Clinical Evaluation Of Tolerance To Residual Refractive Errors Following Implantation With A Refractive Extended Depth Of Focus Iol

In patients implanted with presbyopia correcting IOLs (e.g., multifocal), even small amounts of residual errors can degrade visual performance and lead to high levels of dissatisfaction. The purpose of this study to evaluate the tolerance to residual errors of a refractive EDF IOL (Model DEN00V) and an enhanced monofocal IOL (Model ICB00) by evaluating patients’ satisfaction and distance visual performance in patients with ametropia. 

Six sites in Australia and New Zealand.

This was a prospective, multi-center study in which subjects were bilaterally implanted with a new purely refractive EDF IOL and an enhanced monofocal. Patients that have at least one eye with spherical equivalent larger than 0.25 D were included in the evaluation.  Mean ± stdev logMAR binocular uncorrected distance visual acuity (UCDVA), % of eyes that achieved 20/20^-2 or better binocular UCDVA, patient satisfaction with distance vision and need of glasses at distance are presented (n = 29 per IOL group).

The mean blur strength of the spherocylindrical refractive error was 0.6 D for the refractive EDF IOL and 0.7 D for enhanced monofocal IOL. Mean binocular UCDVA was -0.03 ± 0.08 and -0.02 ± 0.11 logMAR for the EDF IOL and the enhanced monofocal IOL respectively. 93% of the EDF patients achieved 20/20^-2 or better UCDVA, which was 10% more than in the enhanced monofocal group. 100% of the patients in both groups were completely or mostly satisfied with their distance vision and 100% of the EDF patients vs 97 % of the monofocal patients did not need glasses for distance.

The optical design of the refractive EDF IOL provides high tolerance to refractive errors, at the level of an enhanced aspheric monofocal IOL. Ametropic patients implanted with the refractive EDF IOL had high uncorrected distance VA, did not need glasses at distance and were highly satisfied with their distance vision.