to the editor: I read the recent review article on laser-assisted in situ keratomileusis (LASIK) with interest. Although the basics of the procedure and potential adverse effects were outlined, several key aspects need to be discussed in further detail to give a more complete picture of refractive eye surgery.
The article states that LASIK appears to be safe. Those who have experienced adverse effects (e.g., decreased vision, lingering eye pain, dry eye) would likely disagree. In particular, dry eye seems to be common, with a 20 to 50 percent rate six months after surgery.1,2 In most other areas of medicine, a 50 percent adverse effect rate would be considered unacceptable. In addition, there was no discussion of how long dryness may last, or how many patients experience permanent dryness. The reason appears to be that the answer is unknown. Because of these concerns, the U.S. Food and Drug Administration recently began a large-scale study to determine quality of life after LASIK.3
It is critical that patients and primary care physicians understand ophthalmologists' financial stake in the LASIK procedure. The laser costs hundreds of thousands of dollars, and many ophthalmologists own their own laser. Therefore, there is a clear financial motivation to perform more procedures. The potential for adverse effects may be downplayed, and patients may be encouraged to undergo the procedure before thoroughly exploring alternatives. To counter this financial incentive, it should be mandatory for all patients to get a second opinion from an independent ophthalmologist. In addition, ophthalmologists should be required to strongly encourage patients to try contact lenses before surgery.
Finally, we must consider the principle of primum non nocere—first, do no harm. Is LASIK surgery necessary, and do the benefits outweigh the risks? Patients may choose the procedure because the idea of eliminating glasses or contacts is appealing, but this is not an obvious medical indication, especially in light of the potential for adverse effects. According to industry statistics, more than 14 million laser vision procedures were performed in North America between 1997 and 2009.4 A recent meta-analysis reported a 95.4 percent success rate.5 Using these industry-accepted statistics, we can calculate that more than 600,000 Americans “failed” the procedure, a statistic combining adverse effects and poor vision quality. This should give us all reason to pause. Clearly, we need to learn more about the complications and long-term safety and effectiveness of refractive eye surgeries before they can be widely recommended.
in reply: Dr. Bieler raises important issues regarding the safety and potential adverse effects of LASIK. To provide balanced and evidence-based recommendations for patients, family physicians should be aware of the risks and benefits of surgical procedures—particularly elective ones. It was my intention to review the existing evidence on the benefits and likely risks of LASIK.
The meta-analysis that Dr. Bieler cites reported a 95 percent satisfaction rate—not success rate—in patients who underwent LASIK.1 Reasons for dissatisfaction included residual refractive error, halos, glare, and dry eyes. Quality of life was found to be better than that of persons who wear eyeglasses and similar to that of persons with normal, uncorrected vision.
My article reported a 20 to 40 percent rate of dry eyes six months after surgery. There is no evidence in the literature indicating how long this effect persists past that time. Some studies suggest that newer techniques are less likely to cause dry eyes, but the evidence was not strong enough to include in the article.
I agree with Dr. Bieler that the principle of primum non nocere applies, and that family physicians should help patients avoid harm by educating them about conditions we do not personally treat. The current options for nonsurgical vision correction may reduce the quality of life in persons with high degrees of myopia and astigmatism. Thick lenses, poor tolerance of contact lenses, and inability to see without eyeglasses may impede participation in certain activities. As long as patients understand the risks of refractive surgery, weigh them against the possible benefits, and choose the surgeon wisely, I believe the chance of unacceptable complications from LASIK can be reduced.