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Small Incision Corneal Refractive Surgery using the SMILE procedure for the Correction of Myopia and Myopic Astigmatism: Results of a 6 months prospective study

Abstract : Abstract Purpose: This 6 months prospective multi-center study evaluated the feasibility of performing myopic Femtosecond Lenticule Extraction (FLEx) through a small incision using the SMILE procedure. Design: Prospective, non randomized clinical trial. Participants: 91 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 D (± 1.56 D). Methods: A refractive lenticule of intrastromal corneal tissue was cut utilizing a prototype of the Carl Zeiss Meditec AG (CZM) 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 trough one of incisions using a modified McPherson forceps. Main outcome measures: UCVA and BSCVA after 6 months, objective and manifest refraction as well as slit-lamp examination, side effects and a questionnaire. Results: 6 months post-operatively, the mean SE was -0.01 D ± 0.49 D. 95,6 % of eyes treated were within 1.0 D, and 80,2% of eyes within 0.5 D of intended correction. 83.5% of eyes treated had an UCVA of 1.0 (20/20) or better. 53% of eyes remained unchanged, 32.3% gained one line and 3.3% two lines of BSCVA. 8.8% lost one line and 1.1% lost ≥ 2 lines of BSCVA. When answering a standardized questionnaire, 93.3% of patients were satisfied with the obtained results and would undergo the procedure again. Conclusion: SMILE is a new promising flapless minimally invasive refractive procedure to correct myopia.
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Walter Sekundo, Kathleen Kunert, Marcus Blum. Small Incision Corneal Refractive Surgery using the SMILE procedure for the Correction of Myopia and Myopic Astigmatism: Results of a 6 months prospective study. British Journal of Ophthalmology, BMJ Publishing Group, 2010, 95 (3), pp.335. ⟨10.1136/bjo.2009.174284⟩. ⟨hal-00567046⟩

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