Montés-Micó Robert, Rodríguez-Galietero Antonio, Alió Jorge L
Optics Department, Faculty of Physics, University of Valencia, Valencia, Spain.
Ophthalmology. 2007 Jan;114(1):62-8. doi: 10.1016/j.ophtha.2006.07.019. Epub 2006 Oct 27.
To assess efficacy, safety, predictability, stability, and changes in corneal higher-order aberrations (CHOAs) and contrast sensitivity (CS) after a femtosecond laser for LASIK and standard LASIK for myopia.
Prospective, randomized, comparative clinical study.
Two hundred eyes of 100 consecutive patients who underwent LASIK treatment using the VISX S2 laser system. A femtosecond laser for flap creation was used in 100 eyes (50 patients; spherical equivalent [SE], -2.85+/-1.79 diopters [D]), and a mechanical microkeratome was used in 100 eyes (50 patients; SE, -2.90+/-1.63 D).
Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), manifest refraction, CS by means of the Functional Acuity Contrast Test, and CHOAs by means of custom software linked to topography were evaluated preoperatively and 6 months after treatment.
Efficacy, safety, predictability, stability, CHOAs, and CS were evaluated before and after surgery at 6 months' follow-up.
At 6 months postoperatively, UCVA was 1.0 or better in 100% of the eyes. Efficacy indexes were 1.07 for the femtosecond laser for LASIK patients and 1.00 for LASIK patients. No eye lost > or =1 lines of BCVA; for the femtosecond laser for LASIK group, 24 eyes gained 1 line, and 18 eyes gained > or =2 lines; for the LASIK group, 18 eyes gained 1 line. The femtosecond laser for LASIK group showed a percentage of eyes (98%) within the 0.5-D range in SE higher than that of the LASIK group (92%). For a 3.5-mm pupil, CHOAs' root-mean-square (RMS) increased for both the femtosecond laser for LASIK (2.21-fold) and LASIK (2.81-fold) groups. For a 6-mm pupil, CHOA RMSs were increased significantly after femtosecond laser for LASIK (4.18-fold) and LASIK (5.07-fold) surgeries (P<0.01). Contrast sensitivity improved only in the femtosecond laser for LASIK group at the highest spatial frequency (18 cycles/degree; P<0.01) after surgery.
A femtosecond laser for LASIK surgery is an effective and, in this series, safe procedure for treatment of myopia. The improvements in UCVA and CS after the femtosecond laser for LASIK are related to the differences in postoperative CHOAs found with femtosecond and microkeratome flap creation.
评估飞秒激光制瓣准分子原位角膜磨镶术（LASIK）及标准LASIK治疗近视后的疗效、安全性、可预测性、稳定性，以及角膜高阶像差（CHOAs）和对比敏感度（CS）的变化。
前瞻性、随机、对照临床研究。
连续100例接受VISX S2激光系统进行LASIK治疗的患者的200只眼。其中100只眼（50例患者；等效球镜度[SE]，-2.85±1.79屈光度[D]）使用飞秒激光制作角膜瓣，另100只眼（50例患者；SE，-2.90±1.63 D）使用机械微型角膜刀制作角膜瓣。
术前及治疗后6个月评估裸眼视力（UCVA）、最佳矫正视力（BSCVA）、显验光、通过功能性视力对比测试评估的CS，以及通过与地形图相连的定制软件评估的CHOAs。
在术后6个月随访时评估手术前后的疗效、安全性、可预测性、稳定性、CHOAs和CS。
术后6个月时，100%的患眼UCVA达到1.0或更好。飞秒激光制瓣LASIK患者的疗效指数为1.07，标准LASIK患者为1.00。没有患眼BCVA下降≥1行；飞秒激光制瓣LASIK组中，24只眼提高了1行，18只眼提高了≥2行；标准LASIK组中，18只眼提高了1行。飞秒激光制瓣LASIK组等效球镜度在0.5 D范围内的患眼比例（98%）高于标准LASIK组（92%）。对于3.5 mm瞳孔，飞秒激光制瓣LASIK组和标准LASIK组的角膜高阶像差均方根（RMS）均增加（分别为2.21倍和2.81倍）。对于6 mm瞳孔，飞秒激光制瓣LASIK术后（4.18倍）和标准LASIK术后（5.07倍）角膜高阶像差RMS显著增加（P<0.01）。术后仅飞秒激光制瓣LASIK组在最高空间频率（18周/度；P<0.01）时对比敏感度得到改善。
飞秒激光制瓣LASIK手术治疗近视是一种有效且在本研究系列中安全的手术方法。飞秒激光制瓣LASIK术后UCVA和CS的改善与飞秒激光和微型角膜刀制作角膜瓣术后角膜高阶像差的差异有关。
