The Food and Drug Administration
(FDA) has approved a plastic lens that is permanently implanted into the eye
to correct moderate to severe nearsightedness.
The lens, called an intraocular lens (IOL), is similar to the type of lens
implanted in the eye to restore vision following cataract surgery.
Manufactured by Ophtec USA
Inc., of Boca Raton, Fla., the new lens is intended to reduce or eliminate
nearsightedness in adults, and will offer people another alternative to glasses,
contact lenses and laser surgery such as LASIK.
The new IOL, called the Artisan, is intended for use in healthy eyes, in
people with stable vision. It should not be used in people who have more than
minor (2.5 diopters) astigmatism (distorted vision caused by an uneven curvature
of the cornea).
Unlike the IOL implanted during cataract surgery that replaces the eye's
natural lens, the new IOL for nearsightedness does not replace the natural lens
but is implanted in front of it.
FDA approved the new lens based on a review of clinical studies of safety and
effectiveness conducted by the manufacturer and on the recommendation of the
Ophthalmic Devices Panel of FDA's Medical Devices Advisory Committee.
Ophtec studied use of the IOL in 662 patients with moderate to severe
nearsightedness at 22 medical centers in the U.S. After three years, 92 percent
had 20/40 or better vision (considered standard vision necessary to obtain a
driver's license), and 44 percent had 20/20 or better.