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/ LASIK & Safety

LASIK & Safety
by Craig S. Bindi, MD

As a prospective LASIK patient, safety should be the single most important factor guiding your decision
to have LASIK. While “fear of a complication” is a common obstacle to having LASIK, becoming informed
may dismiss unnecessary fear. Here, I present the pertinent information about the safety of LASIK.

Introduction
Performed since 1991, laser vision correction has been performed over 25 million times. In 1995, the
FDA approved laser vision correction in the United States. Though the vast majority of LASIK patients
have been very satisfied with their results, 141 patients have complained to FDA that their laser vision
correction results were unsatisfactory. LASIK is not a “foolproof” procedure. Today, problems are more
likely with older technology, less experienced/less careful surgeons and patients who actually aren’t
good candidates for LASIK. Potential LASIK problems typically fall into the following categories:

Eye Dryness, which occurs from temporarily reduced corneal nerve sensation or other ocular surface conditions. Luckily, this is very treatable and preventable for most patients. For more information about how to avoid & relieve Dry Eye after LASIK, Read ‘LASIK & Dry Eyes

Nighttime side effects (i.e. glare, halo, star-bursting and/or decreased contrast sensitivity) resulting in
reduced quality of vision at night. This is largely a historical issue, having been substantially resolved by
advancements with newer excimer lasers, eye movement tracking lasers and custom Wavefront Technology. These side effects were more common in patients with very large amounts of nearsightedness that were treated with older technology. A recent study showed that a patient is ten-times more likely to see better at night than worse after Wavefront IntraLASIK. Read ‘LASIK & Night Vision

Accuracy & Enhancements: The goal of laser vision correction is to eliminate one’s complete
dependence on glasses/contact lenses. For most patients this is a very realistic goal. But, even in the best of hands, LASIK is not 100% accurate (on the first attempt). After undergoing LASIK/Epi-LASIK, if a patient still has some residual near-sightedness, farsightedness or astigmatism, a re-treatment procedure can fine-tune one’s vision, if desired and appropriate. All objective data reveals that the possibility of a LASIK re-treatment ranges from 2% to 10%. There is a higher chance or needing a re-treatment in patients that have a larger correction, use standard (non-wavefront) LASIK technology, or have a less “detail-oriented” surgeon. The re-treatment rate with standard LASIK ranges from 5-10%. Though standard LASIK has a long track record for effectiveness, newer Wavefront LASIK methods have improved the accuracy of LASIK, and reduced the possibility of a re- treatment to about 2% to 5% (even with a great surgeon and best technology in 2013). In reality, this is a very low percentage and there is no other surgical procedure that can rival the accurate results of LASIK/Epi-LASIK. In my ophthalmology practice, I make every effort to get it right the first time.

Flap problems (i.e. irregular flap during surgery or shifted flap after surgery). With improved technology
and an experienced surgeon, chances of these problems are exceedingly rare and vary depending on the
procedure (about 1 per 2000 with newer microkeratomes, and virtually impossible with 5th generation
All-Laser IntraLASIK or Epi-LASIK/PRK.

Infection (1 per 10,000 surgeries). Though infection is very rare, I advocate using preventative
antibiotic eye drops, just to be safe.

Corneal Inflammation after LASIK (a.k.a. diffuse lamellar keratitis). Careful follow-up care
by the surgeon and appropriate use of anti-inflammatory eye drops can prevent this problem.

Epithelial Ingrowth (1 per 300 to 1000 procedures). Epithelial cell growth under the LASIK flap is a fairly
uncommon occurrence that can be remedied if necessary. Today, this problem is much less common with 5th generation All-Laser IntraLASIK™, due to its patented “manhole-shaped” inverted bevel flap edge architecture. Currently, the 5th generation Intralase™ is the only brand of femtosecond laser on the market with this unique feature.

Inappropriate surgery for patients that were actually not “good candidates” for various reasons
(i.e. thin cornea, asymmetric cornea, keratoconus). To learn about my rationale for careful patient
selection or other reasons for non-candidacy, Read the Info Library topic: ‘Do Not Have LASIK if…’

Unrealistic/unfulfilled expectations. Gathering as much information as possible before your procedure
is integral in giving you realistic expectations, and is the primary goal of this website. You’ll be hard pressed to find anything but glowing testimonials and non-specific propaganda on most LASIK websites and brochures. On this website, I try to be as objective, substantive and factual as possible. When I make a claim, I back it up with scientific evidence and footnote my source. Read the Info Library topic: ‘LASIK & Realistic Expectations’.

After two decades, LASIK has been extensively studied and progressively improved.
Modern technologies, such as Wavefront technology, “All-Laser” LASIK, eye-movement “tracking” lasers
and Wavefront Epi-LASIK have significantly reduced the chances of problems from laser vision correction.
As expected, the safety profile and vision results are better with today’s modern LASIK
compared to “1991-style” LASIK.

The FDA’s role
The FDA’s LASIK policy is readily available on its website for LASIK safety. While the FDA’s website is
unbiased, it is quite generic because it evaluates the safety of medical devices for the general public.
During your personal consultation, I ask the more specific question, “Is LASIK safe for YOU?”

“What if” scenarios
Each week I am inevitably asked about hypothetical “What if” scenarios, such as, “What if there is a power
outage during surgery? What if there is an earthquake?” and “What if the wrong person’s measurements
are entered into the laser?” Just to be safe, our lasers have a backup power supply and the high level of
automation has largely eliminated the possibility of human error. Being meticulously careful and neurotic
about safety helps, too. Listening to these scenarios and worries gives me a keen level of insight into
the inherent “fear of the unknown” that some patients have with elective LASIK eye surgery. In a recent
survey of LASIK patients, over 50% denied being superstitious but admitted that they would rather not
have their LASIK performed on Friday the 13th!

Become Informed
As a prospective patient, it is prudent to adopt a healthy amount of cautious skepticism when considering
any medical procedure. Across the country, some LASIK business models have crossed the line of
acceptable medical standards by neglecting to give patients realistic expectations, failing to properly care
for their patients after surgery, and not focusing on their patient’s best interests.

As a Patient
As a former “glasses wearer”, I was once faced with the decision to have LASIK or not. After
reviewing all the available data at that time, I personally chose to have LASIK in 2000 (Both eyes
treated on the same day, performed by my partner). For me, it has been a great
decision. If I did not believe in the technology for myself, how in the world could I justify
recommending it for someone else? Nevertheless, I am familiar with the inherent fears of elective
vision surgery from a patient’s perspective.

One more thing!
A well-rounded discussion would not be complete without addressing the fact that there are also risks
associated with NOT having LASIK! For example, a contact lens wearer has about an eight-fold risk of a
sight-altering eye infection compared to a patient with LASIK. Also, certain real life scenarios may occur
where being dependent on corrective lenses can be risky or disadvantageous (i.e. losing one’s glasses and
having to drive home or trying to flee a burning building at night without one’s contact lenses available).
So there is no perfect choice and there are potential downsides to any action, or inaction.

Conclusion
Ultimately, the million-dollar question remains… Is LASIK safe? My answer depends on many factors.
Is the patient really a good candidate for surgery? Who says so? What technology is going to be used?
Who is the surgeon? Is the appropriate technology being ideally matched with the appropriate patient?
Who does the follow-up care? This is why I feel it is essential to personally meet with every one of my
patients prior to their procedure. For about 20% of my patients the answer is “No”, and it is better to stick with
glasses or contacts. Luckily, for most people, “Yes, LASIK is very safe”.