Assessing Visual Outcomes: A Comparative Study of US-FDA Premarket Approval Data for Multifocal and EDOF Lens Implants in Cataract Surgery

Abstract

This study compares the efficacy, safety, and patient-reported outcomes of three intraocular implants (IOL): Tecnis Synergy IOL, AcrySof IQ PanOptix Trifocal, and Tecnis Symfony EDOF IOL. Participants achieving 20/20 or better uncorrected binocular visual acuity were as follows: Synergy—67% distance, 64% intermediate, and 47% near; PanOptix—73% distance, 73% intermediate, and 50% near; and Symfony—63% distance, 75% intermediate, and 22% near. Symfony demonstrated superior intermediate visual acuity compared to Synergy (p = 0.0182) for those achieving 20/25 or better. Both Synergy and PanOptix showed superiority over Symfony for near visual acuity (p < 0.0001). Halos were statistically more common in Synergy participants compared to PanOptix (p = 0.0013) and Symfony (p < 0.0001). Each trial lens outperformed its monofocal IOL in terms of independence from glasses or contacts, with Synergy and PanOptix showing statistical significance over Symfony. Comparing contrast sensitivities and defocus curves was challenging due to data variance and as such, standardization of United States Food and Drug Administration (US-FDA) data reporting is key for better comparison of outcomes among different IOL platforms.