Artisan phakic intraocular lens for myopia: Short-term results of a prospective, multicenter study

To evaluate the safety and efficiency of the Artisan iris-supported phakic intraocular lens (Ophtec BV, Groningen, Netherlands) for the correction of high myopia. Nonrandomized, prospective, multicenter trial conducted under a United States Food and Drug Administration (FDA) Investigational Device Exemption. One hundred fifty-five eyes of 155 patients with myopia from −5.5 to −22.5 diopters (D) underwent implantation of an Artisan lens, as part of a phase I, II, or III FDA trial. Eyes were examined at 1 day (154 eyes), 2 weeks (142 eyes), 2 months (130 eyes), and 6 months (84 eyes). Intraocular pressure and presence of flare and cell on slit-lamp biomicroscopy were recorded at each visit. Achieved correction, stability of spherical equivalent refraction, change in astigmatism, postoperative uncorrected vision, change in best spectacle-corrected acuity, and change in endothelial cell count. Mean spherical equivalent manifest refraction stabilized on postoperative day 1. Mean difference between attempted and achieved correction at 2 months was −0.32 ± 0.95 D (mean ± standard deviation; range, −4.42 to +2.2 D). At 6 months, 85% of eyes saw 20/40 or better uncorrected, and 90% of eyes were within 1 D of the attempted correction. Refractive astigmatism increased in 4.8% of eyes and decreased in 17% of eyes at 6 months. At 2 months, six eyes (4.8%) lost two or more lines of best spectacle-corrected visual acuity; by 6 months, no eyes lost two or more lines of best-corrected visual acuity. Endothelial cell count was unchanged at 6 months compared with the preoperative count. Nonprogressive lens opacities developed in four eyes as a result of surgical trauma. Chronic inflammation was not detected in any eye by slit-lamp biomicroscopy, nor did any eye develop angle closure or glaucoma. Short-term results suggest that the Artisan lens is an accurate and safe method for the correction of high myopia. Surgical skill is important in avoiding lens opacities. Longer-term data are needed to assess the impact of the lens on the endothelium, the crystalline lens, and the iris.