SMILE与FS-LASIK治疗高度近视散光患者5年疗效对比

目的 比较飞秒激光小切口角膜基质透镜取出术(SMILE)与飞秒激光辅助准分子激光原位角膜磨镶术(FS-LASIK)治疗高度近视散光患者5年的临床疗效。方法 前瞻性非随机对照研究。根据所接受的手术方式不同患者被分为SMILE组和FS-LASIK组,术后随访5年,对比分析两组患者裸眼远视力(UDVA)、最佳矫正远视力(BCDVA)、等效球镜度(SE)、散光、总高阶像差(HOAs)、球差、彗差、泪液分泌功能、泪膜破裂时间(TBUT)和眼表疾病指数量表(OSDI)评分。采用重复测量资料的方差分析进行统计学分析,采用LSD-t检验进行两两比较,采用独立样本t检验进行组间分析。结果 2组患者相比,术后UDVA、SE、HOAs、球差、彗差、泪液分泌试验、TBUT、OSDI评分差异均有统计学意义(均为P<0.05),但BCDVA、散光的差异均无统计学意义(均为P>0.05)。SMILE组患者术后1个月的SE低于FS-LASIK组,而术后1～5年的SE均高于FS-LASIK组(均为P<0.05)。SMILE组患者术后3～6个月、3～5年的HOAs均较FS-LASIK组更低(均为P<...     

2.0mm小切口飞秒激光角膜基质透镜取出术与飞秒激光辅助的LASIK矫正近视的疗效比较

目的　比较２．０ｍｍ微切口飞秒激光角膜基质透镜取出术（２．０ｍｍｓｍａｌｌｉｎｃｉｓｉｏｎｌｅｎｔｉｃｕｌｅｅｘｔｒａｃｔｉｏｎ,２．０ｍｍＳＭＩＬＥ）与飞秒激光辅助的ＬＡＳＩＫ（ｌａｓｅｒｉｎｓｉｔｕｋｅｒａｔｏｍｉｌｅｕｓｉｓｗｉｔｈｆｅｍｔｏｓｅｃｏｎｄｌａｓｅｒ,ＦＳ-ＬＡＳＩＫ）矫正近视的疗效。方法　研究纳入行２．０ｍｍＳＭＩＬＥ的近视患者４８例（９６眼）,同期行ＦＳ-ＬＡＳＫ者５０例（１００眼）,记录并比较两组术前及术后１ｄ、１周、１个月、３个月及６个月的裸眼视力（ｕｎｃｏｒｒｅｃｔｅｄｖｉｓｕａｌａｃｕｉｔｙ,ＵＣＶＡ）、最佳矫正视力（ｂｅｓｔｃｏｒｒｅｃｔｅｄｖｉｓｕａｌａｃｕｉｔｙ,ＢＣＶＡ）、屈光度、生活质量量表（ｑｕａｌｉｔｙｏｆｌｉｆｅ,ＱＯＬ）得分及手术满意度量表评分。结果　在术后１周以后ＳＭＩＬＥ组视力高于ＦＳ-ＬＡＳＩＫ组,且状态较ＦＳ-ＬＡＳＩＫ组更为稳定。术后１个月、３个月、６个月ＳＭＩＬＥ组ＵＣＶＡ≥术前ＢＣＶＡ的比例高于ＦＳ-ＬＡＳＩＫ组,差异均有统计学意义（均为Ｐ＜０．０５）。术后早期（术后１周）ＳＭＩＬＥ组存在１例过矫,而ＦＳ-ＬＡＳＩＫ组存在１例欠矫,但在术后１个月、３个月、６个月两组手术患者均在±１．００Ｄ范围内。术后平均角膜前表面形态变异指数及垂直不对称指数在各时间点均为ＦＳ-ＬＡＳＩＫ组大于ＳＭＩＬＥ组,差异均有统计学意义（均为Ｐ＜０．０５）。两组术前及术后６个月ＱＯＬ得分组间比较,差异均无统计学意义（均为Ｐ＞０．０５）,术后６个月ＱＯＬ得分均较术前有所增加,且差异均有统计学意义（ＳＭＩＬＥ:ｔ＝－１３．８５,Ｐ＝０．００;ＦＳ-ＬＡＳＩＫ:ｔ＝－１３．２１,Ｐ＝０．００）,而两组术后６个月ＱＯＬ得分比较,差异无统计学意义（Ｐ＞０．０５）。两组均有较高的再次手术选择率及手术推荐率,并且未发生严重的并发症。结论　２．０ｍｍＳＭＩＬＥ与ＦＳ-ＬＡＳＩＫ均具有良好的有效性、稳定性以及可预测性,术后都可获得良好的视力及良好的生活质量,前者更好地保持了角膜前表面的形态。     

Dry eye and corneal sensitivity after small incision lenticule extraction and femtosecond laser-assisted in situ keratomileusis: a Meta-analysis

AIM: To assess the corneal sensitivity and the incidences of dry eye after small incision lenticule extraction (SMILE) and femtosecond laser-assisted in situ keratomileusis (FS-LASIK). METHODS: The Meta-analysis was performed using RevMan 5.3. We searched on PubMed from inception to March 2016. Summary weighted mean difference (WMD) and 95% confidence intervals (CIs) were used to analyze the datum. Random-effects or fixed-effects models were chosen up to between-study heterogeneity. The main outcomes were composed of the Ocular Surface Disease Index (OSDI) scores, tear film break-up time (TBUT), Schirmer Test and corneal sensitivity. RESULTS: Eight eligible studies including 772 eyes (386 in SMILE group and 386 in FS-LASIK group) were identified. The parameters have no significiant difference heterogeneity between SMILE and FS-LASIK group preoperatively. There were significant differences between the two groups in OSDI scores at one and three months postoperatively, in TBUT at one and three months postoperatively, in corneal sensitivity at one week, about one month and three months postoperatively. However, there was no significant difference observed in Schirmer Test at the follow-up periods. CONCLUSION: Compare to FS-LASIK, dry eye and the corneal sensitivity recover better in the SMILE group, in first three months after the surgery.     

SMILE与FS-LASIK术后视觉质量比较

目的：比较飞秒激光小切口角膜基质透镜取出术（SMILE）与飞秒激光制瓣准分子激光原位角膜磨镶术（FS-LASIK）矫正近视及散光术后的视觉质量。方法：前瞻性非随机对照研究。选取2015 年11 月至2016 年2 月在长沙爱尔眼科医院屈光中心接受飞秒激光屈光手术的近视散光患者162 例（324 眼）,按患者选择的手术方式不同分为SMILE组78例（156眼）和FS-LASIK组84例（168眼）。术后随访6个月,分别比较2组患者术后1 d、1个月、6个月的裸眼视力（UCVA）、等效球镜度（SE）以及术后3个月的角膜像差及切削中心偏移量。在术后1、6 个月时对2 组患者进行视觉质量问卷调查,调查问卷为简化后的视觉质量量表。采用重复测量方差分析、单因素方差分析、卡方检验、秩和检验对数据进行统计分析。结果：SMILE组术后1 d的UCVA低于FS-LASIK组（t=4.555,P < 0.001）,术后1、6 个月2组间UCVA差异无统计学意义。术后1 d SMILE组SE大于FS-LASIK组（t=-2.952,P=0.003）,术后1、6个月2组间差异无统计学意义。2组术后3个月角膜总高阶像差、球差、彗差、三叶草差均较术前增加（均P < 0.05）,SMILE组术后3个月球差、三叶草差大于FS-LASIK组,差异有统计学意义（t= 5.633,P < 0.001;t=2.586,P=0.010）。SMILE组术后3个月切削中心偏移量为（0.17 ± 0.09）mm,FS-LASIK组为（0.18 ± 0.10）mm,组间差异无统计学意义。与术后1 个月相比,SMILE组术后6 个月光晕发生比例明显减轻（χ2=5.547,P=0.019）,程度明显减轻（Z=-2.283,P=0.022）,而FS-LASIK组各项症状发生比例差异无统计学意义。术后1、6 个月2 组间各项症状发生眼数及得分差异均无统计学意义。结论：与FS-LASIK手术相比,SMILE术后早期视力恢复较慢,球差和三叶草差增加更多,偏中心切削和不良视觉症状的发生无明显差异。     

Dynamic versus static ultra-widefield fluorescein angiography in eyes with diabetic retinopathy: a pilot prospective cross-sectional study

AIM:To analyze differences in ultra-widefield fluorescein angiography(UWFA)findings between dynamic and static images of eyes with diabetic retinopathy(DR).METHODS:This cross-sectional study included 28 eyes of 28 patients with DR undergoing UWFA.A series of UWFA images acquired from each patient were converted into a time-lapse video and used as a dynamic image.A single,clear,arteriovenous phase image was chosen as a static image.Non-perfusion index(NPI)and its correlation with vascular abnormalities in different zones were compared between dynamic and static UWFA imaging.RESULTS:NPI appeared to increase from the center to the far-periphery in both groups.Dynamic NPI was lower in the total retinal area(0.26 vs 0.29,P=0.009)and farperiphery(0.33 vs 0.36,adjusted P=0.042),which was contrary to the static NPI.Far-peripheral NPI was associated with intraretinal microvascular abnormality in the posterior area in both groups.CONCLUSION:Time-lapse dynamic UWFA imaging is a useful modality to differentially diagnose hypofluorescence in the most peripheral region.This modality could provide a reliable method for NPI measurement.     

口服维生素D3治疗飞秒激光辅助LASIK术后干眼

目的：探讨口服维生素D3对飞秒激光辅助准分子激光原位角膜磨镶术（FS-LASIK）后干眼的治疗效 果。方法：前瞻性临床研究。选择2019 年1 ─12 月在柳州市工人医院接受FS-LASIK且术后1 个月有 明显干眼的患者90例（90眼）。所有患者被随机分为2组：研究组45例（45眼）,连续12周服用维生素 D3 2 000 IU/d;对照组45例（45眼）,不口服任何药物。分别在用药前及用药后第1、3、6个月测定患 者的眼表疾病指数（OSDI）、泪液破裂时间（TBUT）、Schirmer Ⅰ试验、泪河高度,血清维生素D3水平 以及对比敏感度情况。采用Kolmogorov-Smirnov、LSD-t检验和独立样本t检验进行统计分析。结果： 服药后1 个月,研究组OSDI评分均值明显低于对照组,差异有统计学意义（t=4.32,P=0.007）。研究 组的TBUT（t=3.02,P=0.027）和Schirmer Ⅰ试验值（t=2.78,P=0.030）均高于对照组。服药后3个月, 研究组OSDI（t=2.50,P=0.010）、TBUT（t=2.32,P=0.031）和Schirmer Ⅰ试验值（t=3.25,P=0.026）均优于对照组,差异均具有统计学意义。服药后6个月,2组患者OSDI（t=2.31,P=0.025）、TBUT（t=2.30, P=0.039）和Schirmer Ⅰ试验值（t=3.03,P=0.028）差异均具有统计学意义,研究组恢复更好。研究组患者血清维生素D3 水平与OSDI评分呈负相关（r=-0.90,P<0.001）,与Schirmer Ⅰ试验值（r=0.88, P<0.001）、TBUT评分（r=0.89,P<0.001）和TMH（r=0.80,P<0.001）呈正相关。服药后6个月时,研究组患者的明视对比敏感度和暗视对比敏感度均优于对照组（3 cpd：t =2.40,P=0.04;6 cpd： t=2.16, P=0.04;12 cpd：t =2.23,P=0.04;18 cpd：t =2.37,P=0.04）。结论：维生素D3不仅改善了术后干眼症状及泪膜稳定性,而且可以改善FS-LASIK术后的视觉质量。     

飞秒激光小切口基质透镜取出术和飞秒制瓣联合准分子激光原位角膜磨镶术术后有效光学区及角膜像差的比较

目的:比较不同预设光学区组的飞秒激光小切口基质透镜取出术(small incision lenticule extraction,SMILE)和飞秒激光制瓣联合准分子激光原位角膜磨镶术(femtosecond laser-assisted in situ keratomileuses,FS-LASIK)术后有效光学区(...     

飞秒激光制瓣的准分子激光原位角膜磨镶术与全飞秒激光小切口角膜基质内透镜取出术对屈光不正患者眼表的影响

目的 比较飞秒激光制瓣的准分子激光原位角膜磨镶术(FS-LASIK)与全飞秒激光小切口角膜基质内透镜取出术(SMILE)对屈光不正患者眼表的影响.方法 选取2018年1月至2019年6月于郑州大学第一附属医院行角膜屈光手术的63例(126眼)屈光不正患者进行观察.根据患者接受的手术方式不同分为两组,FS-LASIK组3...     

飞秒激光制瓣的LASIK与SMILE术后干眼参数的Meta分析

目的系统评价飞秒激光制瓣的LASIK（FS-LASIK）和飞秒激光小切口角膜基质透镜取出术（SMILE）治疗近视术后干眼参数的差异。方法Meta分析。检索PubMed、Web of Science、超星Medalink、中国生物医学文献数据库（CBM disc）、中国期刊全文数据库（CNKI）、万方数据库,对比较FS-LASIK和SMILE术后干眼参数的文献进行Meta分析。分析内容主要包括术前,术后1周、1个月、3个月及6个月的泪液分泌试验（SIT）、泪膜破裂时间（BUT）、眼表疾病指数（OSDI）。采用RevMan 5．0进行统计分析,计量资料的疗效分析以加权均数差（WMD）及95％CI表示。采用Cochrane风险评价工具进行文献质量评价。结果共有5篇文献符合纳入标准,共317例（477眼）,其中235眼行FS-LASIK,242眼行SMILE。Meta分析结果显示：FS-LASIK和SMILE患者术前SIT（WMD=-0.20,95％CI：-1.16～0.76,P>0.05）、BUT（WMD=-0.10,95％CI：-0.88～0.68,P>0.05）差异无统计学意义;术后1周、1个月、3个月及6个月两者SIT差异均无统计学意义;术后1个月及6个月两者BUT差异有统计学意义（WMD=-0.65,95％CI：-1.10～-0.20,P<0.05;WMD=-1.09,95％CI：-1.77～-0.40,P<0.01）,术后6个月两者OSDI差异有统计学意义（WMD=9.18,95％CI：4.65～13.71,P<0.05）。结论与FS-LASIK相比,SMILE术后干眼症状较轻,对眼表的干扰更小。     

FS-LASIK与SMILE术后干眼参数与角膜知觉的比较

比较飞秒激光制瓣准分子激光原位角膜磨镶术（FS-LASIK）与飞秒激光小切口角膜基质透镜取出术（SMILE）术后不同时间点干眼参数与角膜知觉的变化,探讨不同手术方式对泪膜及角膜知觉的影响并分析2项指标之间的相关性。方法：前瞻性非随机对照研究。行FS-LASIK患者24例（48眼）,行SMILE患者21例（41眼）。在术前及术后1、3个月采用Keratograph 5M眼表综合分析仪行泪河高度（TMH）、非入侵性泪膜破裂时间（NIBUT）[包括首次泪膜破裂时间（NIF-BUT）与平均泪膜破裂时间（NIAvg-BUT）]的检查,并进行中央角膜知觉检查。组内手术前后各观察指标的比较采用重复测量方差分析;组间一般资料及各观察指标的比较用独立样本t检验;角膜知觉与干眼参数的相关性采用 Spearman相关分析。结果：2组间术前各干眼参数与中央角膜知觉差异均无统计学意义。FS-LASIK 组与SMILE组TMH在术后1个月和3个月较术前均下降（F=21.213,P<0.001;F=14.648,P<0.001）, SMILE组术后2 个时间点的TMH高于FS-LASIK组（t=-5.549,P<0.001;t=-3.028,P=0.003）。 FS-LASIK组NIF-BUT术后1个月较术前下降（F=4.603,P=0.019）;而SMILE组NIF-BUT在术后2个时间点较术前值虽下降,但差异无统计学意义（F=0.599,P=0.516）;术后1个月SMILE组NIF-BUT优 于FS-LASIK组（t=-3.430,P=0.001）。FS-LASIK组NIAvg-BUT在术后1个月较术前下降（F=3.580, P=0.042）;SMILE组NIAvg-BUT术后2个时间点较术前虽下降,但差异均无统计学意义（F=0.274, P=0.761）;SMILE组NIAvg-BUT 2 个时间点均在术后优于FS-LASIK组（t=-2.395,P=0.019; t=-2.431,P=0.017）。FS-LASIK组中央角膜知觉术后各时间点较术前下降,术后3个月高于术后1个月（F=121.919,P<0.001）;SMILE组中央角膜知觉术后1个月较术前下降（F=54.032,P<0.001）;术后各时间点SMILE组均优于FS-LASIK组（t=-5.367,P<0.001;t=-3.242,P=0.002）。2组术后各时间点中央角膜知觉与干眼参数均呈正相关性（均P<0.05）。结论：FS-LASIK和SMILE组的干眼参数与中央角膜知觉均会出现不同程度的下降,患者行SMILE术后干眼参数与中央角膜知觉优于行FS-LASIK 者,且中央角膜知觉与干眼参数均呈正相关性。     

SMILE和FS-LASIK与LASIK矫正近视术后6mo的有效性和稳定性分析

目的：对比分析飞秒激光小切口角膜基质透镜取出术、飞秒激光制瓣准分子激光原位角膜磨镶术和准分子激光原位角膜磨镶术后6 mo的视力和屈光度,评价三种手术方式的有效性和稳定性。
　　方法：回顾性分析2014-04/06在我院行角膜屈光手术患者110例220眼术后6 mo的随访资料,其中飞秒激光小切口角膜基质透镜取出术( small incision lenticule extraction, SMILE)患者42例84眼,飞秒激光制瓣准分子激光原位角膜磨镶术( femtosecond laser in situ keratomileusis, FS-LASIK)37例74眼,准分子激光原位角膜磨镶术( laser in situ keratomileusis,LASIK)31例62眼。术前三组患者平均等效球镜度分别为-5.91±1.83、-5.89±1.96、-5.88±1.68D,术前三组患者最佳矫正视力( best corrected visual acuity,BCVA)、瞳孔直径差异及中央角膜厚度均无统计学差异(P>0.05)。对比分析三组患者术后1wk,1、3、6mo随访时裸眼视力( uncorrected visual acuity,UCVA)、最佳矫正视力( best corrected visual acuity,BCVA)、屈光度等。结果：(1)术后1wk 和1mo 所有患者均按时随访,术后3 mo时 SMILE 和 FS-LASIK 与 LASIK 组分别有5例10眼、5例10眼、4例8眼失访,术后6 mo随访SMILE和FS-LASIK与LASIK组分别有9例18眼、6例12眼、7例14眼失访。(2)术后1wk, SMILE 和 FS-LASIK 与 LASIK 组UCVA的差异具有统计学意义( t=4.098, P=0.000;t=2.493,P=0.004)。(3) LASIK组术后1wk与术后3、6mo的UCVA差异具有统计学意义( t=3.410, P=0.001;t=3.771,P=0.000),术后1 mo与术后6 mo的UCVA差异具有统计学意义(t=2.283,P=0.026)。(4)术后1wk,1、3、6 mo三组患者屈光度的差异均无统计学意义(χ2=0.119, P=0.942;χ2=1.504,P=0.471;χ2=0.949,P=0.622;χ2=0.277,P=0.871)。(5)术后1wk,SMILE组和FS-LASIK组与LASIK组裸眼视力≥5.0的眼数差异具有统计学意义(χ2=9.249, P=0.002<0.016;χ2=12.906, P=0.000<0.0016),而FS-LASIK组与LASIK组裸眼视力≥5.0的眼数差异无统计学意义(χ2=0.500,P=0.604)。(6)三组患者术后1wk和1、3、6mo的等效球镜度数在±0.50D范围内的眼数差异无统计学意义(χ2=0.809,P=0.697;χ2=1.176,P=0.634;χ2=0.871,P=0.736;χ2=0.683,P=0.770)。结论：在术后6 mo内SMILE和FS-LASIK与LASIK矫正近视均具备有效性和稳定性,但SMILE在术后1 wk的有效性优于FS-LASIK及LASIK,能够在术后更快速地改善裸眼视力。     

Comparative analysis of the clinical outcomes between wavefront-guided and conventional femtosecond LASIK in myopia and myopia astigmatism

AIM: To compare the clinical outcomes of wavefront guided femtosecond LASIK (WFG LASIK) and conventional femtosecond LASIK (NWFG LASIK) in eyes with myopia and myopia astigmatism. METHODS: This was a retrospective, nonrandomized, comparative investigation enrolling 236 eyes of 122 patients (18-50y) with low & moderate and high myopia. The WFG group including 97 eyes (50 patients) undergone WFG LASIK and the NWFG group including 139 eyes (72 patients) undergone conventional LASIK. Mean efficacy index, high order aberrations (HOAs), pupil size and the quality of visual questionnaire were evaluated 6mo postoperatively. RESULTS: There is no difference between WFG group (-0.054±0.049 in logMAR) and NWFG group (-0.040±0.056) in uncorrected distance visual acuity (UDVA) postoperatively. The myopia astigmatism is higher in WFG group than that in NWFG group (P<0.05). However, the mean efficacy index (MEI) in the WFG group (1.09±0.106) is better than that in the NWFG group (1.036±0.124; P<0.001). Increased HOAs were observed in NWFG group (0.30±0.196) than that in WFG group (0.146±0.188; P<0.001). The pupil size is larger in WFG group (5.15±0.76 mm) than that in NWFG group (4.32±0.52 mm). The patients are satisfied with the clinical surgery, yet WFG group showed better visual quality using the questionnaire survey. Meanwhile, high myopia would result in worse MEI, HOAs and visual quality than low & moderate myopia. CONCLUSION: WFG and NWFG FS-LASIK are both effective and safe procedures to correct low & moderate and high myopia, but WFG FS-LASIK gives a better postoperative MEI, aberrometric control and predictable outcome. Meanwhile, WFG FS-LASIK is better than NWFG FS-LASIK in correction of myopia astigmatism. Low & moderate myopia allow better clinical outcomes than high myopia using any surgical method.     

波前像差引导与角膜地形图引导的LASIK术后视觉质量的比较

目的 比较波前像差引导的个性化飞秒激光辅助的准分子激光原位角膜磨镶术(FS-LASIK)与角膜地形图引导的个性化FS-LASIK矫正近视术后的视觉质量.设计回顾性比较性病例系列.研究对象北京同仁医院连续接受FS-LASIK的近视眼患者130例(130眼).方法 波前像差引导的FS-LASIK的近视眼患者68例(68眼)...     

Clinical outcomes of small incision lenticule extraction versus femtosecond laser-assisted LASIK for myopia: a Meta-analysis

AIM: To evaluate the possible differences in visual quality between small incision lenticule extraction (SMILE) and femtosecond laser in situ keratomileusis (FS-LASIK) for myopia. METHODS: A Meta-analysis was performed. Patients were from previously reported comparative studies treated with SMILE versus FS-LASIK. The PubMed, EMBASE, Cochrane, Web of Science and Chinese databases (i.e. WANFANG and CNKI) were searched in Nov. of 2016 using RevMan 5.1 version software. The differences in visual acuity, aberration and biomechanical effects within six months postoperatively were showed. Twenty-seven studies including 4223 eyes were included. RESULTS: No significant differences were observed between SMILE and FS-LASIK in terms of the proportion of eyes that lost one or more lines of corrected distance visual acuity after surgery (P=0.14), the proportion of eyes achieving an uncorrected distance visual acuity of 20/20 or better (P=0.43), the final refractive spherical equivalent (P=0.89), the refractive spherical equivalent within ±1.00 diopter of the target values (P=0.80), vertical coma (P=0.45) and horizontal coma (P=0.06). Compared with the FS-LASIK group, total higher-order aberration (P<0.001) and spherical aberration (P<0.001) were higher and the decrease in corneal hysteresis (P=0.0005) and corneal resistance factor (P=0.02) were lower in the SMILE group. CONCLUSION: SMILE and FS-LASIK are comparable in efficacy, safety and predictability for correcting myopia. However, the aberration in the SMILE group is superior to that in the FS-LASIK group, and the loss of biomechanical effects may occur less frequently after SMILE than after FS-LASIK.     

飞秒激光小切口基质透镜取出术治疗近视及散光

目的:探讨飞秒激光小切口角膜基质透镜取出术治疗近视及散光的有效性、可预测性、稳定性和安全性.方法:前瞻性临床对照研究.近视及近视散光患者547例1 080眼,按患者选择的手术方式分为两组,小切口角膜基质透镜取出术(small incision lenticule extraction,SMILE)组285例560眼,飞秒激光辅助的准分子激光原位角膜磨镶术(femtosecond laser assisted laser in situ keratomileusis,FS-LASIK)组262例520眼.术后随访12mo,分别于术后第1d,1wk,1、6、12mo复查,检查裸眼及矫正视力、屈光度、裂隙灯及角膜地形图,并测量偏中心切削值.结果:术后第1d,1wk,1、6、12mo,SMILE组的裸眼视力(uncorrected visual acuity,UCVA,以LogMAR视力表示)分别为0.029±0.13、0.001±0.11、-0.019±0.11、-0.020±0.08、-0.011±0.10;FS-LASIK组分别为-0.017±0.08、-0.019±0.09、-0.031±0.10、-0.024±0.09、-0.002±0.12;术后1d和1wk,SMILE组视力低于FS-LASIK组,两组比较差异有统计学意义(P<0.05),其它时间点差异无统计学意义(P>0.05).术后1、6、12mo,SMILE组的等效球镜(spherical equivalent,SE)分别为-0.03±0.29、-0.04±0.28、-0.06±0.32D;FS-LASIK组分别为0.02±0.20、-0.01±0.29、-0.08±0.33D,两组比较术后1mo的结果差异有统计学意义(P<0.05),其余时间点两组的差异无统计学意义(P>0.05).术后3mo,SMILE组测量的偏中心切削值为0.21±0.11mm,FS-LASIK组为0.20±0.08mm,两组比较差异无统计学意义(P>0.05).结论:SMILE治疗近视及近视散光有良好的有效性、可预测性、稳定性和安全性,但与FS-LASIK比较,术后早期视力恢复慢.     

FS-LASIK、WF-LASIK与SMILE术后视觉质量比较的研究

目的探讨飞秒激光制瓣的LASIK(FS-LASIK)、波前像差引导的LASIK(WF-LASIK)和飞秒激光小切口角膜基质透镜取出术(SMILE)矫正近视散光后的视觉质量及高阶像差。方法病例对照研究。本研究纳入2014年9月至2016年9月来北京同仁医院屈光中心手术的108例(212只眼)单纯近视或复性近视散光患者进行研究,其中男性34例(66只眼),女性74例(146只眼);年龄27(24,32)岁。按术式将患者分为3个组,其中FS-LASIK组37例(71只眼),WF-LASIK组35例(69只眼),SMILE组36例(72只眼)。术前及术后12个月记录患者的屈光度、角膜参数、高阶像差值以及对比敏感度值,并进行秩和检验比较不同时间的差异。结果术后12个月时,FS-LASIK组、WF-LASIK组和SMILE组分别有69(97.18%)、67(97.10%)和69只眼(95.83%)裸眼视力≥1.0,3个组分别有59(83.10%)、60(86.96%)和61只眼(84.72%)术后裸眼视力好于术前最佳矫正视力。WF-LASIK组角膜表面规则指数(SRI)从0.11(0.07,0.28)降低为0.07(0.06,0.20)(Z=-2.662,P=0.008),低于FS-LASIK组和SMILE组(Z=-3.236,-3.118;P=0.001,0.000),角膜表面不对称指数(SAI)从0.34(0.25,0.43)增加为0.38(0.30,0.52)(Z=-2.140,P=0.032),均低于FS-LASIK组和SMILE组(Z=-2.910,-3.779;P=0.004,0.000)。FS-LASIK组总高阶像差均方根值从0.32(0.27,0.41)增加为0.53(0.40,0.65)(Z=-6.228,P=0.000),高于WF-LASIK组和SMILE组(Z=-3.595,-4.086;P=0.000,0.000),WF-LASIK组彗差从0.16(0.11,0.24)增加为0.26(0.15,0.37)(Z=-3.816,P=0.000),低于FS-LASIK组(Z=-3.528,P=0.000),FS-LASIK组和WF-LASIK组分别球差从0.10(0.05,0.21)和0.08(0.04,0.12)增加到0.24(0.13,0.34)和0.15(0.09,0.26)(Z=-5.141,-4.864;P=0.000,0.000),高于SMILE组(Z=-2.549,-4.682;P=0.011,0.000)。术后12个月时,WF-LASIK组在12.0周/度空间频率下暗环境对比敏感度从1.34(1.18,1.48)增加为1.48(1.34,1.63)(Z=-2.985,P=0.003),高于FS-LASIK组和SMILE组(Z=-3.194,-2.977;P=0.001,0.003),有眩光对比敏感度在12.0周/度空间频率下从1.26(1.18,1.34)增加为1.34(1.34,1.63)(Z=-3.608,P=0.000),高于FS-LASIK组和SMILE组(Z=-4.033,-2.913;P=0.000,0.004)。结论FS-LASIK、WF-LASIK及SMILE术后12个月均可获得理想的视力,其中WF-LASIK术后角膜对称性最好,高阶像差增加最少,视觉质量最好。     

Five-year results of refractive outcomes and vision-related quality of life after SMILE for the correction of high myopia

AIM: To evaluate the long-term visual, refractive outcomes and vision-related quality of life after small incision lenticule extraction (SMILE) for the correction of high myopia. METHODS: Thirty patients (60 eyes) with high myopia who underwent SMILE more than 5y were selected as the SMILE group. Another 30 high myopia patients (60 eyes) who had worn corrective spectacles for more than 5y were selected as the control group. In SMILE group, the postoperative follow-up time were 3, 6mo, 1 and 5y. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), spherical equivalent (SE), and ocular axial length (AL) were analyzed. The Chinese version of the National Eye Institute Visual Function Questionnaire-25 (CHI-NEI-VFQ-25) was used to evaluate the vision-related quality of life in the SMILE group and the control group. RESULTS: In SMILE group, the mean preoperative SE was -7.29±0.87 D (range -6.00 to -9.125 D). At 5-year follow up, the efficacy index and safety index of SMILE were 1.09±0.18 and 1.19±0.12, respectively. Five years postoperatively, 44 eyes (73%) obtained a visual acuity of 20/20 or better. There were no eyes with CDVA loss of one or more Snellen lines. Forty-nine eyes (82%) and 57 eyes (95%) were within ±0.50 and ±1.00 D of attempted correction at 5-year follow-up, respectively. Forty-eight eyes (80%) had astigmatism <0.50 D at 5-year follow-up. The postoperative mean SE values at 3, 6mo, 1, and 5y were 0.11±0.44, 0.07±0.45, -0.02±0.41, and -0.15±0.46 D, respectively. No significant change was observed in the ocular AL from before operation to 5y postoperatively (26.08±0.96 mm vs 26.01±0.94 mm, P=0.068). Compared to the control group, the SMILE group showed a significantly higher total score on the CHI-NEI-VFQ-25 (90.14 vs 81.43, P<0.001). CONCLUSION: In the present study, in a long-term follow-up we demonstrate that correcting high myopia with SMILE is safe, effective, and predictable. Vision-related quality of life after SMILE is better in the SMILE group than in the control group who wore corrective spectacles.     

Associations of lens thickness and axial length with outcomes of laser peripheral iridotomy

AIM: To compare clinical outcomes and refractive stability of implantable collamer lens (ICL) implantation and femtosecond laser assisted laser in situ keratomileusis (FS-LASIK) for high myopia correction. METHODS: The Optical Quality Analysis System (OQAS) was used to evaluate clinical outcomes objectively after operation for high myopia correction. We compared the two procedures in terms of 1-year changes in uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), safety index, efficacy index, spherical equivalent, modulation transfer function (MTF) cutoff frequency, strehl ratio (SR) and objective scatter index (OSI). RESULTS: At 1y postoperatively, the safety indices was 1.33±0.27 in ICL group, and 1.17±0.24 in FS-LASIK group. 39.58% in the ICL group and 27.59% in the FS-LASIK group gained CDVA in 2 lines or better than that in preoperative CDVA. The efficacy indices was 1.28±0.22 in ICL group, and 1.13±0.26 in FS-LASIK group. The changes of spherical equivalent from 1wk to 1y postoperatively was -0.12±0.37 D in ICL group, and -0.79±0.58 D in FS-LASIK group (P<0.05). Spherical equivalent within ±0.50D was achieved in 97.92% in ICL group and 68.97% in FS-LASIK group. Modulation transfer function (MTF) cutoff frequency were higher with ICL as compared to FS-LASIK (P<0.05) at each postoperative follow-up stage; For postoperative 1mo later, strehl ratio (SR) was statistically significant difference between two groups (P<0.05); With no statistically significant difference in Objective scatter index (OSI) between two groups (P>0.05) in postoperative 3mo later. CONCLUSION: ICL implantation and FS-LASIK procedures both provide good safety and predictability in high myopia correction. ICL implantation provides better clinical outcomes and refractive stability than FS-LASIK.     

小切口角膜基质透镜取出术与飞秒激光辅助准分子原位角膜磨镶术对角膜生物力学特性影响的对比分析

目的　比较小切口角膜基质透镜取出术（small-incision lenticule extraction,SMILE）与飞秒激光辅助准分子原位角膜磨镶术（femtosecond laser-assisted laser in situ keratomileusis,FS-LASIK）治疗近视对患者角膜生物力学特性的影响。方法　选取在我院行SMILE和FS-LASIK手术的近视患者共67例134眼。根据手术方式及等效球镜度数（spherical equivalent,SE）的不同将患者分为4组:中度近视SMILE组15例30眼和中度近视FS-LASIK组16例32眼（-3.00 D≤SE＜-6.00 D）;高度近视SMILE组18例36眼和高度近视FS-LASIK组18例36眼（6.00 D≤SE＜-9.00 D）。分别于术前及术后3 d 、10 d、1个月、3个月使用眼反应分析仪ORA测量4组患者角膜滞后量（corneal hysteresis,CH）和角膜阻力因子（corneal resistance factor,CRF）。计算4组患者术后各时间点的CH和CRF改变量,并分别比较中度近视SMILE组和中度近视FS-LASIK组、高度近视SMILE组和高度近视FS-LASIK组CH和CRF改变量的差异。结果　中度近视SMILE组患者△CH在术后3 d（P=0.030）和术后3个月（P=0.030）时均小于中度近视FS-LASIK组。中度近视SMILE组患者△CRF在术后3 d（P=0.000）、10 d（P=0.008）、1个月（P=0.011）、3个月（P=0.001）时均小于中度近视FS-LASIK组。高度近视SMILE组△CH和△CRF在术后3 d、10 d、1个月、3个月时均小于高度近视FS-LASIK组（均为P=0.000）。结论　SMILE与FS-LASIK手术都会引起角膜生物力学稳定性的降低,但SMILE对角膜生物力学变化的影响更小。     

SMILE手术治疗近视及近视合并散光术后1a视觉质量分析

目的：探讨飞秒激光小切口角膜基质透镜取出术(SMILE)治疗近视及近视合并散光术后1a视觉质量的变化特点。

方法：回顾性研究。纳入2019-07/12行SMILE手术的近视及近视合并散光患者85例85眼,术后随访1a,观察裸眼远视力(UDVA)、矫正远视力(CDVA)、等效球镜度(SE)等情况,评估手术的有效性、安全性及可预测性,并测量全角膜高阶像差及客观视觉质量。

结果：术后1a,本组患者SMILE手术有效性指数1.08,其中84眼UDVA(99%)达到或高于术前CDVA,22眼(26%)UDVA高于术前CDVA 1行; 手术安全性指数1.04,其中59眼(69%)CDVA与术前CDVA一致,24眼(28%)CDVA较术前CDVA增加1行,2眼(2%)CDVA较术前CDVA增加2行; 85眼(100%)等效球镜度均在±0.50D范围内; 术前预期矫正SE与术后实际矫正SE呈高度线性相关(Y=0.9949X-0.0033; R²=0.9977); 本组患者6mm瞳孔直径下全角膜总高阶像差(HOA)、球差、彗差均较术前增加(P<0.001); 调制传递函数截止频率(MTF_cutoff)和斯特列尔比(SR)均高于术前(P<0.05)。

结论：SMILE手术治疗近视安全、有效、稳定、预测性良好,矫正中低度散光准确性好,术后视网膜成像质量优于术前。