The Dry Eye Zone

Rebecca's Blog


4/25/08 FDA LASIK hearing: AAO response

The May 2008 message from AAO president David W. Parke II, MD gives some distinct insight to how the AAO feels about what's going on in LASIK-land and to what extent they are interested in initiating any positive changes.

....We need to work harder at screening prospective patients, informing them of their risks and, frankly, managing expectations.

It is indeed gratifying to know that somebody "gets" what complications patients have been telling them for so many years. Though I think they might have dispensed with "managing expectations" as being redundant. If you screen patients carefully, and give them thorough and accurate information about their risks, there are unlikely to be any inappropriate expectations to manage. There might be fewer customers as well, however.

By the by, I am curious to know whether the AAO feels that working harder at "screening" prospective patients includes such things as looking out for contact lens intolerant patients who are probably at higher risk for LASIK dry eye. - Particularly considering Dr. McDonnell, who was representing AAO at the hearing, went out of his way to mention that such patients often seek LASIK, but - so far from cautioning that this may be a warning sign - he also seemed to suggest that LASIK is safer than contacts overall.

Then too, it seems the AAO desire to help LASIK patients retain vital information they may need down the road for cataract surgery:

The Academy is also developing a new “K-card” to be given to patients by their LASIK surgeons, which captures a patient’s preoperative keratometry readings and refraction. It is often difficult to track down this critical data years later, when the patient is in need of cataract surgery or additional eye care. We are exploring ways to store this information digitally for easy retrieval.

I am struggling to suppress some excessively uncharitable thoughts enough to keep my comments within the bounds of civility. But screw it. Some spades just need to be called spades.

The AAO has known about this problem for YEARS. One of its own members, Craig Berger MD (a corneal specialist in Tampa, Florida) has repeatedly tried to persuade them to actually do something about it, going so far as to develop his own internet-based software system (see Safeguard Your Sight) to help patients safeguard the information they will assuredly need eventually - and will almost as assuredly not be able to find when that day comes.

Has the AAO ever showed a particle of interest? Nothing doing. And even now, when the FDA hearing - which resulted in an agreement to add explicit warnings about this problem on the FDA website - has finally goaded them into some semblance of action, will they consider consulting with Dr. Berger after all the time he's invested? Nothing doing. Their idea of helping patients is giving them a card with their vitals.

By golly, that sounds like a wonderful solution which surely all future LASIK patients will appreciate. Lookie! I'm a card-carrying member of the LASIK club! No more glasses. Intead I get to carry a piece of paper in my wallet for the next 30 years which, if I am lucky enough to understand anything about on the day I get it, I will almost certainly forget altogether within the next year.

Funny, this almost reminds me of the card I got from my surgeon in the mail a week after surgery (at which point I couldn't read a stopsign to save my life) stating that I'm legal to drive without corrective lenses. Apparently for a fleeting moment during one of my early post-op exams - probably overcorrected and squinting - I squeezed out a 20/40 OU UCVA in a manifest refraction.

Bottom line: If I was holding out any hopes that the AAO would be just a teensy, weensy bit different from ASCRS in terms of its inclination to promote higher standards than the last 10 years status quo, I am no longer deluding myself.