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:

Dry eye occurs from temporarily reduced corneal nerve sensation or other ocular surface conditions. For more information about the ways to avoid and relieve Dry Eye, 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 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 about LASIK & Night Vision
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 “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 goal of this website. You’ll be hard pressed to find anything but glowing testimonials and propaganda on the Internet. 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 LASIK & Realistic Expectations.

After two decades, LASIK has been extensively studied and improved. Modern technologies, such as Wavefront technology, All-Laser Intralase, eye-movement tracking lasers and Wavefront Epi-LASIK have significantly reduced the chances of problems from laser vision correction. As expected, it has become evident the safety profile and vision results are better with “2010-style” 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? 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, Dr. Gary Kawesch). 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 some patients the answer is “No”, and it is better to stick with glasses or contacts. Luckily, for most people, “Yes, LASIK is very safe”.

Craig S. Bindi, MD

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