To evaluate the long-term results of iris-fixated foldable phakic intraocular lens (pIOL) implantation for the management of myopia and astigmatism.

Centro Hospitalar Universitário do Porto, Oporto, Portugal.

Prospective clinical study.

Patients who underwent Artiflex Myopia or Artiflex Toric iris-fixed pIOL implantation for the treatment of myopia or astigmatism between 2003 and 2011 were included. Refractive stability, refractive predictability, safety, efficacy, and cumulative probability of success were evaluated at 5 years, 10 years, and 15 years of follow-up.

5-year, 10-year, and 15-year follow-ups were completed by 199 of 217 (91.7%), 187 of 217 (86.2%), and 43 of 45 (95.6%) eyes implanted with pIOLs, respectively. The mean spherical equivalent was −8.36 ± 2.75 diopters (D), −0.11 ± 0.31 D, −0.33 ± 0.62 D, and −0.80 ± 1.32 D preoperatively and after 5 years, 10 years, and 15 years after surgery. At 5 years, 10 years, and 15 years after surgery, 100%, 95.6%, and 81.6% were within ±1.00 D. The safety and efficacy indexes were 1.07 and 1.06 at 5 years, 1.04 and 0.99 at 10 years, and 1.05 and 1.00 at 15 years of follow-up, respectively. Kaplan-Meier analysis showed survival rates of 97% at 5 years, 73% at 10 years, and 43% at 15 years of follow-up.

Long-term results demonstrated that the implantation of Artiflex pIOLs was a stable, predictable, and effective procedure at 5 years, 10 years, and 15 years of follow-up. Annual follow-up visits to evaluate endothelial cell density and anterior chamber depth decrease, to alert patients to this need in the preoperative evaluation, is recommended.