方法：随机选取行角膜屈光手术的中高度近视散光(近视度数-3.00～-10.00D，散光度≤-6.00D)患者86例172眼，分为两组进行研究，86眼使用FLEx术(A组)，86眼使用标准准分子激光原位角膜磨镶术(laser in situ keratomileusis，LASIK)(B组)，随访6mo，记录术后裸眼视力、最佳矫正视力、客观验光值、裂隙灯检查、术后有无并发症、角膜瓣厚度、眼压、角膜地形图。

结果：术后6mo，两组最佳矫正视力提高一行以上的所占比例差异有统计学意义(P<0.05)，A组高于B组； 两组残余屈光度数在±0.50D内所占比例(A组83.7%，B组53.4%)有统计学差异(P <0. 05)； 裸眼视力在1.0及1.0以上的A组占100%，B组占90.7%，差异有统计学意义(P<0.05)。

结论：FLEx术比传统的LASIK手术具有更好的安全性、可预测性和有效性。

METHODS:In the prospective study, 86 cases(172 eyes)with moderate and high myopia astigmatism were enrolled recruited. The myopia degree was -3.00～ -10.00D, the astigmatism degree ≤-6.00D. Eighty-six eyes were treated with FLEx in group A, and 86 eyes were treated with LASIK in group B. All patients in the treatment group completed the final 6mo of follow-up. The uncorrected visual acuity(UCVA)and the best spectacle-corrected visual acuity(BSCVA), objective and manifest refractions, results of slit-lamp examination, the side effects, the corneal flap thickness, intraocular pressure, corneal topography were noted.

RESULTS:Six months postoperatively, the difference between group A and B in BSCVA increases more than one line had statistical significance(χ²=20.67, P<0.05). The difference between group A and B in diopters within ±0.50D(83.7% in group A, 53.4% in group B)had statistical significance(P<0.05). 100% UCVA was equal or greater than 1.0 in group A, 90.7% in group B, there were significant diffirences between two groups(χ²=16.62, P<0.05).

CONCLUSION: FLEx has more perfect accuracy, safety, predictability compared to standard LASIK.