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      Safety and efficacy of VisuMax® circle patterns for flap creation and enhancement following small incision lenticule extraction

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          Abstract

          Background

          The purpose of this case series is to evaluate the safety and efficacy of VisuMax® Circle patterns in eyes that have undergone small incision lenticule extraction, thus creating a flap to perform an enhancement procedure or residual lenticule extraction.

          Methods

          This prospective, single center, case study series evaluated the use of a VisuMax® Circle pattern to create a corneal flap following small incision lenticule extraction. Patients were treated and followed at TRSC International LASIK Center (Bangkok, Thailand) for 3 months to assess the efficacy and safety of the procedure. Efficacy was determined by the surgeon’s ability to lift the created corneal flap.

          Results

          The study enrolled 28 eyes. Twenty-seven underwent the VisuMax® Circle pattern procedure for refractive enhancement, and one for residual lenticule extraction. In 100 % of cases (28 eyes) the lifting of the flap was possible, as planned. In all cases of refractive enhancement (27 eyes) by laser in situ keratomileusis (LASIK), the exposure of the stromal bed was sufficient for the necessary excimer laser ablation. No eyes lost two or more Snellen lines of corrected distance visual acuity (CDVA) and no procedure or flap-related complications or serious adverse events occurred.

          Conclusions

          This initial case series demonstrates that VisuMax® Circle pattern is efficacious and a suitable method to create a corneal flap for enhancement, following small incision lenticule extraction.

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          Most cited references11

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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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            Small-incision lenticule extraction for moderate to high myopia: Predictability, safety, and patient satisfaction.

            To present initial clinical experience with small-incision lenticule extraction for the treatment of moderate to high myopia. Department of Ophthalmology, Aarhus University Hospital, Aarhus, Denmark. Prospective clinical study. For small-incision lenticule extraction, an intrastromal lenticule was cut with a femtosecond laser and manually extracted without creation of a flap. Patients were treated and followed for 3 months. Only 1 randomly chosen eye of each patient was used in the statistical analyses. The study enrolled 144 patients. The mean preoperative spherical equivalent was -7.18 diopters (D) ± 1.57 (SD). Of eyes with emmetropia as target refraction, 40% had an uncorrected distance visual acuity of 0.1 logMAR or less 1 day after surgery; this increased to 73% at 3 months. The mean corrected distance visual acuity (CDVA) improved significantly from -0.01 (logMAR) preoperatively to -0.03 3 months postoperatively. None of the 127 eyes lost 2 lines or more of CDVA and 6 eyes lost 1 line of CDVA after 3 months. In contrast, 1 eye gained 2 lines and 24 eyes gained 1 line of CDVA. The achieved refraction was a mean of -0.09 ± 0.45 D from the attempted refraction. Of the eyes, 77% were within ±0.50 D and 95% were within ±1.00 D. Ninety-five percent of the patients would recommend the procedure to others. The refractive predictability, safety, and patient satisfaction 3 months after small-incision lenticule extraction were high and comparable to results in previous studies of femtosecond laser-assisted techniques. Drs. Hjortdal and Asp received travel reimbursement from Carl Zeiss Meditec AG, Jena, Germany. No other author has a financial or proprietary interest in any material or method mentioned. Copyright © 2012 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.
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              Femtosecond lenticule extraction for the correction of myopia: preliminary 6-month results.

              To report the 6-month results of a new method of refractive correction, femtosecond lenticule extraction (FLEx), and the preliminary outcomes in the first 108 eyes. In this prospective study, a flap and a lenticule of intrastromal corneal tissue were cut simultaneously using a femtosecond laser. Thereafter, the lenticule was removed manually and the flap repositioned. One hundred and seven of 108 myopic eyes of 56 patients in the treatment group completed the final 6 months of follow-up. The patients' mean age was 35 years. The preoperative mean spherical equivalent (SE) was -4.59 +/- 1.3 diopters (D). The uncorrected visual acuity and the best spectacle-corrected visual acuity after 6 months, objective and manifest refractions, results of slit-lamp examination, the side effects, and the responses to a questionnaire are reported. Six months postoperatively, the mean SE was -0.19 +/- 0.47 D; 98.1% of treated eyes were within +/-1.0 D, and 74.8% of eyes within +/-0.5 D of the intended correction. Eight (7.4%) of 108 eyes lost one line of Snellen VA, one (0.9%) eye lost two Snellen lines, 46 eyes (43%) gained one line, ten eyes (9.3%) gained two Snellen lines, and the VA remained unchanged in 42 (39.3%) eyes. The patient responses to a standardized questionnaire indicated that 97.1% of patients were satisfied with the obtained results and would undergo the procedure again. FLEx appears to be a safe and promising corneal refractive procedure for correcting myopia.
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                Author and article information

                Contributors
                +6627332020 , echansue@lasikthai.com
                Journal
                Eye Vis (Lond)
                Eye Vis (Lond)
                Eye and Vision
                BioMed Central (London )
                2326-0254
                26 December 2015
                26 December 2015
                2015
                : 2
                : 21
                Affiliations
                [ ]TRSC International LASIK Center, 6th Floor, U Chu Liang Boulevard, 968 Rama 4 Road, Bangkok, Thailand
                [ ]Flinders University, Bedford Park, Adelaide, South Australia Australia
                [ ]Wenzhou Medical College, Wenzhou, Zhejiang China
                Article
                31
                10.1186/s40662-015-0031-5
                4691292
                26709375
                bb2c2b52-1060-4a00-91de-886212e4e61f
                © Chansue et al. 2015

                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
                : 24 September 2015
                : 11 December 2015
                Categories
                Research
                Custom metadata
                © The Author(s) 2015

                small incision lenticule extraction,smile,lenticule,residual lenticule extraction,flap creation,circle pattern,refractive enhancement,femtosecond laser,refractive surgery

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