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

Abstract

Abstract Purpose: To analyze and report the 13-year follow-up 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: A 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 13-year follow-up. Results: At 4 weeks postoperatively, a significant reduction of manifest sphere and spherical equivalent (SE), with a significant improvement of uncorrected distance visual acuity (UDVA) associated (all p<0.001) were found. 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 an initial significant reduction of anterior chamber depth (p<0.001), with no significant changes during the following 9 years of follow-up (p=0.118). Mean endothelial cell loss changed from 2.01% at 4 weeks after surgery to 9.11% 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.