Efficacy and Safety of Implantable Collamer Lens V4c Implantation in 1,834 Myopic Eyes for 1 Year of Follow-up

Abstract

Purpose: To evaluate visual outcomes of patients with myopia after EVO Implantable Collamer Lens (ICL) (STAAR Surgical) implantation and predict risk factors of postoperative vault abnormalities. Methods: In this single-center, retrospective analysis, 1,834 eyes of 926 patients with myopia who underwent EVO ICL implantation were recruited between 2020 and 2021. Patients were followed up for 1 year, during which surgery outcomes were evaluated. In addition, 31 eyes with vault abnormalities who underwent secondary surgery were enrolled to form a generalized linear model, which aimed to predict risk factors contributing to vault abnormalities. Results: At the final follow-up visit, safety and efficacy indexes were 1.12 ± 0.17 and 1.10 ± 0.19, respectively, and there was no statistical significance between the low and high myopia groups. Furthermore, 79.18% of eyes achieved a residual spherical equivalent within ±0.50 diopters. Except for the temporary elevation of intraocular pressure at 1 week postoperatively, IOP and endothelial cell density remained stable during follow-up visits. The rate of postoperative adverse events was 21.97% and most adverse events were transient. Vault abnormalities accounted for the majority of complications (9.54%). Results of generalized linear model showed that age was a risk factor for postoperative vault abnormalities, and the anterior chamber depth served as a protective factor ( P < .05). Conclusions: Visual outcomes of EVO ICL implantation were satisfactory in safety and efficacy indexes in both the low and high myopia groups for 1 year of follow-up, with acceptable stability in postoperative spherical equivalent, intraocular pressure, and endothelial cell density. This study emphasized cautious ICL size selection for older patients and those with shallow anterior chamber depth. [ J Refract Surg . 2023;39(10):694–704.]