Ten-Year Clinical Outcomes of V4c Implantable Collamer Lens Implantation: Longitudinal Analysis of Visual Acuity, Endothelial Cell Density, and Vault Dynamics.

ABSTRACT

PURPOSE: This study aimed to evaluate the long-term clinical outcomes of V4c Implantable Collamer Lens (ICL) implantation for myopia correction over a 10-year period. DESIGN: Retrospective interventional case series METHODS: This retrospective interventional study involved 103 myopic eyes from 54 patients. Visual outcomes, including visual acuity and manifest refraction were assessed. Annual measurements of endothelial cell density (ECD), vault, anterior chamber depth, and intraocular pressure were analyzed using mixed-effects models. RESULTS: At the 10-year follow-up, the mean Logarithm of the Minimum Angle of Resolution (logMAR) uncorrected distance visual acuity and corrected distance visual acuity (CDVA) were -0.037 ± 0.052 and -0.041 ± 0.046, respectively. The mean efficacy and safety indices were 1.11 ± 0.13 and 1.12 ± 0.12. A loss of one line of CDVA occurred in 2% of cases, while 59% gained one or more lines. Postoperative manifest refraction spherical equivalent (MRSE) was within ±0.5 diopters (D) and ±1.0 D in 74% and 99% of cases, respectively, with a mean MRSE of -0.19 ± 0.41 D. Data for ECD and vault fit an exponential decay model, demonstrating a continuous yet gradually slowing decrease over time. Decay rates were 0.012 ± 0.001 per year for ECD and 0.056 ± 0.003 per year for the vault. Notably, ECD lower outliers had significantly lower preoperative ECD values. There were no instances of cataract formation, angle closure, glaucoma, or ICL removal throughout the study. CONCLUSIONS: The 10-year outcomes of V4c ICL implantation demonstrate effective and safe visual results. Both ECD and vault exhibit exponential decay patterns over the decade. Patients with lower preoperative ECD values require careful post-implantation monitoring.