FDA Approves Laser Device to Surgically Treat Nearsightedness in Younger Adults

Ophthalmology concept. Male patient under eye vision examination in eyesight ophthalmological correction clinic
Ophthalmology concept. Male patient under eye vision examination in eyesight ophthalmological correction clinic

The U.S. Food and Drug Administration (FDA) has recently approved the VisuMax Femtosecond Laser, which is a laser device that treats nearsightedness in younger adults. Nearsightedness, or myopia, is a vision condition in which a person can see close up objects clearly but far away objects appear blurry or distorted. Causes of nearsightedness include an unusual shape of the cornea or excess length of the eye ball. Although in many cases corrective lenses can treat nearsightedness, a laser treatment allows a patient to experience greater visual freedom without the worry about putting on glasses or contacts.

“This approval expands the surgical treatment options available to patients for correcting nearsightedness,” explained Dr. Malvina Eydelman, director of Ophthalmic and Ear, Nose and Throat Devices, in FDA’s Center for Devices and Radiological Health.

The new laser device helps reshape the cornea, but it is not yet effective in just any patient. In the clinical trial involving 328 participants aged 22 or younger, all but one participant had an uncorrected (glasses- or contacts-free) visual acuity of 20/40 or better six months post-surgery. Eighty-eight percent had uncorrected visual acuity of 20/20 or better.

As mentioned, not all patients are good candidates for this procedure; therefore it’s important that you speak to your eye care professional about any risks you may be facing.

The VisuMax Femtosecond Laser works by removing a small amount of corneal tissue as a means to permanently reshape the cornea. A femtosecond laser is a very fast, pulsating laser that creates cuts within the cornea, forming a disc-like shape piece of tissue that the surgeon removes. The removal of the corneal tissue allows for the shape of the cornea to change, which is how nearsightedness becomes corrected.

Some complications experienced after the procedure included dry eye and moderate to severe halos and glare.

The laser device was produced by Carl Zeiss Meditec Inc., which is based in Dublin, California.

“FDA approves VisuMax Femtosecond Laser to surgically treat nearsightedness,” FDA News, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm520560.htm, last accessed September 15, 2016.