Small incision lenticule extraction for the correction of high myopia

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.

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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 ◽

Small Incision Lenticule Extraction ◽

Distance Visual Acuity ◽

Small Incision ◽

Uncorrected Distance Visual Acuity ◽

Manifest Refraction ◽

Corrected Distance Visual Acuity ◽

Lenticule Extraction

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.

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Small Incision Lenticule Extraction (SMILE) for Moderate and High Myopia: Seven-Year Outcomes of Refraction, Corneal tomography and Wavefront Aberrations

10.21203/rs.2.15558/v1 ◽

2019 ◽

Author(s):

Fei Xia ◽

Yang Shen ◽

Tian Han ◽

Jing Zhao ◽

Hai-Peng Xu ◽

...

Keyword(s):

Visual Acuity ◽

Spherical Aberration ◽

Case Series ◽

Final Visit ◽

Small Incision Lenticule Extraction ◽

Wavefront Aberrations ◽

Distance Visual Acuity ◽

Small Incision ◽

Uncorrected Distance Visual Acuity ◽

Lenticule Extraction

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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Clinical outcomes of small incision lenticule extraction versus advanced surface ablation in low myopia

European Journal of Ophthalmology ◽

10.1177/1120672119865699 ◽

2019 ◽

Vol 30 (6) ◽

pp. 1278-1286 ◽

Cited By ~ 1

Author(s):

Suphi Taneri ◽

Saskia Kießler ◽

Anika Rost ◽

Tim Schultz ◽

H Burkhard Dick

Keyword(s):

Visual Acuity ◽

Spherical Equivalent ◽

Small Incision Lenticule Extraction ◽

Distance Visual Acuity ◽

Small Incision ◽

Surface Ablation ◽

Uncorrected Distance Visual Acuity ◽

Corrected Distance Visual Acuity ◽

Spherical Equivalent Refraction ◽

Lenticule Extraction

Purpose: To compare the visual and refractive outcomes of small incision lenticule extraction and advanced surface ablation for low myopia or myopic astigmatism. Methods: Retrospective, observational case series of our first 50 consecutive small incision lenticule extraction patients compared to refraction-matched 50 advanced surface ablation treatments with attempted spherical equivalent correction ⩽−3.5 D, astigmatism ⩽−1.5 D, and corrected distance visual acuity of 1.0 (decimal scale) or better. Only one eye per patient was included. Results: Small incision lenticule extraction: mean attempted spherical equivalent correction was −2.80 ± 0.63 D. Uncorrected distance visual acuity was 0.85 and 1.0 at days 1 and 5, respectively. At 3 months, mean spherical equivalent refraction was 0.02 ± 0.32 D (range: −0.5 to +0.75 D), mean cylinder was −0.24 ± 0.21 D (range: 0 to −0.75 D), mean uncorrected distance visual acuity was 1.27, mean efficacy index was 0.96, and mean safety index was 1.05. Uncorrected distance visual acuity was same or better than corrected distance visual acuity in 96%, astigmatism ⩽0.5 D in 98% and ⩽1 D in 100% of eyes, respectively. Advanced surface ablation: mean attempted spherical equivalent correction was −2.75 ± 0.5 D. Uncorrected distance visual acuity was 0.72 and 0.61 at days 1 and 5, respectively. At 3 months, mean spherical equivalent refraction was 0.22 ± 0.32 D, mean cylinder was −0.27 ± 0.27 D, mean uncorrected distance visual acuity was 1.21, mean efficacy index was 1.03, and mean safety index was 1.08. Conclusion: Small incision lenticule extraction for low myopia was found to be safe and effective with outcomes at 3 months similar to those obtained with advanced surface ablation while offering a quicker visual recovery.

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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 ◽

Small Incision Lenticule Extraction ◽

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.

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Small Incision Lenticule Extraction for Postkeratoplasty Myopia and Astigmatism

Journal of Ophthalmology ◽

10.1155/2016/3686380 ◽

2016 ◽

Vol 2016 ◽

pp. 1-9 ◽

Cited By ~ 1

Author(s):

Tamer H. Massoud ◽

Osama Ibrahim ◽

Kitty Shehata ◽

Moones F. Abdalla

Keyword(s):

Visual Acuity ◽

Case Series ◽

Small Incision Lenticule Extraction ◽

Distance Visual Acuity ◽

Small Incision ◽

Refractive Outcomes ◽

Laser Vision ◽

Lenticule Extraction ◽

The Mean ◽

Myopic Astigmatism

Purpose. To evaluate the visual and refractive outcomes after small incision lenticule extraction (SMILE) for treating myopia and myopic astigmatism after penetrating keratoplasty (PKP).Design. Case-series.Methods. Ten eyes of 10 patients with previous PKP and residual myopic astigmatism for whom pentacam imaging and thickness measurements were acceptable for laser vision correction. Manifest refraction (MR), uncorrected distance visual acuity (UDVA), and corrected distance visual acuity (CDVA) were obtained preoperatively and one day, one week, and one, 3, and 6 months postoperatively. Cases were operated on the VisuMax® femtosecond laser platform with 500 kHz repetition rate.Results. The mean correction ratio for spherical errors was0.84±0.19 D and for the mean refractive spherical equivalent (MRSE) was0.79±0.13 D. Vector analysis showed a mean astigmatism reduction at the intended axis of67±25.25%, a correction index of0.81±0.21, and an overall mean percentage of success of astigmatism surgery of53±37.9%. The postoperative MRSE was stable throughout the 6-month follow-up period. The efficacy index was 0.93 and the safety index was 1.12.Conclusion. SMILE for correction of post-PKP myopia and astigmatism is effective, safe, and stable with moderate accuracy and predictability. Centration of the treatment within the grafts was easily performed.

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Small incision lenticule extraction (SMILE) monovision for presbyopia correction

European Journal of Ophthalmology ◽

10.5301/ejo.5001069 ◽

2017 ◽

Vol 28 (3) ◽

pp. 287-293 ◽

Cited By ~ 13

Author(s):

Nikolaus Luft ◽

Jakob Siedlecki ◽

Walter Sekundo ◽

Christian Wertheimer ◽

Thomas C. Kreutzer ◽

...

Keyword(s):

Visual Acuity ◽

Small Incision Lenticule Extraction ◽

Distance Visual Acuity ◽

Small Incision ◽

Uncorrected Distance Visual Acuity ◽

Corrected Distance Visual Acuity ◽

Effective Option ◽

Near Visual Acuity ◽

Lenticule Extraction ◽

Target Refraction

Purpose: To evaluate the outcomes of myopic small incision lenticule extraction (SMILE) monovision in presbyopic patients. Methods: This study included 49 presbyopic patients older than 45 years seeking surgical correction of myopia or myopic astigmatism who underwent bilateral SMILE with planned monovision in the SMILE Eyes Clinic Linz, Austria. Target refraction was plano for dominant (distance) eyes and ranged between -1.25 and -0.50 D for nondominant (near) eyes. Best-corrected distance visual acuity, uncorrected distance visual acuity (UDVA), uncorrected near visual acuity, as well as spectacle dependence were assessed after a mean postoperative period of 7.2 ± 4.8 months. Results: Mean age was 49 ± 3 years and female to male ratio was 30:19. Distance eyes achieved a spherical equivalent correction of ±0.50 D from target refraction in 80% of patients and 96% were within ±1.0 D. Binocular UDVA of 20/20 or better was achieved by 90% of patients and all patients achieved 20/25 or better. The proportion of patients with a binocular UDVA of 20/20 or better who could read J2 or better amounted to 84%. Complete spectacle independence was achieved by 84% of patients and independence from reading glasses was achieved in 92% of cases. No patient requested refractive enhancement or monovision reversal. Conclusions: This first evaluation of SMILE monovision endorses the approach as a safe and effective option for the correction of presbyopia in myopic patients seeking refractive surgery.

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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 ◽

Small Incision Lenticule Extraction ◽

Distance Visual Acuity ◽

Small Incision ◽

Lenticule Extraction

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.

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Small Incision Lenticule Extraction (SMILE) for Moderate and High Myopia: Seven-Year Outcomes of Refraction, Corneal Tomography, and Wavefront Aberrations

Journal of Ophthalmology ◽

10.1155/2020/3825864 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7 ◽

Cited By ~ 1

Author(s):

Fei Xia ◽

Yang Shen ◽

Tian Han ◽

Jing Zhao ◽

Haipeng Xu ◽

...

Keyword(s):

Visual Acuity ◽

High Myopia ◽

Spherical Aberration ◽

Final Visit ◽

Small Incision Lenticule Extraction ◽

Wavefront Aberrations ◽

Distance Visual Acuity ◽

Small Incision ◽

Lenticule Extraction ◽

Corneal Tomography

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.

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A Case Report Of Retained Lenticules After SMILE Surgery

10.21203/rs.2.426/v1 ◽

2019 ◽

Author(s):

YangCheng Zou ◽

Kaiwei Cao ◽

Ting Yu ◽

Ji Bai ◽

Ting Liu

Keyword(s):

Visual Acuity ◽

Case Report ◽

Female Patient ◽

Separation Method ◽

Small Incision Lenticule Extraction ◽

Distance Visual Acuity ◽

Small Incision ◽

Uncorrected Distance Visual Acuity ◽

Second Surgery ◽

Lenticule Extraction

Abstract A 28-year-old female patient (right eye: -3.75DS, left eye: -4.00DS) underwent bilateral small incision lenticule extraction. One week after small incision lenticule extraction, her left eye uncorrected distance visual acuity (UDVA) did not reach her preoperative best corrected distance visual acu¬ity (BCDVA) as expected. Examination confirmed that corneal stromal lens fragments remained in the left eye. The lens fragments were removed with a second surgery, and the patient's vision was restored to her preoperative BCDVA. The results of this case yield the following suggestions: ① The lens separation method must be gentle and performed in the same plane. ② It is necessary to confirm the integrity of the lens after the lens is removed.

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Impact of extreme (flat and steep) keratometry on the safety and efficacy of small incision lenticule extraction (SMILE)

Scientific Reports ◽

10.1038/s41598-021-97375-4 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Nikolaus Luft ◽

Jakob Siedlecki ◽

Franziska Reinking ◽

Wolfgang J. Mayer ◽

Benedikt Schworm ◽

...

Keyword(s):

Visual Acuity ◽

Spherical Aberration ◽

Spherical Equivalent ◽

Small Incision Lenticule Extraction ◽

Safety And Efficacy ◽

Distance Visual Acuity ◽

Small Incision ◽

Department Of Ophthalmology ◽

Corrected Distance Visual Acuity ◽

Lenticule Extraction

AbstractLittle is known about the connection between preoperative keratometry and postoperative results of myopic small-incision lenticule extraction (SMILE). To determine the influence of extreme (flat and steep) corneal keratometry on the safety and efficacy of SMILE, the databases of the Department of Ophthalmology, Ludwig-Maximilians-University Munich, Germany, and SMILE Eyes Linz, Austria, were screened for patients with steep and flat keratometry who had undergone SMILE. In this cross-sectional matched comparative cohort study, eyes with markedly flat (< 42.0 diopters; D) or steep (≥ 47.0D) preoperative corneal keratometry were matched to a cohort of eyes with regular keratometry (42.0–46.9D) by preoperative manifest refractive spherical equivalent and cylinder, age, corrected distance visual acuity and surgical SMILE parameters. The standardized graphs and terms for refractive surgery results were applied to compare the three groups. Changes in higher order aberrations (HOAs) were evaluated on Scheimpflug imaging. In total, 63 eyes (21 each) of 54 patients with a mean refractive spherical equivalent of − 5.21 ± 1.59 D were followed up for a mean of 9.2 ± 6.1 (minimum ≥ 3) months. Mean baseline keratometry was 41.3 ± 0.7D (flat), 45.5 ± 1.0D (regular) and 47.7 ± 0.6D (steep) (p < 0.0001). Compared to the regular group, the flat and the steep cornea group resulted in a non-inferior percentage of eyes within ± 0.50 D of target refraction (p = 0.20), uncorrected distance visual acuity (p = 0.95) and corrected distance visual acuity (p = 0.20). Flat corneas however experienced a stronger induction of spherical aberration (SA) compared to the steep group (p = 0.0005). In conclusion, non-inferior outcomes of SMILE can also be expected in eyes with steep (≥ 47D) or flat (< 42D) preoperative keratometry, while SMILE however induces more SA in eyes with a flat keratometry.

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