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Smile procedure safely, accurately corrects spherical myopia
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SAN FRANCISCO — Femtosecond laser-assisted small-incision lenticule extraction safely treated spherical myopia, according to initial clinical trial results presented here.
Jon Dishler, MD, FACS, discussed preliminary data from the first U.S. Food and Drug Administration investigational device exemption clinical trial for the ReLEx smile procedure using the VisuMax femtosecond laser (Carl Zeiss Meditec).
Jon Dishler
"We think this compares very favorably to other data," Dishler said at the American Society of Cataract and Refractive Surgery meeting. "Most eyes were unchanged. There were more eyes gaining a line [of vision] than losing a line. Some eyes gained three lines. No eyes lost two or more lines of best corrected vision."
ReLEx smile generates a refractive lenticule in the intact cornea with the femtosecond laser. The surgeon removes the lenticule through an incision smaller than 4 mm without the need to move the patient to an excimer laser.
The study included 79 eyes of 79 patients treated at five sites. Average patient age was 35 years.
Study results showed that correction was within 0.5 D of the target in 95% of eyes at 1 month and 98% of eyes at 3 months; correction was within 0.25 D of the target in 89% to 90% of eyes at 3 months.
Uncorrected visual acuity was 20/25 or better in 97% of eyes at 1 month and 98% of eyes at 3 months. One case of slight undercorrection was identified at 3 months; UCVA in that eye was 20/40.
No adverse events were recorded, and four potential adverse events were resolved successfully.
Disclosure: Dishler is a consultant for Carl Zeiss Meditec and an investigator in the clinical trial.