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FDA approves VisuMax femtosecond laser to treat myopia
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The FDA approved the VisuMax femtosecond laser to surgically reduce or eliminate myopia in certain patients 22 years of age or older.
The VisuMax femtosecond laser (Carl Zeiss Meditec) was approved for the small incision lenticule extraction (SMILE) procedure, which removes a small amount of eye tissue to permanently reshape the patient’s cornea, according to an FDA press release.
“This approval expands the surgical treatment options available to patients for correcting nearsightedness,” Malvina Eydelman, MD, director of Ophthalmic and Ear, Nose and Throat Devices, in FDA’s Center for Devices and Radiological Health, said in the release.
A clinical study of safety and effectiveness of the device found the SMILE procedure resulted in stable vision correction at 6 months. The study included 328 patients, and all but one had uncorrected visual acuity of 20/40 or better. Additionally, 88% had uncorrected visual acuity of 20/20 or better at final follow up.
The fast, short-pulsed laser makes cuts within the cornea and creates a disc-shaped piece of tissue that is removed through a small incision in the surface of the cornea. The removal of the tissue changes the shape of the cornea to correct myopia, according to the release.
Perspective
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Jason Brinton, MD
Jason Brinton, MD, shares his perspective on the recent FDA approval of the VisuMax femtosecond laser for the small incision lenticule extraction (SMILE) procedure. See the video here.
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