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

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 over 6 months. Results: This report includes a retrospective review of 200 eyes of 114 subjects with mean age 35.1 ± 5.1 years that completed the 6-month visit. Mean preoperative spherical equivalent (SE) measured -4.61 ± 0.87 D (range: -3.00 to -6.00 D). At 6 months, mean SE was -0.085 ± 0.26 D, with 91.5% within ± 0.50 D of target and 100.0% within ±1.00 D of target. Mean postoperative UDVA and CDVA were -0.065 ± 0.08 logMAR and -0.14 ± 0.07 logMAR, respectively. About 98.0% of eyes maintained or gained lines of CDVA, and no eye lost more than 1 line CDVA. Efficacy and safety indices were 1.03 and 1.21, respectively. No eye experienced pupillary block, required preoperative or postoperative peripheral iridotomy or iridectomy, developed anterior subcapsular cataract or had elevated IOP due to angle narrowing or pigment dispersion. Mean endothelial cell density declined by 2.2%. Conclusion: EVO ICL lenses demonstrated accuracy, predictability and stability of refractive correction with achievement of high levels of UDVA and an excellent safety profile for patients with moderate myopia with or without astigmatism.