[Femtosecond lenticule extraction (FLEx) - Results after 12 months in myopic astigmatism]

This clinical trial is focussed on the 12-month results of a new method for refractive correction, femtosecond lenticule extraction (FLEx).

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) VisuMax 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.

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.

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.