Aim 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.
Design 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.
Methods 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.
Main outcome measures 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.
Results 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.
Conclusion SMILE is a promising new flapless minimally invasive refractive procedure to correct myopia.
- treatment lasers
- clinical trial
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Funding This study was supported by Carl Zeiss Meditec, Germany.
Competing interests None.
Patient consent Obtained.
Ethics approval This study was conducted with the approval of the Ethics Committee of the Chamber of Physician of Thuringia, Germany, and the Ethics Committee of the Chamber of Physicians of Rheinland-Palatine, Germany.
Provenance and peer review Not commissioned; externally peer reviewed.
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