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LASIK Safety Information: Then and Now

Millions of people have benefited from LASIK surgery in the almost 20 years that it has been in use, and millions more will have the procedure this year and in the years to follow. Still, there are many that could benefit that will not because of fear and uncertainty. Lasers and computers in the operating room still sound a bit too sci-fi, and some people question the safety of this new technology. If you are one of the hesitant few, then you will be relieved to know that LASIK surgery has a long history of safety.

LASIK stands for “laser-assisted in situ keratomileusis,” the scientific term for the procedure. It was first performed overseas in 1989, and surgeons in the United States began practicing it only a year later. To gain credibility, the procedure was presented to the Food and Drug Administration for approval in the early 1990’s. To gain approval, a number of clinical trials were required in an effort to prove the procedure’s safety, efficiency and predictability; the trial results consistently demonstrated all three values, and LASIK received FDA approval in 1998.

There are two ways to gain FDA approval for procedures or instruments in the medical field. The first is through a Pre-market Approval Application (or PMA). Approval through a PMA requires large quantities of scientific and safety data backed by consistent and well-regulated clinical trials. The idea behind this process is that the procedures undergoing this scrutiny will be perfected prior to approval and that upon receiving FDA approval they will already be safe and proven before hitting the market. The second way to gain FDA approval is through a 510(k) Approval Application. A 510(k) application typically only applies to things of smaller impact, like instruments. Much less data is required to obtain approval this way; in fact, many devices approved through this process have no clinical history before hitting the market.

Many of the afore-mentioned products made available through the 510(k) process are essentially being tested and proven on their first patients. While LASIK surgery itself is well-tested and has consistently produced high success rates both in clinical studies and with regular patients, some instrumentation used by surgeons promoting “new and improved” procedures may not have the same history of safety and predictability. For this reason, it is important to be familiar not only with your surgeon but with their preferred procedure. One instrument that has undergone several clinical studies and has consistently been proven safe and effective is the Excimer laser. Patients undergoing LASIK surgery with the old tried and true Excimer laser can rest assured that this equipment has been well-tested and to this date has aided in improving vision in millions of patients.

It is not uncommon for companies selling and promoting medical devices or drugs to take advantage of a paranoid public through aggressively targeted marketing. The buying public is led to believe that these products are critical to their well-being, and this pressure in turn trickles down to their doctors who are forced to offer fad procedures and products to remain viable and keep their patients happy. Even LASIK surgeons are not immune to patient demand, so it is important for you to do your own research when considering refractive surgery.

Traditional LASIK with the Excimer laser has stood the test of time and of trials. When performed on a properly screened and prepped candidate by a trained surgeon, the results can be nothing short of miraculous. New procedures are being promoted all the time, and some like Epi LASIK show real improvement over the traditional procedure, while others like Phakic Intraocular Lens offer a safe alternative to non-traditional patients. No medical procedure is without some risk, but LASIK surgeons and other proponents of the procedure have worked hard to reduce that risk.


 
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