Optical Quality and Centration Stability of a Novel Capsule Reconstructor for Intraocular Lens Fixation: Laboratory Evaluation of the fixOflex Device

Purpose: To evaluate the in vitro optical quality of intraocular lenses (IOLs) implanted into the novel fixOflex device, a capsular bag stabilization concept. Methods: Five monofocal (AcrySof IQ SN60WF) and five trifocal (AcrySof IQ PanOptix) IOLs of the same dioptric power were assessed in a laboratory setting before and after implantation into five fixOflex devices. Optical quality was analyzed using modulation transfer function (MTF) and forward light scatter (straylight) across clinically relevant aperture sizes and spatial frequencies. Vertical and horizontal IOL decentration within the device was also quantified. Results: Implantation into the fixOflex preserved the high optical quality of the IOLs. Changes in MTF were minimal and not statistically significant (P > 0.1) across all focus distances, spatial frequencies, and aperture sizes. The fixation clips caused a slight increase in straylight (0.10 log(s) at a 5.5-mm pupil), which remained well below clinically relevant thresholds. The device provided high IOL centration, with decentration below 0.03 mm along the clip axis and below 0.25 mm along the haptic axis, without significant tilt. Conclusions: Implantation of monofocal and multifocal IOLs into the fixOflex device preserved their high optical quality and provided stable centration under controlled laboratory conditions. Translational Relevance: These findings provide a translational basis for considering the fixOflex as a stabilizing platform for decentration-sensitive IOL designs, supporting clinical evaluation in patient populations.