Clinical Evaluation of Visual Outcomes in LEAP, HIGH, COMP and VISN Extension Cohort
Clinical Evaluation of Visual Outcomes in LEAP, HIGH, COMP and VISN Extension Cohort
This is a prospective, multicenter, parallel groups, non-interventional, examiner masked, comparative clinical study. Patients that participated in previous Hoya studies, and patients previous implanted with Hoya non-toric monofocal IOLs (sub-study only) will be enrolled in the study. The sample size for this study is based on demonstrating the non-inferiority of the mean distance-corrected intermediate visual acuity (DCIVA) in Group 1 (Site 1) compared with Group 2 (Site 2).
Inclusion Criteria:
Main study:
Exploratory sub-study:
1. Additional inclusion criteria: Pseudophakic eyes implanted with one of the IOLs in one eye from 3 previous IOL studies
Exclusion Criteria:
Main study:
Exploratory sub-study:
1. Additional exclusion criteria: Pseudophakic eyes with oblique residual astigmatism.
srividhya.vilupuru@hoya.com+1-909-680-3900