Three Year Results from the United States FDA Prospective Multicenter Clinical Study of the EVO/EVO+ Implantable Collamer Lens

Abstract

Background: Continued safety and effectiveness of collamer EVO ICL posterior chamber phakic lenses with a central port design for the correction of myopia with or without astigmatism. Patients and Methods: Subjects aged 21 to 45 years with moderate to high myopia and astigmatism up to 4.00 D underwent EVO or EVO+ Sphere or Toric ICL (collectively referred to as EVO ICL) surgery. Uncorrected and corrected distance visual acuity (UDVA, CDVA), manifest refraction, intraocular pressure (IOP), endothelial cell density (ECD), and adverse events were assessed over 3 years. Results: This prospective multicenter study included 629 eyes (327 subjects), with a mean age of 35.6 ± 5.1 years. Mean spherical equivalent (SE) was −7.62 ± 2.75 D (range: −3.00 to −15.62 D) preoperatively, and −0.12 ± 0.30 D at 3 years with 90.7% of eyes within ± 0.50 D and 99.0% within ±1.00 D of target. Mean postoperative UDVA and CDVA were −0.053 ± 0.12 logMAR and −0.13 ± 0.08 logMAR, respectively. Additionally, 48.9% of eyes gained 1 or more lines of CDVA. Efficacy and safety indices were 1.07 and 1.25, respectively. Two eyes (0.32%) underwent lens exchange for high vault; neither of these demonstrated increased IOP. One eye (0.16%) developed an anterior subcapsular cataract (ASC) at 2 years. No eyes experienced pupillary block requiring peripheral iridotomy or iridectomy (PI), elevated IOP due to angle narrowing, or pigment dispersion. Mean ECD decreased by 3.0% from baseline at 1 year and by 6.7% at 3 years. Conclusion: This 3-year study confirmed the central port design of the EVO ICL functions effectively to allow physiologic flow of aqueous humor, thus eliminating the requirement for preoperative PI and reducing the incidence of ASC and pupillary block. EVO ICL lenses demonstrated accuracy and stability of refractive correction and achievement of high levels of UDVA.