Iris-supported phakic lenses (rigid vs foldable version) for treating moderately high myopia:: Randomized paired eye comparison

center dot PURPOSE: To compare refractive performance of Artisan (Ophtec, Groningen, The Netherlands) or Verisyse phakic intraocular lens and its foldable version, Artiflex (Ophtec), for the correction of moderately high myopia. center dot DESIGN: Randomized pilot study. center dot METHODS: SETTING: Institutional practice. PATIENT POPULATION: Thirty-one patients with myopia that ranged from -6 to -14 diopters (D). INTERVENTIONAL PROCEDURE: One eye was implanted with an Artisan phakic intraocular lens (PIOL) and the other with an Artiflex PIOLs. MAIN OUTCOME MEASURES: Primary outcome measure was the percentage of eyes with uncorrected visual acuity (UCVA) of > 20/40 at one year after the operation. Main secondary outcome measures were the safety index, the change of two lines or more of best spectacle-corrected visual acuity (BSCVA) and the endothelial cell count. center dot RESULTS: No intraoperative complications were noticed. One year after surgery, the percentage of eyes with UCVA of > 20/40 was 51.6% (16/31 patients) for Artisan-treated eyes and 77.4% (24/31 patients) for Artiflex-treated eyes (P =.033). One month after surgery, this same percentage was 42.9% (13/31 patients) and 77.4% (24/31 patients), respectively (P =.004). The safety index at one year was 1.13 +/- 0.24 for Artisantreated eyes and 1.12 +/- 0.21 for Artiflex. treated eyes, which is a difference that was not statistically significant (P = 0.742). At one year after surgery, the changes of two lines or more of BSCVA and the endothelial cell loss were similar for both groups. center dot CONCLUSION: To correct moderately high myopia, the Artiflex lens provides a faster visual recovery and a better UCVA than does the Artisan lens. The safety of the lens should be supported by an enlarged sample size and a longer follow-up period.