PURPOSE: To compare the visual performance and patient- reported outcomes after bilateral implantation of a new full visual range (FVR) intraocular lens (IOL) or its monofocal version. Setting: 9 sites in Canada.

DESIGN: Prospective, multicenter, randomized, double-mask, controlled study.

METHODS: This study included patients who underwent bilateral implantation of either a FVR enVista Envy or monofocal MX60E IOL. Postoperative assessments included visual acuities, defocus curves, contrast sensitivity, and patient-reported outcomes using quality of vision and near activity visual questionnaire.

RESULTS: The FVR IOL was noninferior to the control monofocal IOL for monocular uncorrected distance visual acuity and statisti- cally superior to the monofocal IOL for monocular uncorrected intermediate visual acuity and uncorrected near visual acuity. Binocular defocus curves showed a range of vision of ~4.0 diopters (D) at 0.2 logMAR or better in the FVR group. In the intermediate and near range (−1.5 to−2.5 D), the FVR group demonstrated a plateau at ~0.1 logMAR (20/25), whereas in the monofocal group, visual acuity decreased to 0.27 logMAR (20/37) at−1.50 D defocus and to 0.48 logMAR (20/60) at−2.50 D defocus. Postoperatively, 92.7% (102/110) of the FVR patients were satisfied with their near vision, and 91.7% (99/108) of them did not require spectacles to do near-vision tasks, even for a prolonged duration.

CONCLUSIONS: The FVR group exhibited a continuous range of vision from distance to near. Postoperatively, more than 90% of FVR patients were satisfied with their near vision and had no difficulty doing near-vision tasks while being spectacle-free.