Work

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

Year: 2025

Type: article

Abstract: 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.

Source: Journal of Cataract & Refractive Surgery

DOI: 10.1097/j.jcrs.0000000000001742

Authors: John P. Berdahl, Leslie Grosinger, Olivia Reed

Institutions: Vance Thompson Vision, Alcon (United States)

Language: English

Topic: Intraocular Surgery and Lenses

Subfield: Ophthalmology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $3,000