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      Comparison of visual results and higher-order aberrations after small incision lenticule extraction (SMILE): high myopia vs. mild to moderate myopia

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          Abstract

          Background

          To compare the refractive results and higher-order aberrations (HOAs) after small incision lenticule extraction (SMILE) in high myopia and mild to moderate myopia patients.

          Methods

          This prospective study included 165 eyes (86 patients) undergoing SMILE. According to the preoperative spherical equivalent (SE), treated eyes were divided into two groups: the high myopia group (more than -6.0 D, group-H) and the mild to moderate group (less than -6.0 D, group-M). Follow-up intervals were at 1 day, 10 days, 1 month and 3 months postoperatively. We obtained the following parameters: uncorrected (UDVA) and corrected distance visual acuity (CDVA), SE, efficacy and safety index, and HOAs.

          Results

          Preoperative SE was -7.16 ± 0.93 D in group-H and -4.34 ± 0.97 D in group-M. At 3 months postoperatively, the SE in group-H and group-M was -0.20 ± 0.37 D and 0.01 ± 0.19 D ( t = - 4.11, P<0.05), respectively. It was found that 77% and 98% had an UDVA of 20/20, 98% and 99% had a CDVA of 20/20 in group-H and group-M, respectively, while 87% and 95% had a SE within ±0.5 D and ±1.0 D in group-H, and 98% and 100% in group-M. The efficacy indexes were 0.98 ± 0.18 in group-H and 1.05 ± 0.10 in group-M ( t = - 3.084, p < 0.05). The safety indexes were 1.06 ± 0.09 and 1.06 ± 0.09 ( t = 0.153, p > 0.05), respectively. There were significant increases in total HOAs, 3 rd-order coma, and 4 th-order spherical aberrations.

          Conclusions

          SMILE is an effective and safe surgery for correcting myopia. But the target correction amount in high myopia patients should be adjusted to avoid undercorrection and acquired more satisfaction. SMILE induced increases of HOAs.

          Trial registration

          ChiTrial registration number: ChiCTR-OON-16009164. Retrospectively registered: 06.September.2016

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          Most cited references25

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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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            Statistical guidelines for the analysis of data obtained from one or both eyes.

            Measurements obtained from the right and left eye of a subject are often correlated whereas many statistical tests assume observations in a sample are independent. Hence, data collected from both eyes cannot be combined without taking this correlation into account. Current practice is reviewed with reference to articles published in three optometry journals, viz., Ophthalmic and Physiological Optics (OPO), Optometry and Vision Science (OVS), Clinical and Experimental Optometry (CEO) during the period 2009-2012.
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              Safety and complications of more than 1500 small-incision lenticule extraction procedures.

              To evaluate the safety and complications of small-incision lenticule extraction (SMILE). Clinical control cohort study. A total of 922 healthy patients (1800 eyes) who were treated for myopia or myopic astigmatism between January 2011 and March 2013 at the Department of Ophthalmology, Aarhus, Denmark. Patients received a full preoperative examination and were treated with SMILE in both eyes and followed for 3 months (1574 eyes). Patients with complications, including loss of corrected distance visual acuity (CDVA) or dissatisfaction, were offered a late reexamination. Surgical complications and CDVA. Mean preoperative spherical equivalent refraction was -7.25±1.84 diopters (D). Average postoperative refraction was -0.28±0.52 D, and mean error of treatment was -0.15±0.50 D. By 3 months, 86% (1346 eyes) had unchanged or improved CDVA. A loss of 2 or more lines was observed in 1.5% of eyes; however, at a late follow-up visit (average, 18 months), CDVA was within 1 line of the preoperative level in all eyes. Perioperative complications included epithelial abrasions (6%), small tears at the incision (1.8%), and difficult lenticule extraction (1.9%). The cap was perforated in 4 eyes, and a major tear occurred in 1 eye; however, none of these patients had late visual symptoms. In 0.8% (14 eyes), suction was lost during surgery. Re-treatment was successful in 13 eyes, whereas 1 eye had ghost images and was re-treated with topography-guided photorefractive keratectomy (PRK). Postoperative complications included trace haze (8%), epithelial dryness on day 1 (5%), interface inflammation secondary to central abrasion (0.3%), and minor interface infiltrates (0.3%); these complications had an impact on CDVA at 3 months in only 1 case. Irregular corneal topography occurred in 1.0% of eyes, resulting in reduced 3-month CDVA (12 eyes) or ghost images (6 eyes). Topography-guided PRK was performed in 4 eyes, with improvement in 3 cases. Satisfaction was high, with only 2 patients dissatisfied at their latest visit because of blurred vision or residual astigmatism. Overall, SMILE had acceptable safety. Although 1.5% of eyes had reduced CDVA by 3 months, visual acuity was restored in the long term. Likewise, patient satisfaction was high. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                hongyingj@163.com
                64230519@qq.com
                fangwuu@126.com
                +86 571 87783897 , xlren@zju.edu.cn
                Journal
                BMC Ophthalmol
                BMC Ophthalmol
                BMC Ophthalmology
                BioMed Central (London )
                1471-2415
                6 July 2017
                6 July 2017
                2017
                : 17
                : 118
                Affiliations
                ISNI 0000 0004 1759 700X, GRID grid.13402.34, Eye Center, Second Affiliated Hospital, College of Medicine, , Zhejiang University, ; Hangzhou, 310009 China
                Article
                507
                10.1186/s12886-017-0507-2
                5501544
                28683793
                e618d56e-7e89-45ce-9988-4f9dc3358834
                © The Author(s). 2017

                Open AccessThis 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
                : 5 April 2017
                : 22 June 2017
                Funding
                Funded by: Zhejiang Key Laboratory Fund of China
                Award ID: 2011E10006
                Award Recipient :
                Funded by: Zhejiang Province Key Research and Development Program
                Award ID: 2015C03042
                Award Recipient :
                Funded by: National Natural Science Foundation of China
                Award ID: 81500694
                Award Recipient :
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2017

                Ophthalmology & Optometry
                refractive surgery, small incision lenticule extraction, myopia, higher-order aberrations, complication

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