Visual and Patient-Reported Outcomes of a Novel Full Visual Range Intraocular Lens Versus a Monofocal Intraocular Lens: A Randomized Multicenter US Trial

PURPOSE: To compare the visual, refractive, and patient-reported outcomes following bilateral implantation of a novel full visual range (FVR) intraocular lens (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 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 days 120 to 180. RESULTS: The noninferiority 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 < .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 2 groups at 1.5, 3, and 12 cpds was less than the minimum detectable difference of 0.15 logCS. CONCLUSIONS: 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).