Laser Vision Correction-The Safety of LASIK & Laser Eye Surgery
Reviewed by Brad Spagnolo, M.D.
The safety of LASIK is dependent on a number of factors that include not only the Laser and instrumentation to be used but also the care and experience of the LASIK Surgeon.
Laser Eye Surgery for the Laser Vision Correction of nearsightedness was first performed in the United States upon Food and Drug Administration (FDA) approval of the Excimer Laser on October 20, 1995 . The Excimer Laser was specifically FDA approved for LASIK in 1998 . So as of 2009, Laser Eye Surgery for Laser Vision Correction has been performed for just under 15 years and LASIK has been performed under FDA approval for just over 10 years. It is estimated that some 16 million patients worldwide have had LASIK. LASIK is generally considered one of the most successful and safe surgical procedures of any type. In skilled hands nearsighted patients can expect to achieve 20/40 vision more than 98 percent of the time, and uncorrected vision of 20/20 or 20/25 in more than 90 percent of cases. The safety record is equally as impressive with the loss of best-corrected vision to worse than 20/40 being quite rare after LASIK, occurring in about only 3 per 1,000 cases. Serious complications, such as infection or corneal damage, occur even more infrequently in fewer than 1 in 1,000 cases.
While not an infinite amount of time, the availability of the various Laser Vision Correction procedures, including LASIK does give access to real world experience and data that can be used to evaluate the various Laser Eye Surgery procedures and their safety. But, there is more to safety than simply the Laser device itself.
FDA approval provides some assurance that a particular medical device, in this case an Excimer Laser, is safe and effective for its intended use. However, the FDA does not have the authority or jurisdiction to regulate physician practices or in any way get involved in the practice of medicine. As a practical matter then, FDA approval does not indicate or imply that LASIK Surgeons will provide a complete review of the possible risks and complications of LASIK-nor does it imply that a LASIK Surgeon will use the appropriate screening and decision criteria to be sure that a patient is in fact a good candidate for LASIK or any Laser Eye Surgery for that matter.
Thus, choosing a LASIK Surgeon is the most important decision a patient makes in deciding to have LASIK and is a significant part of making LASIK a safe and effective procedure. You should not choose a LASIK Surgeon based on slick advertising or low price. You should choose a LASIK Surgeon based on reputation in the community, the length of time they have been performing LASIK and the comfort and rapport established during your consultation. In addition, the equipment used may provide a slight advantage or disadvantage in safety, however it is ALWAYS the skill and experience of the surgeon that contributes the most to the overall safety of Laser Eye Surgery for the correction of nearsightedness, farsightedness and astigmatism.
As one might expect, there is a correlation between LASIK surgery volume and the predisposition for malpractice events. However, it is not as one would expect. While surgeons performing greater numbers of LASIK surgeries would be expected to have more experience and thus less likely to experience incidents of malpractice, just the opposite is true. Lower volume LASIK surgeons experience fewer incidents of malpractice. This may be explained in part by the fact that higher surgery volume simply correlates with increased exposure due to the number of cases performed. However, it is believed that in high-volume practices, the time spent per patient in the preoperative evaluation and counseling process may tend to be shortened and the patient fails to develop an adequate rapport with the surgeon. In addition, shortened consultation times may lead to inadequate time to set realistic expectations regarding what the Laser Eye Surgery results might be able to deliver for the patient.