November 12, 2012
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Femtosecond small-incision lenticule extraction shows promise for spherical myopia

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CHICAGO — Femtosecond laser-assisted small-incision lenticule extraction effectively treated spherical myopia, according to preliminary study results presented during a company-sponsored symposium here.

The event, coinciding with the joint meeting of the American Academy of Ophthalmology and Asia-Pacific Academy of Ophthalmology, featured early results of 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, MD

Jon Dishler

“I really do believe that this is a paradigm shift,” Jon Dishler, MD, the trial’s medical monitor, said. “It’s going to take awhile for it to catch on worldwide, although I understand it’s becoming more popular.”

The study included 24 eyes of 24 patients with 1 D to 8 D of spherical myopia treated at two sites. Contralateral eyes were treated with LASIK. Average patient age was 33 years. Optical zones were 6 mm and 6.5 mm.

Study results showed that all eyes were within 0.5 D of intended correction and had uncorrected visual acuity of 20/40 or better at 1 week and 1 month after surgery. Ninety percent of eyes were within 0.25 D of targeted manifest refraction spherical equivalent at 1 week, Dishler said.

“The visual recovery is very fast,” he said.                                                           

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.

Disclosure: Dishler is a consultant for Carl Zeiss Meditec.