Clinical outcomes and optical performance of a new segmental refractive extended depth-of-focus intraocular lens

Abstract Background The visual performance and the optical quality of a segmental refractive extended depth-of-focus (EDoF) intraocular lens (IOL) were evaluated in a prospective, single-arm, single-center study. Methods A total of 20 patients (40 eyes) after bilateral implantation of the refractive segmental EDoF Acunex Vario AN6V were included. Assessment procedure: refraction outcome, monocular and binocular uncorrected (UCVA) and distance-corrected visual acuity (DCVA), defocus curve, contrast sensitivity (CS), higher-order aberrations (HOAs) and patient satisfaction were evaluated 1 and 3 months after surgery. Results At 3-month follow-up, mean spherical equivalent was − 0.23 ± 0.32 D. Binocular uncorrected distance visual acuity (VA) at distance, intermediate and near was − 0.08 ± 0.06 logMAR at 4 m, -0.03 ± 0.06 logMAR at 66 cm and 0.16 ± 0.06 logMAR at 40 cm, respectively. The binocular defocus curve showed a VA better than 0.20 logMAR over a range from + 1.50 to − 2.45 D. Contrast sensitivity aligned with monofocal lenses, highlighting the lens’s clinical value. Aberrometry showed minimal changes in corneal aberrations. NEI-RQL-42-Questionnaire showed a high patient satisfaction for daily activities and revealed reduced dependence on glasses, particularly for near and intermediate vision. The Acunex Vario AN6V demonstrated minimal dysphotopsias, making it a promising option for those seeking spectacle independence. Conclusion This segmental refractive EDoF IOL provides a high degree of spectacle independence for far and intermediate distances with functional near VA. Although inducing residual coma aberrations, it showed subjectively good results with little dysphotopsias. Trial registration This study protocol was reviewed and approved by ethics committee of Charité University, Berlin, Germany, with approval number EA4/126/20.