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      Efficacy, predictability and safety of small incision lenticule extraction (SMILE)

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          Abstract

          Background

          The purpose of this case series is to report the one-year outcomes of small incision lenticule extraction (SMILE) using the VisuMax® femtosecond laser.

          Methods

          Two hundred and six patients were recruited for this retrospective, single center study at TRSC International LASIK Center in Bangkok, Thailand. Patients underwent SMILE, whereby an intrastromal lenticule was cut using a femtosecond laser and then manually extracted without the need for flap creation. Outcome measures included refraction, visual acuity and contrast sensitivity evaluation. Patients were treated and followed for one year.

          Results

          SMILE for the correction of low to high myopia was performed on 347 eyes of 206 patients. The mean preoperative spherical equivalent was −4.96 ± 1.88 diopters (D). On the first day following surgery, for eyes with a plano target refraction (99.14 % of all eyes), uncorrected distance visual acuity (UDVA) was 20/20 or better in 90 % of eyes. At the one week postoperative exam, the mean spherical equivalent was 0.01 ± 0.36 D and UDVA was 20/20 or better in 84 % of eyes. After one year follow-up, no eyes showed loss of 2 or more lines of visual acuity and 31 % of eyes gained one or more lines. The photopic contrast sensitivity of SMILE treated eyes at 12 and 18 cycles per degree (cpd) improved from 1.59 and 0.94 preoperatively to 1.6 and 0.98, respectively, after one year.

          Conclusions

          In this series, SMILE using the VisuMax® femtosecond laser demonstrated that after one year it is an effective, predictable and safe minimally invasive corneal refractive procedure.

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          Most cited references23

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

          Samir Shah, Pankaj Shah, S Sengupta (2010)
          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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            LASIK world literature review: quality of life and patient satisfaction.

            Kerry Solomon, Luis E Fernández de Castro, Helga Sandoval … (2009)
            To analyze the patient reported outcome of satisfaction after LASIK surgery. Systematic review. Patient data from previously reported studies. A literature search conducted for the years 1988 to 2008 that included pertinent LASIK surgery information from the review of 2915 retrieved citations. All abstracts from these citations were reviewed and 1581 were deemed to be relevant for review. Complete copies of each of these relevant (1581) articles were obtained, and after thorough analysis each was rated based on the strength of the study design and weight of evidence. A level I rating was assigned to properly conducted, well-designed, randomized clinical trials; a level II rating to well-designed cohort and case-control studies; and a level III rating to case series, case reports, and poorly designed prospective and retrospective studies. Level I and II rated, peer-reviewed articles were entered into a database, and level III articles were eliminated. A total of 309 articles were incorporated into this database, representing level I and level II well-controlled studies of primary LASIK surgery. Patients' satisfaction rates and factors associated with dissatisfaction. Nineteen of the 309 database articles (6.1%) reported on both patient quality of life and satisfaction and together encompassed a total of 2198 subjects. The procedures from these 19 articles took place between 1995 and 2003. The overall patient satisfaction rate after primary LASIK surgery was 95.4% (2097 of 2198 subjects; range of patient satisfaction for the 19 articles was 87.2%-100%). The patient satisfaction rate after myopic LASIK was 95.3% (1811 of 1901 patients), and after hyperopic LASIK was 96.3% (286 of 297 subjects). Based on this review, worldwide, an average 95.4% of patients were satisfied with their outcome after LASIK surgery. With 16.3 million procedures performed worldwide, and more than a decade of clinical studies and technological innovation, LASIK surgery should be considered among the most successful elective procedures. LASIK surgery compares more favorably with other elective surgical procedures in terms of generally higher satisfaction rates.
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              First efficacy and safety study of femtosecond lenticule extraction for the correction of myopia: six-month results.

              G Stobrawa, Wilfried Bissmann, Markus Sticker … (2008)
              To prospectively study the feasibility of femtosecond lenticule extraction (FLE), a new method of refractive correction. Department of Ophthalmology, Philipps University of Marburg and Helios Clinic, Erfurt, Germany. A flap and a lenticule of intrastromal corneal tissue were simultaneously cut with a VisuMax femtosecond laser system. Next, the lenticule was manually removed and the flap repositioned. The target refraction in all cases was -0.75 diopter (D). All 10 myopic eyes in the initial treatment group completed the final 6-month follow-up. The mean patient age was 39 years. The mean spherical equivalent (SE) was -4.73 +/- 1.48 (SD) preoperatively and -0.33 +/- 0.61 D 6 months postoperatively. Ninety percent of eyes were within +/-1.00 D and 40% were within +/-0.50 D of the intended correction. No eye lost 2 or more Snellen lines. Corneal topography showed large, prolate optical zones. Aberrometry showed no significant induction of higher-order aberrations. On a standardized questionnaire, all patients said they were very satisfied with the results. Preliminary results indicate that FLEx [corrected] is a promising new corneal refractive procedure to correct myopia.
              Article 0 comments Cited 77 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Ekktet Chansue: +6627332020 , echansue@lasikthai.com
                Journal
                Journal ID (nlm-ta): Eye Vis (Lond)
                Journal ID (iso-abbrev): Eye Vis (Lond)
                Title: Eye and Vision
                Publisher: BioMed Central (London )
                ISSN (Electronic): 2326-0254
                Publication date (Electronic): 31 August 2015
                Publication date PMC-release: 31 August 2015
                Publication date Collection: 2015
                Volume: 2
                Electronic Location Identifier: 14
                Affiliations
                [ ]TRSC International LASIK Center, 6th Floor U Chu Liang Building, 968 Rama 4 Road, Bangkok, Thailand
                [ ]Flinders University, Bedford Park, Adelaide, South Australia Australia
                [ ]Wenzhou Medical College, Wenzhou, Zhejiang China
                Article
                Publisher ID: 24
                DOI: 10.1186/s40662-015-0024-4
                PMC ID: 4657258
                PubMed ID: 26605367
                SO-VID: 10935e58-e6a7-44a4-bcf2-926aa29d1f4f
                Copyright © © Chansue et al. 2015
                License:

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 31 March 2015
                Date accepted : 17 August 2015
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © The Author(s) 2015

                Keywords: small incision lenticule extraction,visumax,femtosecond
                Data availability:
                Keywords: small incision lenticule extraction, visumax, femtosecond

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