Statistical Analyses

Because this is a single-arm, open-label study, no formal statistical hypothesis testing was planned for any endpoints; data were summarized using descriptive statistics. Categorical data were summarized using sample size, number in the category, and percentage in the category. Continuous data were summarized using sample size, mean, SD, range, and 2-sided 90% CIs based on Student t statistics.

All eyes with successful implantation with the study IOL were included in the all-implanted analysis set. All eyes with attempted implantation with the study IOL (ie, successful implantation or implantation aborted after contact with the eye) were included in the safety analysis set. Planned enrolment included 156 patients who were to receive the study IOL bilaterally to ensure that at least 140 evaluable patients completed the study, assuming a dropout rate of approximately 10%.