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

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.