Los Angeles, CA (PRWEB) September 14, 2006
The first morning Carol Rice rolled over to see that her bedside alarm clock read 6 o'clock, she let out a jubilant hurrah that nearly knocked her husband out of bed.
"It was the first time in more than 20 years that I could see the time without first putting on my glasses or bringing the clock an inch from my face," said the 36-year-old San Diegan, who had undergone refractive laser eye surgery the day before. "Those first few days (after surgery) I just walked around grinning and looking at things -- the trees, the birds, my kids' faces, the cobwebs in the corners. What a thrill."
Thanks to laser technology, 20/20 vision may be within sight for millions of people who must rely on glasses or contact lenses.
Although various modern methods of corrective eye surgery have been around for more than 25 years -- all using the same concept of flattening the cornea to change the way light is bent when it enters the eye -- the techniques have changed dramatically.
Ophthalmologists used to rely solely on steady hands and scalpels while patients had to endure long and painful recoveries, often with imprecise results.
Now, thanks to lasers and computers, the risks have been reduced (although not eliminated), along with the recovery time and discomfort.
Today, many myopic (nearsighted) patients who can barely make out the big E on the eye chart can undergo laser surgery and usually be back to work or play in a few days with vastly improved vision.
"The procedure itself was nothing. About 15 minutes (for both eyes), a little tearing, and I was done," said Rice, who underwent Lasik surgery, one of the two laser procedures offered by a growing number of eye surgeons. "By the next day, I was taking kids to soccer practice, going to the dry cleaners and getting groceries. It was life as usual -- except that I could see."
Of the more than 40 people interviewed for this story, Rice's positive experience was by far the most common.
Yet experts urge anyone considering the procedure to go into it with their eyes wide open.
Not only are there no guarantees of perfect vision, but there are also certain risks -- some quite serious. Add to that the fact that doctors don't always see eye-to-eye on which laser procedure is best, and laser eye surgery can be a big blur to consumers.
Two current procedures
There are two types of corrective laser surgeries being performed today -- photorefractive keratectomy (PRK) and laser in-situ keratomileusis (Lasik).
PRK is similar to radial keratotomy (RK), the older and now outdated surgical procedure that involves cutting incisions around the rim of the cornea to change its shape. PRK is less invasive than the older technique because the surgeon uses an excimer laser instead of a scalpel and the corneal tissue is vaporized, not cut. No stitches are needed.
Approved by the Food and Drug Administration in 1995, PRK is used to correct mild to moderate cases of myopia. The procedure doesn't work as well on patients with severe myopia.
Lasik is the newest kid on the laser block and is often touted as the "Wow! surgery," because patients recover so quickly.
Sometimes called "flap 'n zap" surgery, the surgeon slices a tiny flap in the cornea (about the thickness of a contact lens) with a small surgical instrument known as a microkeratome. The flap is folded back, and the surgeon uses a laser to vaporize small amounts of tissue from the cornea's central layer. The flap is then folded back into place, requiring no stitches.
Lasik is generally recommended for moderate to severe cases of myopia.
With Lasik, the surface of the cornea is not treated so patients usually have both eyes lasered at a time with minimal discomfort and improved vision almost immediately. PRK, on the other hand, affects the outermost layer of the cornea, so recovery is not as quick or as comfortable. The eyes may hurt for a few days to a couple of weeks while the surface of the
eye repairs. PRK patients may experience hazy vision, night glare (seeing halos around headlights when driving, for example) and be unable to see objects up close for a few weeks to several months.
The final results of laser surgery -- the best vision the patient will achieve -- can take as long as three months with PRK. It takes a couple days to a week with Lasik.
Because PRK has a longer healing time, the FDA recommends the procedure be done separately on each eye at least three months apart, although some doctors still perform the procedure on both eyes at once.
Despite the longer recovery time, some people regard PRK as the safer procedure because it uses a computer to make all the laser surgery calculations. Since Lasik involves an incision, it is dependent on a surgeon's operating skills.
Glasses for reading
It's not unusual for both Lasik and PRK patients to require an additional laser procedure -- delicately referred to as a "touch-up" or "enhancement" -- to achieve optimum results. Because over-corrections can't be remedied, doctors would rather under-correct the eye, then go back later and make more corrections. The "enhancement procedure" is usually performed a few months after the initial surgery.
Although both PRK and Lasik successfully restore distance vision, anyone who thinks either corrective laser eye surgery will get them out of glasses forever should think again.
Refractive surgery doesn't alter the aging process of the eye, and at some age you'll probably still have to get reading glasses. Presbyopia, the hardening of the lens inside the eye that usually occurs in the mid-40s, causes people to have difficulty focusing on nearby objects. Nearsighted people over 40 who must remove their glasses for close work need to give
extra thought to vision correction surgery.
"If you're nearsighted, the surgery will get rid of your nearsightedness," said Dr. Richard Burns, a refractive surgeon at Sharp Rees-Stealy's Vision Surgery Center. "But if you wear reading glasses or bifocals, you're still going to need reading glasses and perhaps a stronger reading prescription."
For those people who would like to improve their distance vision but don't want to wear reading glasses, monovision may be a solution. Monovision corrects one eye for distance and leaves the other one sightly nearsighted for reading. About two-thirds of patients who try monovision are able to adapt to it. Those who can't adapt can have their reading eye further corrected, so both eyes will be used for distance vision.
An FDA panel recently recommended approval of a laser procedure for correcting hypermetropia, or farsightedness. As with laser surgery to correct nearsightedness, both PRK and Lasik procedures will be offered to help patients who have difficulty seeing objects at close range. Instead of flattening the cornea as done to correct myopia, a doughnut shape is cut around the middle of the cornea, making the center steeper.
Ophthalmologists predict they'll be able to perform laser surgery for farsightedness in about six months.
Lasik and the FDA
One issue that has caused some confusion and a little concern is that, unlike PRK, Lasik is not approved by the FDA. Although the same laser is used for both procedures, the agency hasn't OK'd the laser to perform Lasik surgery.
Most doctors don't seem bothered by this, and it doesn't deter them from doing the Lasik procedure.
Since the FDA only regulates the laser machine -- not the surgical procedure or the surgeon -- the FDA allows Lasik to be performed if physicians believe it's the best procedure for that patient. The FDA doesn't allow doctors to advertise Lasik surgery or call their practices Lasik clinics, although they can advertise themselves as Lasik experts. Lengthy consent forms must be signed by the patient.
The reason the FDA hasn't approved the laser to perform Lasik is because data proving the safety and efficacy of the procedure hasn't been submitted to the agency.
However, the doctors we talked to say the lack of FDA approval is of little consequence. Just because the procedure doesn't have the federal nod doesn't mean it's unsafe, ineffective or illegal. Doctors say it simply means they haven't spent the time and money on unnecessary clinical studies and data. Many ophthalmologists doubt that Lasik will ever have the FDA stamp of approval, and they don't seem to care.
"The FDA only approves the machine. And, the laser has already been approved. So has the microkeratome (the surgical tool that slices the flap). So why supply the data for this? There's no need to," said Dr. Glenn Kawesch, a San Diego refractive surgeon.
Some doctors point out that lots of treatments recommended to patients don't have FDA approval. Aspirin, for example, isn't FDA-approved to prevent strokes by thinning blood, but doctors still prescribe it because it works.
The fact that Lasik isn't approved by the FDA doesn't seem to bother patients, either.
"They gave me lots of research information and explained all the risks," said Jill Pfeiffer, 40, a mortgage broker in Sorrento Valley. "My biggest concern was the long-term effects. But the way they explained it and with all the (procedures) they'd done without problems, it seemed safe and worth the risk."
Both surgical procedures are fairly new, with limited studies done in this country. Research data and studies over the past 11 years have been collected on PRK. While Lasik is much newer to the United States, the surgical procedure has been around for about nine years in other countries, said Dr. Burns of Sharp Rees-Stealy.
While there are advantages and disadvantages for both PRK and Lasik, which laser procedure patients undergo often depends on who's doing the surgery, since different doctors have very different opinions about the two.
Proponents of PRK say dealing with the thin flap in the Lasik surgery can be risky. The flap can tear, wrinkle or rip off completely. Many of those problems can be treated, but a few can cause permanent damage or blindness. "Lasik is more complex than PRK. And, the more complex the process, the greater the risk of potential complications," said Dr. Barry Kassar, a refractive surgeon at Scripps Memorial's Mericos Eye Institute, who does both procedures but prefers PRK.
While he admits PRK can be painful and requires more recovery time than Lasik, in two or three weeks the outcome for both is usually the same, he says.
"So if the two procedures are identical in the long run, which would you rather have?" Kassar asked. "I would rather have a little more discomfort and fewer complications."
However, Kawesch argues that Lasik is the superior procedure. He believes PRK will eventually be phased out, just as RK has been.
"Lasik is very patient friendly," said Kawesch, whose practice is 99 percent Lasik. "Sure, PRK patients are happy about three months after (the surgery). But, before that, they're probably not telling their friends it was a great experience."
Comparing PRK and Lasik, he offered the analogy of removing a cyst beneath the skin using two different methods:
"You can cut a big hole in the skin and remove it. Then the skin has to heal, usually with a lot of discomfort and risk of infection and possible scarring," he said comparing a procedure to PRK. "Or, you can lift up a flap of skin and take out the cyst. The skin is perfectly intact with minimal discomfort and little risk of infection or scarring."
About one-half percent to 1 percent of Lasik patients have problems after surgery. Approximately 2 percent to 3 percent of PRK patients develop problems -- mostly trouble with wound healing, says Dr. David Schanzlin, a professor of ophthalmology and a refractive surgeon at UCSD's Shiley Eye Center.
"Almost all of the complications with Lasik I can go back and fix. But the problems with PRK have to do with tissue healing. It's difficult to go back and fix the cornea where it has thickened as part of the healing process," he said.
According to Kawesch, which laser procedure a doctor recommends for a patient is likely to depend on how much experience he or she has had with refractive surgery.
"Those (ophthalmologists) who are exclusively doing refractive surgery are almost exclusively doing Lasik," he said. "Those doctors who are occasional refractive surgeons (but also treat other eye ailments such as cataracts, etc.) don't do as many Lasik because Lasik is more technically difficult and they're not comfortable with it yet."
However, Kassar cautions patients to beware of the sensationalism surrounding the newest laser eye surgery.
"The doctors who promote Lasik exclusively aren't telling patients the whole story. You need to separate hype from reality," Kassar said.
Neither the American Academy of Ophthalmology nor the California Association of Ophthalmology, both based in San Francisco, take a position on either laser surgery.
"Each individual doctor has his or her own preferences. So, it's important you go to somebody you trust," said Michelle Stephens, spokeswoman for the American Academy of Ophthalmology. "Laser eye surgery is definitely one of those `buyer beware' kinds of things. We urge people to really check it out and do their homework before they have it done."
Despite the cost, discomfort and lack of guarantees, most patients -- both PRK and Lasik -- are very satisfied customers. Of the laser eye surgery patients we talked to for this story (none of them referred to us by doctors), nearly all of them gave rave reviews to their laser procedure and their new improved vision.
"I only wish they would have had PRK 10 years ago," said Mark Hagger, a 38-year-old computer salesman from Carlsbad, who had the laser procedure last fall. "It's like a whole new world opened up once I could see without my glasses."
Hagger said the after-surgery pain was "not that significant" and worth the end result -- 20/25 eyesight.
"If I somehow lost my new vision tomorrow, I'd do it again in a heartbeat," he said.
Sharon Courmousis, a financial adviser in University Heights, echoed Hagger's enthusiasm. A severe myopic, her dependence on glasses for the past 30 years made her feel vulnerable, she said.
She and her ophthalmologist decided Lasik monovision was for her.
"I knew I wanted (the surgery) even after all the statistics and risks were explained to me. I thought at worst I might need another procedure or have to wear a lens or glasses with a (lesser) level of correction," she said. "But things turned out better than I ever expected. I'd recommend it without hesitation."
Even those people who had to have a PRK or Lasik "touch-up" were impressed with the final outcome of their laser eye surgery.
After Richard Phillips had PRK last January, his left eye was only corrected to 20/60. The 41-year-old management analyst for the city of Encinitas wanted better, so he had the procedure repeated on that eye four months later. Today he sees 20/20 out of one eye, and 20/30 from the other.
"For me it's a quality-of-life thing. I always had to worry about taking contacts on trips or losing one or tearing one," Phillips said.
Jill Pfeiffer had her first Lasik surgery on both eyes in July of last year. Her right eye needed to be redone last January and her left eye needed a touch-up in March because her vision regressed to about 20/70 in one eye and 20/80 in the other. Her vision now seems to have stabilized and is approximately 20/25 for both eyes.
"Although I was very upset when my eyes first regressed, I knew there were no guarantees," said Pfeiffer, who had to sign "a pile of waivers" before the surgery. "I'm still glad I had it done and would recommend it. It's just so nice not to have to wear contacts all the time."
Of all the laser eye patients we talked to, only one person had a bad experience.
Tere Baleme, 49, of Kearny Mesa had PRK in one eye in May 1997 after her ophthalmologist told her she'd be a good candidate for the surgery.
Much to her dismay and the doctor's surprise, nothing happened.
"(The doctors) said they'd never had this happen before. They blamed it on the (laser) and that it wasn't calibrated properly," she said.
Not only was she disappointed by the failure, but she still had to go through the discomfort of the surgery -- "all for nothing," she said.
Last September, she had PRK on the same eye again. While Baleme's nearsightedness improved, she was left with an epithelial or surface defect in the center of her eye, creating a blur when she looks straight ahead.
"It's been no fun. Supposedly (the defect) will go away, but it hasn't yet and it's been months," she said, exasperated.
Baleme still hasn't had the procedure on her other eye and doesn't know if she ever will.
"I think I will just stick with a contact lens, at least, until this blotch (on the lasered eye) clears up," she said, knowing there's a chance the blotch may never disappear.
However, despite the risks, controversy and high cost, nearsighted folks are lining up for laser surgery.
"I know it's not a panacea -- there are risks and a moderate amount of pain, and I may need to wear glasses sometime as my eyes change," said PRK patient Richard Phillips. "But, I'd still do it again and recommend it to anyone."
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