An Eye Doctor's Counterpoint

Comments (2)
Tuesday, March 02, 2010

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.
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. Eye tracking technology is now the standard of care; prior to its introduction, the laser beam could be misplaced upon the eye, a major cause of double vision.

Another major development is lasers that perform “wave front” treatments. These advanced systems decrease optical aberrations that were the cause of many complaints of glare and halos.

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.

John P. Frangie, M.D. is a board certified ophthalmologist specializing in cornea and refractive surgery. He received his medical degree from the University of Kansas and served his ophthalmology residency at the Boston University School of Medicine. Following residency training, Dr. Frangie completed a fellowship in cornea and refractive surgery at the University of Rochester School of Medicine and Dentistry, where he participated in research with the Excimer laser and laser vision correction.
Following completion of his cornea and keratorefractive surgery fellowship, Dr. Frangie returned to the Boston University School of Medicine as director of the Cornea and Refractive Surgery Services. While at BU, Dr. Frangie trained resident and fellow surgeons, in addition to publishing numerous articles and chapters on corneal disease and surgery.

Dr. Frangie returned to Western Massachusetts to be closer to his family in 1998. At that time he established Pioneer Valley Optathalmic Consultants, P.C. with offices in Greenfield and Amherst. In 2003 Dr. Frangie established NorthEast Laser Center in West Springfield. It was the first center in the area exclusively for laser vision correction, and the first center to offer Intralase all-laser surgery.

Comments (2)
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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

President

The Dry Eye Company

Posted by Rebecca Petris on 3.5.10 at 3:26

I suffer from Post LASIK dry eye and it is horrible. Dr Frangie did you or will you under go LASIK yourself? And, would you let your child or family member to it? If then you are a fool! There are numerous recent studies indicating permanent corneal never damage! I cannot argue you the technical’s with you and I have no desire to do so. I have been researching LASIK for the last 4 years and for the life of me I cannot understand why the FDA approved this? It is absolutely harmful to the cornea. I can tell you – you should be ashamed of yourself – promoting a unecessary surgery that has such risks. As a lay person, no way did I or could I in vision or understand the risks or what it would be living with dry eye. If I could I would take you license away from you and all those promoting LASIK. I would put all of you in prison where you belong. But before doing this I would make you all undergo LASIK! People like you are disgusting!

Posted by ron on 3.11.10 at 2:02
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