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

PURPOSE: To compare intraindividual differences in visual performance of two refractive extended-depth-of-focus (EDF) intraocular lenses (IOLs) targeted for emmetropia.

DESIGN

Prospective, randomized, patient- and examiner-masked intraindividual comparative study.

METHODS

A total of 40 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 & 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 37 patients (74 eyes), mean UDVA at 4 m, DIVA at 66 cm and UDNVA at 40 cm 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 = .01) and 0.25 ± 0.10 (P = .01) logMAR for the AN6V. 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 an extended range of functional vision, preserved contrast sensitivity, and minimal photopic phenomena. A statistically significant difference was observed for the primary endpoint, UIVA, favoring the AN6V.