The Dry Eye Zone

Rebecca's Blog

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LASIK in the news again...

End of a long day... sclerals sitting in their case... here I sit, gritting my teeth while trying to motivate myself to write some commentary about the recent ABC interview of Morris Waxler (former FDA chief responsible during the period excimer lasers were first being approved... and who awhile back testified against a manufacturer that was sued and later investigated by the FDA for failing to report complications it knew of) as he discussed concerns about the inadequacy of the FDA's safety review back in the beginning.

But before I could lay hands on a link to the article, I ran across a more recent response to it from a refractive surgeon that made me squirm so much I actually wrote in a response.

Here's the article:

An Eye Doctor's Counterpoint
Tuesday, March 02, 2010
By Dr. John P. Frangie
Some two years ago, I was troubled and disappointed as I read Abby Ellin’s article in the New York Times. Her story—the tale of an intelligent patient who carried out her due diligence, selected a well-trained and capable surgeon, only to experience a poor outcome—embodied a tragedy to an ophthalmologist who helped collect data for the FDA laser correction trials.

Ellin’s latest article in the Advocate is timely, as the FDA is again scrutinizing the safety and efficacy of LASIK (an eponym for laser assisted in situ keratomileusis). Coincidentally, Good Morning America also had a feature regarding LASIK safety on February 25, 2010 (http://abcnews.goGMA/OnCall/lasik-surgery-side-effects-fda-regulator/story?id=9933008).

Ellin’s writings, and the FDA‘s investigation, underscore a number of important points. First and foremost, LASIK is a surgical procedure; as such, it has attendant risks, and no surgeon is able to unequivocally “guarantee” the results. Complications may occur—even in the most skilled hands, utilizing the most advanced technology. These complications may have long-lasting or even permanent implications.

The Advocate article by Ellin also mentions that she signed an informed consent, but in retrospect, she did not truly realize or envision the impact and extent of the potential problems that she has had to endure. There is a plethora of ethical and medicolegal treatises which document and debate the informed consent process. The question which is inevitably raised is, Can a lay person truly give complete, informed consent where they are cognizant of the risks and implications of those risks upon their life?

I have no qualms with points made by Good Morning America and Ellin, but I believe their reports could offer more balance.
Allow me to offer a few observations:

Relatively few patients experience the complications of dry-eye, glare and halos after LASIK.


Okay... stop RIGHT THERE. Relatively few? You lost me. It's just not true. Even the medical literature says so - at least, in such of the peer-reviewed journals as are not industry mouthpieces.

The Good Morning America feature does acknowledge the overwhelming success rates of LASIK
It is not accurate to compare the outcomes of LASIK procedures performed five years ago (and certainly not 12 years ago) to those offered today, as many advances in the technology and understanding of laser correction have been made. For instance, most LASIK flaps in the United States today are not created with a blade— the major cause of ocular dryness and flap complications prior to 2003....


The way this is phrased seems to imply that so long as a microkeratome isn't used, this won't happen to you. Problem one.

Second, what is this ostensible obsolence of microkeratomes based upon? Nonsense. Show me some statistics. Microkeratomes are still widely used - often the same surgeon uses both techniques.

I think this reference to "prior to 2003" is rather devious. You mean microkeratome flaps were the problem... only up to 2003? That's when it was barely launched. I was alive and well in 2003 and I know as well as you do that surgeons weren't stampeding to lay down $500k for an Intralase the moment they hit the market. It took years for them to even get a significant chunk of the market for that technology. Obsolescence is a long ways off.

Besides, um... us millions who WERE lasered in the last 15 years of microkeratomes, plus the rest that will be in future years till microkeratomes become obsolete (if they do), what are we, chopped liver?


In summary, LASIK is one of the safest, most effective surgical procedures performed, with a constantly improving safety and efficacy profile. Despite this, the patient must keep in mind that it is a surgical procedure with potential risks. LASIK is an elective procedure, and therefore affords one the luxury of time—to meet with your surgeon, express your concerns and goals and have your questions addressed. Your physician will give you an informed consent document. Bring it home and read it at your leisure; if you have questions, ask them before the day of your treatment. It is important that one is comfortable with the surgeon, the procedure, and the decision to proceed. While hindsight is 20/20, moving forward with your eyes open will serve you well.


These elegant little summary statements sound eminently reasonable to everyone except those who, after experiencing complications without receiving adequate treatments, come to realize that asking the questions is only useful if the answers are grounded in practical reality from the patient's point of view rather than the doctor's.

I might as well post here my response to the article.

Dr. Frangie,

You state in this article, "Relatively few patients experience the complications of dry-eye...after LASIK".

This statement is not supported by the medical literature. Medical studies abound suggesting rates in the neighborhood of 5%, 10%, 20%, and at least one as high as 36%, employing a variety of methods assessing signs and/or symptoms. By any credible measure of ocular surface disease symptoms, the incidence of post LASIK dry eye is more than a little significant. Dry eye is in fact well known to be the most frequently occurring complication after LASIK - as is stated in the majority of informed consent forms that I have seen over the years, though most do not go so far as to explain the potential severity or persistence of this condition or possibility of available treatments not sufficing.

Everyone in the ophthalmic pharmaceutical industries know that LASIK dry eye is a big deal. New products have been developed specifically for people with LASIK dry eye. The cat has been out of the proverbial bag too long to make statements downplaying the significance of post LASIK dry eye.

Respectfully,

Rebecca Petris
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