Positioning of enhanced monofocal intraocular lenses between conventional monofocal and extended depth of focus lenses: a scoping review

Background New intraocular lenses (IOLs) have emerged since the originally coined monofocal and multifocal IOLs. The extended depth of focus (EDoF) and enhanced monofocal IOLs (mono‑EDoF) that have appeared in the last decade have caused some confusion in their classification. The aim of this review was to summarize the outcomes provided by mono‑EDOF IOLs and to determine which of the endpoints, described by the American National Stand‑ ard (ANSI) for EDoF IOLs, are fulfilled. Methods The MEDLINE, EMBASE, and WEB OF SCIENCE databases were searched. Two independent reviewers screened the studies for inclusion and data extraction. The search strategy was limited to studies published between 2020 and 2022, but not by language. The results are presented as a narrative summary accompanied by tables, in alignment with the objectives of this scoping review. Compliance with the endpoints for clinical outcomes described in the American National Standard Z80.35–2018 (ANSI) for EDoF lenses was checked and additional endpoints were defined. Results Two systematic reviews, 13 laboratory, 21 clinical, and two mixed studies were included. Tecnis Eyhance was the mono‑EDOF with the highest volume of evidence to date. Although laboratory studies included other IOLs, clini‑ cal evidence for them is still scarce, with only one study of IsoPure compared to a standard monofocal IOL. Evidence in comparison to EDoF lenses is also scarce, even for Tecnis Eyhance, with only three studies including this lens in comparison to an EDoF lens. After evaluation of the ANSI criteria, agreement was found in the failure for the increase in depth of field equal to or greater than 0.5 D for a visual acuity (VA) level of 0.2 logMAR and none of the studies sup‑ ported that the median monocular VA at intermediate distance was at least 0.2 logMAR. Conclusions Additional clinical evidence is required for other mono‑EDOF IOLs beyond Tecnis Eyhance. Until the arrival of a standard classification, mono‑EDOF should be better still classified as monofocal because the ANSI stand‑ ards were not fully met.