NewsOctober 30, 1995

Dr. Charles H. Cozean, a Cape Girardeau ophthalmologist, and Doctors' Park Surgery Inc., soon will be offering outpatient laser operations to correct vision disorders such as nearsightedness and astigmatism. "This is the next generation of eye care," Cozean said of the VISX Inc. Excimer Laser System, which recently was approved by the FDA. "This is big news for everyone. We can now commercially perform these procedures."...

Dr. Charles H. Cozean, a Cape Girardeau ophthalmologist, and Doctors' Park Surgery Inc., soon will be offering outpatient laser operations to correct vision disorders such as nearsightedness and astigmatism.

"This is the next generation of eye care," Cozean said of the VISX Inc. Excimer Laser System, which recently was approved by the FDA. "This is big news for everyone. We can now commercially perform these procedures."

Cozean, one of about 20 ophthalmologic surgeons in the country who have studied the use of laser surgery to correct astigmatic eyesight, said procedures will get under way during the fourth quarter of this year.

VISX Inc., which has developed and patented laser vision correction technology, received FDA approval last week to sell its Excimer Laser Systems commercially in the U.S.

Excimer lasers are computer-controlled devices that perform photorefractive keratectomy, or PRK. During the procedure, ultraviolet laser beams shave off microscopic bits of the cornea, reshaping the eye in a matter of seconds.

"Thirty seconds at most," said Cozean, who has been studying the procedure over the past 15 years.

"The entire procedure takes less than 30 minutes," said Cozean. "

Before FDA approval of the laser system, Americans who hoped to shed their glasses or contact lenses had to undergo a procedure called radial keratotomy, or RK. A surgeon uses a knife to make tiny cuts on the cornea, the clear tissue covering the iris and pupil. The cuts flatten misshapen corneas to bring vision closer to normal. Some 250,000 Americans undergo RK each year.

In the new laser operation, the laser uses a cold beam of ultraviolet light to flatten the cornea by vaporizing corneal cells. Some doctors say the laser is safer and more precise than RK. The process uses a chemical reaction rather than heat to remove tissue. As a result, no scar tissue is formed.

A large number of patients have been treated with laser technology over the past two years under FDA testing.

Cozean has treated a total of 65 patients from across the U.S. with his VISX Excimer Laser System, located in Doctors' Park Surgery Inc., 30 Doctors Park.

"Strict statistics and data have been kept under FDA Protocol," said Cozean. "A panel review of the statistics reveals that 93 percent of patients treated received visual acuity of 20/40 or better."

In most cases, sight improvements occur over a four-week period, said Cozean.

The laser operations are expected to cost about $2,000 per eye, and are performed on one eye at a time.

Several generations of the laser have been widely available in Europe for a number of years.

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Since the late 1980s, more than 250,000 people in 40 countries have had PRK operations. In the U.S., about 2,000 people underwent PRK as part of FDA trials

Cozean first became familiar with the laser system during a 1980 visit to Russia, where he met Dr. Syvatoslav Fyodorov, a pioneer in the development of laser surgery.

Since then, Cozean has studied under Fyodorov and has become noted nationally in the field.

Some 60 million Americans have myopia, with the majority of them falling in the low myopia category, which qualifies them for the current laser surgery. Meanwhile, testing under FDA Protocol resumes on laser operations for medium myopia.

Doctors must undergo certification training before using the laser, and some states allow only ophthalmologists to offer the operation.

Cozean, a clinical instructor at St. Louis University and one of about 20 people who can now perform the laser eye surgery in the U.S., and Doctors' Park Surgery Inc., have already arranged for a certification training course to be held in Cape Girardeau starting in March 1996.

Cozean will offer the two-day course here, with Dr. Don Johnson of Alcorn Surgical Laboratories Inc., Fort Worth, Tex., as principal speaker. Once certifications for new doctors are issued, Cozean will continue to monitor procedures by the doctors for a period of time. Operations will be conducted at Doctors' Park Surgery.

Johnson will be the course director for a Pacific Coast Refractive Symposium to be held in Canada in February. Cozean is one of 63 instructors invited to that conference.

Doctors' Park Surgery is the only surgery center in the nation with the laser equipment.

"Most facilities are located in connection with university centers and major hospitals," said Ron Wittmer, president of DPS. "In Missouri, equipment is in place at the University of Missouri-Kansas City medical school, and at Barnes Hospital in St. Louis."

FDA officials, meanwhile, say the surgery is not for everyone.

It's something new, and it may be the right thing for some people, but it does not mean it's right for everybody, Dr. Bruce Burlington, of the FDA, told the Associated Press.

Risks include glare or hazy vision, particularly at night, and a tendency to over-correct so that patients require reading glasses, noted Burlington.

"We advise patients to talk it over with one or more eye-care professionals and find whether the right fit for them is spectacles, contact lenses, RK or the laser," Burlington said.

PRK should not be performed on high-risk diabetics, auto-immune or glaucoma patients or pregnant women. Also, previous RK patients who attempt to sharpen their vision further with the laser may actually see worse, the FDA warned.

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