Purpose: The aim of this study was to evaluate the long-term efficacy and safety of the Artiflex® lens implant and to follow the evolution of the number of corneal endothelial cells over time.
Design: It was a retrospective study of an observational case series of patients who underwent surgery at "The INVISION Ophthalmic Hospital" (Almería, Spain) in 2007 and who were followed for 10 years.
Methods: Setting: Clinical practice. Study population included 53 eyes of 30 patients who underwent an Artiflex® lens implant for the correction of myopia from -4 to -14 D. Each patient included in this study had stable myopia for at least 2 years and a contraindication for corneal refractive surgery. The efficacy index was defined as the quotient between uncorrected distance visual acuity postoperative and best-corrected distance visual acuity (BCDVA) preoperative. The safety index was calculated as the quotient between BCDVA postop and BCDVA preop.
Results: The average efficacy and safety indices of the lenses implanted were 1.1 (SD 0.30) and 1.06 (SD 0.2) at 10 years of follow-up. In this period of time there has been a loss of 12% of the corneal endothelial cells. The postoperative complications were pigment dispersion in four eyes (7%) of four patients and decentration of phakic intraocular lens in two eyes (4%) of another two patients.
Conclusions: The Artiflex® foldable phakic lens could be a safe and effective long-term alternative for myopic patients in whom laser surgery was contraindicated.