Long-term efficacy and safety results after iris-fixated foldable phakic intraocular lens for myopia and astigmatism: 6-year follow-up

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Abstract
Purpose: To evaluate the long-term efficacy and safety of iris-fixated foldable phakic intraocular lenses (pIOLs) for the management of myopia and astigmatism after 6-year follow-up. Setting: Ophthalmology Department, Hospital Braga, Portugal. Design: Retrospective cohort study. Methods: Patients included underwent iris-fixated foldable Artiflex pIOL implantation between January 2010 and December 2013. Follow-up evaluations were performed 6 months postoperatively and every 12 months until 72 months. Preoperative and follow-up data on uncorrected and corrected distance visual acuity (CDVA), manifest refraction, endothelial cell density (ECD), and anterior chamber depth (ACD) were analyzed. Results: A total of 177 eyes of 98 patients with a mean age of 32.33 ± 7.13 years were analyzed. There was a statistically significant improvement in CDVA from 0.09 ± 0.02 logMAR preoperatively to 0.04 ± 0.02 logMAR (P < .0001) at 6 years postoperatively. The spherical equivalent demonstrated a statistically significant improvement from −9.50 ± 2.93 diopters (D) to −0.41 ± 0.45 D at 6 years. At 72 months, the efficacy and safety indexes were 0.94 and 1.15, respectively. A mean loss of 31.77 cells/mm2 (1.19%) was observed each year until the sixth year. The overall mean ECD loss after correction for the physiological loss was 3.02% after 6 years. No correlations were observed between the mean ECD loss and the preoperative ACD. Conclusions: The Artiflex pIOL was a safe, effective, and a stable option to correct myopia. A mean ECD loss of 3.02% was observed over 6 years. No pIOL was explanted due to corneal decompensation.

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