Visual performance of a novel wavefront shaping EDOF intraocular lens on a new hydrophobic acrylic platform.

PURPOSE: 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).

SETTING

8 investigational sites in the United States.

DESIGN

Ambispective, nonrandomized, controlled clinical study.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.