Efficacy and Safety Evaluation of a New Full Visual Range versus Monofocal IOL in Cataract Patients: A Randomized, Controlled Canadian Clinical Trial.

Purpose: To compare the visual performance and patient-reported outcomes following bilateral implantation of a novel full visual range IOL or its monofocal version.

Setting: 9 sites in Canada.

Design: Prospective, multicenter, randomized, double-masked, controlled study.

Methods: This study included patients who underwent bilateral implantation of either a full visual range (FVR) enVista Envy (Bausch+Lomb) or monofocal MX60E (Bausch+Lomb) IOL. Postoperative assessments included visual acuities, defocus curves, contrast sensitivity, and patient-reported outcomes using Quality of vision (QoV) and near activity visual questionnaire (NAVQ).

Results: The FVR IOL was non-inferior to the control monofocal IOL for monocular UDVA and statistically superior to the monofocal IOL for monocular UIVA and UNVA. Binocular defocus curves showed a range of vision of ∼4.0 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.

Conclusion: 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.