PURPOSE: The aim of this study is to assess the mesopic monocular and binocular visual acuity outcomes after cataract surgery with implantation of a novel Full Range of Vision (FRoV) enVista intraocular lens (IOL) or its parent monofocal IOL in US subjects.

SETTING: 23 US clinical sites.

METHODS: Data from this prospective, multicenter, randomized, controlled clinical trial evaluated outcomes after bilateral implantation of a novel full range of vision (FRoV) enVista Envy IOL (Bausch + Lomb) (study group, n=284) or a monofocal enVista IOL (control group, n=142) in patients undergoing cataract surgery. Distance-corrected monocular and binocular visual acuity at intermediate (DCIVA, 66 cm) and near (DCNVA, 40 cm) under mesopic conditions at 120-180 days post-surgery was assessed.

RESULTS: At 120-180 days post-surgery, the mean monocular and binocular mesopic DCIVA was significantly better in the FRoV group (0.29±0.14 vs 0.46±0.16 logMAR and 0.21±0.12 vs 0.39±0.13logMAR, respectively) than in the monocular group (both p>0.0001). Likewise, the mean mesopic DCNVA was also significantly better in the FRoV group (monocular 0.35±+0.15 logMAR vs 0.66±0.18 logMAR and binocular 0.26±0.13 vs 0.59±0.15 logMAR) compared to monofocal group (both p>0.0001).

CONCLUSION: enVista Envy FRoV IOL demonstrated good efficacy under mesopic conditions achieving good binocular DCIVA (20/32) and DCNVA (20/37). Patients implanted with the FRoV IOL showed a mean binocular DCIVA of more than 2 lines better and a mean DCNVA of 4 lines better than the monofocal group.