U.S. clinical trial for Zeiss microinvasive laser vision correction technology expands

Feb. 11, 2014
Two years after its international launch, the small incision lenticule extraction (SMILE) procedure developed by Zeiss has been used to treat more than 80,000 eyes worldwide, and has received FDA approval for an expanded U.S. clinical trial.

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.

Related: Ultrafast pulses for precision procedures

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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About the Author

BioOptics World Editors

We edited the content of this article, which was contributed by outside sources, to fit our style and substance requirements. (Editor’s Note: BioOptics World has folded as a brand and is now part of Laser Focus World, effective in 2022.)

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