Femtosecond Lenticule Extraction (FLEx) - Results after 12 Months in Myopic Astigmatism

Background: This clinical trial is focussed on the 12-month results of a new method for refractive correction, femtosecond lenticule extraction (FLEx). Patients and Methods: In a prospective 6-month study 108 eyes were treated in Erfurt and Marburg. Both a flap and a lenticule of intrastromal corneal tissue were simultaneously cut utilising the Carl Zeiss Meditec AG (Jena, Germany) Visu-Max femtosecond laser system. Thereafter, the lenticule was manually removed and the flap repositioned. 31 patients all treated in Erfurt volunteered for a 12-month follow-up. UCVA and BSCVA after 12 months, objective and manifest refraction as well as slit-lamp examination and late side effects were documented. Results: 62 eyes of 31 patients were examined in this study. The spherical equivalent before surgery was -4.81 (+/- 1.16) D; after 12 months -0.15 (+/- 0.46) D were manifest. No significant change was observed after the 6 months control. Starting with UCVA of 0.12 (+/- 0.09) before surgery UCVA was 1.10 (+/- 0.26) after 12 months. In one patient corneal ectasia was diagnosed. All other patients did not have any late side effects. Conclusion: The stability of the correction of myopic astigmatism with the FLEx procedure is very good. The fact that one patient presented with a corneal ectasia demonstrates that one general problem of refractive corneal surgery persists with this new fs technology.