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Sometime in the 13th century, the first ungainly pair of spectacles
were placed over squinting eyes. Since then the lenses have grown
thinner; and the spectacles more elegant. But even amid radical
innovations, including surgery, techniques for measuring visual
acuity have failed to keep pace.
Now the science of vision measurement and correction is set to push
beyond the familiar 20/20 line on eye charts to a benchmark described
as “eagle vision.” The basis for this shift is a
powerful diagnostic technology known as wavefront analysis, which
gives doctors a new window into the imperfections of the human eye.
Paired with laser vision surgery and, in time, with implantable,
light tunable lenses—the technology will enable physicians
to customize laser treatments, yielding unparalleled results.
“We’re embarking on a monumental paradigm shift,”
says Dr. Steven C. Schallhorn, at the Navy’s Refractive
Surgery Center in San Diego.
Such shifts are always accompanied by risks. Fresh in the minds
of many practitioners are the injuries, lawsuits, and bankruptcies
caused by the unchecked explosion of laser surgery in the late
1990s.
Nevertheless, wavefront technology has already sparked a lot of
excitement—in part because of purported improvements in
quality. Armed with special software, doctors first generate a
three-dimensional model, or wavefront map, of the changes they
must make to a patient’s cornea in order to correct a pattern
of defects unique to his or her eye. Then, by positioning the map
over the eye and tracing its contours with a laser, they can nullify
each of the defects.
Alcon Laboratories zinc. Of Fort Worth, Texas, was first to market
with such a customized treatment, for near-sightedness, winning
Food & Drug Administration approval last fall. Alcon reports
that many patients achieved greater that 20/20 vision, and other
studies produced similar evidence. Last year, in clinical trial by
VISX Inc, of Santa Clara, CA, 189 patients with mild nearsightedness
were treated using a wavefront system. Six months later, 94% of the
patients saw 20/20 without glasses, and 74% saw 20/16 or better.
“That’s what we call super-vision,” says Dr.
Robert K. Maloney, one of the study’s investigators.
Analysts say VISX should receive FDA approval by midyear. And
Rochester (N.Y.)-based Bausch & Lomb Inc.’s wavefront
system could be approved by yearend.

The innovation behind these systems goes back to the late 1970’s,
when German physicist Josef Bille devised a precursor to wavefront
to correct for the atmospheric distortion of star light. A lens based
on Bille’s mathematical models was used to fix the Hubble Space
Telescope’s blurry vision in 1993.
Eye specialists began to adapt the method in the 1990s. By measuring
how the cornea, lens, and transparent tissues of the tested eye
process light differently from people with natural eagle vision,
they were able to characterize visual disorders that went beyond
near and far-sightedness and astigmatism. These visual flaws, called
higher-order aberrations, are associated with subtle problems such
as effects around light sources. “We’re just beginning
to understand how these aberrations affect vision,” says Dr.
Schallhorn.
Fortunately for wavefront pioneers, corrective laser surgery was
already an established procedure, approved by the FDA in 1995. In
LASIK short for “laser-assisted in situ keratomileusis,”
a thin flap of transparent tissue covering the cornea is peeled back.
Laser pulses then vaporize—or ablate—a pattern of cells
below, and the flap is closed. By varying the shape of this ablation
pattern, surgeons can resculpt the cornea to improve vision and
correct most commonplace focusing errors.
What makes wavefront-guided LASIK so promising is its ability to
customize the surgical procedure n the basis of the wavefront map,
which is programmed into the LASIK devise. In Alcon’s clinical
trials, some patients received traditional LASIK on one eye and
wavefront-guided treatment on the other. Even with 20/20 vision
in both eyes post-surgery, many patients reported superior clarity
in the wavefront-treated eye. “It’s not just about
making out a letter on a chart,” says Dr. Ronald Krueger,
who has performed some 70 wavefront procedures using Alcon’s
devise at the Cleveland Clinic. “Patients can see that letter
in lower light. Contrast and night vision are improved.”
The vision industry is depending on wavefront to halt a worrying slide.
The number of LASIK procedures soared through the 1990s, fueled by
the economic boo and a steady fall in the average price of the
procedure from more than $2,000 to under $1,600. But after peaking
at 1.4 million in 2000, the market has contracted by 8% over the
past two years, says David Harmon, president of Market Scope, a St.
Louis-based research firm.
The economic slowdown explains part of the decline in demand. But
industry practices are also to blame. As LASIK started to catch
on, a blitz of consumer marketing—complete with direct mail,
billboard, TV, and radio centers and nationwide chains. Advertised
LASIK prices fell ass low as $299 per eye. “There were ads
making unsupported claims and improper comparisons,” says
Matt Daynard, senior attorney at the Federal Trade Commission’s
Bureau of Consumer Protection. “People were going into this
with their eyes shut.”
Complaints rose as the number of procedures ballooned. Some doctors
performed LASIK on candidates whose eye conditions were beyond the
accepted range of LASIK treatment. A small percentage of patients
suffering from maladies such as worsened night vision, painfully
dry eyes, or infection sued their doctors. Mired in dept, a handful
of national discount chains slid into bankruptcy.
With wavefront, the industry has a second chance. “It will
attract a percentage of the population that was hesitant before,”
predicts Elizabeth H. Davila, president and CEO of VISX. SG Cowen
Securities Corp. expects the total number of procedures to rebound
by 4% this year. Within two years, half of all LASIK procedures will
use wavefront, predicts Cowen analyst Peter J. Bye.
The Defense dept. is spreading the word. After s 20 year ban,
the military is funding corrective surgery, including wavefront
techniques. It’s giving priority to special forces and others
likely to go into combat, figuring that freedom from glasses or
contacts con improve combat readiness. One initiative, the Warfighter
Refractive Surgery Program, has a $15 million dollar budget to correct
the vision of soldiers, sailors, and aviators.
The new procedures aren’t risk free. To date, the most serious
problems—detailed on Web sites such as surgicaleyes.org—stem
from sloppy surgical practices. If doctors disregard FDA guidelines,
“it doesn’t mater how good the technology is,”
says Ron Lin, executive director of Surgical Eyes Foundation.
SG Cowen’s Bye says the FDA is now tightening up approval
standards. And that will benefit more advanced techniques on the
horizon. For example, interest is growing in a new generation of
lenses that are surgically implanted into the eye, then customized
in the doctor’s office using pulsed lasers. Called light-adjustable
intraocular lenses (IOLS), these promise to deliver more consistent
visual accuracy. And the surgical technique is well established: A
version of IOLS has been used for many years to treat millions of
cataract patients. With the development of inject able, flexible
form of IOLS, these techniques “could give 50-year-olds the
adaptive vision of a 15-year-old,” says Verne Sharma, CEO
of Calhoun Vision INC. Calhoun hopes to apply for FDA approval on
its adjustable IOLS next year. Such cure-alls, though, are many years
away. In the meantime, wavefront-guided LASIK offers the best chance
for squinters to see like eagles. |