Evaluation of the EVO/EVO+ Sphere and Toric Visian ICL: Six Month Results from the United States Food and Drug Administration 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 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 trial enrolled 629 eyes of 327 subjects with mean age 35.6 ± 5.09 years. Mean preoperative spherical equivalent (SE) measured −7.62 ± 2.75 D (range: −3.00 to −15.62 D). At 6 months, mean SE was −0.079 ± 0.33 D, with 90.5% within ± 0.50 D of target and 98.9% within ±1.00 D of target. Mean postoperative UDVA and CDVA were −0.059 ± 0.10 logMAR and −0.13 ± 0.08 logMAR, respectively. 52.3% of eyes gained lines of CDVA. Efficacy and safety indices were 1.06 and 1.24, respectively. No eye experienced pupillary block, required 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 2.3%. CONCLUSION: EVO ICL lenses demonstrated accuracy of refractive correction and achievement of high levels of UDVA. This clinical trial confirmed that the central port design of EVO and EVO+ Sphere and Toric Visian ICL lenses functions effectively to allow physiologic flow of aqueous humor, thus eliminating the requirement for preoperative peripheral iridotomies. The results of this clinical trial resulted in FDA approval on March 25, 2022.