Abstract
INTRODUCTION: The aim of this study was to evaluate the safety and efficacy of a violet-light filtering intraocular lens (IOL) compared to a colorless IOL control. METHODS: This was a prospective, bilateral, randomized, comparative, patient/evaluator-masked multi-center clinical trial at 12 sites in the USA. Patients underwent standard small-incision phacoemulsification cataract extraction. Visual acuity, contrast sensitivity, and color vision were tested 12 months postoperatively. Patient satisfaction and vision-related quality of life were evaluated based on directed patient responses obtained from a binocular subjective questionnaire. RESULTS: A total of 250 subjects were bilaterally implanted with the violet-light filtering TECNIS monofocal ZV9003 (n = 126) and colorless TECNIS monofocal ZA9003 (n = 124). Mean uncorrected distance visual acuity (UDVA) was 0.123 LogMAR for ZV9003 and 0.116 LogMAR for the ZA9003 group. Mean corrected distance visual acuity (CDVA) was 0.00 LogMAR for both groups. No significant difference was found between the groups for 22/25 questionnaire categories, including color perception. A significant difference was found in favor of the ZV9003 group for day driving, night driving, and frustration with vision. Contrast sensitivity mean difference was < 0.05 log units across all lighting conditions and spatial frequencies. CONCLUSION: No difference was found between groups for visual acuity, contrast sensitivity, color testing, and adverse events as well as with the majority of optical/visual symptoms. A statistical difference was noted in driving and frustration with eyesight that may be related to benefits of using a violet-light filtering chromophore. Overall, the violet-light filtering ZV9003 showed excellent visual acuity and contrast sensitivity results with a low incidence of optical/visual symptoms.