Purpose: To analyse long-term efficacy, safety, visual and refractive stability and physiological changes of Artiflex Myopia and Toric phakic intraocular lenses (pIOL) separately throughout an 8-year follow-up. Design: Retrospective cohort study. Methods: A total of 67 eyes of 37 patients underwent Artiflex Myopia (47 eyes) or Artiflex Toric (20 eyes) implantation for correcting myopia and/or astigmatism. Follow-up evaluations were performed 1, 3, 5 and 8 years after surgery. Preoperative and postoperative data included corrected (CDVA) and uncorrected distance visual acuity (UDVA), manifest refraction, endothelial cell density (ECD) and intraocular pressure (IOP) assessments. Efficacy and safety indexes were analysed. The vectorial analysis was performed using the Thibos method. Results: Mean CDVA and UDVA of both pIOLs significantly improved from preoperative to 1 year after implantation, and then it remained stable over the 8-year follow-up. The efficacy and safety indexes after 8 years were 0.94 ± 0.16 and 1.07 ± 0.18 for Artiflex Myopia and 1.00 ± 0.11 and 1.10 ± 0.15 for Artiflex Toric, respectively. The spherical equivalent (SE) significantly improved after surgery. J0, J45 and SE refractive components showed no changes between postoperative visits. A total ECD loss of 4.8% ( p < 0.001) and 10.4% ( p = 0.005) was found after 8 years for Artiflex Myopia and Toric, respectively. Conclusions: Artiflex Myopia and Toric pIOLs are a safe, efficient and predictable option for the correction of myopia and/or astigmatism. The vectorial analysis showed excellent rotation stability for the toric version.
To evaluate the clinical outcomes obtained after cataract or crystalline lens surgery with implantation of a new continuous transitional focus (CTF) intraocular lens (IOL).
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.
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