Study info about cases of underwenting LASIK procedures and the clinical tests made by FDA to study laser system in performing LASIK procedures.

For Jeri Goldstein everything was indistinct. Without her contact lenses she couldn't distinguish people, the scenes on television and the world in general. Then, in March 1998, the 49-year-old California resident had eye surgery, and all that changed.

"After wearing contact lenses for 35 years, you can't imagine the freedom I felt," says Goldstein.
Goldstein went through the refractive eye surgery, an optional procedure destined to correct common eye disorders, known as refractive errors, for example myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (distorted vision). Even though there are several types of surgical techniques being performed today to correct refractive errors, according to the American Academy of Ophthalmology in San Francisco, laser refractive correction is speedy becoming the most technologically advanced method available. As doctors say, it allows for a supreme degree of accuracy and predictability.

After studying the options, Goldstein first decided on the LASIK procedure, but was surprised to learn that her doctor advised against it.

"In the beginning, I wanted the quick recovery that LASIK offers," Goldstein says, "but the highlight moment was which surgery will give me the best results, and after taking into account everything, finally we agreed on PRK."

 At present, James Salz is involved in an FDA-sanctioned clinical test at Cedars-Sinai Medical Center in Los Angeles, which is now studying the laser system specifically for farsightedness (hyperopia) with astigmatism. Even if routinely performing laser eye surgery, he still encourages a small percentage of his low to moderately nearsighted patients to undertake radial keratotomy, or RK, an earlier refractive correction procedure that does not require the excimer laser.

"Last year, across the country, 40 to 45 percent of refractive surgeries performed by physicians were LASIK, which associates with approximately 80,000 procedures," asserts Ken Taylor, O.D., vice president of Arthur D. Little, Inc., a technology and management consultant firm in Cambridge, Mass. Doctors who don’t take part in clinical test may choose to use the approved laser to perform LASIK procedures at their prudence, says Morris Waxler, Ph.D., chief of FDA's diagnostic and surgical devices section. However, most uses are considered "off label" and are not regulated by FDA.

Ralph A. Rosenthal, M.D., director of FDA's division of ophthalmic devices, says, "The agency has ruled that individual physicians can perform LASIK under the general practice of medicine, if it's in the patient's best interest."

Sooner than the procedure begins, the patient's eye is measured to determine the degree of visual problem, and a map of the eye's surface is constructed. The necessary corneal change is calculated and then entered into the laser's computer.