scholarly journals Clinical outcomes after small-incision lenticule extraction versus femtosecond laser-assisted LASIK for high myopia: A meta-analysis

PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0242059
Author(s):  
Yanyan Fu ◽  
Yewei Yin ◽  
Xiaoying Wu ◽  
Yuanjun Li ◽  
Aiqun Xiang ◽  
...  

Aim To compare postoperative clinical outcomes of high myopia after small-incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK). Methods From March 2018 to July 2020, PubMed, MEDLINE, Embase, the Cochrane Library, and several Chinese databases were comprehensively searched. The studies meeting the criteria were selected and included; the data were extracted by 2 independent authors. The clinical outcome parameters were analyzed with RevMan 5.3. Results This meta-analysis included twelve studies involving 766 patients (1400 eyes: 748 receiving SMILE and 652 receiving FS-LASIK). Pooled results revealed no significant differences in the following outcomes: the logarithm of the mean angle of resolution (logMAR) of postoperative uncorrected distance visual acuity (weighted mean difference (WMD) = -0.01, 95% confidence interval (CI): -0.02 to 0.00, I2 = 0%, P = 0.07 at 1 mo; WMD = -0.00, 95% CI: -0.01 to 0.01, I2 = 0%, P = 0.83 at 3 mo; WMD = -0.00, 95% CI: -0.01 to 0.00, I2 = 32%, P = 0.33 in the long term), and the postoperative mean refractive spherical equivalent (WMD = -0.03, 95% CI: -0.09 to 0.03, I2 = 13%, P = 0.30). However, the SMILE group had significantly better postoperative corrected distance visual acuity (CDVA) than the FS-LASIK group (WMD = -0.04, 95% CI, -0.05 to -0.02, I2 = 0%, P<0.00001). In the long term, postoperative total higher-order aberration (WMD = -0.09, 95% CI: -0.10 to -0.07, I2 = 7%, P<0.00001) and postoperative spherical aberration (WMD = -0.15, 95% CI: -0.19 to -0.11, I2 = 29%, P<0.00001) were lower in the SMILE group than in the FS-LASIK group; a significant difference was also found in postoperative coma (WMD = -0.05, 95% CI: -0.06 to -0.03, I2 = 30%, P<0.00001). Conclusion For patients with high myopia, both SMILE and FS-LASIK are safe, efficacious and predictable. However, the SMILE group demonstrated advantages over the FS-LASIK group in terms of postoperative CDVA, while SMILE induced less aberration than FS-LASIK. It remains to be seen whether SMILE can provide better visual quality than FS-LASIK; further comparative studies focused on high myopia are necessary.

2020 ◽  
Author(s):  
Yanyan Fu ◽  
Yewei Yin ◽  
Yang Zhao ◽  
Aiqun Xiang ◽  
Ying Lu ◽  
...  

Abstract Background To compare postoperative clinical outcomes of high myopia after being treated by Small incision lenticule extraction (SMILE) and femtosecond laser in situ keratomileusis (FS-LASIK).Methods Comprehensive studies were conducted on the PubMed, MEDLINE, EMBASE, the Cochrane Library, and Chinese databases.Trials meeting the selection criteria were quality appraised, and the data were extracted by 2 independent authors, and the RevMan 5.3 version software were used in analyzing.Result Ten studies involving 637 patients (1093 eyes;575 eyes in the SMILE group and 518 eyes in the FS-LASIK group) were included in this meta-analysis. Pooled result revealed no significant differences in the following outcomes: the logMAR values of postoperative UDVA(WMD = -0.01, 95% CI: -0.02,0.00, I²=0%, P = 0.10 at postoperative 1mo; WMD =-0.01, 95% CI: -0.00 to 0.01, I²=0%,P = 0.35 at postoperative 3mo; WMD = -0.01, 95% CI:-0.02 to 0.01, I²=17%,P = 0.26 at long term), the logMAR values of postoperative CDVA(WMD = -0.02, 95% CI, -0.04 to 0.00, I²=0%, P = 0.11),and the postoperative mean refractive SE (WMD =0.02, 95% CI:0.04 to 0.08, I²=29%, P=0.60) . In the long-term observation, postoperative tHOA (WMD =-0.10, 95% CI:-0.13 to -0.07, I²=15%, P<0.00001)and postoperative spherical aberration (WMD =-0.13, 95% CI:--0.17 to -0.09, I²=38%, P<0.00001) were found to be less in the SMILE group compared with the FS-LASIK group, but no significant difference was found in postoperative coma (WMD =-0.02, 95% CI:-0.04 to 0.00, I²=98%, P=0.40).We also found greater PCE change post FS-LASIK than SMILE at long term follow-ups(WMD =-0.69, 95% CI:-1.36 to -0.01, I²=0%, P<0.05, however, there was no significant difference between the two groups at 3- or 6- months.(WMD =-0.19, 95% CI:-0.41 to 0.03, I²=31%, P=0.09;WMD =-0.20, 95% CI:-0.50 to 0.10, I²=17%, P=0.20)Conclusion For patients with high myopia, both SMILE and FS-LASIK are safe and efficacious. However, SMILE induced less tHOA and spherical aberration compared with FS-LASIK. Besides, FS-LASIK showed a greater increase in PCE than SMILE only at long term follow-ups. It remains to be seen whether the patients can get a better visual quality after SMILE and more comparative studies focused on high myopia is necessary.


2019 ◽  
Vol 30 (5) ◽  
pp. 917-927
Author(s):  
Suphi Taneri ◽  
Saskia Kießler ◽  
Anika Rost ◽  
Tim Schultz ◽  
H Burkhard Dick

Purpose: Excimer laser-based refractive procedures can have less predictable results when used for correcting high myopia than when used for moderate myopia. Small incision lenticule extraction might overcome this weakness. However, small incision lenticule extraction is only Food and Drug Administration approved for use in myopic eyes up to −8 D with astigmatism of −3 D or less. We report outcomes of small incision lenticule extraction in highly and moderately myopic eyes and compare these to modern laser-assisted in situ keratomileusis. Methods: Retrospective, observational consecutive case series. Inclusion criteria: attempted myopic spherical correction ⩾−8 or−3 to −7.75 D with astigmatism ⩽−3 D, and corrected distance visual acuity of 1.0 (decimal scale) or better. Results: A total of 62 highly myopic and 407 moderately myopic eyes were included. At 3 months postoperatively, the highly myopic eyes had a mean spherical equivalent refraction of −0.28 ± 0.41 D (range: −1.13 to +0.75 D). Mean uncorrected distance visual acuity was 1.0. Mean efficacy index was 0.84. Mean safety index was 1.03. Uncorrected distance visual acuity same or better than corrected distance visual acuity: 61%. Astigmatism was ⩽0.5 D in 90% and ⩽1 D in 100%. The results in the moderately myopic eyes were comparable. Conclusion: We found equally good visual and refractive outcomes after small incision lenticule extraction for the correction of high and of moderate myopia combined with an astigmatic correction of up to 3 D, respectively.


2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Alper Ağca ◽  
İhsan Çakır ◽  
Beril Tülü Aygün ◽  
Dilek Yaşa ◽  
Yusuf Yıldırım ◽  
...  

Purpose. To report long-term visual and refractive results of small-incision lenticule extraction (SMILE) in treatment of high myopia. Materials and Methods. Medical records of patients who underwent SMILE for surgical correction of myopia or myopic astigmatism were retrospectively reviewed. Only patients with a preoperative spherical equivalent of subjective manifest refraction (SE) ≥ 6 D and a postoperative follow-up of 5 years were included in the study. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and SE were analyzed preoperatively and at 1-, 3-, and 5-year postoperative periods. Results. Thirty-seven eyes of 37 patients were included in the study. The mean attempted SE was −7.47 ± 1.10 D (range −6.00 to −10.00 D). At the 5-year visit, the mean difference between achieved and attempted SE was −0.43 ± 0.47 (0.50 to −1.25 D). Mean postoperative UDVA and CDVA were 0.20 ± 0.18 and 0.06 ± 0.08 logMAR, respectively. At the 1-year visit, 70% and 97% of the eyes were within ±0.50 D and ±1.00 D of the intended correction. At the 5-year follow-up, 59% and 92% percent of the eyes were within ±0.50 D and ±1.00 D of the intended SE, respectively. At the 5-year visit, the efficacy index was 0.89 ± 0.26 and the safety index was 1.16 ± 0.20. Fifty-four percent of the eyes gained one or more lines of CDVA. Conclusion. SMILE with an intended correction of up to a spherical equivalent of 10 D is safe and effective. However, there is regression of the refractive effect over extended follow-up.


2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Hui Zhang ◽  
Yan Wang ◽  
Hua Li

Purpose. To investigate corneal spherical aberration and corneal asphericity after small incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK). Methods. This study enrolled 70 patients having SMILE and 64 subjects receiving FS-LASIK. The preoperative spherical equivalent (SE) was −5.83 ± 1.23 diopters (D) and −6.20 ± 1.52 D, respectively. The uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), SE, corneal spherical aberration, and asphericity over the 6.0 mm cornea were evaluated preoperatively and postoperatively. Results. At 6 months, the UDVA, CDVA, and SE were −0.12 ± 0.11, −0.05 ± 0.05, and −0.16 ± 0.19 D in SMILE and −0.10 ± 0.06, −0.03 ± 0.06, and −0.08 ± 0.25 D in FS-LASIK. There was no difference between groups in the postoperative UDVA, CDVA, or SE (P>0.05). SMILE showed lower inductions of spherical aberration along the anterior surface and the total cornea and less increases in corneal asphericity of the anterior surface postoperatively than FS-LASIK (P<0.01). There were significant correlations between the changes in spherical aberration and corneal asphericity (P<0.001). Conclusions. SMILE and FS-LASIK exhibited excellent visual results and refractive outcomes. SMILE induced less increase in corneal spherical aberration and better preserved the corneal asphericity of the anterior corneal surface than FS-LASIK. Corneal asphericity changes contributed to the corneal spherical aberration changes following SMILE and FS-LASIK.


2020 ◽  
Vol 2020 ◽  
pp. 1-7 ◽  
Author(s):  
Fei Xia ◽  
Yang Shen ◽  
Tian Han ◽  
Jing Zhao ◽  
Haipeng Xu ◽  
...  

Purpose. To investigate the long-term outcomes of refraction, corneal tomography, and wavefront aberrations after small incision lenticule extraction (SMILE) for moderate and high myopia. Methods. Prospective, nonconsecutive case series. A total of 26 patients (26 eyes) who underwent SMILE from May 2010 to March 2013 at the Fudan University Eye and ENT Hospital (Shanghai, China) were enrolled. The periods of follow-up were 1 month, 1 year, 5 years, and 7 years after surgery. The routine eye examinations included uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), manifest refraction, and corneal tomography. Results. All surgeries were executed without any complications. At the final visit, an UDVA of 20/20 or better was achieved in 26 eyes (100%) and 11 eyes (42%) exhibited no change in CDVA. 9 eyes (35%) gained one line, 6 eyes (23%) gained two lines, and no eyes lost CDVA. 24 eyes (92%) and 26 eyes (100%) were within ±0.5 D and ±1.00 D of the target refraction, respectively. A mean refractive regression of −0.17 D was observed between 1 month and 7 years postoperatively. Mean corneal front curvature (MCFC) was significantly decreased between pre- and post-SMILE surgery (P<0.0001). Higher-order aberrations (HOAs) and vertical coma were significantly increased after SMILE compared to those measured before surgery (all P<0.001). There were no significant differences in trefoil and spherical aberration between pre- and post-SMILE surgery (all P>0.05). Conclusion. SMILE is an effective, safe, and stable procedure for moderate and high myopia, with relatively constant corneal stability and wavefront aberrations. This trial is registered with ChiCTR-ONRC-13003114.


2016 ◽  
Vol 27 (2) ◽  
pp. 153-159 ◽  
Author(s):  
Joaquín Fernández ◽  
Almudena Valero ◽  
Javier Martínez ◽  
David P. Piñero ◽  
Manuel Rodríguez-Vallejo

Purpose To determine the safety, efficacy, and predictability of small-incision lenticule extraction at 6-month follow-up, depending on the level of the myopic refractive error. The surgeries were performed by a surgeon new to this technique. Methods Seventy-one subjects with a mean age of 31.86 ± 5.57 years were included in this retrospective observational study. Subjects were divided into 3 groups depending on the preoperative spherical equivalent (SE): low group from -1.00 D to -3.00 D, medium from -3.25 D to -5.00 D, and high from -5.25 D to -7.00 D. Manifest refraction, corrected distance visual acuity (CDVA), and uncorrected distance visual acuity (UDVA) were measured before surgery and at 6 months after the treatment. Results In total, 1.4% of the eyes lost 1 line of CDVA after the procedure, whereas 95.8% remained unchanged and 2.8% gained 1 line. A significant undercorrection (p = 0.031) was found in the high myopia group (median -0.50 D), whereas the low and medium groups remained near to emmetropia. In terms of efficacy, no statistically significant intergroup differences for postoperative UDVA (p = 0.282) were found. The vector analysis also showed undercorrection of the preoperative cylinder, even though the standard deviations decreased from 0.9 D in the x axis and 0.7 D in the y axis to 0.24 D and 0.27 D, respectively. Conclusions Small-incision lenticule extraction might be a safe, effective, and predictable procedure even for inexperienced surgeons. No differences in efficacy were found among myopia levels even though undercorrections were found for SE and cylinder in high myopia.


2018 ◽  
Vol 103 (4) ◽  
pp. 565-568 ◽  
Author(s):  
Tian Han ◽  
Ye Xu ◽  
Xiao Han ◽  
Li Zeng ◽  
Jianmin Shang ◽  
...  

AimsTo compare long-term clinical outcomes following small incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) for myopia and myopic astigmatism correction.MethodsIn this retrospective study, we enrolled a total of 101 patients (101 eyes) who underwent SMILE or FS-LASIK 3 years prior. Measured parameters included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction and corneal wavefront aberrations.ResultsNo significant differences in patient characteristics were found between the two groups. At the 3-year follow-up, UDVA was better than or equal to 20/20 in 90% and 85% (p=0.540) of the eyes; the efficacy indexes were 1.05±0.19 and 1.01±0.21 in the SMILE and FS-LASIK groups, respectively (p=0.352). Safety indexes were 1.19±0.17 and 1.15±0.20 in the SMILE and FS-LASIK groups, respectively (p=0.307). Eighty per cent and 65% of eyes were within ±0.50 D of the attempted spherical equivalent correction after SMILE and FS-LASIK, respectively (p=0.164). Vector analysis revealed no significant differences in astigmatic correction between the two groups (p>0.05). Surgically induced spherical aberration was higher in the FS-LASIK group than in the SMILE group (p<0.001).ConclusionLong-term follow-up analysis suggested that both SMILE and FS-LASIK were safe and equally effective for myopic and astigmatic correction.


2020 ◽  
Author(s):  
Min Lang ◽  
Kaiwei Cao ◽  
Ting Liu ◽  
Jiao Pan ◽  
Jian Ye

Abstract Background To investigate long-term refractive visual quality outcomes and vision-related quality of life after small-incision lenticule extraction (SMILE) in the treatment of high myopia.Methods Thirty patients (60 eyes) with high myopia who underwent SMILE more than 5 years previously were selected as the SMILE group. Another 30 high myopia patients (60 eyes) who had worn corrective spectacles for more than 5 years were selected as the control group. In the SMILE group, the postoperative follow-up times were 3 months, 6 months, 1 year and 5 years. The uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), spherical equivalent (SE), and ocular axial length (AL) were analysed. 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 the SMILE group, the mean preoperative SE was -7.29±0.87 D (range -6.00 to -9.125 D). 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 D and ±1.00 D of attempted correction, respectively. Forty-eight eyes (80%) had astigmatism < 0.50 D. The postoperative mean SE values at 3 months, 6 months, 1 year, and 5 years were 0.11±0.44 D, 0.07±0.45 D, -0.02±0.41 D, and -0.15±0.46 D, respectively. No significant change was observed in the ocular axial length from before operation to 5 years postoperatively (26.08±0.96 mm vs 26.01±0.94 mm, p>0.05). 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).Conclusions In the present study, in a long-term follow-up, we demonstrated that correcting high myopia with SMILE is safe, effective, and predictable. In addition, there is slight undercorrection.


2019 ◽  
Author(s):  
Fei Xia ◽  
Yang Shen ◽  
Tian Han ◽  
Jing Zhao ◽  
Hai-Peng Xu ◽  
...  

Abstract Background To investigate the long-term corneal stability and wavefront aberrations after small incision lenticule extraction (SMILE) for moderate and high myopia.Methods Prospective, non-consecutive case series. A total of 26 patients (42 eyes) who underwent SMILE from May 2010 to March 2013 at the Fudan University Eye and ENT Hospital (Shanghai, China) were enrolled. The periods of follow-up were 1 month, 1 year, 5 years and 7 years after surgery. The routine eye examinations included uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), manifest refraction and corneal topography.Results All surgeries were executed without any complications. At the final visit, a UDVA of 20/20 or better was achieved in 42 eyes (100%), 21 eyes (50%) exhibited no change in CDVA. 15 eyes (36%) gained one line, 6 eyes (14%) gained two lines, and no eyes lost CDVA lines. 93% and 100% of eyes were within ±0.5 D and ±1.00 D of the target refraction, respectively. A mean refractive regression of -0.17 D was observed between 1 month and 7 years postoperatively. Mean corneal front curvature (KMF) were significantly increased between pre- and post-SMILE surgery (P<0.0001). Higher-order aberrations (HOAs) and vertical coma were significantly increased after SMILE compared to those measured before surgery (all P<0.001). There were no significant differences in horizontal coma, trefoil and spherical aberration between pre- and post-SMILE surgery (all P>0.05).Conclusions SMILE is an effective, safe and stable procedure for myopia correction, with relatively constant corneal stability and wavefront aberrations.


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