Visual performance of a refractive extended depth of field intraocular lens in monovision and emmetropic settings.

Abstract

To compare visual performance, low-contrast visual acuity, stereopsis, and patient-reported outcomes of a refractive Extended Depth of Field (EDF) intraocular lens (IOL) implanted targeting mini-monovision or emmetropia target. Prospective, randomized, controlled, patient- and examiner-masked single-center clinical trial. Sixty patients (120 eyes) undergoing bilateral cataract surgery at the Hanusch Hospital (Vienna, Austria) received the refractive EDF intraocular lens (DEN00V, Tecnis PureSee). Patients were randomized to receive either binocular mini-monovision (MMV), targeting -0.75 D in the non-dominant eye, or emmetropia (EMM). Binocular uncorrected and corrected distance visual acuity (UDVA/CDVA), uncorrected intermediate (UIVA) and near visual acuity (UNVA), low contrast visual acuity, defocus curves, stereopsis, and patient-reported outcomes (PRSIQ, AIOLIS) were evaluated three months postoperatively. Binocular UDVA and CDVA were excellent and did not differ significantly between groups (110 eyes; 55 participants completed follow-up), -0.02±0.07 logMAR for MMV and -0.05±0.07 logMAR for EMM (mean difference: 0.03 logMAR; 95% Confidence Interval -0.01 to 0.07; p=0.14) and -0.05±0.06 logMAR for MMV and -0.09±0.08 logMAR for EMM (0.04 logMAR; 95% CI -0.01 to 0.09; p=0.06), respectively. Binocular UIVA was 0.06±0.08 logMAR for MMV and 0.10±0.09 logMAR for EMM (-0.04 logMAR; 95% CI -0.09 to 0.01; p=0.09) and UNVA 0.20±0.07 logMAR for MMV and 0.23±0.09 logMAR for EMM (-0.03 logMAR; 95% CI -0.08 to 0.02; p=0.18). Low contrast visual acuity was statistically significantly better in the emmetropia group at 5% (0.10 logMAR; 95% CI 0.04 to 0.16; p<0.001) and 1.25% (0.10 logMAR; 95% CI 0.03 to 0.17; p=0.01) levels of contrast after Holm-Bonferroni correction. Binocular defocus curves were comparable with no statistically significant differences after correction for multiple comparisons. Stereopsis was preserved in both groups without significant differences. Patient-reported outcomes demonstrated high satisfaction and low spectacle dependence in both groups for far and intermediate distance, with slightly reduced near spectacle dependence but increased glare in the mini-monovision group. Bilateral implantation of the DEN00V, a refractive EDF intraocular lens, in a mini-monovision or emmetropia setting, provides excellent distance and intermediate vision with good low-contrast visual acuity and preserved stereopsis. Applying a mini-monovision strategy preserved good distance vision with compromises in low-contrast visual acuity and subjective visual phenomena.