Two-Year Follow-Up of the MINI WELL Non-Diffractive Extended Depth-of-Focus Intraocular Lens: A Retrospective...

To describe long-term visual outcomes, functional vision, and safety following implantation of the MINI WELL non-diffractive extended depth-of-focus (EDoF) intraocular lens over a two-year follow-up period.

This monocentric, retrospective, observational study included patients who underwent cataract surgery with binocular implantation of the MINI WELL non-diffractive EDoF intraocular lens. Visual outcomes were assessed postoperatively over 24 months. Evaluations included monocular and binocular uncorrected and corrected visual acuity at distance, intermediate, and near; defocus curve assessment under photopic conditions; contrast sensitivity; binocular reading performance using Radner Reading Charts; and patient-reported outcomes measured with the Visual Function Questionnaire VF-11R. Safety outcomes included adverse events, secondary surgical interventions, and patient-reported photic phenomena.

Twenty-three patients (46 eyes) completed the two-year follow-up and were included in the analysis. At 24 months, monocular and binocular visual acuity was maintained across all tested distances. Binocular uncorrected distance visual acuity of 20/32 Snellen or better was achieved in all patients. Intermediate and near visual acuity were consistent with common daily visual tasks. The binocular defocus curve demonstrated a smooth decline in visual acuity across intermediate defocus levels without distinct focal gaps. Mean binocular reading speed at near distance met established criteria for fluent reading. Contrast sensitivity remained within manufacturer-defined normative ranges across spatial frequencies. Patient-reported outcomes indicated minimal difficulty in vision-dependent daily activities. No intraoperative or postoperative adverse events, secondary surgical interventions, or clinically relevant late complications were reported. Mild photic phenomena were infrequently reported.

At two years, implantation of the MINI WELL non-diffractive EDoF intraocular lens was associated with maintained visual outcomes, functional intermediate and near vision, and a favorable safety profile. These findings support the long-term stability of visual performance with this EDoF intraocular lens. Larger prospective and comparative studies are warranted to confirm these observations.

ClinicalTrials.gov identifier NCT04801992.