Efficacy and safety evaluation of a new full visual range vs monofocal intraocular lens in patients with cataract: randomized, controlled Canadian clinical trial.

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 statistically 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.