Approach LASIK with caution, education

Issue: December 1996

ByStanley B. Teplick, MD

Almost everyone connected with the excimer laser vision correction business agrees that the market has been slower to develop than expected. Most overestimated the watershed of American consumers who were just waiting for Food and Drug Administration (FDA) approval, ready to rush into the office of the nearest U.S. excimer laser center and pay for this new technology. The consumer has proven to be more conservative and cautious than we expected.

In addition, extensive national marketing by laser manufacturers and other providers has failed to develop, thus leaving individual practitioners trying to market laser vision correction to their regional patient base without national support. Many of these doctors have limited marketing budgets and, frankly, limited experience in consumer marketing.

We have also done a poor job of educating the public. Many patients still do not understand the difference between radial keratotomy (RK) and photorefractive keratectomy (PRK).

Others still consider PRK experimental. And the "sticker shock" when confronted with current pricing is very discouraging, especially when RK pricing has dropped precipitously in the last few years. Finally, many doctors who have been doing RK for years have had trouble selling both procedures to the already confused patient.

LASIK: New kid on the block

Now into this milieu comes laser in situ keratomileusis (LASIK). Most studies, as well as our personal experience, indicate that LASIK has significant advantages compared to traditional PRK, particularly on the front end.

Patients having LASIK recover visual acuity within days, whereas PRK patients may take weeks. In addition, there appears to be less haze with LASIK and, consequently, less need for prolonged topical steroids.

The downside of LASIK involves a number of issues, not the least of which is the fact that the procedure is very dependent upon the skill of the surgeon, introducing yet another steep learning curve into the equation.

Most important, however, LASIK is not currently approved by the FDA. Although the agency has stated that the performance of the procedure is within the "scope of medical practice," there are still FDA studies pending. This presents a significant informed consent issue between surgeon and patient. Referring optometrists, as well as surgeons, should understand that there is increased liability with LASIK should things go sour.

In addition, LASIK currently has a high enhancement rate, likely due to inexperience and poorly developed nomograms. While this re-operation rate will certainly decrease during the next year or two, it does represent a retreat from traditional PRK, which, if nothing else, was a huge improvement compared to RK in regard to enhancements.

Unanswered LASIK questions

The questions then remain: Is LASIK the answer? Is it the answer to our ability to correct myopia? And perhaps equally important: Is it the answer to our marketing efforts for excimer laser vision correction in general?

The answer to these questions is probably yes. LASIK will, no doubt, be the primary mode of laser vision correction over the next year and, indeed, its immediate advantages will encourage market growth and maturation more quickly than that of traditional PRK.

Nonetheless, it is wise to keep the following concepts in mind as we race into the LASIK age:

We need to be careful in our relationship with the public and resist the temptation for hype. No one operation is the answer to all of our ametropic needs, and undue hype will only give the public a message that we are superficial and interested primarily in financial motives.
Patients need thorough informed consent, including a clear understanding of FDA status. Informed consent begins when patients meet their optometrist. It is the relationship you develop over time and not the signed document that actually protects you in the long run; therefore, take care to nurture and maintain this relationship throughout the refractive surgery process.

Referring optometrists should be intimately familiar with the experience their patients will encounter, including details of surgical technique as well as the status of current regulatory issues.
Certification by the surgeon and comanaging OD is essential. Becoming certified and maintaining updated knowledge of laser procedures and comanagement is the single most comforting message you can give your patients.

Strict comanagement protocols are necessary to insure that patient data is appropriately recorded both in the surgical and comanagement records. These should be developed jointly between you and your referral center.
Patient monitoring, follow-up and meticulous results analysis is critical. In lieu of obtaining an FDA Investigative Device Exemption (the formal FDA study for any new device or procedure), it is imperative to monitor all patient data and perform outcome analysis that is available to all referring doctors and patients. If your surgeon is not providing this data, you might suggest an outside agency to monitor the results.

As LASIK makes its mark on the refractive surgery scene, let us learn from past experience and base our comanagement relations solidly upon the principles of education, service and quality surgical results. The market may be slow to develop, but we will all benefit from a sensible maturation process.