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      Risk factors and incidence of suction loss during small incision lenticule extraction (SMILE) in 8493 eyes

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          Abstract

          Background

          To report the incidence and risk factors of suction loss during small incision lenticule extraction (SMILE).

          Methods

          This retrospective comparative case control study included 8493 eyes of 4261 patients. Patients underwent SMILE surgery between January 2014 and September 2019 were included. Videos of suction loss were reviewed, and the direct causes of suction loss were noted. An independent samples t-test was used for comparisons between the suction loss group and the control group. A binary logistic regression model was used to determine the possible significant risk factors that might increase the likelihood of suction loss during SMILE surgery.

          Results

          Suction loss occurred in 31 (0.37%) eyes of 30 patients; 23 (74.2%) cases occurred in the right eye (the first operative eye) and 8 (25.8%) cases occurred in the left eye. Among the 30 patients, 23 (76.7%) were male and 7 (23.3%) were female. The incidence in the six consecutive years were 0, 2.13, 0.34, 0.24, 0.22, and 0.25%. Head and eye movements during surgery caused suction loss in 16 (51.6%) and 15 (48.4%) eyes, respectively. Comparison between the suction loss group and the control group showed that the first operative eye and male sex are at a significantly high risk for suction loss ( p < 0.05).

          Conclusions

          The risk factors of suction loss were first operative eye and male sex. Head and eye movements due to patient anxiety are the most common direct causes of suction loss. Surgeon’s experience may help to reduce the incidence of suction loss. Preoperative education and better communication during surgery needs to be emphasized.

          Trial registration

          Retrospectively registered. ChiCTR-ORC-17011040. Registered 1 April 2017. Name of registry: The observation of clinical results after corneal refractive surgery. Data of enrolment of the first participant to the trial: 1 January 2014.

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          Most cited references14

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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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            Incidence and management of intraoperative complications during small-incision lenticule extraction in 3004 cases

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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

              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. There were significant increases in total HOAs, 3rd-order coma, and 4th-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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                Author and article information

                Contributors
                hongyingj@zju.edu.cn
                Journal
                BMC Ophthalmol
                BMC Ophthalmol
                BMC Ophthalmology
                BioMed Central (London )
                1471-2415
                16 October 2020
                16 October 2020
                2020
                : 20
                : 412
                Affiliations
                [1 ]GRID grid.506261.6, ISNI 0000 0001 0706 7839, Chinese Academy of Medical Sciences, Peking Union Medical College, ; Beijing, China
                [2 ]GRID grid.13402.34, ISNI 0000 0004 1759 700X, Eye Center, Second Affiliated Hospital, School of Medicine, , Zhejiang University, ; No. 88 Jiefang Road, Hangzhou, China
                Article
                1680
                10.1186/s12886-020-01680-x
                7566065
                33066752
                51f1a03e-5a3e-4788-9fa0-d5bf079e2227
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.

                History
                : 6 August 2020
                : 5 October 2020
                Funding
                Funded by: Zhejiang Province Natural Science Foundation of China
                Award ID: No. LY20H120010
                Award Recipient :
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2020

                Ophthalmology & Optometry
                suction loss,risk factors,small incision lenticule extraction,refractive surgery

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