Summary
PURPOSE: To evaluate the mesopic monocular and binocular visual acuity outcomes following implantation of either a novel Full Range of Vision enVista IOL or monofocal enVista IOL in US subjects undergoing cataract surgery.
METHODS: This prospective, multicenter, randomized, controlled study included cataract subjects who underwent bilateral implantation of either enVista Envy full range of vision (FRoV) IOL (study group, N=284) or enVista monofocal IOL (control group, N = 142). Outcome measures included assessment of the monocular and binocular distance-corrected visual acuity at intermediate (DCIVA, 66 cm) and near (DCNVA, 40 cm) under mesopic conditions at postoperative 120-180 days.
RESULTS: Postoperatively, the FRoV group showed significantly better mean mesopic DCIVA (monocular 0.29 ± 0.14 vs 0.46 ± 0.16 logMAR and binocular 0.21 ± 0.12 vs 0.39 ± 0.13 logMAR) compared to the monofocal group (both p<0.0001). similarly the mesopic dcnva was also statistically significantly better in the frov group monocular 0.35 0.15 logmar vs 0.66 0.18 logmar and binocular 0.26 0.13 logmar vs 0.59 0.15 logmar compared to the monofocal group both p><0.0001).>0.0001).>0.0001).>
CONCLUSION: The Envy FRoV IOL showed good binocular mesopic DCIVA (20/32) and DCNVA (20/37), suggesting that the FRoV IOL had good efficacy even under mesopic conditions. While the Envy FRoV group demonstrated a mean binocular DCIVA of more than 2 lines better, the mean DCNVA was approximately 4 lines better than the monofocal group.