Visual and Patient-Reported Outcomes of a Bilaterally Implanted Enhanced Monofocal IOL: A Prospective, Multicenter Study

Purpose: To evaluate the real-world visual and patient-reported outcomes of partial-depth-of-field enhanced monofocal IOL bilaterally implanted in cataract patients targeted for emmetropia. Setting: 57 US clinical sites. Design: Prospective, multicenter, single-arm study. Methods: This study included 338 subjects (651 eyes) who desired cataract surgery and implantation of an enVista Aspire IOL to achieve bilateral emmetropia. Results: The mean MRSE was -0.18 ± 0.37 D; 85% (551/648) of eyes were within ±0.50 D. The mean binocular UDVA and CDVA were 0.02±0.10 and -0.03±0.07 logMAR, respectively, with 96.5% (299/310) and 99.7% (309/310) of subjects achieving binocular UDVA and CDVA of 20/32 or better. Mean binocular UIVA was 0.20±0.15 logMAR, with 70.9% (219/309) of subjects achieving UIVA of 20/32 or better. Vision at far and intermediate distances without corrective devices was rated as pretty to perfectly well by 92.6% (286/309) of subjects, and 89.6% (277/309) of subjects were satisfied with their postoperative vision. The frequency and bothersomeness of visual symptoms were low (90% or higher proportion of subjects reported visual symptoms occurring “never” to “sometimes”), and almost 90% or higher reported being “not at all” or “only a little” bothered by them. With NAVQ, 52.1% to 71.8% of subjects reported “no or a little difficulty” in doing intermediate to near vision tasks. Conclusion: Bilateral implantation of enVista Aspire partial-depth-of-field enhanced monofocal IOL demonstrated very good uncorrected visual acuity at far and intermediate and can be a good option for patients who prioritize good distance and intermediate vision and a favorable dysphotopsia profile.