Long-Term Results In Patients With Iris-Fixated Foldable Phakic Intraocular Lens For Myopia And Astigmatism: 5-, 10- And 15-Year Follow-Up

The Artiflex Myopia and Artiflex Toric lenses (Ophtec, B. V., Groningen, the Netherlands) are anterior chamber and iris-enclaved phakic intraocular lenses (pIOLs) for the correction of myopia and/or astigmatism.

The purpose of this study was to evaluate the long-term results after iris-fixated foldable pIOLs for the management of myopia and astigmatism after 5-, 10- and 15-years of follow-up.

Refractive Surgery Unit of Ophthalmology Department of Centro Hospitalar Universitário do Porto, Oporto, Portugal.

Prospective, clinical study, that included a total of 217 eyes of 133 patients receiving the Artiflex Myopia or Artiflex Toric iris-fixed pIOL, between 2003 and 2011. Refractive stability, refractive predictability, safety, efficacy, and cumulative probability of success were evaluated at 5-, 10- and 15 years of follow-up.

The safety index [ratio between mean postoperative corrected distance visual acuity (CDVA) and mean preoperative CDVA] and efficacy index [ratio between mean postoperative uncorrected distance visual acuity (UCVA) and mean preoperative CDVA] were measured.

Five, 10 and 15 years of follow-up were completed by 199 (91.7%), 187 (86.2%), and 43 eyes (95.6%) implanted with pIOL, respectively. The safety and efficacy indexes were 1.07 and 1.06 at 5, 1.04 and 0.99 at 10, and 1.05 and 1.00 at 15 years of follow-up, respectively. The mean preoperative anterior chamber depth (ACD) was 3.25±0.26mm and decreased to 3.09±0.32mm at 5 years (p=0.004), 3.01±0.32mm at 10 years (p<0.001) and 2.81±0.24mm (p=0.390) at 15 years of follow-up. Endothelial cell density (ECD) loss showed an annual decline of 34, 50, and 31 cell/mm², until the 5^th, 10^th, and 15^th-year of follow-up, respectively. Kaplan-Meier analysis indicated probabilities of success of 97% at 5 years, 73% at 10 years, 43% at 15 years of follow-up.

Long-term results demonstrate that the implantation of Artiflex Myopia and Artiflex Toric pIOLs, is a stable, predictable, and effective procedure, at 5, 10 and 15 years of follow-up. Artiflex Toric pIOLs had a maximal follow-up of 12 years because it was introduced in 2009. We keep recommending scheduling patients with pIOLs for annual follow-up visits to evaluate the ECD loss and ACD decrease, alerting patients to this need in the preoperative evaluation. The excellent long-term refractive stability and the emigration rate in the younger age groups can contribute to the patients missing, as it happened in a small proportion of patients in our sample above mentioned in the methods section, even after multiple rescheduling.