机构地区:[1]中南大学爱尔眼科学院,长沙410000 [2]武汉爱尔眼科医院汉口医院,430000
出 处:《中华实验眼科杂志》2021年第5期430-438,共9页Chinese Journal Of Experimental Ophthalmology
基 金:湖南省科技创新项目(2018SK50108);武汉市卫生健康科研基金项目(WX19C12);爱尔眼科集团科研基金项目(AF2018008)。
摘 要:目的评估飞秒激光小切口角膜基质透镜取出术(SMILE)联合角膜胶原交联术(CXL)治疗近视术后早期的生物力学变化以及安全性和有效性,并与单纯SMILE进行比较。方法采用非随机对照临床研究方法,纳入2017年12月至2018年7月于武汉爱尔眼科医院汉口医院拟接受角膜屈光手术的近视和散光患者25例44眼,依据术眼术前Pentacam HR中Belin图角膜后表面高度差异图情况分为SMILE组和SMILE-CXL组。SMILE组为Belin图角膜后表面高度差异图正常者,接受单纯SMILE手术,共13例22眼;Belin图角膜后表面高度差异图为黄或红色且Corvis生物力学指数、角膜地形图联合生物力学指数<0.3者(除外圆锥角膜)接受SMILE联合CXL手术,为SMILE-CXL组,共12例22眼。2个组患者基线特征比较差异均无统计学意义(均P>0.05)。采用综合验光仪测定术前和术后6个月2个组术眼屈光度变化,包括球镜度、柱镜度及等效球镜度(SE);采用Corvis ST测定2个组术眼术前及术后6个月角膜生物力学参数变化;比较2个组术眼术后安全指数和有效指数,其中安全性指数为术后平均BCVA值/术前平均BCVA值,有效性指数为术后平均UCVA值/术前平均BCVA值。结果术后6个月,2个组的裸眼视力较术前均明显提高且≥1.0,2个组术眼安全性指数和有效性指数、SE的变化差异均无统计学意义(均P≥0.05)。2个组术眼术后6个月第2次压平时间、最大压陷时间顶点和2 mm位置之间的形变幅度比值均较术前增加,差异均有统计学意义(均P<0.05),SMILE-CXL组术后6个月与术前的变化幅度值小于SMILE组,差异均有统计学意义(P=0.001、0.001、0.036);术后6个月,2个组术眼最大压陷深度、第1次压平速度、最大压陷时两峰间距、综合半径较术前均明显增加,最大压陷时角膜反向曲率半径、第1次压平长度、第2次压平长度、水平方向Ambr sio相关厚度、角膜硬度参数、生物力学校正眼压均明显低于�Objective To evaluate early corneal biomechanical change,safety and effectiveness after small-incision lenticule extraction combined with ultraviolet A corneal collagen cross-linking(SMILE-CXL)for myopic eyes and compare with SMILE.Methods A non-randomized controlled clinical study was performed.Forty-four myopic eyes of 25 patients were included in Hankou Aier Eye Hospital from December 2017 to July 2018.SMILE-CXL or SMILE was carried out for 22 eyes of 12 patients or 22 eyes of 13 patients,respectively,based on the normal posterior surface manifestation of Belin by Pentacam tomography or not.The posterior surface manifestation of Belin was normal in the SMILE group,and the posterior surface of Belin was yellow or red with Corvis biomechanical index and tomographic biomechanical index<0.3(except keratoconus)in the SMILE-CXL group.The refractive diopter of the eyes was detected before and 6 months after surgery,including spherical diopter,cylindrical diopter and spherical equivalent(SE)with a comprehensive refractometer.The corneal biomechanical parameters of the eyes were detected before and 6 months after surgery with a Scheimpflug-based dynamic tonometry(Corvis ST).The safety index,a ratio of postoperative mean best corrected visual acuity(BCVA)to preoperative mean BCVA,and efficacy index,a ratio of postoperative uncorrected visual acuity(UCVA)to preoperative BCVA,were compared between SMILE-CXL group and SMILE group.BCVA and UCVA were examined using standard chart and converted to logarithm of the minimal angle of resolution(LogMAR)units.This protocol complied with the Declaration of Helsinki and was approved by an Ethics Committee of Hankou Aier Eye Hospital(No.WHS2017052701).Written informed consent was obtained from each patient prior to entering into the cohort.Results The postoperative UCVA of the eyes in both groups was more than 1.0.There were no significant differences in safety index,efficacy index and SE change between the SMILE-CXL group and SMILE group(all at P≥0.05).At 6 months after surgery,th
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