LASIK is a more complex procedure than PRK. It is performed for all degrees of nearsightedness. The surgeon uses a knife called a microkeratome to cut a flap of corneal tissue, removes the targeted tissue beneath it with the laser, and then replaces the flap.
“With LASIK, the skill of the surgeon is important because he’ll be making an incision,” says Stephen Crawford, O.D., an optometrist practicing in Virginia, “compared to the PRK method where the machine does more of the work.” Crawford urges people to find qualified, experienced doctors to perform this surgery. “You’ll want someone who’s done a number of LASIK procedures since this is a surgeon-dependent operation,” he said.
According to Ken Taylor, O.D., vice president of Arthur D. Little, Inc., a technology and management consultant firm in Cambridge, Mass., “Last year, across the country, 40 to 45 percent of refractive surgeries performed by physicians were LASIK, which equates to approximately 80,000 procedures.” Doctors not participating in clinical trials may choose to use the approved laser to perform LASIK procedures at their discretion, says Morris Waxler, Ph.D., chief of FDA’s diagnostic and surgical devices section. But most uses are considered “off label” and are not regulated by FDA.
Advantages of LASIK
Some doctors believe that LASIK is a suitable procedure for correcting the most severe refractive errors. They also say that there is generally a faster recovery time after LASIK than after PRK. In addition, LASIK patients can see well enough to drive immediately and have good vision within a week.
After studying the options, Goldstein first decided on the LASIK procedure, but was surprised to learn that her doctor advised against it.
“Initially, I wanted the quick recovery that LASIK offers,” Goldstein says, “but the bottom line was, which surgery will give me the best results, and after considering everything, eventually we agreed on PRK.”
James Salz is currently involved in an FDA-sanctioned clinical trial at Cedars-Sinai Medical Center in Los Angeles, which is now studying the laser system specifically for farsightedness (hyperopia) with astigmatism. Although routinely performing laser eye surgery, he still encourages a small percentage of his low to moderately nearsighted patients to undergo radial keratotomy, or RK, an earlier refractive correction procedure that does not require the excimer laser.
Is Laser Surgery for You?
For some, like Goldstein, laser surgery has been the ultimate freedom from the everyday hassles of contact lenses, and a second chance at having normal eyesight. But can everyone expect such dramatic results?
“The answer is no,” says Rosenthal. “It’s not a foolproof procedure and people need to know that some can end up with worse eyesight than before they went in.”
Mary Ann Duke, M.D., a general ophthalmologist practicing in Potomac, Md., adds that there are other reasons why the expectations for laser surgery vary from person to person.
“People who are slow healers or who have ongoing medical conditions [such as glaucoma or diabetes] are not good candidates for laser surgery,” she says. “That’s why it’s so important for patients to undergo a thorough examination with their doctor.”
Poor candidates for this surgery also include those with uncontrolled vascular disease, autoimmune disease, or people with certain eye diseases involving the cornea or retina. Pregnant women should not have refractive surgery of any kind because the refraction of the eye may change during pregnancy.
Looking Ahead
At present, a number of other lasers for eye surgery are currently being tested in FDA-sanctioned studies to determine their safety and effectiveness. Investigational Device Exemptions (IDEs) filed with FDA allow for clinical studies involving the excimer laser and the correction of farsightedness. The IDE process is designed to investigate the safety and effectiveness of a device, or a new procedure with an already approved device, either to obtain information for publication or to generate the data needed to obtain marketing approval from FDA.
“If the refractive surgery center says the laser is approved by FDA, it probably is,” Waxler concludes. “Still, it is wise for consumers to check that the device being used for their surgery is FDA-approved,” he says, or that they make sure they are being treated with a laser that is under study in an FDA-sanctioned clinical trial.
During the first few weeks immediately following laser surgery, Goldstein says, “Every week I kept thinking, ‘this is as good as it gets’?” Then, she discovered by the sixth week, as predicted by her surgeon, that her eyesight was noticeably better and eventually stabilized.
“I would tell others to be patient about their expected outcome,” she advises. “Even though with LASIK you can expect quicker results, I’m happy with the choice of PRK.”
Source: www.fda.gov
//Tags: Lasik new york city, advantages lasik, is lasik worth
written by Gazpachor