PURPOSE: To compare the visual, refractive, and patient-reported outcomes following bilateral implanta- tion 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 implanta- tion 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, DC- NVA, 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 monocu- lar DCIVA and DCNVA over the monofocal group were established. Binocular UIVA, DCIVA, UNVA, and DC- NVA 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 monocu- lar DCNVA and DCIVA, with comparable CDVA. Binocular visual acuity was 0.09 logMAR or bet- Supplemental Material available at AJO.com . Accepted for publication August 25, 2025. From Shultz Chang Vision (M.C.S.), Northridge, California, USA; Cleveland Eye Clinic (W.F.W.), Elyria, Ohio, USA; Center For Sight (E.L.), Las Vegas, Nevada, USA; Central Ohio Eye & Plastic Surgery (A.T.E.), The Eye Center of Columbus, Columbus, Ohio, USA; Key- Whitman Eye Center (J.W.), Dallas, Texas, USA Inquiries to Mitchell C. Shultz, Shultz Chang Vision, Northridge, Cali- fornia, USA;e-mail: mitchellshultzmd@gmail.com ter ( ~20/25) from distance to near (-0.5 D to -2.5 D).