One patient in 5 lost a line of low contrast acuity in the Alcon LADARVision wavefront clinical trials.
http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3883t1.rtf
Quote:
PMA P970043/S010, CustomCornea Myopic
LASIK With the LADARVision 4000 System
I just wanted to make sure I'm understanding your low contrast acuity data properly. It appears that whether we look at the sphere analysis or the all eyes analysis, 20 percent or one in five patients experienced a loss in low contrast acuity. I know that's different, lower than the rate in the conventional surgery, but I just want to make sure I understand. Twenty percent of the patients, one in five, experienced at least a one line or greater loss?
DR. PETTIT: That is correct.
DR. OWSLEY: Thank you.
