Long-term safety and efficacy of a foldable iris-fixated phakic intraocular lens for the correction of myopia.

Purpose: To analyze and report the long-term outcomes in terms of efficacy and safety of eyes implanted with the spherical version of a foldable iris-fixated phakic intraocular lens (pIOL) for the correction of myopia.

Methods: Retrospective analysis of the results of 56 eyes of 32 patients (age, 19-45 years) who underwent implantation of the spherical model of the Artiflex pIOL (Ophtec B.V., Groningen, The Netherlands) for the correction of myopia. Visual, refractive, biometric, intraocular pressure (IOP) and corneal endothelial changes were evaluated during a long-term follow-up: 2, 7, 10 and 12 years for more than 50, 30, 20 and 10 eyes, respectively.

Results: At 4 weeks postoperatively, a significant reduction of manifest sphere and spherical equivalent (SE), with a significant improvement of uncorrected distance visual acuity were found (all p < 0.001). No significant changes were found during the rest of follow-up in sphere (p ≥ 0.072). The percentage of eyes with SE within ± 1.00 D was over 83% during the whole follow-up. A non-significant trend to IOP increase was observed at 4 weeks postoperatively (p = 0.530), with a significant reduction at 1 year after (p = 0.039) and no significant changes during the rest of follow-up (p = 0.180). There was a significant reduction of anterior chamber depth at 4 weeks after surgery (p < 0.001), with no significant changes during the following 9 years of follow-up (p = 0.118). However, an additional significant decrease of this parameter was observed between 10 and 13 years after surgery (p = 0.027). Mean endothelial cell loss changed from 2.01 ± 4.49% at 4 weeks after surgery to 9.11 ± 2.24% at the end of the follow-up. No complications were reported during the follow-up.

Conclusions: Myopia correction with the Artiflex pIOL is an effective and safe procedure in the long term.