评估视觉效果：白内障手术中多焦点和扩展景深人工晶状体植入的美国食品药品监督管理局上市前批准数据的比较研究

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

作者信息

Moshirfar Majid, Stoakes Isabella M, Theis Joshua S, Porter Kaiden B, Santos Jordan M, Martheswaran Tanisha, Payne Carter J, Hoopes Phillip C

机构信息

Hoopes Vision Research Center, Hoopes Vision, Draper, UT 84020, USA.

John A. Moran Eye Center, University of Utah School of Medicine, Salt Lake City, UT 84132, USA.

出版信息

J Clin Med. 2023 Jun 28;12(13):4365. doi: 10.3390/jcm12134365.

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 ( = 0.0182) for those achieving 20/25 or better. Both Synergy and PanOptix showed superiority over Symfony for near visual acuity ( < 0.0001). Halos were statistically more common in Synergy participants compared to PanOptix ( = 0.0013) and Symfony ( < 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.

本研究比较了三种人工晶状体（IOL）：Tecnis Synergy人工晶状体、AcrySof IQ PanOptix三焦点人工晶状体和Tecnis Symfony EDOF人工晶状体的疗效、安全性及患者报告的结局。实现20/20或更好的未矫正双眼视力的参与者比例如下：Synergy人工晶状体——远距离为67%，中距离为64%，近距离为47%；PanOptix人工晶状体——远距离为73%，中距离为73%，近距离为50%；Symfony人工晶状体——远距离为63%，中距离为75%，近距离为22%。对于视力达到20/25或更好的患者，Symfony人工晶状体在中距离视力方面表现优于Synergy人工晶状体（P = 0.0182）。Synergy人工晶状体和PanOptix人工晶状体在近距离视力方面均优于Symfony人工晶状体（P < 0.0001）。与PanOptix人工晶状体（P = 0.0013）和Symfony人工晶状体（P < 0.0001）相比，Synergy人工晶状体的患者出现光晕的统计学发生率更高。每种试验镜片在摆脱眼镜或隐形眼镜方面均优于其单焦点IOL，其中Synergy人工晶状体和PanOptix人工晶状体在这方面表现出优于Symfony人工晶状体的统计学差异。由于数据差异，比较对比敏感度和散焦曲线具有挑战性，因此，美国食品药品监督管理局（US-FDA）数据报告的标准化对于更好地比较不同IOL平台的结局至关重要。