Tuan Kuang-mon Ashley, Liang Junzhong
Visx, Inc., Advanced Medical Optics, Inc., Santa Clara, California 95051, USA.
J Cataract Refract Surg. 2006 Feb;32(2):215-20. doi: 10.1016/j.jcrs.2005.07.045.
To evaluate changes in contrast sensitivity and visual acuity following wavefront-guided laser in situ keratomileusis (LASIK) procedures with the Visx CustomVue system.
Six clinical sites that participated in an Investigational Device Exemption clinical study.
Two hundred seventy-four myopic astigmatic eyes (spherical equivalent range -0.63 to -6.00 diopters) completed 6 months of follow-up examinations. Wavefront-guided procedures using the WaveScan aberrometer and Star S4 excimer laser system with variable spot scanning were performed at 6 clinical locations. Visual acuity and contrast sensitivity under photopic, mesopic, and mesopic-with-glare lighting conditions were tested preoperatively and over a 6-month follow-up period. This study was a retrospective analysis of contrast sensitivity data with controls for the effects of retinal magnification, mesopic pupil size, and the influence of prior soft contact lens wear on visual outcome.
Patients experienced statistically significant improvements in contrast sensitivity at all spatial frequencies and under all lighting conditions (P<.05, Student t test). Contrast sensitivity under mesopic conditions with glare improved in 40% of patients. There was more improvement at higher (12 cycles per degree [cpd], 18 cpd) than lower (3 cpd) spatial frequencies. No correlation was found between mesopic pupil size and contrast sensitivity. Results stratified by spectacle or soft contact lens wear were similar. Soft contact lens wearers had slightly higher disability glare scores than spectacle wearers.
A significant number of patients experienced improved corneal optical quality after wavefront-guided LASIK. The contrast sensitivity in most patients was unchanged. Contrast sensitivity improved in a significant number of patients. There was no correlation between mesopic pupil size and mesopic or mesopic-with-glare contrast performance. Spectacle wearers improved more than soft contact lens wearers.
使用威视CustomVue系统评估波前引导的准分子原位角膜磨镶术（LASIK）术后对比敏感度和视力的变化。
六个参与研究器械豁免临床研究的临床站点。
274只近视散光眼（等效球镜度范围为-0.63至-6.00屈光度）完成了6个月的随访检查。在6个临床地点使用WaveScan像差仪和具有可变光斑扫描功能的Star S4准分子激光系统进行了波前引导手术。在术前以及6个月的随访期内，测试了明视、中间视觉和有眩光的中间视觉照明条件下的视力和对比敏感度。本研究是一项对对比敏感度数据的回顾性分析，控制了视网膜放大率、中间视觉瞳孔大小以及既往软性接触镜佩戴对视觉结果的影响。
患者在所有空间频率和所有照明条件下的对比敏感度均有统计学意义的改善（P<0.05，学生t检验）。40%的患者在有眩光的中间视觉条件下对比敏感度有所提高。在较高空间频率（每度12周/度[cpd]，18 cpd）比在较低空间频率（3 cpd）有更多改善。未发现中间视觉瞳孔大小与对比敏感度之间存在相关性。按佩戴框架眼镜或软性接触镜分层的结果相似。软性接触镜佩戴者的残疾眩光评分略高于框架眼镜佩戴者。
大量患者在波前引导的LASIK术后角膜光学质量得到改善。大多数患者的对比敏感度未发生变化。相当数量的患者对比敏感度有所提高。中间视觉瞳孔大小与中间视觉或有眩光的中间视觉对比性能之间无相关性。框架眼镜佩戴者的改善比软性接触镜佩戴者更多。
