AIM： To examine differences in efficacy, accuracy, safety, aberrations and corneal biomechanical between Small incision lenticule extraction （SMILE） and femtosecond lenticule extraction （FLEx） for myopia. METH...AIM： To examine differences in efficacy, accuracy, safety, aberrations and corneal biomechanical between Small incision lenticule extraction （SMILE） and femtosecond lenticule extraction （FLEx） for myopia. METHODS： Comprehensive studies were conducted on the PubMed, MEDLINE, EMBASE, and Cochrane Controlled Trials Register before 31 July, 2015. Meta-analyses were performed on the primary outcomes [loss of ≥2 lines of corrected distance visual acuity （CDVA）, uncorrected distance visual acuity （UDVA） ≥20/20, spherical equivalent （SE） within ±0.50 diopters （D）, final refractive SE], secondary outcomes were high-order aberrations （HOAs） and corneal biomechanical [central corneal thickness （CCT）, corneal hysteresis （CH） and corneal resistance factor （CRF）]. RESULTS： Seven trials describing a total of 320 eyes with myopia were included in this Meta-analysis. No significant differences were found in the efficacy [UDVA weighted mean difference （WMD） -0.01; 95%CI： -0.04 to 0.01; P=0.37, UDVA ≥20/20, OR 1.49; 95%CI： 0.78 to 2.86; P=0.23], accuracy （SE WMD -0.03; 95%CI： -0.12 to 0.07; P=0.58 , SE within ±0.5 D OR 1.25; 95%CI： 0.34 to 4.65; P=0.74）, HOAs （WMD -0.04; 95%CI： -0.09 to 0.01; P=0.14） and CCT WMD 1.83; 95%CI： -7.07 to 10.72; P=0.69, CH WMD -0.01; 95%CI： -0.42 to 0.40; P=0.97, CRF WMD 0.17; 95%CI： -0.33 to 0.67; P=0.50） in the last fellow-up. But for safety, FLEx may achieve fewer CDVA lost two or more two lines （OR 11.11; 95%CI： 1.27 to 96.86; P=0.03） than SMILE, however CDVA （WMD 0.00; 95%CI： -0.03 to 0.02; P=0.77） is similar. CONCLUSION： SMILE and FLEx are comparable in terms of both efficacy, accuracy, aberrations and corneal biomechanical measures in the follow-up,but FLEx seems to be better in safety measures. The results should be interpreted cautiously since relevant evidence is still limited, although it is accumulating. Further large-scale, well-designed randomized controlled trials are urgently needed展开更多
AIM： To identify possible differences of efficacy, safety predictability, higher-order aberrations and cornea biomechnical parameters after small-incision lenticule extraction（SMILE） and femtosecond lenticule extra...AIM： To identify possible differences of efficacy, safety predictability, higher-order aberrations and cornea biomechnical parameters after small-incision lenticule extraction（SMILE） and femtosecond lenticule extraction（FLEx）.· METHODS： A systematic literature retrieval was conducted in Medline,Embase and the Cochrane Library up to October, 2015. The included studies were subject to a Meta-analysis. Comparison between SMILE and FLEx was measured as pooled odds ratio（OR） or weighted mean differences（WMD）. Of 95% confidence intervals（CI） were used to analyze data.·RESULTS： A total of seven studies were included Firstly, there were no differences in uncorrected distance visual acuity（UDVA） 20/20 or better（OR, 1.37; 95% CI0.69 to 2.69; P =0.37） and log MAR UDVA（WMD,-0.02;95% CI,-0.05 to 0.01; P =0.17） after SMILE versus FLEx We found no differences in corrected distance visua acuity（CDVA） unchanged（OR, 0.98; 95% CI, 0.46 to 2.11;P =0.97） and log MAR CDVA（WMD,-0.00; 95% CI,-0.01 to 0.01; P =0.90） either. Secondly, we found no differences in refraction within ±1.00 D（OR, 0.98; 95% CI0.13 to 7.28; P =0.99） and ±0.50 D（OR, 1.62; 95% CI0.62 to 4.28; P =0.33） of target postoperatively. Thirdly for higher-order aberrations, we found no differences in the total higher-order aberrations（WMD,-0.04; 95%CI,-0.09 to 0.01;P =0.14）, coma（WMD,-0.04; 95% CI,-0.09 to 0.01; P =0.11）, spherical（WMD, 0.01; 95% CI,-0.02 to0.03; P =0.60） and trefoil（WMD,-0.00; 95% CI,-0.04 to0.03; P =0.76）. Furthermore, for corneal biomechanica parameters, we also found no differences（WMD, 0.08;95% CI,-0.17 to 0.33; P =0.54） after SMILE versus FLEx.·CONCLUSION： There are no statistically differences in efficacy, safety, predictability, higher-order aberrations and corneal biomechnical parameters postoperative between SMILE and FLEx.展开更多
目的对比分析改良飞秒激光基质内透镜取出术(reforming femtosecond lenticule extraction,R-FLEx)与小切口飞秒激光基质内透镜取出术(small incision lenticule extraction,SMILE)治疗高度近视术后泪膜稳定性的变化。方法回顾性分析行...目的对比分析改良飞秒激光基质内透镜取出术(reforming femtosecond lenticule extraction,R-FLEx)与小切口飞秒激光基质内透镜取出术(small incision lenticule extraction,SMILE)治疗高度近视术后泪膜稳定性的变化。方法回顾性分析行全飞秒近视矫正手术治疗的高度近视患者40例80眼,其中SMILE组20例40眼,R-FLEx组20例40眼。观察术后1个月、3个月、6个月、1 a两组患者的干眼症状,包括干涩感、烧灼感、异物感,并依次行基础泪液分泌试验(Schirmer I test,SIt)、泪膜破裂时间(break up time of tear film,BUT)、角膜荧光素染色检查(corneal fluorescein staining,FL),并对其泪膜稳定性的变化进行对比分析。结果干眼症状问卷调查评分:术后1个月SMILE组和R-FLEx组分别为0.35±0.48、0.90±0.67,差异有统计学意义(P<0.05);术后3个月、6个月、1 a SMILE组和R-FLEx组分别为0.18±0.38、0.08±0.27、0.05±0.22,0.28±0.45、0.10±0.30、0.10±0.30,差异均无统计学意义(均为P>0.05)。两组FL检查评分:术后1个月SMILE组和R-FLEx组分别为0.88±0.69、1.30±0.69,差异有统计学意义(P<0.05);术后3个月、6个月、1 a SMILE组和R-FLEx组分别为0.18±0.38、0.08±0.27、0.03±0.16,0.28±0.45、0.05±0.22、0.05±0.22,差异均无统计学意义(均为P>0.05)。SIt试验结果:术后1个月、3个月SMILE组和R-FLEx组分别为(8.20±0.76)mm、(8.95±0.60)mm,(6.65±0.66)mm、(8.30±0.61)mm,差异均有统计学意义(均为P<0.05);术后6个月、1 a SMILE组和R-FLEx组分别为(9.65±0.58)mm、(10.70±0.99)mm,(9.63±0.84)mm、(10.70±1.12)mm,差异均无统计学意义(均为P>0.05)。两组BUT检查结果:术后1个月、3个月SMILE组和R-FLEx组分别为(7.75±0.98)s、(8.90±0.93)s,(6.25±0.89)s、(8.50±0.78)s,差异均有统计学意义(均为P<0.05);术后6个月、1 a SMILE组和R-FLEx组分别为(9.65±0.58)s、(10.70±0.99)s,(9.53±0.78)s、(10.33±1.19)s,差异均无统计学意义(均为P>0.05)。结论 SMILE较R-FLEx术后早期泪膜稳�展开更多
目的:研究不透明气泡层(opaque bubble layer,OBL)对飞秒激光小切口角膜基质透镜取出术(femtosecond small incision lenticule extraction,SMILE)患者视觉质量的影响。方法:采用前瞻性队列研究方法,依次纳入2015-06/09在解放军四七四...目的:研究不透明气泡层(opaque bubble layer,OBL)对飞秒激光小切口角膜基质透镜取出术(femtosecond small incision lenticule extraction,SMILE)患者视觉质量的影响。方法:采用前瞻性队列研究方法,依次纳入2015-06/09在解放军四七四眼科医院屈光手术中心行SMILE患者116例116眼,按照术中是否产生OBL分为OBL组(51眼)和对照组(65眼)。随访OBL组与对照组的研究对象在术前、术后1、3、6mo患者最佳矫正视力(BCVA)、调制传递函数截止空间频率(modulation transfer function cut off frequency,MTF_(cut off))、斯特列尔比(strehl ratio,SR)、眼内客观散射指数(objective scattering index,OSI)、全眼高阶像差(RMSH)、垂直彗差(C7)、水平彗差(C8)和球差(C12)等视觉质量指标的差异。结果:在术前及术后各个时间点上比较OBL组与对照组间BCVA的差异均无统计学意义(P>0.05),OBL组和对照组的BCVA组内各个时间点间比较发现术后3、6mo分别与术前相比差异有统计学意义(P<0.05),两组的BCVA在术后3、6mo均显著优于术前;OBL组和对照组内的SR,MTF_(cut off),OSI,C7,C12,RMSH 6个指标在各个时间点间比较差异有统计学意义(P<0.05),而C8指标在各个时间点间差异无统计学意义(P>0.05);RMSH指标在术后1mo时在OBL组与对照组间差异有统计学意义(P<0.05)。结论:SMILE手术过程中OBL的产生对术后患者视觉质量的恢复在术后6mo时无明显影响,因此SMILE手术过程中OBL的产生对患者视觉质量的影响较小。展开更多
基金Supported by the National Natural Science Foundation of China(No.81370993)
文摘AIM： To examine differences in efficacy, accuracy, safety, aberrations and corneal biomechanical between Small incision lenticule extraction （SMILE） and femtosecond lenticule extraction （FLEx） for myopia. METHODS： Comprehensive studies were conducted on the PubMed, MEDLINE, EMBASE, and Cochrane Controlled Trials Register before 31 July, 2015. Meta-analyses were performed on the primary outcomes [loss of ≥2 lines of corrected distance visual acuity （CDVA）, uncorrected distance visual acuity （UDVA） ≥20/20, spherical equivalent （SE） within ±0.50 diopters （D）, final refractive SE], secondary outcomes were high-order aberrations （HOAs） and corneal biomechanical [central corneal thickness （CCT）, corneal hysteresis （CH） and corneal resistance factor （CRF）]. RESULTS： Seven trials describing a total of 320 eyes with myopia were included in this Meta-analysis. No significant differences were found in the efficacy [UDVA weighted mean difference （WMD） -0.01; 95%CI： -0.04 to 0.01; P=0.37, UDVA ≥20/20, OR 1.49; 95%CI： 0.78 to 2.86; P=0.23], accuracy （SE WMD -0.03; 95%CI： -0.12 to 0.07; P=0.58 , SE within ±0.5 D OR 1.25; 95%CI： 0.34 to 4.65; P=0.74）, HOAs （WMD -0.04; 95%CI： -0.09 to 0.01; P=0.14） and CCT WMD 1.83; 95%CI： -7.07 to 10.72; P=0.69, CH WMD -0.01; 95%CI： -0.42 to 0.40; P=0.97, CRF WMD 0.17; 95%CI： -0.33 to 0.67; P=0.50） in the last fellow-up. But for safety, FLEx may achieve fewer CDVA lost two or more two lines （OR 11.11; 95%CI： 1.27 to 96.86; P=0.03） than SMILE, however CDVA （WMD 0.00; 95%CI： -0.03 to 0.02; P=0.77） is similar. CONCLUSION： SMILE and FLEx are comparable in terms of both efficacy, accuracy, aberrations and corneal biomechanical measures in the follow-up,but FLEx seems to be better in safety measures. The results should be interpreted cautiously since relevant evidence is still limited, although it is accumulating. Further large-scale, well-designed randomized controlled trials are urgently needed
文摘AIM： To identify possible differences of efficacy, safety predictability, higher-order aberrations and cornea biomechnical parameters after small-incision lenticule extraction（SMILE） and femtosecond lenticule extraction（FLEx）.· METHODS： A systematic literature retrieval was conducted in Medline,Embase and the Cochrane Library up to October, 2015. The included studies were subject to a Meta-analysis. Comparison between SMILE and FLEx was measured as pooled odds ratio（OR） or weighted mean differences（WMD）. Of 95% confidence intervals（CI） were used to analyze data.·RESULTS： A total of seven studies were included Firstly, there were no differences in uncorrected distance visual acuity（UDVA） 20/20 or better（OR, 1.37; 95% CI0.69 to 2.69; P =0.37） and log MAR UDVA（WMD,-0.02;95% CI,-0.05 to 0.01; P =0.17） after SMILE versus FLEx We found no differences in corrected distance visua acuity（CDVA） unchanged（OR, 0.98; 95% CI, 0.46 to 2.11;P =0.97） and log MAR CDVA（WMD,-0.00; 95% CI,-0.01 to 0.01; P =0.90） either. Secondly, we found no differences in refraction within ±1.00 D（OR, 0.98; 95% CI0.13 to 7.28; P =0.99） and ±0.50 D（OR, 1.62; 95% CI0.62 to 4.28; P =0.33） of target postoperatively. Thirdly for higher-order aberrations, we found no differences in the total higher-order aberrations（WMD,-0.04; 95%CI,-0.09 to 0.01;P =0.14）, coma（WMD,-0.04; 95% CI,-0.09 to 0.01; P =0.11）, spherical（WMD, 0.01; 95% CI,-0.02 to0.03; P =0.60） and trefoil（WMD,-0.00; 95% CI,-0.04 to0.03; P =0.76）. Furthermore, for corneal biomechanica parameters, we also found no differences（WMD, 0.08;95% CI,-0.17 to 0.33; P =0.54） after SMILE versus FLEx.·CONCLUSION： There are no statistically differences in efficacy, safety, predictability, higher-order aberrations and corneal biomechnical parameters postoperative between SMILE and FLEx.
文摘目的对比分析改良飞秒激光基质内透镜取出术(reforming femtosecond lenticule extraction,R-FLEx)与小切口飞秒激光基质内透镜取出术(small incision lenticule extraction,SMILE)治疗高度近视术后泪膜稳定性的变化。方法回顾性分析行全飞秒近视矫正手术治疗的高度近视患者40例80眼,其中SMILE组20例40眼,R-FLEx组20例40眼。观察术后1个月、3个月、6个月、1 a两组患者的干眼症状,包括干涩感、烧灼感、异物感,并依次行基础泪液分泌试验(Schirmer I test,SIt)、泪膜破裂时间(break up time of tear film,BUT)、角膜荧光素染色检查(corneal fluorescein staining,FL),并对其泪膜稳定性的变化进行对比分析。结果干眼症状问卷调查评分:术后1个月SMILE组和R-FLEx组分别为0.35±0.48、0.90±0.67,差异有统计学意义(P<0.05);术后3个月、6个月、1 a SMILE组和R-FLEx组分别为0.18±0.38、0.08±0.27、0.05±0.22,0.28±0.45、0.10±0.30、0.10±0.30,差异均无统计学意义(均为P>0.05)。两组FL检查评分:术后1个月SMILE组和R-FLEx组分别为0.88±0.69、1.30±0.69,差异有统计学意义(P<0.05);术后3个月、6个月、1 a SMILE组和R-FLEx组分别为0.18±0.38、0.08±0.27、0.03±0.16,0.28±0.45、0.05±0.22、0.05±0.22,差异均无统计学意义(均为P>0.05)。SIt试验结果:术后1个月、3个月SMILE组和R-FLEx组分别为(8.20±0.76)mm、(8.95±0.60)mm,(6.65±0.66)mm、(8.30±0.61)mm,差异均有统计学意义(均为P<0.05);术后6个月、1 a SMILE组和R-FLEx组分别为(9.65±0.58)mm、(10.70±0.99)mm,(9.63±0.84)mm、(10.70±1.12)mm,差异均无统计学意义(均为P>0.05)。两组BUT检查结果:术后1个月、3个月SMILE组和R-FLEx组分别为(7.75±0.98)s、(8.90±0.93)s,(6.25±0.89)s、(8.50±0.78)s,差异均有统计学意义(均为P<0.05);术后6个月、1 a SMILE组和R-FLEx组分别为(9.65±0.58)s、(10.70±0.99)s,(9.53±0.78)s、(10.33±1.19)s,差异均无统计学意义(均为P>0.05)。结论 SMILE较R-FLEx术后早期泪膜稳�
文摘目的:研究不透明气泡层(opaque bubble layer,OBL)对飞秒激光小切口角膜基质透镜取出术(femtosecond small incision lenticule extraction,SMILE)患者视觉质量的影响。方法:采用前瞻性队列研究方法,依次纳入2015-06/09在解放军四七四眼科医院屈光手术中心行SMILE患者116例116眼,按照术中是否产生OBL分为OBL组(51眼)和对照组(65眼)。随访OBL组与对照组的研究对象在术前、术后1、3、6mo患者最佳矫正视力(BCVA)、调制传递函数截止空间频率(modulation transfer function cut off frequency,MTF_(cut off))、斯特列尔比(strehl ratio,SR)、眼内客观散射指数(objective scattering index,OSI)、全眼高阶像差(RMSH)、垂直彗差(C7)、水平彗差(C8)和球差(C12)等视觉质量指标的差异。结果:在术前及术后各个时间点上比较OBL组与对照组间BCVA的差异均无统计学意义(P>0.05),OBL组和对照组的BCVA组内各个时间点间比较发现术后3、6mo分别与术前相比差异有统计学意义(P<0.05),两组的BCVA在术后3、6mo均显著优于术前;OBL组和对照组内的SR,MTF_(cut off),OSI,C7,C12,RMSH 6个指标在各个时间点间比较差异有统计学意义(P<0.05),而C8指标在各个时间点间差异无统计学意义(P>0.05);RMSH指标在术后1mo时在OBL组与对照组间差异有统计学意义(P<0.05)。结论:SMILE手术过程中OBL的产生对术后患者视觉质量的恢复在术后6mo时无明显影响,因此SMILE手术过程中OBL的产生对患者视觉质量的影响较小。
