Tolerance To Refractive Error With A New Extended Depth Of Focus Intraocular Lens

To evaluate the tolerance to refractive error of a new purely refractive extended depth of focus (EDF) intraocular lens (IOL) using preclinical and clinical metrics.  

Multicentre ophthalmology clinics in Australia and New Zealand

Preclinical evaluation included computer simulations of visual acuity (sVA) and dysphotopsia profile of different IOL designs (refractive EDF, diffractive EDF, multifocal, standard, and enhanced monofocals) using an appropriate eye model with and without ±0.50 D defocus and/or +0.75 D of astigmatism. Patients bilaterally implanted with a refractive EDF IOL (Model ZEN00V) or an enhanced monofocal IOL (Model ICB00) from a prospective, randomized study were included. At the 6-month postoperative visit, uncorrected and corrected distance vision (UDVA and CDVA), visual symptoms, satisfaction and dependency on glasses were evaluated in a subgroup of patients with absolute residual refractive error of >0.25 D in one or both eyes. 

In the presence of defocus and astigmatism, sVA was comparable for all except the multifocal IOL design. The refractive EDF IOL was more tolerant to myopic outcomes and maintained a monofocal-like dysphotopsia profile with defocus. Binocular UDVA was -0.03 ± 0.08 logMAR for the EDF IOL and -0.02 ± 0.11 logMAR for the enhanced monofocal. 100% EDF IOL and 97% enhanced monofocal patients did not need glasses for distance vision and were satisfied with their distance vision. Monocular CDVA, contrast sensitivity and visual symptoms were also similar between both groups.  

The clinical outcomes of the refractive EDF IOL demonstrated high quality distance vision and dysphotopsia comparable to a monofocal IOL, even in the presence of refractive error, thus matching the design expectations of the EDF IOL.