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. DESIGN: Randomized pilot study. 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. 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 Artisan-treated 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. 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.
RCT Entities:
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. DESIGN: Randomized pilot study. 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. 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 Artisan-treated 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. 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.