Femtosecond laser receives FDA clearance to surgically treat nearsightedness
Carl Zeiss Meditec (Dublin, CA) has received FDA approval for its VisuMax femtosecond laser to be used in the small incision lenticule extraction (SMILE) procedure to reduce or eliminate myopia (nearsightedness) in certain patients 22 years of age or older.
Related: U.S. clinical trial for Zeiss microinvasive laser vision correction technology expands
The VisuMax system removes a small amount of eye tissue to permanently reshape the cornea. A femtosecond laser makes cuts within the cornea, creating a disc-shaped piece of tissue that is removed by the surgeon through a small incision in the surface of the cornea. This tissue removal causes the shape of the cornea to change, which corrects the nearsightedness.
A clinical study of the safety and effectiveness of the device to correct nearsightedness found the procedure resulted in stable vision correction at six months. Of the 328 participants evaluated at six months, all but one had uncorrected (without glasses or contacts) visual acuity of 20/40 or better, and 88% had uncorrected visual acuity of 20/20 or better.
For more information, please visit www.zeiss.com/meditec/en_us.
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