The EVO ICL for Moderate Myopia: Results from the US FDA Clinical Trial.

ABSTRACT:

Purpose

To evaluate the safety and effectiveness of collamer posterior chamber phakic refractive lenses with a central port design (EVO and EVO+ Sphere and Toric implantable collamer lenses [ICLs]) for correction of moderate myopia with or without astigmatism.

Patients and methods

Six-month results of a multicenter clinical trial were performed under United States FDA Investigational Device Exemption. Subjects 21 through 45 years of age with manifest refraction spherical equivalent ranging from -3.00 D to -6.00 D and astigmatism up to 4.00 D underwent implantation of EVO or EVO+ Sphere or Toric ICLs. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, intraocular pressure (IOP), endothelial cell density, and adverse events were evaluated ov

SUBMITTER: Packer M 

PROVIDER: S-EPMC9738966 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature