The U.S. Food and Drug Administration (FDA) has announced it has approved the VisuMax Femtosecond Laser manufactured by Carl Zeiss Meditec Inc. for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older.
According to the FDA, the VisuMax Femtosecond Laser works by removing a small amount of eye tissue to permanently reshape the cornea. A clinical study of the safety and effectiveness of the device to correct nearsightedness reportedly found the procedure resulted in stable vision correction at six months. Of the 328 participants evaluated at six months, all but one reportedly had uncorrected (without glasses or contacts) visual acuity of 20/40 or better, and 88 percent had uncorrected visual acuity of 20/20 or better.
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Source: U.S. Food & Drug Administration