Two years after its international launch, the small incision lenticule extraction (SMILE) procedure developed by Zeiss (Oberkochen, Germany) has been used to treat more than 80,000 eyes worldwide, and has received FDA approval for an expanded U.S. clinical trial. Currently, the procedure is established in Europe, China, and India.
SMILE is a microinvasive method that offers improved predictability of the vision correction outcome without the need to create a corneal flap. It combines ultrafast laser technology and precise lenticule extraction: the company's VisuMax femtosecond laser creates a very thin disc of tissue (lenticule) inside the intact cornea, which can then be extracted through a small incision. An excimer laser is not required.
According to studies published in the American Journal of Ophthalmology and British Journal of Ophthalmology, post-surgery inflammation was less common, healing of the cornea was better, and dry-eye syndrome was reduced compared to LASIK.
In December 2013, the FDA granted approval to extend the trial to include myopia of up to -10.00 diopters. To date, a total of 255 patients have been treated at five centers in the U.S. Outside the U.S., there are more than 150 centers in 38 countries, with more than 300 surgeons performing the procedure.
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