When Nancy Wright opted to have a new type of laser eye surgery, it wasn't a lifetime of nearsightedness but the 1994 Northridge earthquake that convinced her.
Her contact lenses were lost in falling debris, leaving her fumbling in the darkness as she made her way to her 6-month-old son's bedroom. "It was an awful feeling to not be able to see," the Northridge resident recalled.
So, despite some initial hesitation, Wright recently had the outer surface of her left eye reshaped by a special laser beam at Cedars-Sinai Medical Center. Moments later, she was awe-struck: She could read a wall clock across the room.
Known as photorefractive keratectomy, or PRK, many ophthalmologists are touting the procedure as something akin to a miracle--although they cautiously avoid using that word. The procedure uses an excimer laser to reshape the surface of the cornea, the eye's clear protective covering.
Seeing great potential to treat the more than 100 million Americans with bad eyesight, a host of start-up companies, physicians and hospitals have set up laser vision centers--promoting them with ads that proclaim: "Say Goodbye to Your Eyeglasses" or "Live Lens-Free!"
Their aim is to capture a sizable chunk of the roughly $15 billion-a-year U.S. market for vision correction products by convincing patients that laser surgery is a safe and effective alternative to eyeglasses, contact lenses and other surgical-correction methods.
Such promotions already have prompted one warning from federal regulators about misleading and unsubstantiated advertising claims about PRK.
As the U.S. Food and Drug Administration points out, about 5% of patients who have the procedure still need glasses all the time for distance and up to 15% need glasses occasionally, such as when driving.
For the majority of people, though, the procedure results in dramatic improvement in vision, albeit with some minor risks. And that potential is what attracted about 80,000 people to have the PRK procedure performed last year in the United States, a figure that is expected to more than double in 1997.
Although more than 500,000 PRK procedures have been performed worldwide in the last decade, the FDA didn't deem the laser devices as safe and effective until October 1995. So far, only two publicly held companies, Summit Technology of Waltham, Mass., and VISX Inc. of Santa Clara, Calif., have won the FDA's blessing for laser devices for PRK use.
The market prospects could improve significantly if the FDA approves VISX's application to use its laser for treating myopic astigmatism, a defect that causes the eye to improperly focus--a condition effecting 23 million Americans. An FDA advisory panel will take up that issue Tuesday.
Mark Logan, chief executive of VISX, says people with astigmatism will be more motivated to get the PRK procedure than those with only myopia because their vision can't be perfectly corrected with glasses.
As more people hear about the procedure, experts warn that patients should exercise caution about how and where the procedures are performed.
Although the majority of doctors use the two FDA-approved laser machines, the FDA last July issued a strong warning intended to stop eye doctors from using unapproved lasers, many of them low-cost imports from Europe.
These so-called black box machines can be purchased for $150,000 to $250,000, far less than the approximately $500,000 cost of the Summit and VISX machines. Also, eye doctors who use such machines can avoid paying the $250-per-operation royalties that VISX and Summit require.
"Doctors are trying to save a couple hundred thousand dollars by buying one of these lasers," Logan said. "We know of at least 30 of these machines. There is no FDA supervision, their reliability is not tested and you don't know if the machines are calibrated correctly."
Last March, an Arizona woman filed a medical negligence lawsuit against a Phoenix physician, alleging he used a black box laser to perform eye surgery, resulting in severe vision loss in both her eyes.
Laser eye surgery, a procedure that is performed in the physician's office and that costs roughly $2,000 per eye, is essentially the latest way that science has found to correct nearsightedness.
In a perfect eye, light is focused close to the retina at the back of the eye, providing a crisp image. But in nearsighted people, the cornea's shape causes the light to focus in front of the retina, blurring the image.
Glasses and contact lenses correct vision by bending or refracting the light entering the eye so that it strikes the retina precisely. PRK achieves the same result by using an excimer laser to reshape the cornea.
Experts recommend that the procedure not be performed on people under 18, because their vision may still be changing, and that any patient who undergoes the procedure have a record of stable vision for at least a year.
