New Laser Device Approved to Treat Nearsightedness Surgically
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New Laser Device Approved to Treat Nearsightedness Surgically

The device removes a small amount of tissue in the eye to reshape the cornea

September 14, 2016

The Food and Drug Administration (FDA) has approved a laser device that can reduce or eliminate nearsightedness in certain patients.

The VisuMax Femtosecond Laser is used as part of the small incision lenticule extraction procedure to treat the condition in patients at least 22 years old.

Not every patient is a candidate for the procedure, and interested patients should thoroughly review the patient labeling information and discuss the procedure and their expectations with their eye care professional.

"This approval expands the surgical treatment options available to patients for correcting nearsightedness," said Malvina Eydelman, M.D., director of ophthalmic and ear, nose and throat devices at the FDA's Center for Devices and Radiological Health.

Myopia—more commonly known as nearsightedness—is a common problem in which patients can see objects close up clearly but farther objects are blurry. It happens when light is focused by the eye in front of the retina and may be the result of a too-steep cornea and/or a too-long length of the eyeball.

The result of the procedure conducted as part of a clinical study of the safety and efficacy of the device in correcting nearsightedness was stable vision correction six months after the procedure. Out of 328 study participants who were evaluated at that time, all but one had uncorrected (not using glasses or contacts) visual acuity of 20/40 or better, and 88 percent had 20/20 or better.

There were a few common complications during and after surgery. Those during surgery included difficulty in removing the corneal tissue and loss of the suction keeping the laser aligned with the eye. Those occurring after the surgery included debris at the tissue removal site, dry eye, moderate-to-severe glare, and moderate-to-severe halos.