Visual, Refractive, and Patient-Reported Outcomes Following Bilateral Implantation of an Enhanced Monofocal IOL: An Exploratory Comparison of Achieved Mini-Monovision and Bilateral Emmetropia.
Jai G Parekh, Christopher M Spearman, J Morgan Micheletti, Inder Paul Singh, Nisha Kumar, Eric Mann, Karolinne Maia Rocha, Eric Donnenfeld
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Abstract
Purpose: To compare the clinical and patient-reported outcomes following bilateral implantation of partial-depth-of-field enhanced monofocal IOL in subjects achieving bilateral emmetropia vs mini-monovision.
Patients and methods: This prospective, non-interventional, multicenter, cross-sectional study included subjects who had undergone cataract surgery and implantation of enVista Aspire IOL. For the post hoc analysis, patients were classified into bilateral emmetropia (BE) or mini-monovision (MM) based on achieved postoperative manifest refraction. Postoperative assessments included visual outcomes, manifest refraction, defocus curve, contrast sensitivity function, and patient-reported outcomes of questionnaires (AIOLIS and NAVQ).
Results: In the BE group (N = 49), the mean MRSE in the first and the second operated eye was -0.18 ± 0.26 D and -0.11 ± 0.26 D, respectively, and the mean UDVA was 0.07 ± 0.11 logMAR and 0.05 ± 0.12 logMAR, respectively. Mean UIVA in the first- and second-operated eyes of the BE group was ~0.23 logMAR, and mean UNVA was ~0.46 logMAR. In the MM group (N = 21), with the mean MRSE of -0.33 ± 0.17 D, the mean UDVA in the distance eye was 0.11 ± 0.12 logMAR. With a mean MRSE of -0.96 ± 0.34 D, mean UIVA and UNVA of the intermediate eye were 0.13 ± 0.09 logMAR and 0.29 ± 0.16 logMAR, respectively. The defocus curve showed 0.2 logMAR or better visual acuity up to a myopic defocus of ~-1.25 D. A higher proportion (~14 to 31%) of subjects in the MM group reported "no or little difficulty" with various intermediate- to near-vision-related tasks. The frequency and bothersomeness of visual symptoms were similar between the two groups. A total of 85.7% of subjects in the MM group were "completely to very satisfied" with their overall postoperative vision compared to the BE group (77.6%).
Conclusion: The MM group demonstrated improved intermediate and near visual performance and favorable patient-reported outcomes.
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