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.