Non-Interventional Study to Evaluate the Effect of Non-Diffractive Extended Depth of Focus Intraocular Lens Centration and Tilt on Visual Performance

Purpose: Evaluate whether visual acuity is influenced by intraocular lens (IOL) decentration or tilt with Clareon ® Vivity ® and Clareon ® Vivity ® Toric IOLs. Methods: This was a non-interventional, retrospective, single-arm, observational study. Adults with Clareon ® Vivity ® or Vivity ® Toric IOLs without significant posterior capsule opacification, significant history of ocular surgery, or major ocular pathologies were included. Postoperative assessments performed ≥ 1 month after surgery included monocular high-contrast corrected and uncorrected distance visual acuity (CDVA, UDVA, 4 m), distance-corrected and uncorrected intermediate visual acuity (DCIVA, UIVA, 66 cm), manifest refraction spherical equivalent (MRSE), low-contrast CDVA, IOL decentration and tilt, mesopic pupil size, and corneal higher-order aberrations. The primary outcome was the association between the CDVA and IOL decentration or tilt. Results: A total of 202 eyes (n=101) were analyzed: 140 eyes (69%) received Clareon ® Vivity ® and 62 eyes (31%) received Vivity ® Toric. The mean IOL decentration was 0.211 mm (SD 0.13) and the mean tilt was 5.6° (SD = 1.18). Mean CDVA was 0.056 logMAR, UCDVA was 0.155 logMAR, DCIVA was 0.018 logMAR, UCIVA was 0.019 logMAR, and MRSE was – 0.147 D. In unadjusted analyses, no significant correlations were found between CDVA and decentration (r = 0.12, p = 0.08) or tilt (r = 0.06, p = 0.43), nor between DCIVA and decentration (r = 0.07, p = 0.34) or tilt (r = – 0.13, p = 0.07). In adjusted multivariable regression analyses, IOL decentration was significantly associated with postoperative CDVA100 (β=0.618, p=0.023), whereas residual refractive cylinder and IOL tilt were not independently associated with postoperative visual outcomes. Conclusion: Clareons’ Vivity ® and Vivity ® Toric IOLs demonstrated excellent distance and intermediate visual acuity. Visual outcomes remained generally favorable despite modest decentration or tilt, although adjusted analyses identified a modest association between decentration and postoperative CDVA100, supporting clinical reliability of this IOL design.