Evaluation of the EVO/EVO+ Sphere and Toric Visian ICL: Six Month Results from the United States Food and Drug Administration 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 Visian ICLs) for correction of moderate-to-high myopia with or without astigmatism.

Patients and methods

Six-month results of a multicenter clinical trial performed under United States FDA Investigational Device Exemption. Subjects 21 through 45 years of age with myopia ranging from -3.00 D to -20.00 D and astigmatism up to 4.00 D underwent implantation of EVO or EVO+ Sphere or Toric Visian ICLs. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, manifest refraction, intraocular pressure (IOP), endothelial cell density, and adverse events were evaluated over 6 months.

Results

This clinical tria

SUBMITTER: Packer M 

PROVIDER: S-EPMC9132105 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature