Intra-individual Comparison of Two Refractive Extended-Depth-of-Focus Intraocular Lens Designs.

Abstract

PURPOSE To compare intra-individual differences in visual performance of two non-diffractive refractive extended-depth-of-focus (EDF) intraocular lenses (IOLs) targeted for emmetropia. DESIGN Prospective, randomized, patient-and examiner-masked intra-individual comparative study. METHODS Forty patients (80 eyes) with bilateral age-related cataract underwent phacoemulsification with implantation of refractive EDF IOL in each eye: a wavefront-shaped refractive EDF IOL (DEN00V, Johnson and Johnson Vision) in one eye and a sector-segmented EDF IOL (AN6V, Teleon) in the fellow eye. After 3 months, monocular distance corrected and uncorrected distance (CDVA/UDVA) intermediate (DIVA/UIVA), and near (DNVA/UNVA) visual acuity, refractive outcomes, defocus curves, contrast sensitivity, halometry, and subjective visual quality using questionnaires were compared. RESULTS In thirty-seven patients (74 eyes) mean UDVA at 4m, DIVA at 66cm and UDNVA at 40cm were 0.05±0.10, 0.17±0.11 and 0.31±0.11 logMAR for the DEN00V and 0.06±0.10, 0.15±0.10 and 0.32±0.11 logMAR for the AN6V respectively with no significant differences. A statistically significant difference was observed for the primary endpoint, UIVA, with 0.18±0.13 logMAR for the DEN00V and 0.12±0.09 logMAR for the AN6V. Nominal differences were observed for CDVA and UNVA with 0.01±0.07 and 0.32±0.12 logMAR for the DEN00V and -0.02±0.07 (p=0.01), and 0.25±0.10 (p=0.01) logMAR for the AN6V, respectively. Further nominal differences could be shown for contrast sensitivity under photopic and mesopic conditions. However, these differences did not remain statistically significant after adjustment for multiple comparisons. CONCLUSIONS Both IOLs demonstrated and extended range of functional vision, preserved contrast sensitivity, and minimal photopic phenomena. A statistically significant difference was observed for the primary endpoint UIVA, favouring the AN6V.