Reviewed by Jason Jacobs, M.D.
In any field of medicine or surgery, and especially in eye care, advances in the understanding of how to better treat to eye conditions, eye disorders and eye diseases often leads to development of new technology and procedures for treatment. In the past 25 years it has become commonplace for medical device manufacturers and pharmaceutical companies to use aggressive marketing tactics aimed directly at healthcare consumers in order to promote the rapid adoption and sales of their particular product. Often, these companies will also use forceful tactics whereby if they create enough "patient demand" for a particular product, drug or treatment it forces eye surgeons to "offer" it so that they will not be "left behind" and be perceived as out of date by patients. Eye care technology has and will continue to emerge at a very rapid pace. Patients need an objective understanding of alternatives when considering LASIK so as not to get caught by the "latest and greatest" fad that may be sweeping LASIK Eye Surgery today.
There are a number of facts that potential LASIK patients should consider as they are evaluating or are presented with alternatives to LASIK.
LASIK has Withstood the Test of Time
LASIK was first performed internationally in 1989 and was introduced to United States LASIK surgeons in about 1990. LASIK underwent Food and Drug Administration clinical trials to demonstrate safety, efficacy and predictability in the early 1990's and was FDA approved in 1998 from the data provided as part of a Pre-market Approval Application (PMA). A PMA requires extensive safety data and clinical trials. Eye care consumers should not be completely lulled into feeling confident when a device or procedure is FDA approved. Most eye care consumers do not realize that there are two completely different paths to FDA approval that may be required. One, the PMA approval process, is extensive, time consuming and approximates how a device or procedure will perform in the "real world" in terms of safety or efficacy. The second route is called the 510(k) Approval in which a manufacturer must only demonstrate a limited amount of safety data in order to obtain approval. Sometimes devices such as surgical instruments can be FDA approved with little or no clinical trials under the 510(k) process.
What Does this All Mean?
It means that LASIK performed with the Excimer Laser has had extensive FDA monitored clinical testing and data analysis whereas other "new devices" introduced to perform "better" LASIK or other vision correction procedures may have not undergone the same level of testing and scrutiny to be certain that a particular procedure or device was "real world" safe and effective. This means that these so called 510(k) approved devices may actually be doing their clinical trials on the first several thousands of patients treated in order to refine their devices and make them effective. This is why "latest and greatest" in LASIK surgery is NOT always the best. It has not been subjected to the scrutiny...yet.
Where Does the Real Scrutiny for LASIK Alternatives Occur?
With any drug, device or procedure, the true testament to its safety and efficacy becomes obvious in the "real world", when real eye surgeons, in real practices using the drug, device or procedure actually use it to meet the expectations of patient satisfaction. If in the "real world" use of a drug, device or procedure it is unable to predictably meet or exceed patient expectations in terms of what it actually delivers without an undue amount of risks and complications then it will ultimately fail and diminish in use in the consumer marketplace. So, the real test of safety and efficacy is the sustainability of a drug, device or procedure such as LASIK over a long period of time in the consumer healthcare marketplace.
While exact worldwide data are difficult to obtain, we are able to obtain fairly good LASIK data in the United States because of the monitoring of laser use through patent license fees paid to Excimer laser manufacturers. LASIK was FDA approved in 1998 through the more rigorous PMA process, and conservatively since that time over 12 million LASIK procedures have been performed on the United States. During that period of time, a number of special interest groups such as various specialties of personal injury and malpractice lawyers and public relations promoters have demonstrated opportunistic behavior in their attempts to discredit or damage LASIK surgeons, the LASIK procedure, LASIK technology and the industry as a whole. While there have been times of LASIK consumer trepidation, the fact is that LASIK has withstood the test of time and remains the procedure of choice for the vast majority of patients wishing to correct nearsightedness, farsightedness or astigmatism for distance vision. That is not to say that there have not been poor results. The test of time however, tells us that when LASIK is performed by an experienced LASIK surgeon, in carefully selected patients, for LASIK patients who have the opportunity to fully understand the risks, benefits and complications in their particular set of circumstances, and who have a strong understanding of what their criteria for success are...LASIK is in fact a safe, effective and predictable method of correcting vision.
What About "New Procedures" and Techniques?
Within this website we attempt to provide unbiased information about LASIK procedures and LASIK surgeons. There is a constant evolution of LASIK technology. Many of those "new" approaches such as LASEK and Epi LASIK have been at least illustrated in this site. LASIK alternatives that have come and gone from the marketplace have been intentionally ignored as they have not withstood the test of time and represent fads. Other LASIK alternatives such as Lens Replacement Surgery with ReSTOR & Crystalens for those patients with presbyopia needing help in order to replace bifocals for near vision, and Phakic Intraocular Lenses such as Verisyse for patients with extremely high degrees of nearsightedness who may have LASIK contraindications and as thus not good LASIK candidates have been included as they may be appropriate alternatives to LASIK for certain patients. As always, the ONLY way to find out if you are a good candidate for LASIK, Lens Replacement Surgery, or a Phakic Intraocular Lens is to schedule a consultation with a surgeon who is experienced in these procedures and to make sure that you fully understand what each procedure can and cannot do for you and by setting realistic expectations for your success.