Visual and Patient-Reported Outcomes After Bilateral Implantation of Two Enhanced Monofocal IOLs.

Background/

Objectives

Enhanced monofocal intraocular lenses (IOLs) aim to extend functional vision into the intermediate range while preserving the distance visual quality of standard monofocal aspheric lenses. This study compared the clinical and patient-reported outcomes of two enhanced monofocal IOLs, TECNIS Eyhance™ and Evolux™, and characterised the anterior surface profile of the Evolux™ optic.

Methods

This single-centre, retrospective comparative case series included consecutive patients who received bilateral implantation of either Evolux™ or TECNIS Eyhance™ between February and July 2023. Primary outcomes were monocular uncorrected and distance-corrected intermediate visual acuity (UIVA, DCIVA). Secondary outcomes included monocular and binocular distance and near visual acuity, binocular intermediate visual acuity, spherical equivalent and patient-reported outcomes assessed using the Revised Heidelberg Daily Task Evaluation (DATE) questionnaire. Equivalence testing, Welch's t-test, and covariate-adjusted ANCOVA were performed. Anterior surface profilometry of the Evolux™ IOL was conducted using an optical profilometer.

Results

A total of 44 patients were included, 14 in the Evolux™ group and 30 in the TECNIS Eyhance™ group. Monocular and binocular UIVA and DCIVA were statistically equivalent between groups (TOST p = 0.028, 0.016, 0.008, and 0.005, respectively). Monocular and binocular distance outcomes were likewise equivalent. Binocular distance-corrected near visual acuity was significantly better in the Evolux™ group (0.164 ± 0.084 vs. 0.233 ± 0.112 logMAR; p = 0.030; Cohen's d = 0.661), without a corresponding monocular difference. This isolated finding should be interpreted cautiously given the exploratory, multiple-outcome analysis and because it did not retain statistical significance after covariate adjustment for baseline biometric imbalances.

Conclusions

In this exploratory study, both IOLs showed no statistically significant differences in intermediate and distance visual outcomes at one month after second eye surgery. The unadjusted binocular near vision finding for Evolux™, which did not retain significance after covariate adjustment, warrants further investigation in prospective, adequately powered, biometrically balanced studies.