Five-years Results of Small-incision Lenticule Extraction in High Myopia

Small Incision ◽

Related Quality ◽

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.

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

International Journal of Ophthalmology ◽

10.18240/ijo.2021.09.11 ◽

2021 ◽

Vol 14 (9) ◽

pp. 1365-1370

Author(s):

Min Lang ◽

◽

Ting Liu ◽

Ying Zhu ◽

Jian Ye ◽

...

Keyword(s):

Quality Of Life ◽

Visual Acuity ◽

High Myopia ◽

Control Group ◽

Distance Visual Acuity ◽

Refractive Outcomes ◽

Related Quality

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.

Visual and Refractive Outcomes of Small-Incision Lenticule Extraction in High Myopia: 5-Year Results

Journal of Ophthalmology ◽

10.1155/2018/5893126 ◽

2018 ◽

Vol 2018 ◽

pp. 1-6 ◽

Cited By ~ 7

Author(s):

Alper Ağca ◽

İhsan Çakır ◽

Beril Tülü Aygün ◽

Dilek Yaşa ◽

Yusuf Yıldırım ◽

...

Keyword(s):

Visual Acuity ◽

High Myopia ◽

Spherical Equivalent ◽

Distance Visual Acuity ◽

Small Incision ◽

Refractive Outcomes ◽

Lenticule Extraction ◽

The Mean

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.

Two-year observation of posterior corneal elevations after small incision lenticule extraction (SMILE) for myopia higher than −10 dioptres

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2018-313498 ◽

2019 ◽

Vol 104 (1) ◽

pp. 142-148 ◽

Cited By ~ 5

Author(s):

Xueyi Zhou ◽

Jianmin Shang ◽

Bing Qin ◽

Yu Zhao ◽

Xingtao Zhou

Keyword(s):

Central Area ◽

Control Group ◽

Small Incision ◽

Long Term Follow Up ◽

Lenticule Extraction ◽

Measured Change

AimTo investigate the change in posterior corneal elevations (PCEs) of eyes with extremely high myopia 2 years after small incision lenticule extraction (SMILE).MethodsWe evaluated 39 eyes of 39 patients with spherical equivalent higher than −10.00 dioptres (D). Using a Scheimpflug camera (Pentacam), we measured change in PCEs at 1 day, 3 months, 6 months and 2 years after SMILE. Another 34 eyes of 34 patients who underwent femtosecond laser-assisted in situ keratomileusis (FS-LASIK) were examined before, at 1 day and long-term after surgery as the control group. For each eye, elevations at central, thinnest, maximal points and 24 other predetermined points were measured.ResultsNo significant forward displacements of PCEs were observed in both surgeries. The maximal but not significant forward displacement occurred around 3–6 months following SMILE, and all returned to original levels 6 months postoperatively except superior area. The peripheral area tended to displace backward, while the central area tended forwardly. In both procedures, elevations along horizontal meridians, inferior and temporal hemispheres were significantly higher than those along vertical meridians, superior and nasal hemispheres, respectively (p<0.05). Elevation on the 4 mm, 6 mm diameters at 1 day and on the 6 mm diameter and temporal hemisphere at long-term follow-up postoperatively were significantly higher in FS-LASIK than SMILE (p<0.05). Change in elevations on the 6 mm diameter circle correlated with residual bed thickness (p=0.047).ConclusionsSMILE is a safe way to correct for myopia higher than −10 D, with PCEs remaining stable 2 years after surgery.

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

PLoS ONE ◽

10.1371/journal.pone.0242059 ◽

2021 ◽

Vol 16 (2) ◽

pp. e0242059

Author(s):

Yanyan Fu ◽

Yewei Yin ◽

Xiaoying Wu ◽

Yuanjun Li ◽

Aiqun Xiang ◽

...

Keyword(s):

Visual Acuity ◽

Femtosecond Laser ◽

Clinical Outcomes ◽

High Myopia ◽

Meta Analysis ◽

Distance Visual Acuity ◽

Small Incision ◽

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.

Short-Term Outcomes of Small-Incision Lenticule Extraction (SMILE) for Low, Medium, and High Myopia

European Journal of Ophthalmology ◽

10.5301/ejo.5000849 ◽

2016 ◽

Vol 27 (2) ◽

pp. 153-159 ◽

Cited By ~ 12

Author(s):

Joaquín Fernández ◽

Almudena Valero ◽

Javier Martínez ◽

David P. Piñero ◽

Manuel Rodríguez-Vallejo

Keyword(s):

Visual Acuity ◽

High Myopia ◽

Distance Visual Acuity ◽

Small Incision ◽

Uncorrected Distance Visual Acuity ◽

Manifest Refraction ◽

Corrected Distance Visual Acuity ◽

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.

Three-year outcomes of small incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) for myopia and myopic astigmatism

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2018-312140 ◽

2018 ◽

Vol 103 (4) ◽

pp. 565-568 ◽

Cited By ~ 15

Author(s):

Tian Han ◽

Ye Xu ◽

Xiao Han ◽

Li Zeng ◽

Jianmin Shang ◽

...

Keyword(s):

Visual Acuity ◽

Femtosecond Laser ◽

Laser In Situ Keratomileusis ◽

Small Incision ◽

Lenticule Extraction ◽

Myopic Astigmatism

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.

Combined small-incision lenticule extraction and intrastromal corneal collagen crosslinking to treat mild keratoconus: Long-term follow-up

Journal of Cataract & Refractive Surgery ◽

10.1016/j.jcrs.2015.06.027 ◽

2015 ◽

Vol 41 (11) ◽

pp. 2524-2532 ◽

Cited By ~ 8

Author(s):

Enrique O. Graue-Hernandez ◽

Gabriela L. Pagano ◽

Guillermo Garcia-De la Rosa ◽

Arturo Ramirez-Miranda ◽

Jesus Cabral-Macias ◽

...

Keyword(s):

Collagen Crosslinking ◽

Small Incision ◽

Long Term Follow Up ◽

Lenticule Extraction ◽

Corneal Collagen Crosslinking ◽

Corneal Collagen

Corneal Safety and Stability in Cases of Small Incision Lenticule Extraction with Collagen Cross-Linking (SMILE Xtra)

Journal of Ophthalmology ◽

10.1155/2019/6808062 ◽

2019 ◽

Vol 2019 ◽

pp. 1-10 ◽

Cited By ~ 1

Author(s):

Ihab Mohamed Osman ◽

Hany Ahmed Helaly ◽

Mohsen Abou Shousha ◽

Amir AbouSamra ◽

Islam Ahmed

Keyword(s):

Visual Acuity ◽

Cross Linking ◽

Distance Visual Acuity ◽

Small Incision ◽

Corneal Densitometry ◽

Lenticule Extraction ◽

Safety And Stability ◽

Collagen Cross Linking

Purpose. To assess the safety and stability in cases of small incision lenticule extraction with collagen cross-linking (SMILE Xtra). Methods. This study was a retrospective interventional comparative study that included 60 eyes of 30 patients divided equally into two groups: SMILE Xtra and SMILE alone. The inclusion criteria were patients >18 years of age, myopic error >6 D, thinner cornea <520 microns, and abnormal corneal topography. Outcome data were recorded including uncorrected distance visual acuity and corrected distance visual acuity (UDVA and CDVA), manifest refraction spherical equivalent (MRSE), central corneal thickness, average keratometry, endothelial cell density, corneal resistance factor (CRF), and corneal densitometry. The follow-up period was 24 months. Results. There was a significant difference between the 2 groups regarding UDVA, CDVA, and MRSE at 1 month. In the SMILE Xtra group, 90% of eyes had postoperative UDVA of 20/20 and 97% had UDVA of 20/30 at 24 months. At 24 months, 26 eyes (87%) vs. 25 eyes (84%) were within ±0.50 D of attempted correction in SMILE Xtra and SMILE groups, respectively. Regarding stability, both groups showed improvement of MRSE at 1st month postoperatively and remained stable along the 24 months of follow-up. CRF and corneal densitometry were higher in the SMILE Xtra group along the whole follow-up period (p=0.001). Conclusion. Combining corneal cross-linking with SMILE procedure (SMILE Xtra) is a promising tool to prevent ectasia in high-risk patients. It is a safe and simple procedure that can be offered to patients undergoing SMILE with risk for ectasia. Trial registration no: PACTR201810577524718.

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

10.21203/rs.2.23101/v1 ◽

2020 ◽

Author(s):

Yanyan Fu ◽

Yewei Yin ◽

Yang Zhao ◽

Aiqun Xiang ◽

Ying Lu ◽

...

Keyword(s):

Femtosecond Laser ◽

Clinical Outcomes ◽

High Myopia ◽

Spherical Aberration ◽

Meta Analysis ◽

Small Incision ◽

Significant Difference ◽

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.

Small incision lenticule extraction for the correction of high myopia

European Journal of Ophthalmology ◽

10.1177/1120672119861481 ◽

2019 ◽

Vol 30 (5) ◽

pp. 917-927

Author(s):

Suphi Taneri ◽

Saskia Kießler ◽

Anika Rost ◽

Tim Schultz ◽

H Burkhard Dick

Keyword(s):

Visual Acuity ◽

High Myopia ◽

Case Series ◽

Distance Visual Acuity ◽

Small Incision ◽

Refractive Outcomes ◽

Uncorrected Distance Visual Acuity ◽

Corrected Distance Visual Acuity ◽

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.