Randomization
±
IOL
Subjects had their preoperative examinations at Visit 1 and were assessed for eligibility. Randomization and the first eye surgery occurred at Visit 2 between 0 and 30 days following Visit 1. Randomization occurred prior to the procedure with a 1:1 ratio to receive either a Vivinex™ IOL or the AcrySof® IOL in the first eye operated; while the second eye received the IOL which was not implanted in the first. The second eye surgery occurred at Visit 3 between 7 and 45 days after the first eye surgery. Computer-generated randomization lists were used. A separate randomization list was prepared for each clinical site and provided in envelopes by the Sponsor. The study was organized such that all clinical personnel performing examination tests would not be informed of the randomization assignment. All sites received envelopes containing a letter indicating the name of the IOL that should be implanted; HOYA Vivinex™ or Alcon AcrySof®. Subjects had their post-operative assessments at Visit 4 where both eyes were evaluated. This visit was scheduled at 6 months (± 15 days after the second implant). The remaining post-operative visits occurred at Year 1 (12 months ± 30 days after the second implant), Year 2 (24 months ± 45 days after the second implant) and Year 3 (36 months ± 60 days after the second implant).