Two-Year Follow-Up clinical Study of Mini WELL Extended Depth-of-Focus Intraocular Lens Implantation: Performance and Safety Evaluation

Abstract

Background Cataracts can be effectively treated with intraocular lens (IOL) implantation following lens removal via phacoemulsification. The growing demand for additional correction of near and intermediate vision in the aging population has led to the development of multifocal intraocular lenses (IOLs). More recently, a novel class of intraocular lenses (IOLs), known as extended depth-of-focus (EDoF) IOLs, was introduced. The EDoF IOLs extend a single focal point over a range of distances, thereby enhancing intermediate and near performance and providing greater spectacle independence. Moreover, EDoF IOLs represent a promising solution to minimize photic phenomena and contrast sensitivity (CS) issues associated with traditional multifocal IOLs. Currently, there is a lack of long-term data on the performance and safety of EDoF lenses. Methods This monocentric, retrospective, observational, open-label investigation was aimed at assessing the long-term (two years) performance and safety of the EDoF Mini WELL after IOL implantation. The study included 23 male and female patients who underwent cataract surgery with the Mini WELL. Data collection included subjective refraction, defocus curve assessment, uncorrected and corrected visual acuity at all distances, binocular reading performance, contrast sensitivity (CS), Visual Function Questionnaire VF-11R, and the collection of potential adverse events during the two-year follow-up period. Results The results demonstrated that Mini WELL provided a long-term visual performance, safety profile, and improved reading speed. The defocus curve indicates a continuous range of vision without a significant loss in intermediate vision. A high percentage of patients maintained the clear vision outcomes, for both monocular and binocular measures, at the two-year follow-up. No adverse events (AEs) were reported. Conclusion The use of EDoF Mini WELL represents an interesting option for the long-term solution for visual correction of aphakia in adult patients with presbyopia. Trial registration The retrospective study was registered in the ClinicalTrials.gov database as NCT04801992 on March 15, 2021