Background The aim of this study was to perform the first femtosecond laser cuts with a new prototype femtosecond laser, in vivo and to evaluate its safety, stability and efficacy.
Methods A LASIK cut was performed with a prototype 200 kHz femtosecond laser in both eyes of nine patients and one eye of two patients (20 individual eyes in total). A complete ophthalmic examination was performed preoperatively and postoperatively at 1, 3, 6 and 12 months after the procedure.
Results In the pilot series of 20 eyes, flap creation was possible in each case. The mean preoperative manifest refractive spherical equivalent was À−4.22 D (SD±61.22 D). The postoperative spherical equivalent refraction was À−0.1 D (SD±60.26 D) at 1 month, À−0.22 D (SD±60.24 D) at 3 months and À−0.15 D (SD±60.16 D) 12 months after surgery.
Conclusions Femto-LASIK with this new laser system showed high levels of safety, stability and efficacy without any enhancement.
Clinical trials registration http://www.dimdi.de. DE/CA126/AP4/3332/27/09. Bfam registration 09/03/2009, DE/CA126.
- excimer laser
- femtosecond laser
- flap creation
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Competing interests CWvM, RK, JS, MM and CPL none. CW and CD are employees of WaveLight GmbH, Erlangen, Germany.
Patient consent Obtained.
Ethics approval Ethics approval was obtained from the local ethics board.
Provenance and peer review Not commissioned; externally peer reviewed.