There is a 9% dissatisfaction rate.
See the FDA Alcon Meeting link for even more information.
DR. GRIMMETT: Dr. Michael Grimmett. I just had an observation and would like to hear if you have a comment. You may have none. There may be no answer. I found it curious that despite a very comprehensive analysis and sophisticated technology, that the patients that were unsatisfied or extremely unsatisfied approximated 9 percent. It's notable that the PERK study (A study of radial keratotomy patients) by comparison, using bear skins and stone knives, had an 11-percent dissatisfaction rate, and I found it curious that one in 10 patients are unsatisfied, despite a phenomenal amount of technology and analysis, and I would like to commend you on a superb analysis and presentation. Do you have a comment why it's still one in 10 despite all the sophisticated technology or is there no answer to that, sir?
DR. PETTIT: No. Well, I don't know everything."
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.