Statistical analysis
IOL
Descriptive summary statistics for continuous variables included the number of observations (n), mean, standard deviation (SD), median and range (minimum, maximum) by collection timepoint and device arm (HOYA and Alcon). For categorical variables, frequency and percentage were computed. A t-test was used for continuous endpoints and p-values reported, where applicable. All statistical analyses were conducted at a 2-sided alpha level of 0.05, and confidence intervals (CI) was calculated at 95%, 2-sided.For the PCO evaluation, the analysis was based on the paired differences of PCO scores (HOYA minus Alcon). The differences between paired observations were assumed to be normally distributed and a t-test was used for analysis. A two-sided 95% CI for the mean of the difference between the two IOLs was computed as well as the corresponding p-value. If the CI lay completely within -0.5 and 0.5, it was concluded that the HOYA IOL was comparable to the Alcon IOL. For the measurements of PCO obtained from PCO photos, EPCO was analyzed for all post-operative visits, leading to the 36-months results. For the glistening evaluation, a t-test was used on the paired differences of glistening scores (HOYA minus Alcon). The p-value for this test and the corresponding 95% CI was computed. If the p-value was < 0.05, and the mean of paired differences was less than zero, the HOYA IOL was considered superior to the control.The statistical analysis was conducted using SAS versions 9.3 and 9.4.