美国食品药品监督管理局（FDA）报告的三种最新准分子激光原位角膜磨镶术（LASIK）平台视觉效果的比较与分析：波前像差引导的威视iDesign、角膜地形图引导的鹰视酷眼Allegro Contoura以及角膜地形图引导的尼德克EC-5000 CATz
Comparison and analysis of FDA reported visual outcomes of the three latest platforms for LASIK: wavefront guided Visx iDesign, topography guided WaveLight Allegro Contoura, and topography guided Nidek EC-5000 CATz.
作者信息
Moshirfar Majid, Shah Tirth J, Skanchy David Franklin, Linn Steven H, Kang Paul, Durrie Daniel S
机构信息
HDR Research Center, Hoopes Vision, Salt Lake City, UT; Department of Ophthalmology and Visual Sciences, John A Moran Eye Center, University of Utah School of Medicine, Salt Lake City, UT.
University of Arizona College of Medicine Phoenix, Phoenix, AZ.
出版信息
Clin Ophthalmol. 2017 Jan 4;11:135-147. doi: 10.2147/OPTH.S115270. eCollection 2017.
PURPOSE
To compare and analyze the differences in visual outcomes between Visx iDesign Advanced WaveScan Studio™ System, Alcon Wavelight Allegro Topolyzer and Nidek EC-5000 using Final Fit™ Custom Ablation Treatment Software from the submitted summary of safety and effectiveness of the US Food and Drug Administration (FDA) data.
METHODS
In this retrospective comparative study, 334 eyes from Visx iDesign, 212 eyes from Alcon Contour, and 135 eyes from Nidek CATz platforms were analyzed for primary and secondary visual outcomes. These outcomes were compared via side-by-side graphical and tabular representation of the FDA data. Statistical significance was calculated when appropriate to assess differences. A -value <0.05 was considered statistically significant.
RESULTS
The mean postoperative uncorrected distance visual acuity (UDVA) at 12 months was 20/19.25±8.76, 20/16.59±5.94, and 20/19.17±4.46 for Visx iDesign, Alcon Contoura, and Nidek CATz, respectively. In at least 90% of treated eyes at 3 months and 12 months, all three lasers showed either no change or a gain of corrected distance visual acuity (CDVA). Mesopic contrast sensitivity at 6 months showed a clinically significant increase of 41.3%, 25.1%, and 10.6% for eyes using Visx iDesign, Alcon Contoura, and Nidek CATz, respectively. Photopic contrast sensitivity at 6 months showed a clinically significant increase of 19.2%, 31.9%, and 10.6% for eyes using Visx iDesign, Alcon Contoura, and Nidek CATz, respectively.
CONCLUSION
FDA data for the three platforms shows all three were excellent with respect to efficacy, safety, accuracy, and stability. However, there are some differences between the platforms with certain outcome measurements. Overall, patients using all three lasers showed significant improvements in primary and secondary visual outcomes after LASIK surgery.
目的
根据美国食品药品监督管理局（FDA）提交的安全性和有效性数据摘要，使用Final Fit™定制消融治疗软件，比较并分析威视iDesign Advanced WaveScan Studio™系统、爱尔康威视波前像差仪和尼德克EC - 5000在视觉效果上的差异。
方法
在这项回顾性比较研究中，对来自威视iDesign的334只眼、爱尔康角膜地形图仪的212只眼和尼德克CATz平台的135只眼进行了主要和次要视觉效果分析。通过FDA数据的并排图形和表格展示来比较这些效果。在适当的时候计算统计学显著性以评估差异。P值<0.05被认为具有统计学显著性。
结果
威视iDesign、爱尔康角膜地形图仪和尼德克CATz在术后12个月时的平均未矫正远视力（UDVA）分别为20/19.25±8.76、20/16.59±5.94和20/19.17±4.46。在3个月和12个月时，至少90%接受治疗的眼睛中，所有三种激光显示矫正远视力（CDVA）要么没有变化，要么有所提高。使用威视iDesign、爱尔康角膜地形图仪和尼德克CATz的眼睛在6个月时的中间视觉对比敏感度分别有41.3%、25.1%和10.6%的临床显著提高。使用威视iDesign、爱尔康角膜地形图仪和尼德克CATz的眼睛在6个月时的明视觉对比敏感度分别有19.2%、31.9%和10.6%的临床显著提高。
结论
三个平台的FDA数据显示，在疗效、安全性、准确性和稳定性方面，三者均表现出色。然而，在某些结果测量方面，各平台之间存在一些差异。总体而言，使用这三种激光的患者在LASIK手术后的主要和次要视觉效果均有显著改善。
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