Artiflex Toric Foldable Phakic Intraocular Lens: Short-term Results of a Prospective European Multicenter Study

PURPOSE: To evaluate the short-term efficacy, predictability, stability, and safety of the foldable Artiflex Toric phakic intraocular lens (pIOL; Ophtec) for the correction of myopia with astigmatism. DESIGN: Prospective, nonrandomized multicenter study. METHODS: One hundred fifteen eyes of 73 patients were implanted with an Artiflex Toric pIOL. Mean implanted spherical and cylindrical powers were -7.10 +/- 2.70 diopters (D) and -2.14 +/-.80 D, respectively. Total follow-up was 6 months. Outcome parameters included uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), subjective manifest refraction (used for vector analysis), intraocular pressure, and endothelial cell density (ECD). RESULTS: At 6 months, 99.0% of eyes had a UCVA of >= 20/40, and 81.8% of eyes were 0.5 D of the intended refraction. In 74.5% postoperative UCVA was equal to or better than preoperative BSCVA; 2 eyes lost 2 or more lines of BSCVA postoperatively because of the development of synechiae. In 75.5% of eyes the remaining cylinder was +/- 0.5 D. There was a significant decrease in ECD after 3 months (4.8% +/- 11.9%), with no additional decline between 3 and 6 months. There were few complications, except for the incidence of pigment and nonpigment precipitates (14.8% and 12.2%, respectively at 6 months). Mean misalignment was 0.6 +/- 1.5 degrees (range 0-8). CONCLUSIONS: The Artiflex Toric pIOL effectively and safely corrects myopia and astigmatism in the short term, with stable and predictable visual results after 6 months, when strict inclusion criteria are applied. Deposition of pigment and nonpigment precipitates on the pIOL warrants further investigation. (Am J Ophthalmol 2012;154:730-739. (C) 2012 by Elsevier Inc. All rights reserved.)