Comparison of Visual Acuity Outcomes of Enhanced Monofocal Versus Standard Monofocal Intraocular Lenses from a Randomized, Multicenter, Active-Controlled Trial

Abstract

Purpose: To compare visual performance of the Vivinex Impress enhanced monofocal intraocular lens (IOL) (HOYA Surgical Optics) with the Acrysof IQ monofocal IOL (Alcon Laboratories, Inc).

Methods: In this multicenter, active-controlled trial, participants were randomized 2:1 to bilateral implantation with the enhanced monofocal (test) or standard monofocal (control) IOL and examined through 12 months postoperatively for visual acuities, refractive outcomes, defocus curves, and pupil diameters.

Results: Ninety-eight test and 46 control participants completed testing for the first implanted eye. The test arm demonstrated a statistically significant benefit in monocular distance-corrected intermediate visual acuity (DCIVA) (photopic: 1.2 lines, P < .001; mesopic: 0.7 lines, P = .01) and uncorrected intermediate visual acuity (0.8 lines; P < .001) but no significant difference in monocular corrected distance visual acuity (P = .07). Using a stepwise regression analysis for DCIVA, the final model (adjusted R-square, 0.31) identified three significant predictor variables (age, pupil diameter, and treatment arm). Photopic defocus curves showed the test arm produced better monocular visual acuity from -1.00 through -2.50 D than the control arm. The intermediate vision benefit of the test IOL is independent of pupil size and axial length. Cumulative and persistent adverse events for the test IOL did not exceed the Safety and Performance Endpoint rates per International Organization for Standardization 11979-7.

Conclusions: Compared to a standard monofocal IOL, the Vivinex Impress enhanced monofocal IOL offers an extended range of vision, with significant improvements in intermediate vision and a DCIVA benefit unaffected by pupil size and axial length. This IOL is safe and effective for patients seeking improved intermediate vision following cataract surgery. [J Refract Surg. 2025;41(4):e300-e309.].