Thoughts on LASIK, complications and the FDA study of the procedure

Issue: March 25, 2011

ByRichard L. Lindstrom, MD

Richard L. Lindstrom

There are many interesting issues to discuss in the ongoing saga of the controversy over LASIK safety, efficacy and the level of patient satisfaction generated by the procedure.

I confess that I am highly engaged in this issue and at one time chaired a LASIK Task Force, later disbanded, which included participation by members of the American Society of Cataract and Refractive Surgery, the American Academy of Ophthalmology, the U.S. Food and Drug Administration, the National Eye Institute and the military. Let me also disclose immediately that I am a cornea fellowship-trained refractive surgeon, actively perform LASIK and PRK on appropriate patients with appropriate informed consent, serve as a consultative surgeon managing complex cases and dissatisfied patients referred by other doctors, am Chief Medical Officer for TLCVision, and consult for three major manufacturers that market excimer and femtosecond lasers (Abbott Medical Optics, Bausch + Lomb and Alcon). I also serve on the Refractive Surgery Clinical Committee of ASCRS and am Global Education Liaison for ISRS/AAO. I am a past president of ASCRS and ISRS/AAO.

I have participated in multiple clinical trials of laser corneal refractive surgery. I also perform other anterior segment surgery, including phacoemulsification with refractive lens implantation, keratoplasty and some glaucoma surgery. I have been an MD for 40 years and dedicated to ophthalmology exclusively for 39 of them, including residency and fellowship training.

Bottom line, no hesitation, looking you or any patient straight in the eye: LASIK is the best surgical procedure I perform today in regards to safety, efficacy, risk-benefit ratio, patient satisfaction and transformative impact on patients’ lives when treating low to moderate myopia and astigmatism in patients between the ages of 18 and 45 years. Absolutely no contest in my opinion. For the right patient with a well-trained surgeon and modern equipment, LASIK is the best surgical procedure I have to offer, period. Nothing else comes close in regards to refractive outcomes and patient satisfaction, which approaches 98%-plus in recent series from the military, large centers such as TLCVision and Optical Express, as well as numerous experienced surgeons around the world.

As a comparative, most of the popular plastic surgery procedures generate patient satisfaction between 80% to 90% and cataract surgery with lens implantation is a stretch to generate patient satisfaction in the low 90s. The world literature published before the development of femtosecond laser flap making and wavefront-driven or optimized procedures generated a mean patient satisfaction of 95.4%, including patients with high levels of myopia, hyperopia, astigmatism and presbyopia, many of whom we would not treat today. In regards to the 5% who were not happy, 3% had residual refractive error that could be treated with an enhancement. That leaves us with 1% each who had some level of dissatisfaction from dry eye symptoms or night vision symptoms such as glare or halo. These are no surprise to the LASIK surgeon.

We all should, and do, advise patients that they might need a second treatment or develop some dry eye symptoms or difficulty with night vision after laser corneal refractive surgery, whether LASIK of PRK. Usually these are treatable and resolve with time, but occasionally they persist. I make all patients aware of these possible side effects. This knowledge is not new and was fully evident in the multiple FDA clinical trials of several excimer laser platforms. It is already in the labeling and in every informed consent document I have ever seen. Every study in every country by every LASIK surgeon has confirmed this finding.

So, now we will spend a decade and millions of dollars to study LASIK again? We will learn 5 or more years from now that a small number of patients after LASIK surgery benefit from a second treatment and that 1% or so have enough dry eye symptoms to be somewhat dissatisfied. I suspect night vision symptom complaints may well disappear, because recent phase 4 studies supported by several manufacturers suggest that modern LASIK, whether wavefront-guided or optimized, in most patients actually improves night vision performance. The military experience, where every complex task, such as marksmanship to landing a jet fighter on a moving aircraft carrier at night, is graded before and after surgery, confirms this finding.

Why are we doing this study? We are doing this study to appease a very small number of extremely vocal critics who in most cases had a surgical procedure totally different from that which will be studied and that which we offer to our patients today.

To be direct, in my opinion this study is primarily being done for political reasons. As a consultative ophthalmologist, I see some of these dissatisfied LASIK patients, and I care that they are unhappy and am committed to do all I can to help them overcome their visual disability. If you also see these patients, it might help to share a few of my insights into their needs.

I have learned from them that they want to know exactly what “went wrong.” They want to know what I am going to do to try to help them, and they want to know that I am going to leave no stone unturned and get any other help I need to help them function better. Perhaps even more, they want to know that I care and that I am sorry they did not achieve the outcome they and their surgeon desired. Finally, they want to know what I as an individual surgeon and what we collectively as a group of LASIK surgeons have done and are doing to see that it does not happen to others.

My experience is that most of the unhappy patients are extremely altruistic. They do not want others to suffer as they have suffered. Some are angry and want the procedure to be banned, but most, just like we surgeons, want it to get better. In this regard, surgeons should be their best partner and advocate. I personally find the vast majority of surgeons to be extremely altruistic as well and know of no fellow surgeon who does not do everything in his or her power to generate the best possible outcome for patients.

What is the barrier to surgeons and our occasional unhappy patient collaborating to make LASIK ever better? Sadly, when we are in conflict, it is almost always a lack of trust. So, other parties become engaged, including government regulatory bodies, all under the watchful eyes of opportunistic attorneys specializing in malpractice and class-action litigation. But neither the unhappy patients nor the concerned, compassionate LASIK surgeons striving to make the procedure better usually trust the government regulators, and their mutual distrust is returned in kind. And, as we all know, the litigating attorney is rarely motivated to enhance the art and science of medicine and surgery, just to benefit from the occasional maloccurrence. What an amazingly expensive and unproductive web we weave through our inability to trust one another and work together constructively toward the common goal of better educated patients and progressively safer and more effective treatments for those who find dependence on glasses and contact lenses a significant handicap and an obstacle to their quality of life.

So, some have chosen to spend huge sums of human and financial capital performing yet another redundant study of our current method of performing LASIK to again learn that some patients require a second treatment, a few suffer from dry eye symptoms, perhaps especially middle-aged women or men who are on anti-depressant therapy, and maybe a small number have night vision symptoms. Meanwhile, others of us working together with the industry that supports innovation will look for ways to prevent these problems from occurring through advancements in technology, technique and medical therapy.

LASIK, and every other surgical procedure that we perform, and for that matter, the contact lenses we fit, will never be perfect and totally risk free. I remain very comfortable offering today’s LASIK to select patients with proper informed consent, but I want the procedure to advance in safety, efficacy and patient satisfaction. I remain concerned and committed to help rehabilitate those who suffer outcomes they find unsatisfactory and want them to know that I am sorry and care. While skeptical that we will learn much we do not already know, I am even willing to help study again the most studied surgical procedure in ophthalmology. However, most exciting to me is the continuous quest to advance the art and science of laser corneal refractive surgery so that patient satisfaction rates approach 100% and complications occur with a progressively lower incidence.

My hope and prediction is that, by the time the currently planned LASIK study is completed and the results published, we will no longer be doing the procedure evaluated, and the outcomes will be of historical interest only, much like the 10-year outcomes of the Prospective Evaluation of Radial Keratotomy study I participated in 30 years ago.