Visual and patient-reported outcomes of a novel full visual range IOL versus a monofocal IOL: A randomized multicenter US trial

Abstract

Purpose: To compare the visual, refractive, and patient-reported outcomes following bilateral implantation of a novel full visual range IOL and a monofocal IOL in subjects undergoing cataract surgery.

Design: Prospective, masked, multicenter, controlled pivotal trial.

Methods: Subjects scheduled to undergo cataract surgery were randomized to bilateral implantation of a novel full visual range (FVR) IOL (enVista Envy MX60EF, Bausch + Lomb; N=332) or enVista monofocal IOL (MX60E; N=169). Primary effectiveness endpoints were monocular corrected distance visual acuity (CDVA, 4 m), distance-corrected intermediate (DCIVA, 66 cm), and near (DCNVA, 40 cm) visual acuity, and secondary effectiveness endpoints were binocular DCIVA, DCNVA, uncorrected intermediate (UIVA), and near visual acuity (UNVA), at postoperative Day 120-180.

Results: The non-inferiority of the FVR IOL group for monocular CDVA and statistical superiority for monocular DCIVA and DCNVA over the monofocal group were established. Binocular UIVA, DCIVA, UNVA, and DCNVA were also better in the FVR group compared to the monofocal group (all p<0.0001). Mean postoperative MRSE was -0.14±0.39 D (FVR) and -0.14±0.40 D (monofocal group). The FVR group showed consistent visual acuity of ∼0.1 logMAR from -1.50 to -2.50 D. The difference in mesopic contrast sensitivity (without glare) between the two groups at 1.5, 3, and 12 cpds was less than the minimum detectable difference of 0.15 logCS.

Conclusion: Compared to the monofocal group, the FVR IOL group exhibited superior monocular DCNVA and DCIVA, with comparable CDVA. Binocular visual acuity was 0.09 logMAR or better (∼20/25) from distance to near (-0.5 D to -2.5 D).

Keywords: Full visual range IOL; Multifocal IOL; enVista Envy IOL; enVista IOL.