Abstract
OBJECTIVES: The purpose of this study is to evaluate the optical and expected clinical performance of a new refractive Extended Depth of Focus (EDF) intraocular lens (IOL), TECNIS PureSee™ IOL, designed to maintain a monofocal-like dysphotopsia profile. METHODS: Simulated visual acuity (sVA) with varying defocus was calculated using the area under the Modulation Transfer Function measured in an average eye model and from computer simulations in eye models with corneal higher-order aberrations. Tolerance to defocus was evaluated using computer simulations of the uncorrected distance sVA under defocus. To evaluate the dysphotopsia profile, halo pictures obtained using an IOL-telescope, as well as simulated images in a realistic eye model under defocus were assessed. The results of the refractive EDF were compared to those of a diffractive EDF of the same platform. RESULTS: The refractive EDF IOL provides similar range of vision to the diffractive EDF IOL with the same distance, and similar intermediate and near sVA. The refractive EDF IOL provides the same tolerance to hyperopia as the diffractive EDF but more tolerance to myopia. Halo pictures and simulations showed that the refractive EDF provides comparable dysphotopsia profile to the monofocal IOL and better than the diffractive EDF. CONCLUSIONS: The results of this preclinical study in clinically relevant conditions show that the new refractive EDF IOL is expected to provide similar range of vision to the diffractive IOL of the same platform and higher tolerance to refractive errors. The refractive EDF provides a dysphotopsia profile that is better than the diffractive EDF and comparable to that of the monofocal IOL, also in the presence of residual refractive errors.