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      Refractive and Visual Outcomes of SMILE for Compound Myopic Astigmatism With the VISUMAX 800

      , , , ,
      Journal of Refractive Surgery
      SLACK, Inc.

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          Abstract

          Purpose:

          To report the first refractive and visual outcomes of small incision lenticule extraction (SMILE) using the VISUMAX 800 femtosecond laser (Carl Zeiss Meditec AG).

          Methods:

          This was a retrospective analysis of consecutive eyes treated by SMILE using the VISUMAX 800 femtosecond laser at London Vision Clinic, EuroEyes Group, London, United Kingdom. Inclusion criteria were patients aged younger than 45 years, a corrected distance visual acuity (CDVA) of 20/20 or better, and the 3-month postoperative timepoint data being available for analysis. Standard outcomes analysis and vector analysis by the Alpins method were performed.

          Results:

          During the study period, 128 eyes of 66 consecutive patients were treated. Three-month data were available for 118 eyes (92%), and 10 eyes (8%) were lost to follow-up. The mean attempted spherical equivalent refraction (SEQ) was −4.65 ± 1.91 diopters (D) (range: −1.90 to −10.05 D) and the mean cylinder was −0.98 ± 0.78 D (range: 0.00 to −4.00 D). The mean age was 30 ± 5 years (range: 20 to 43 years), with 54% women and 46% men. Postoperative SEQ was within ±0.50 D in 86% and ±1.00 D in 100% of eyes. Uncorrected distance visual acuity was 20/20 or better in 91% of eyes. One line of CDVA was lost in 8% of eyes, and no eyes lost two or more lines. There was a small but statistically significant increase in contrast sensitivity at 3, 6, 12, and 18 cpd.

          Conclusions:

          Early outcomes data for SMILE with the second generation VISUMAX 800 femtosecond laser demonstrated an effective and safe option equivalent to published first generation VisuMax outcomes for the treatment myopia and astigmatism.

          [ J Refract Surg . 2023;39(5):294–301.]

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          Most cited references18

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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 corneal refractive surgery using the small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism: results of a 6 month prospective study.

            This 6 month prospective multi-centre study evaluated the feasibility of performing myopic femtosecond lenticule extraction (FLEx) through a small incision using the small incision lenticule extraction (SMILE) procedure. Prospective, non-randomised clinical trial. PARTICIPANTS; Ninety-one eyes of 48 patients with myopia with and without astigmatism completed the final 6 month follow-up. The patients' mean age was 35.3 years. Their preoperative mean spherical equivalent (SE) was −4.75±1.56 D. A refractive lenticule of intrastromal corneal tissue was cut utilising a prototype of the Carl Zeiss Meditec AG VisuMax femtosecond laser system. Simultaneously two opposite small ‘pocket’ incisions were created by the laser system. Thereafter, the lenticule was manually dissected with a spatula and removed through one of incisions using modified McPherson forceps. Uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BSCVA) after 6 months, objective and manifest refraction as well as slit-lamp examination, side effects and a questionnaire. Six months postoperatively the mean SE was −0.01 D±0.49 D. Most treated eyes (95.6%) were within ±1.0 D, and 80.2% were within ±0.5 D of intended correction. Of the eyes treated, 83.5% had an UCVA of 1.0 (20/20) or better, 53% remained unchanged, 32.3% gained one line, 3.3% gained two lines of BSCVA, 8.8% lost one line and 1.1% lost ≥2 lines of BSCVA. When answering a standardised questionnaire, 93.3% of patients were satisfied with the results obtained and would undergo the procedure again. SMILE is a promising new flapless minimally invasive refractive procedure to correct myopia.
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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

                Journal
                Journal of Refractive Surgery
                J Refract Surg
                SLACK, Inc.
                1081-597X
                May 2023
                May 2023
                : 39
                : 5
                : 294-301
                Article
                10.3928/1081597X-20230301-02
                37162399
                8063da17-0d3c-4708-9130-a6fd30579ef3
                © 2023
                History

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