PURPOSE: To determine the visual, refractive, and patient-reported outcomes after bilateral implantation of enVista Aspire intraocular lens (IOL), targeted for either bilateral emmetropia or mini-monovision.

SETTING: 7 sites in the United States

METHODS: This noninterventional, prospective, multicenter study included 140 eyes of 70 patients who had undergone bilateral implantation of enVista Aspire enhanced monofocal IOL (Bausch and Lomb). Of these 70 patients, 49 patients (98 eyes) were targeted for emmetropia in both eyes (defined as ≤0.5 D manifest refraction spherical equivalent (MRSE) (BE group), and 21 patients (42 eyes) were targeted for mini-monovision (emmetropia in one eye and myopia of more than -0.50 D MRSE in the other) (MM group). MRSE, monocular uncorrected distance visual acuity (UDVA), uncorrected intermediate (UIVA), and patient-reported outcomes using Near Activity Visual Questionnaire (NAVQ) were evaluated at postoperative 60-270 days after the second eye surgery.

RESULTS: Postoperatively, the BE group had a mean MRSE of -0.15±0.26 D, UDVA of 0.06±0.12, and UIVA of 0.24±0.15 logMAR. UDVA and UIVA of 20/32 or better were achieved in 94.9% and 52.0% of eyes, respectively. In the emmetropic eyes of the MM group, 85.7% had a UDVA of 20/32 or better with a mean MRSE of -0.33±0.17 D and UDVA of 0.11±0.12 logMAR; in the myopic eyes of the MM group, 90.5% had a UIVA of 20/32 or better with a mean MRSE of -0.96±0.34 D and UIVA of 0.13±0.09 logMAR. Per NAVQ outcomes, 71-81% patients in the MM group versus 57-61% in the BE group could perform intermediate vision tasks without spectacles. In the MM group, 76.2% patients (versus 59.2% in the BE group) were satisfied with their near vision.

CONCLUSIONS: Patients targeted for bilateral emmetropia achieved excellent distance visual acuity, while those with mini-monovision experienced enhanced intermediate visual acuity. Among patients targeted for mini-monovision, 14-20% more patients reported no or minimal difficulty with intermediate vision-related tasks, and 17% more were satisfied with their near vision compared with those targeted for bilateral emmetropia. These results indicate that, when targeted for mini-monovision, the enVista Aspire IOL provides additional benefits for intermediate vision and greater patient satisfaction with near vision.