Evidence Study

目的:本研究是一项真实世界证据(real-world evidence,RWE)研究,旨在评价在博鳌超级医院实施的3D OCT飞秒激光辅助白内障手术的性能。方法:共纳入139眼(113例患者),其中32眼(28例患者)在手术医师培训和认证期间接受了治疗(手术医师认证人群),107眼(92例受试者)在手术医师得到认证后接受了治疗(分析人群)。使用CATALYS眼科飞秒激光治疗机对单眼或双眼实施了角膜切口、晶状体前囊膜切开术和晶状体粉碎术。结果:99.3%的患者成功完成了囊膜切开术,97.8%的患者成功完成了晶状体粉碎术,90.7%的患者成功完成了角膜切口。术后4周,82.5%术眼的裸眼远视力(uncorrected distance visual acuity,UCDVA)达到20/40或更佳,而术前该比例为17.3%;97.1%术眼的最佳矫正远视力(best corrected distance visual acuity,BCDVA)达到20/40或更佳,而术前该比例为46.8%。在经治疗的139眼中,总计发生了10例手术并发症。结论:本项真实世界证据研究表明,当按照角膜切口、晶状体前囊膜切开术和晶状体粉碎术的适应症使用CATALYS眼科飞秒激光治疗机时,其能够安全且有效地应用于成人患者。

Objective:A real-world evidence(RWE)study is conducted to evaluate the performance of a 3D OCT femtosecond laser-assisted cataract surgery at the Boao Super Hospital of Lecheng International Medical Tourism Pilot Zone of Hainan province in China.Methods:A total of 139 eyes(113 subjects)were treated,of which 32 eyes(28 subjects)were treated during the surgeons’training and certification period(surgeon certification population)and 107 eyes(92 subjects)were treated after surgeon certification(analysis population).Subjects were selected from normal cataract surgical populations and received treatment with the CATALYS System for corneal incisions,anterior capsulotomies and phacofragmentation in one or both eyes.Results:99.3%had successful capsulotomy,97.8%had successful phacofragmentation and 90.7%had successful corneal incisions.UCDVA of 20/40 or better was achieved by 82.5%of eyes at 4 weeks post-surgery compared to 17.3%of eyes pre-surgery.BCDVA of 20/40 or better was achieved in 97.1%of eyes at 4 weeks compared to 46.8%pre-surgery.A total of 10 operative complications occurred in the 139 eyes treated.Conclusions:This real-world evidence study results demonstrate that the CATALYS Precision Laser System is safe and effective when used according to the indications for use for the creation of corneal incisions,anterior capsulotomies and phacofragmentation in adult subjects.