Visual performance and patient reported outcomes of an extended depth of focus IOL compared to a monofocal IOL – a randomized trial

Purpose: To evaluate clinical performance and visual outcomes of the Acunex Vario AN6V in comparison to the monofocal version, the Acunex AN6. Setting: Hanusch Hospital Vienna, Department of Ophthalmology Design Prospective, randomized, monocenter trial Methods: Patients undergoing bilateral cataract surgery were randomized to receive extended depth of field IOL, the Acunex Vario AN6V (EDF group) or the monofocal IOL Acunex AN6 (monofocal group; both Teleon Surgical B.V., Germany). Primary outcome was spectacle independence six months after surgery. Further, uncorrected and distance corrected distance, intermediate and near visual acuity, stereo vision, defocus curves and rate of photopic phenomena were assessed. Results: A total of 50 patients were included in the study, of whom 42 completed the two months and 35 the six months visit. Two months after the procedure, a significantly higher proportion of patients in the EDF were spectacle-free during near tasks than in the monofocal group (37.5% vs. 5.3%). Uncorrected and distance-corrected intermediate (UIVA and DCIVA) as well as near (UNVA and DCNVA) visual acuities were significantly better in the EDF group (UIVA: 0.09±0.12 vs. 0.16±0.07; p=0.035; DCIVA: 0.12±0.10 vs.0.16±0.08; p=0.03; UIVA: 0.24±0.12 vs. 0.37±0.11; p=0.001; DCNVA: 0.24±0.12 vs 0.37±0.11; p=0.001) Furthermore, the EDF group had a larger range of defocus. Stereo vision and the occurrence of photopic phenomena were comparable between both groups. Conclusion: In comparison with the monofocal version, the EDF IOL AN6V demonstrated greater spectacle independence and significant enhancement in both intermediate and near visual acuity. Notably, the incidence, severity, and degree of perceived dysphotopsia were similar in both groups.