Exposing the LASIK Scam

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 Post subject: CLINICAL TRIALS FOR LASIK FLAWED
PostPosted: Mon Dec 19, 2005 12:38 am 
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Reposted with permission from the author:

CLINICAL TRIALS FOR LASIK FLAWED

On the subject of LASIK complications, and who knew what and when...let's just say I can't wait for some depositions to go public.

Here's something that is public that may interest you. Hopefully you have read it. If you have, you would know that there was a BIT of a clinical trials problem, with VISX being much more, shall we say 'problematic' than Alcon. Now there's an understatement.

Now why do you think a company would collect contrast sensitivity data and not report same? Hint, LASIK causes loss of contrast sensitivity in all
patients. Don't want to have to actually tell the victims, er... I mean 'patients' about that, so suppress THOSE DATA!!!

Hard to believe that less than 25% of LASIK patients in a clinical study would bother to show up for their follow-up appointments! It is in their medical best interests to be followed for a year. What do you think that huge patient population gone missing has in common? What do you think the patients who were included had in common? Why do you think they lied about 12 month accountability? If you were to derive means of several metrics of outcome measure, do you think the differences between these groups would be statistically significant?

How about patients who report being dropped from clinical trials for having bad outcomes?

Why the reliance on subjective survey data of symptoms when the technology to gather objective clinical data was available? And then to present inferior subjective survey data on only a subset of patients... in a format that any Stats 101 dropout drooling idiot can easily recognize as bad science! Who set up these 'studies', who was monitoring these clinical trials, who was involved in these clinical trials, and who voted to approve these devices?

If your choices in a subjective survey are on a 'better' or 'worse' scale with no actual measure of magnitude, then a patient who sees starbursts that are a bit larger after surgery is scored the same way as the patient who is incapacitated by starbursts from headlights that are larger than the cars that generate them. How much sense does this make?

If you own, operate or participate in another website, please repost this post including the reference below. Liberally. All over the internet.

http://www.ncbi.nlm.nih.gov/entrez/...3980&query_hl=2

J Refract Surg. 2004 Sep-Oct;20(5):S588-92.

Understanding pre-market approval and labeling differences of two leading customized ablation platforms: a call for reform at the FDA.

Wachler BS, Hiatt JA.
Boxer Wachler Vision Institute, Beverly Hills, CA 90210, USA.
b...@boxerwachler.com

From the full text:
"...the refractive outcomes for >70% of the study population are not
reported."

ABSTRACT

PURPOSE: To analyze the Food and Drug Administration (FDA) pre-market approval reported data for two currently available wavefront-guided excimer laser systems.

METHODS: VISX and Alcon myopic wavefront laser in situ keratomileusis (LASIK) trials were analyzed based on public information available in the pre-market approval documents.

RESULTS: Clinical tests and outcomes reporting varied between pre-market approvals. One pre-market approval reported contrast sensitivity whereas the other did not, although data was collected in both studies. Based on the FDA definition of "accountability," one pre-market approval reported 12-month accountability of 97.7% although only 24.5% of patients were analyzed at that interval. One pre-market approval reported 6-month results whereas the other reported 6- and 12-month results. One pre-market approval reported grouped pre- and postoperative subjective survey results; the other reported individual
changes in pre- to postoperative subjective symptoms.

CONCLUSION: We recommend an FDA revision to the definition of "accountability" and also recommend future FDA refractive surgery trials be guided by standardized criteria.


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