Visual performance of a novel wavefront shaping EDOF 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 United States.

Ambispective, nonrandomized, controlled clinical study.

Participants aged 18 years or older bilaterally implanted with either Clareon EDOF IOLs (Clareon EDOF) or Clareon Monofocal IOLs 3 to 6 months before enrollment were included. 2 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 noninferior to the Monofocal for binocular CDVA (mean difference [MD] = 0.034, 95% CI 0.001 to 0.067). Clareon EDOF was superior to the Monofocal for binocular DCIVA (MD = -0.091, 95% CI -0.120 to -0.061) and for binocular DCNVA (MD = -0.129, 95% CI -0.169 to -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 with a monofocal control, and superior intermediate vision, near vision, and spectacle independence.