Wang Yan, Bao Xi-liu, Tang Xin, Zuo Tong, Geng Wei-li, Jin Ying
Tianjin Eye Hospital, Tianjin Key Lab of Ophthalmology and Visual Science, Tianjin Eye Institute, Clinical College of Ophthalmology, Tianjin Medical University, Tianjin 300020, China.
Zhonghua Yan Ke Za Zhi. 2013 Apr;49(4):292-8.
To evaluate the safety, efficacy, predictability, stability and complications of femtosecond laser corneal small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism.
In this prospective study, 50 patients (88 eyes) with myopia and myopic astigmatism were chosen to be performed SMILE procedure randomly. These patients were followed up at 1 day, 1 week, 1 month and 3 months postoperatively and were examined for uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), manifest refraction, intraocular pressure (IOP) and corneal topography. The results were analyzed with paired-t test, independent-samples t test and regression analysis.
SMILE procedure was performed well in all patients, only 3 cases (3 eyes, 3.4%) suffered from the suction loss, 14 cases (26 eyes, 29.5%) developed opaque bubble layer. All patients gained perfect UCVA (20/20), no eye had decrease of BCVA. The residual spherical equivalent was (-0.11 ± 0.29) D, the astigmatism was (0.01 ± 0.33) D 3 months postoperatively. The incidence of diffuse lamellar keratitis and haze was low, and no other complications were observed. The IOP was decreased slightly after 1 month(t = 6.238, P < 0.05), but no changes after 3 months (t = 0.053, P < 0.05).
The SMILE procedure is good at the safety, efficacy, predictability and stability for the correction of myopia and myopic astigmatism.
评估飞秒激光角膜微小切口基质透镜切除术（SMILE）矫正近视及近视散光的安全性、有效性、可预测性、稳定性及并发症。
在这项前瞻性研究中，随机选择50例近视及近视散光患者（88只眼）行SMILE手术。术后1天、1周、1个月及3个月对这些患者进行随访，检查裸眼视力（UCVA）、最佳矫正视力（BCVA）、显验光、眼压（IOP）及角膜地形图。结果采用配对t检验、独立样本t检验及回归分析。
所有患者SMILE手术均顺利完成，仅3例（3只眼，3.4%）出现吸环失败，14例（26只眼，29.5%）出现透明气泡层。所有患者均获得了理想的UCVA（20/20），无眼BCVA下降。术后3个月残余球镜等效度为（-0.11±0.29）D，散光为（0.01±0.33）D。弥漫性板层角膜炎及 haze的发生率较低，未观察到其他并发症。术后1个月眼压略有下降（t=6.238，P<0.05），但3个月后无变化（t=0.053，P<0.05）。
SMILE手术在矫正近视及近视散光方面具有良好的安全性、有效性、可预测性及稳定性。
