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Home > Archive > Lasik Eyes Surgery > April 2005 > Check out the nastiness hidden in the FDA transcripts!
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Check out the nastiness hidden in the FDA transcripts!
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| FDAgoldminer 2005-04-14, 8:42 am |
| THE SPEEDING QUOTE:
http://www.fda.gov/ohrms/dockets/ac...ipts/3883t1.doc
DR. GRIMMETT: Dr. Bradley stated wavefront-guided LASIK does not reduce the
level of higher-order aberrations of the preoperative eye, and he also wrote
there's no way wavefront-guided LASIK can correct higher-order aberrations
and render super-normal vision. That's the second statement. Is that not
correct?
DR. BRADLEY: Your memory is better than mine, but I can look at the slide.
DR. GRIMMETT: No, I believe I transcribed it correctly.
DR. BULLIMORE: I agree. This is Dr. Bullimore. I agree with the sentiments
of both of those statements. Exactly how the second one is worded, we could
come back to, but the first one adequately ??
DR. WEISS: Can you repeat the first one again?
DR. GRIMMETT: Sure. Wavefront-guided LASIK does not reduce the level of
higher-order aberrations of the preoperative eye.
DR. WEISS: Would that not be confusing to someone? Wouldn't that be
confusing?
DR. GRIMMETT: Michael Grimmett.
It may suggest somehow wording in that wasn't it that the higher-order
aberrations were 20 percent higher than the preop eye in the
wavefront-guided versus what, 80 percent was the number?
PARTICIPANT: Seventy-seven percent.
DR. WEISS: In here, is there any place saying that LASIK itself increases
aberrations and that customized corneal ablation increases them less than
conventional treatment?
DR. GRIMMETT: I think that's the idea.
DR. WEISS: So maybe we could put that wavefront-guided ablation ??
DR. GRIMMETT: Conventional LADARVision LASIK increases higher-order
aberrations by that figure 77 percent while wavefront-guided LASIK increases
them by whatever, 20 percent, whatever the number is, or you can say reduces
them to a 20-percent level, if you want to use the word "reduces."
DR. BULLIMORE: I would avoid the term "reducing."
DR. WEISS: I would say each of them increases it because basically whether
or not you're treating the preexistent or what's induced, the bottom line is
you still have more aberrations than you did when you started off.
DR. GRIMMETT: Well, the intent is telling the traffic cop that you're
speeding less than the other speeders.
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