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.