J Refract Surg. 2021 Feb 1;37(2):98-104. doi: 10.3928/1081597X-20201111-02.
To review and compare the results of unpublished premarket approval studies for recent multifocal and extended depth of focus (EDOF) intraocular lenses.
Lenses without previously published pre-market approval trials were identified and clinical and patient-reported outcomes were reviewed and compared.
Lenses included the DFT/DAT (Acrysof Vivity) EDOF lens, the TFNT/TFAT (PanOptix) trifocal lens, and the SV25T (ReStor ActiveFocus) lens (all from Alcon Laboratories, Inc), as well as the ZXR/ZXT (Tecnis Symfony and Symfony Toric), the ZLB00 (Tecnis Multifocal +3.25), and the ZKB00 (Tecnis Multifocal +2.75, all Tecnis lenses from Johnson & Johnson Vision). All lenses produced equivalent distance vision and superior intermediate and near vision compared to monofocal controls. Patient-reported difficulty with glare, halos, and starbursts was higher in the multifocal and EDOF lens cohort compared to monofocal controls. Spectacle independence was higher in the multifocal and EDOF cohort with the exception of the SV25T (ActiveFocus) lens, which was not significantly different than the control lens.
Clinical trial data from the U.S. Food and Drug Administration premarket approval studies supports multifocal and EDOF lenses as an effective treatment for aphakia and presbyopia. [J Refract Surg. 2021;37(2):98-104.].
回顾和比较近期多焦点和扩展景深（EDOF）人工晶状体未发表的上市前研究结果。
确定无先前发表的上市前试验的镜片，并回顾和比较临床及患者报告的结果。
所纳入的镜片包括来自爱尔康公司的 DFT/DAT（Acrysof Vivity）EDOF 镜片、TFNT/TFAT（PanOptix）三焦点镜片和 SV25T（ReStor ActiveFocus）镜片，以及来自强生视力公司的 ZXR/ZXT（Tecnis Symfony 和 Symfony Toric）、ZLB00（Tecnis Multifocal +3.25）和 ZKB00（Tecnis Multifocal +2.75）镜片（所有均为 Tecnis 镜片）。所有镜片在产生等效远距视力的同时，提供了优于单焦点对照的中距和近距视力。与单焦点对照组相比，多焦点和 EDOF 镜片组的患者报告在眩光、晕影和星爆方面的困难更高。多焦点和 EDOF 组的不依赖眼镜的比例更高，除了 SV25T（ActiveFocus）镜片，其与对照镜片无显著差异。
美国食品和药物管理局上市前研究的临床试验数据支持多焦点和 EDOF 镜片作为治疗无晶状体和老视的有效方法。[J Refract Surg. 2021;37(2):98-104.]。
