Visual Performance of a Novel Wavefront Shaping Extended Depth-of-Focus Intraocular Lens on a New Hydrophobic Acrylic Platform

To evaluate the real-world performance and safety of a nondiffractive, wavefront shaping, extended depth-of-focus (EDOF) intraocular lens (IOL) on the new hydrophobic acrylic Clareon platform (Clareon Vivity/ Vivity Toric) compared with a monofocal control (Clareon Monofocal/ Toric). 8 investigational sites in the U.S. Ambispective, non-randomized, controlled clinical study. Participants aged ≥ 18 years bilaterally implanted with either Clareon EDOF IOLs (Clareon EDOF) or Clareon Monofocal IOLs 3-6 months prior to enrollment were included. Two prospective visits were conducted to collect performance data and a retrospective chart review to collect baseline and safety data. Performance endpoints included binocular photopic corrected distance visual acuity (CDVA), distance-corrected intermediate visual acuity (DCIVA), distance-corrected near visual acuity (DCNVA), and rate of spectacle independence. The study included 149 participants (n=73 Clareon EDOF, n=75 Clareon Monofocal). Clareon EDOF was non-inferior to the Monofocal for binocular CDVA (MD: 0.034, 95% CI: 0.001, 0.067). Clareon EDOF was superior to the Monofocal for binocular DCIVA (MD: -0.091, 95% CI: -0.120, -0.061) and for binocular DCNVA (MD: -0.129, 95% CI: -0.169, -0.089). Rates of "never/rarely" needing spectacles were 45.7% in the Clareon EDOF group and 16.4% in the Monofocal group. Rates of severe visual disturbances were ≤ 5.6% and ≤ 4% in the Clareon EDOF and Monofocal groups, respectively. This study supports the continued performance of the EDOF design on the Clareon platform by demonstrating comparable distance vision and a visual disturbance profile to a monofocal control, and superior intermediate vision, near vision, and spectacle independence.