Foldable Artiflex phakic intraocular lens for the correction of myopia: two-year follow-up results of a prospective European multicenter study.

Objective: To evaluate the safety, efficacy, predictability, stability, and complications of the foldable Artiflex iris-fixated intraocular lens (Ophtec BV, Groningen, The Netherlands) for the correction of myopia in phakic eyes.

Design: Prospective, nonrandomized, open-label, multicenter trial.

Participants: Two hundred ninety eyes of 191 patients aged 18 to 60 years with average spherical equivalent of -7.33+/-2.60 diopters (D; range, -12.63 to -1.5 D) were analyzed.

Methods: All eyes underwent implantation of the foldable iris-fixated Artiflex phakic intraocular lens (PIOL) with an optic zone of 6 mm. The follow-up was 2 years. Phakic intraocular lenses were implanted in powers ranging from -2.0 to -12.0 D.

Main Outcome Measures: The main parameters assessed were best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), refraction, and endothelial cell count.

Results: After 2 years, a UCVA of 20/40 or better was observed in 97.2% of eyes. The BSCVA was 20/40 or better in all eyes. A gain of 1 line or more of BSCVA was found in 49.9% of eyes, and 0.8% lost 2 or more lines. The mean endothelial cell change was -0.05%, 1.79%, and -1.07% at 6 months, 1 year, and 2 years, respectively. Complications were comparable with complications that have been reported previously of the Artisan PIOL, the only exception being a higher incidence of iris pigment precipitates (4.8% at 2 years after surgery).

Conclusions: After 2 years of follow-up, the implantation of the foldable iris-fixated Artiflex intraocular lens proved to be effective and predictable for the correction of myopia in phakic eyes.