LASIK & Safety

Is LASIK Safe?
by Craig 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 alleviate unnecessary fear. Here, I present the pertinent information about the safety of LASIK.

 

Introduction

Performed since 1991, laser vision correction has been performed over 30 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 that weren’t actually good candidates for LASIK.

 

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. Fortunately, this is largely a historical issue and has been substantially improved by advancements in modern wavefront excimer lasers and eye-movement tracking lasers. These side effects were more common in patients with very large amounts of nearsightedness, very large pupils, and patients that were treated with older laser 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 to accomplish. 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 medically-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 non-wavefront 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 2017). 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 modern femtosecond lasers, like VisuMax or Intralase (Or 100% impossible with flap-less Epi-LASIK/PRK or SMILE)

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 removed if necessary. Today, this problem is much less common with All-Laser LASIK, due to its patented “manhole-shaped” inverted bevel flap edge architecture.

Inappropriate surgery for patients that were actually not “good candidates” for various reasons (i.e. thin cornea, asymmetric cornea, keratoconus). This is why I personally meet with each prospective patient to determine if a vision correction procedure is appropriate. About 80% of patients are good candidates, but about 20% are better-served to just continue with glasses or contacts instead. We have told over 8,000 patients to NOT have a procedure… It’s our “Safety-First” approach.

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?”

 

The “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-losing 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”.