Exposing the LASIK Scam

One Surgeon at a Time
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 Post subject: Prepare to be nauseated
PostPosted: Fri Apr 11, 2008 6:39 am 

Joined: Fri Jun 29, 2007 3:11 am
Posts: 102
http://www.eyeworld.mobi/current-issue- ... hp?id=4321

See the link above for the full text. I've only listed parts that I think we would be most interested in below ...


A year of collaboration and challenges
by Vanessa CaceresEyeWorld Contributing Editor

Richard L. Lindstrom, M.D.

Dr. Lindstrom reflects on his presidency

EW: Can you say a little more about the collaboration with the FDA?
Dr. Lindstrom: The two ongoing collaborations with the FDA are for TASS and issues of patient satisfaction following LASIK.
The other issue is that there is a significant amount of concern about patient satisfaction following LASIK. There?s no doubt that the objective outcomes of LASIK are outstanding, but these trials haven?t done as good of a job looking at patient-reported outcomes. The FDA has some concerns in that area, and they came to us asking how we might help evaluate this situation. We enlisted the help of the AAO and the National Eye Institute. What we?re doing now is putting together a review of the literature. We found eight well-done studies that suggest that patient satisfaction after LASIK is in the 97 and 98% range. That?s certain reassuring, but that means there?s a small percentage of patients who aren?t fully satisfied?in the two to three percent range. We?re looking next at how we might understand that group better?how we might counsel them better about potential issues in patient satisfaction and how we might avoid certain classes of patients who have reduced satisfaction with LASIK or other excimer laser procedures. In that regard, we?re working on validating the capabilities of a quality-of-life study that would be Web-based and create a tool that would give us a valid study. It would be a tool that could be used both in a potential study of LASIK but also with other refractive modalities such as presbyopia-correcting IOLs.
Depending on how things evolve with the committee over the next year or two, we may look at a prospective clinical trial. If we do so, it?d be a first. I?m told by Malvina Eydelman [M.D.], head of the FDA?s division of ophthalmic devices, that this is a first example of the FDA, National Eye Institute, and the two societies working together collaboratively to look at an issue that?s important to all of them. From a pioneering fashion, it?s important to us and to patients. That?s something new and exciting and should bear positive fruit.

Contact Information

Lindstrom: 612-813-3633, rllinstrom@mneye.com

Let the FDA know about your poor LASIK outcome by reporting it through the FDA MedWatch program ... http://www.lasik-flap.com/forum/viewtopic.php?t=1620

 Post subject:
PostPosted: Thu Apr 24, 2008 5:27 pm 

Joined: Sat Mar 04, 2006 8:13 pm
Posts: 168

So far, the agency is citing ?a few? unhappy post-LASIK patients? complaints as the impetus. They must be really big, really loud or really unhappy patients to induce a grossly overworked and underfunded agency that clearly has better things to do than reexamine a surgical procedure that has been safely performed for almost a decade and a half. The agency could just review Jorge Alio?s 10-year follow-up on LASIK and PRK published in January and February in AJO and the British Journal of Ophthalmology and save a lot of people another night in the Gaithersburg Hilton. But we?re being positive here.

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