This is a revised version of FDA Talk Paper T03-38,
originally issued September 13, 2004.
Revisions have been made Oct. 15, 2004, to correct the incidence of
adverse reactions in the ninth paragraph.
FDA Talk Paper
T03-38
September 13, 2004
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FDA Approves Implanted Lens to Correct Nearsightedness
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 Verisyse, 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.
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. 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%) and cataract development (0.6%).
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 Verisyse 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 Verisyse
lens does not correct astigmatism. Glasses may need to be worn for night
driving or other activities performed in low light. They may also be
needed for reading.
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