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Artisan phakic intraocular lens for myopia:short-term results of a prospective, multicenter study
Robert K Maloney1, Lien H Nguyen, Maurice E John
1Maloney Vision Institute, Los Angeles, California. Jules Stein Eye Institute, Los Angeles, California. John-Kenyon Eye Center, Jeffersonville, Indiana,USA.
Purpose:
To evaluate the safety and efficiency of the Artisan iris-supported phakic intraocular lens (Ophtec BV, Groningen, Netherlands) for the correction of high myopia.
Study Design:
Nonrandomized, prospective, multicenter trial conducted under a United States Food and Drug Administration (FDA) Investigational Device Exemption.
Participants:
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.
Methods:
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.
Main Outcome Measures:
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.
Results:
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.
Conclusions:
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.