CLMA - What You Should Know About Refractive Surgery

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About Refractive Eye Surgery

WHAT YOU SHOULD KNOW
ABOUT REFRACTIVE EYE SURGERY

Don't throw away your contact lenses yet!

The Contact Lens Manufacturers Association (CLMA) is dedicated to providing the contact lens wearing public with timely and useful information concerning your vision. With the issuance of marketing approval of Photorefractive Keratectomy (PRK) and the continued use of Radial Keratotomy (RK), many people are now considering these procedures in the hopes of eliminating the need for further visual correction through lens wear. Before agreeing to one of these procedures, please take a moment to review the following information provided by the Federal Trade Commission (reprinted with permission).

Refractive Eye Surgery: Is It Time
to Throw Away Your Contact Lenses for Good?

If you're among the 68 million Americans who are nearsighted, you probably wear glasses or contact lenses to improve your distance vision. You may also hear a lot about Radial Keratotomy (RK) and Photorefractive Keratectomy (PRK) -- surgical procedures that treat your vision problem.

Don't throw away your glasses or contact lenses yet. The Federal Trade Commission (FTC) cautions that, although some advertising and promotional materials for RK and PRK may suggest otherwise, refractive eye surgery is not always a short cut to perfect vision.

The RK and PRK Surgical Procedures

RK and PRK reduce nearsightedness. In RK, the surgeon uses a diamond knife to make incisions in the cornea in a radial or spoke-like pattern. This causes the cornea's curvature to flatten, changing the way it focuses light on the retina. In PRK, the surgeon uses a computer-controlled excimer laser to sculpt the surface of the cornea, changing its shape and the way light is "refracted" to the retina.

RK and PRK are surgical procedures. They are not used to treat people who have difficulty seeing near objects -- those who are farsighted -- or people who need reading glasses as a natural result of the aging process -- those who are presbyopic.

Both RK and PRK are outpatient surgical procedures. Some surgeons who perform RK schedule two operations, allowing one eye to stabilize before operating on the second. The U.S. Food and Drug Administration (FDA) recommends a three-month waiting period between PRK operations. Many RK patients and a small percentage of PRK patients also need or want additional surgery, usually called an "enhancement," to fine-tune the results of the initial operation. Neither RK nor PRK is considered a medically necessary procedure because the operation is performed on a healthy organ. As a result, the surgery usually is not covered by health insurance.

Seeing Through Claims

If you or someone you care about is considering RK or PRK, here is some information that will help you evaluate claims about these surgeries. Even with 20/20 vision, it can be difficult to read between the lines. Among the claims you may see or hear are:

"No more glasses or contact lenses!"

One possible claim about refractive surgery is that you'll never need glasses or contact lenses again. The truth is that for a variety of reasons, you still may need corrective lenses after RK and PRK. Like any surgical procedure, refractive surgery is not 100 percent predictable. RK and PRK surgery may result in overcorrection, rendering you farsighted, or undercorrection, leaving you nearsighted. And, almost everyone who undergoes RK or PRK surgery eventually will need reading glasses.

What's more, studies have shown that a number of patients who undergo RK surgery to treat their nearsightedness eventually may become farsighted and need corrective lenses for near vision because of a hyperopic shift -- a gradual but continuing shift toward farsightedness. Some doctors deliberately undercorrect and leave patients with residual nearsightedness after RK surgery to compensate for any slow drift toward farsightedness that may occur over time. In recent years, RK equipment and techniques have developed and surgical results have improved. Nevertheless, studies assessing RK surgery continue to document an ongoing need for corrective lenses after surgery for a significant number of patients.

The FDA recently approved two laser systems as safe and effective for performing PRK on adult patients with mild to moderate nearsightedness only. In clinical studies that were submitted as part of the FDA approval process for one of the laser systems, about 5 percent of patients followed after surgery still needed to wear corrective lenses often for distance vision, and up to 15 percent needed corrective lenses occasionally for distance vision, such as when driving. Those who wore reading glasses for near vision before the surgery still needed them afterward. In addition, there were indications that some patients who did not need reading glasses before surgery might need them afterward or earlier in life than they might have had they never had the surgery.

"RK or PRK surgery offers permanent, stable, or predictable long-term results!"

Although research on RK surgery has identified a shift toward farsightedness in a significant number of RK patients, newer techniques in performing RK are being studied to determine whether they result in more stable vision. One such technique, known as "mini-RK," uses shorter and fewer incisions. It may provide more stable vision for people with a low degree of myopia only. Research on this technique is ongoing. One possible effect of PRK surgery may be a return to some degree of nearsightedness. Studies of the long-term effects of PRK are being conducted to determine whether vision remains stable over long periods of time.

"95 percent of patients achieve 20/40 vision or better!"

You may have read or heard claims that a high percentage of patients achieve 20/40 vision or better. Although 20/40 vision may be enough to pass a driver's license eye test in most states, you still may need or choose to wear corrective lenses for distance vision, particularly at night. A 95 percent chance for 20/40 vision or better doesn't mean that you have a 95 percent chance of never wearing glasses or contacts again.

Other claims about the safety and effectiveness of the surgical procedures...

No surgical procedure is risk-free. In rare instances, RK and PRK may result in serious complications such as loss of vision or infection. In addition, there are several potential side-effects. For example, after RK surgery, patients may experience fluctuating vision, a weakened cornea, halos around lights, increased sensitivity to light and glare, and temporary pain. Clinical studies submitted to the FDA by one laser manufacturer reported that those who have PRK surgery may also experience pain 24 to 48 hours after surgery in addition to other side-effects that occurred within six months after surgery, including corneal haze (2.3% of patients), loss of best vision achieved with glasses (6.8%), minor glare (10%), and mild halos around images (9.7%).

For More Information

For more information about possible benefits, limitations, side-effects, and complications of RK and PRK surgery, and your suitability for either surgery, consult your eye doctor.

You also may contact the National Eye Institute, Building 31 Room 6A32, 31 Center Drive MSC 2510, Bethesda, MD 20892-2510, (301) 496-5248, and your local office of the U.S. Food and Drug Administration. For help finding RK or PRK practitioners, or to check for complaints about particular RK and PRK surgeons, contact your state medical board or county medical society.

You also may contact the Federal Trade Commission. The FTC is not authorized to intervene in individual cases, but the information you provide may indicate a pattern of possible law violations requiring action by the Commission.

For a free list of all the FTC's consumer publications, write: Best Sellers, Public Reference, Federal Trade Commission, Washington, D.C. 20580 or call (202) 326-2222. TDD: (202) 326-2502. You also can access FTC publications at www.ftc.gov.

From the Contact Lens Manufacturers Association

Thank you for taking the time to review this informative report. Refractive eye surgery can be successful, but as the information compiled by the FTC indicates, it may still be a risk for a number of corrective lens wearers.

Contact lenses are an excellent option for those people who choose not to wear glasses. Whether your eye care professional chooses soft or oxygen permeable contact lenses for your specific visual requirements, you can be assured that your eyesight will be at its best. So when you are considering alternatives to glasses, be sure to make contact lens wear one of your options.

For more information on refractive surgery click here.