【摘要】 目的 探讨SMILE矫正近视的安全性、有效性、可预测性及稳定性等。方法 前瞻性研究。符合屈光手术常规适应证的94例（170眼）近视患者入选，行常规SMILE手术。患者年龄为18~44岁，平均（26.8±4.7）岁，术前等效球镜度（SE）-3.25~-9.13 D，平均（-6.20±1.37）D，散光0.00~-3.25 D，中位数-0.75（0.75）D，角膜厚度484~600 μm，平均（554.7±27.5）μm。常规检查包括UCVA、BCVA、屈光度、眼压及角膜地形图、像差、裂隙灯显微镜检查等。术后随访6~24个月。采用配对t检验、线性回归分析进行统计分析。结果 所有病例手术顺利。术后2年UCVA≥1.0、≥0.8的眼数分别为97%、100%。100%的术眼BCVA达到或高于术前BCVA，35%BCVA提高1行，10%BCVA提高2行。术后SE为（-0.01±0.45）D，87%术眼SE在±0.50 D以内，100%术眼SE在±1.00 D以内。术后总高阶像差、球差、彗差均方根值与术前比较均增加（t=-6.861、-2.078、-5.672，P<0.05），分别增加（0.15±0.12）μm、（0.04±0.11）μm、（0.14±0.14）μm。结论 SMILE矫正近视临床效果肯定，具有较好的有效性、安全性、可预测性及稳定性；术后高阶像差、球差、彗差均增加，球差增加较少。
【关键词】 飞秒激光； 飞秒激光小切口基质透镜取出术； 近视； 治疗结果
DOI：10.3760/cma.j.issn.1674-845X.2014.07.005
基金项目：国家自然科学基金（11074052）；上海市科委创新计划基础研究重点项目（11JC1402000）
作者单位：200031 上海，
通信作者：周行涛，Email：doctzhouxingtao@163.com
Clinical evaluation of SMILE for correction of myopia He Li， Miao Huamao， Zhao Yu， Zhang Xiaoyu， Tian Mi， Wang Xiaoying， Zhou Xingtao. Department of Ophthalmology， Eye and ENT Hospital， Fudan University， Key Laboratory of Health Ministry for Myopia， Shanghai 200031， China
Corresponding author：Zhou Xingtao，Email：doctzhouxingtao@163.com
【Abstract】 Objective To investigate the clinical efficacy， safety， predictability and stability of femtosecond laser small incision lenticule extraction （SMILE） for the treatment of myopia. Methods In this prospective observational study， 94 patients （170 eyes） with myopia underwent SMILE surgeries. The average age of the patients was 26.8±4.7 years （range 18 to 44 years）. The mean preoperative spherical equivalent （SE） was -6.20±1.37 diopters （D）， from -3.25 to -9.13 D. The median myopic astigmatism was -0.75（0.75） D， up to -3.25 D. The mean corneal thickness was 554.7±27.5 μm （range 484 to 600 μm）. Routine ophthalmic examinations were performed. The patients were followed from 6 months to 2 years with uncorrected visual acuity （UCVA）， best corrected visual acuity （BCVA）， manifest refraction， intraocular pressure， corneal topography， and slit lamp examinations. The results were analyzed with a paired t test and linear regression analysis. Results All procedures were completed successfully. At the long-term follow-up examination， 97% of eyes had a UCVA of 1.0 or better and 100% of eyes had a UCVA of 0.8 or better. BCVA was equal to or better than the preoperative BCVA in 100% of eyes. 35% gained one line and 10% gained two lines of BCVA. The mean postoperative SE was -0.01±0.45 D and 87% and 100% were within ±0.50 and ±1.00 D of the attempted correction. The root mean square （RMS） values of total higher order aberrations （HOA）， spherical aberrations and coma increased by a significant amount after surgery： 0.15±0.12 μm， 0.04±0.11 μm， 0.14±0.14 μm （t=-6.861， -2.078， -5.672， P<0.05）. Conclusion The SMILE procedure is safe， effective， predictable and the results were stable for treating myopia. HOA， spherical and coma aberrations increased postoperatively but the change in spherical aberrations was small.
【Key words】 Femtosecond laser； Small incision lenticule extraction； Myopia； Therapy outcome
![]()
![]()