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.
Origin : Files produced by the author(s)
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