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The lens, called an intraocular lens, 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 intraocular lens, 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.
Astigmatism is distorted vision caused by an uneven curvature of the
cornea.
Unlike the intraocular lens implanted during cataract surgery to
replace the eye's natural lens, the new intraocular lens 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 intraocular lens in 662 patients with
moderate to severe nearsightedness at 22 medical centers in the
United States. 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.
One potential concern raised by the study was the loss of
endothelial cells in the corneas of patients who received the
implants. The endothelium is a layer of cells that line the
undersurface of the cornea and are essential to keeping the cornea
clear. The three-year data showed a continual, steady loss of
endothelial cells of 1.8 percent a year. At this point, it is not
known whether this loss will continue at the same rate or what the
long-term effect of this device on the cornea's health might be.
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To minimize any potential long-term effects of the device on the
corneal endothelium, FDA is requiring the labeling for the new lens
to specify that it should be used only on patients whose corneal
endothelial cells are dense enough to withstand some loss over time.
Other adverse events reported in the study included retinal
detachment (0.6 percent), cataract development (0.6 percent) and
corneal swelling (0.4 percent).
FDA is requiring Ophtec to conduct a five-year post-marketing
study to better assess the rate of cataract development, retinal
detachment and other eye problems.
The Artisan lens is intended to be a permanent implant. Although
it can be removed surgically, vision may not return to what it was
before receiving the lens.
The lens may not eliminate the need for glasses, because the
Artisan lens does not correct astigmatism. Recipients may need to
wear glasses for night driving or other activities performed in low
light. Glasses may also be needed for reading.
[Food
and Drug Administration
news release]
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