Artiflex® Phakic Intraocular Lens Implantation For The Correction Of High Myopia: Up To 10 Years Of Follow-Up.

Our primary purpose was to determine efficacy and safety of the foldable Artiflex® intraocular lens (IOL) implant (Ophtec BV, Groningen, Netherlands) for refractive correction of high myopia.

Patients over 18 years-old, submitted to surgical correction of high myopia with anterior chamber phakic Artiflex® lens implantation at our ophthalmology department in Centro Hospitalar Universitário de São João, Porto, Portugal.

The electronic medical records of consecutive patients who underwent surgery between 2013 and 2021 were reviewed retrospectively. The longest follow-up time considered in this study was 10 years and the minimum was 2 years. Data from 128 eyes of 65 patients (20 male 45 female) was analysed. The main outcomes evaluated were stable best corrected visual acuity (BCVA) before surgery, uncorrected visual acuity (UCVA) and BCVA at the latest visit after surgery (reported in LogMAR score), pre- and post-operative spherical equivalent (SE, in diopters), and pre- and post-operative endothelial cell density (ECD) count (cells/mm²). The occurrence of procedure related complications and the need for a second surgical intervention was also assessed.

Mean age at the time of surgery was 31.18 years [SD=6.02]. Mean follow-up time was 5.82 years [SD=2.67]. Mean BCVA before surgery was 0.03±0.05 with a mean SE of -9.07±3.12 at baseline. At the latest visit there was a statistically significant improvement in visual acuity (mean final UCVA 0.03±0.09 and BCVA 0.01±0.03) compared to initial evaluation (t=-8.86, p<0.01), which represents favourable safety and efficacy profiles. The SE decreased to -0.11±0.39 at the final visit (t=257.48, p<0.01). The mean decrease rate in ECD count was 0.44 ± 1.92 cells/mm² per year. Eighteen eyes (14.1%) needed IOL repositioning following traumatic events not related to the initial surgery. No eye in this study needed explantation of the IOL.

In our experience, Artiflex® phakic intraocular lens is an effective, predictable, safe, and stable treatment option of high myopia, particularly suited for myopic patients where laser surgery is not an option. Follow-up is necessary to monitor endothelial cells density and the occurrence of other possible complications, as well as to determine refractive stability over a longer period of time.