Prospective Long-term Evaluation of the Efficacy, Safety, and Stability of the Phakic Intraocular Lens for High Myopia

OBJECTIVE: To evaluate the safety, efficacy, predictability, and long-term stability of the Artisan Phakic Intraocular Lens (Ophtec BV, Groningen, the Netherlands) for the correction of high myopia. METHODS: Prospective analysis of 26 eyes from 15 patients who underwent placement of the Artisan lens for the correction of high and extreme myopia. The mean (SD) preoperative spherical equivalent was - 12.30 (2.69) diopters (D) (range, - 17.25 to - 8.25 D). RESULTS: At 5 years, the mean (SD) manifest refraction was - 0.37 (0.69) D, with 95% of eyes within 1 D of attempted correction and 74% of eyes within 0.5 D of the attempted correction. Ninety-five percent of eyes achieved an uncorrected visual acuity of 20/40 or better and 74% achieved an uncorrected visual acuity of 20/20 or better. No eyes experienced a loss of 1 or more lines of best-corrected visual acuity. Sixteen percent of eyes gained 2 or more lines of best-corrected visual acuity. From preoperative measurements, the mean endothelial cell density decreased by 14.05% at 5 years postoperatively. CONCLUSIONS: Placement of the Artisan lens is predictable, stable, and effective at reducing high and extreme myopia 5 years after implantation. The rate of endothelial cell loss was significantly higher than has been reported in previous studies.