Strangely VISX collected post-op contrast sensitivity data but
failed to report it in their PMA (for patients reading... this is the
data from clinical trials that is submitted for approval). Isn't it odd
that the FDA let this PMA slide through anyway?
Then there is the odd fact that VISX left out over 70% of their
clinical outcomes from the PMA.
>From the full text:
"...the refractive outcomes for >70% of the study population are not
reported."
http://www.ncbi.nlm.nih.gov/entrez/quer ... =pubmed&...
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
