Baseline patient characteristics
IOL
The Intent-to-Treat Population (ITT) consisted of 87 subjects. As per randomization, the HOYA Vivinex™ IOL was implanted into the first eye of 43 subjects, and the Alcon AcrySof® IOL into the first eye of 44 subjects. Sixty-seven (67) subjects (the Completer population) finished the 3-year follow-up. The Completer population consisted of 32 subjects implanted with the HOYA IOL in the first eye and 35 implanted with the Alcon IOL. The remaining 20 subjects had withdrawn from the study. Demographics and baseline characteristics of the ITT are presented in Table Summary of subject demographics and baseline characteristics intent-to-treat population.Percentages are based on the number of subjects in the sequence.[1] Age is the number of full years from date of birth to the date of informed consent.Subject disposition (all randomized subjects).Percentages are based on the number of randomized subjects in the sequence.The intent-to-treat population consists of all randomized subjects who have at least one IOL implanted.The completer population consists of all the ITT subjects who have both IOLs implanted with follow-up through the primary assessment time point.The per protocol population includes all subjects who are in the completer population with no significant protocol deviations.