Clinical outcomes of effectiveness and safety in cataract patients implanted with the novel hybrid extended depth-of-focus intraocular lens AM2UH: a prospective study.

BACKGROUND

AM2UH was a novel bifocal hybrid extend the depth of focus (EDF) intraocular lens (IOL). This study is to evaluate the effectiveness and safety by comparing it with a monofocal IOL (AW-UV).

METHODS

A prospective, comparative, single-center study. 37 patients (37 eyes) were implanted with novel hybrid EDF IOL model AM2UH. 36 patients (36 eyes) were implanted with monofocal IOL model AW-UV. At 6 months postoperatively, the visual acuity (uncorrected and distance corrected), defocus curves, refractive outcomes, contrast sensitivity, questionnaires of visual quality were assessed and compared between 2 groups.

RESULTS

Compared to AW-UV, AM2UH showed non-inferior monocular corrected distance visual acuity (p > 0.05), but superior intermediate and near visual acuity (all p < 0.05). Additionally, AM2UH provided satisfactory DCVA at 1.0 m (0.15 ± 0.07 logMAR) and an extended depth of focus, with an increase of 1.08 D at the 0.2 logMAR. AM2UH group showed high spectacle independence rate and satisfaction rates about intermediate and near vision. There were no significant differences in contrast sensitivity, the incidences of photic phenomena, intraocular pressure and adverse events between 2 groups.

CONCLUSION

AM2UH IOL is an effective and safe EDF IOL that offers satisfactory intermediate vision and distance vision, improves near vision, and delivers an extended visual range while maintaining favorable visual quality.

CLINICAL TRIAL REGISTRATION: Identifier: MR-50-25-086616.