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      Small Incision Lenticule Extraction (SMILE) versus Femtosecond Laser-Assisted In Situ Keratomileusis (FS-LASIK) for Myopia: A Systematic Review and Meta-Analysis

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          Abstract

          Purpose

          The goal of this study was to compare small incision lenticule extraction (SMILE) with femtosecond laser-assisted in situ keratomileusis (FS-LASIK) for treating myopia.

          Methods

          The CENTRAL, EMBASE, PubMed databases and a Chinese database (SinoMed) were searched in May of 2016. Twelve studies with 1,076 eyes, which included three randomized controlled trials (RCTs) and nine cohorts, met our inclusion criteria. The overall quality of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group framework. Data were extracted and analysed at three to six months postoperatively. Primary outcome measures included a loss of one or more lines of best spectacle corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA) of 20/20 or better, mean logMAR UCVA, postoperative mean spherical equivalent (SE) and postoperative refraction within ±1.0 D of the target refraction. Secondary outcome measures included ocular surface disease index (OSDI), tear breakup time (TBUT) and Schirmer’s 1 test (S1T) as dry eye parameters, along with corneal sensitivity.

          Results

          The overall quality of evidence was considered to be low to very low. Pooled results revealed no significant differences between the two groups with regard to a loss of one or more lines in the BSCVA (OR 1.71; 95% CI: 0.81, 3.63; P = 0.16), UCVA of 20/20 or better (OR 0.71; 95% CI: 0.44, 1.15; P = 0.16), logMAR UCVA (MD 0.00; 95% CI: -0.03, 0.04; P = 0.87), postoperative refractive SE (MD -0.00; 95% CI: -0.05, 0.05; P = 0.97) or postoperative refraction within ±1.0 D of the target refraction (OR 0.78; 95% CI: 0.22, 2.77; P = 0.70) within six months postoperatively. The pooled analysis also indicated that the FS-LASIK group suffered more severely from dry eye symptoms (OSDI; MD -6.68; 95% CI: -11.76, -2.00; P = 0.006) and lower corneal sensitivity (MD 12.40; 95% CI: 10.23, 14.56; P < 0.00001) at six months postoperatively.

          Conclusions

          In conclusion, both FS-LASIK and SMILE are safe, effective and predictable surgical options for treating myopia. However, dry eye symptoms and loss of corneal sensitivity may occur less frequently after SMILE than after FS-LASIK.

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          Most cited references26

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          Results of small incision lenticule extraction: All-in-one femtosecond laser refractive surgery.

          To report the clinical results of small incision lenticule extraction to correct refractive errors using a femtosecond laser to refine the femtosecond lenticule extraction technique. Private laser center, Vadodara, India. Prospective clinical study. The VisuMax femtosecond laser system was used to perform small incision lenticule extraction to treat refractive errors. The laser was used to cut a refractive lenticule intrastromally to correct myopia and myopic astigmatism. The lenticule was then extracted from the stroma through a 3.0 to 5.0 mm incision. Outcome measures were corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), and manifest refraction during 6 months of follow-up. Corneal topography and ocular wavefront aberrations were also measured. The study enrolled 51 eyes of 41 patients. The mean spherical equivalent was -4.87 diopters (D) ± 2.16 (SD) preoperatively and +0.03 ± 0.30 D 6 months postoperatively. Refractive stability was achieved within 1 month (P<.01). Six months after surgery, 79% of all full-correction cases had a UDVA of 20/25 or better. The 6-month postoperative CDVA was the same as or better than the preoperative CDVA in 95% of eyes. Two eyes lost 1 line of CDVA. All-in-one femtosecond refractive correction using a small incision technique was safe, predictable, and effective in treating myopia and myopic astigmatism. No author has a financial or proprietary interest in any material or method mentioned. Additional disclosure is found in the footnotes. Copyright © 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.
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            Dry eye disease after refractive surgery: comparative outcomes of small incision lenticule extraction versus LASIK.

            To compare small incision lenticule extraction (SMILE) versus LASIK for post-refractive dry eye disease.
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              Comparison of visual and refractive outcomes following femtosecond laser- assisted lasik with smile in patients with myopia or myopic astigmatism.

              To compare the visual and refractive out-comes of femtosecond laser-assisted LASIK with small-incision lenticule extraction (SMILE) in terms of visual acuity, contrast sensitivity, aberrations, and dry eye. A single-center prospective randomized study in which patients diagnosed as having myopia presenting for refractive correction were allocated to either a LASIK or SMILE group. The primary outcome measures were refractive efficacy, predictability, and safety, postoperative contrast sensitivity, aberrations, and dry eye status. Patients were followed up at days 1 and 15 and 3 months; postoperative uncorrected visual acuity (UCVA), aberrations, dry eye, and contrast sensitivity were recorded and compared to preoperative data. Two postoperative subjective questionnaires were used to assess pain, pricking sensation, redness, glare, and overall patient satisfaction. At day 1 postoperatively, 48 (96%) of 50 eyes in the SMILE group achieved a UCVA of 20/20 compared with 46 (92%) of 50 eyes in the LASIK group. At day 15 postoperatively, contrast sensitivity was similar in the two groups (P = .15), but by 3 months, it was better in the SMILE group than the LASIK group at all spatial frequencies (P < .0001). At 3 months postoperatively, 42 (84%) eyes in each group achieved a UCVA of 20/20, with 6 (12%) eyes in the SMILE group and 2 (4%) eyes in the LASIK group achieving 20/15. Higher-order aberrations at 3 months postoperatively were significantly higher in the LASIK group (0.437 + 0.103 pm) than in the SMILE group (0.267 + 0.07 pm; P < .001). Postoperative dry eye and glare were significantly more common following LASIK (P < .001). Three-month results demonstrate that refractive accuracy, dry eye, contrast, and induced aberrations are better following SMILE rather than LASIK.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                1 July 2016
                2016
                : 11
                : 7
                : e0158176
                Affiliations
                [1 ]Eye Center, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China
                [2 ]Department of Gastroenterology, First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China
                University of Florence, ITALY
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: ZRS KY. Performed the experiments: YHY YCL. Analyzed the data: KDS. Contributed reagents/materials/analysis tools: XNY. Wrote the paper: ZRS. Revised the manuscript: KY.

                Article
                PONE-D-16-12290
                10.1371/journal.pone.0158176
                4930219
                27367803
                0b4f3102-8c96-448c-ac91-95593572007d
                © 2016 Shen et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 25 March 2016
                : 11 June 2016
                Page count
                Figures: 6, Tables: 4, Pages: 16
                Funding
                Funded by: Zhejiang Key Laboratory Fund of China
                Award ID: 2011E10006
                Award Recipient :
                Funded by: Project of National Clinical Key Discipline of Chinese Ministry of Health
                Award Recipient :
                This work was supported by Zhejiang Key Laboratory Fund of China (2011E10006) and Project of National Clinical Key Discipline of Chinese Ministry of Health. KY is the recipient. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
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                Biology and Life Sciences
                Anatomy
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                Eyes
                Medicine and Health Sciences
                Anatomy
                Head
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