PURPOSE
To assess the efficacy, safety, and predictability of
the VisuMax femtosecond laser (Carl Zeiss Meditec).
METHODS
In a prospective, multicenter clinical trial, 32 eyes
of 17 patients underwent LASIK and flap creation with the VisuMax femtosecond
laser and ablation with the MEL 80 excimer laser (Carl Zeiss Meditec). Mean
patient age was 35 years (range: 23 to 52 years). Mean preoperative spherical
equivalent refraction was -4.04±1.39 diopters (D) (range: -1.50 to -7.25
D), and the planned flap thickness was 110, 120, 140, and 150 µm.
RESULTS
At the 3-month postoperative examination, all eyes had
best spectacle-corrected visual acuity of 20/25 and uncorrected visual acuity
(UCVA) of 20/40; 91% of eyes reached UCVA of 20/20 or better. Ninety-four
percent of eyes were within ±0.50 D of the planned correction.
Complications were limited to one case of suction loss, and no other adverse
events were noted at 3 months. The flaps were planar and the mean achieved
central flap thickness was 118±9.2 µm for an attempted thickness
of 120 µm.
CONCLUSIONS
The investigators achieved LASIK outcomes exceeding the
US Food and Drug Administration guidelines for refractive procedures in this
series of myopic eyes using the VisuMax femtosecond laser and MEL 80 excimer
laser. The curved contact lens of the applanation glass combined with low
suction permitted continuous fixation during treatment. [J Refract Surg.
2009;25:350-356.]
AUTHORS
From the Department of Ophthalmology, Helios Hospital,
Erfurt (Blum, Kunert); Carl Zeiss Meditec, Jena (Gille); and University Eye
Hospital, Mainz (Sekundo), Germany.
Ms Gille is a paid employee of Carl Zeiss Meditec, Jena,
Germany. The remaining authors have no financial or proprietary interest in the
materials presented herein.
The authors thank John Dishler, MD, Denver, Colo, for
his helpful comments.
Correspondence: Marcus Blum, MD, Augenklinik des Helios
Klinikum Erfurt, Nordhäusser Str 74, 99089 Erfurt, Germany. Tel: 49 0361
7812070; Fax: 49 0361 7812072; E-mail: mblum@erfurt.helios-kliniken.de
Received: May 31, 2007; Accepted: June 10, 2008
Posted online: August 15, 2008