The Dry Eye Zone

Rebecca's Blog


Industry news: Upcoming FDA hearing on quality of life after LASIK

I've been following this for some time but did not comment earlier because I was not sure what to make of it. I'm still not, but the most recent press report irked me enough that I need to make a start on it. Since dry eye is well documented as the #1 complaint following LASIK, any serious post-market surveillance the FDA is doing needs to be taking a good look at dry eye.

Last month, there was an announcement that ASCRS, AAO and the FDA were forming a joint task force "charged with formulating a viable study design to identify dissatisfied post-LASIK patients, define their significant symptoms and evaluate the influence of those symptoms on quality of life, according to a joint press release from ASCRS and AAO."

OSN Supersite's March 17 article explains the origins of this meeting as follows:

Encouraged by FDA petitions urging for an effective freeze on nonessential eye surgeries, the FDA initially approached ASCRS in fall 2006 for assistance in designing the post-LASIK quality-of-life trial. Although the FDA did not deem the majority of requests worthy of new investigation, the agency has permitted the petitioners to present testimony at a special meeting of the Ophthalmic Devices Panel scheduled for April.

...suggesting that unhappy LASIK patients have been successful in getting some amount of attention from the FDA.

More recently, the FDA confirmed the date for the next ODP meeting as April 25th. This is open to public participation.

Today, ASCRS in this release...

ASCRS To Participate In and Co-Fund Study on Post-LASIK Quality of Life with U.S. Food and Drug Administration

...elaborated, a little anyway, on how it is teaming up with the FDA, NEI and AAO for the study.

Now down to the part that is really irking me. Read this:

Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients. In 2006, the FDA re-evaluated symptoms and satisfaction data and reaffirmed that while the vast majority of LASIK patients were indeed satisfied with their outcomes, a few were not.

While I'm not going to dispute that a large majority of LASIK patients are satisfied, this quote bothers me terribly. It appears to be trying to convey that the dissatisfaction rate is as low as 1 in 10,000 and I think this is a disingenuous use of the statistics, i.e. the 140 "comments" received by the FDA.

First of all, a rate of 1 in 10,000 (0.01%) is flatly contradicted by pretty much every study of patient satisfaction I've ever seen.

Second, most consumers who are dissatisfied after a surgery are not going to file a complaint with the FDA. Why? Because we (consumers) associate surgeries with doctors, not devices, and the FDA regulates only the latter not the former. Of the people who are dissatisfied with their outcome, the minority who go so far as to try to file some kind of complaint are far more likely to contact the bodies overseeing the doctors, i.e. state medical boards. Complaints to state medical boards are, in general, kept confidential, except in those very exceptional cases where the complaint actually results in disciplinary action.

Third, what are these 140 "comments" received by the FDA about patient dissatisfaction? What reporting system did they go into? I don't suppose it occurred to anyone to check the MAUDE database. Surely, at least some of the device malfunctions serious enough to be reported as an MDR must have resulted in dissatisfied patients? In the time period covered by those 140 comments (1998-2006), there were 339 MDRs filed on the LADARvision excimer laser alone. Another 156 on the Intralase femtosecond flap-making laser. To say nothing of the various mechanical microkeratomes.

Like I said, I'm not arguing that everyone's unhappy after LASIK. But LASIK dry eye IS a widespread problem; patients know it; doctors know it; and our Dry Eye Talk community bulletin boards provide ample daily evidence of the dramatic impact on "quality of life" for those unfortunate enough to experience it.
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