Artisan phakic intraocular lens for myopia:short-term results of a prospective, multicenter study.
OBJECTIVE
To evaluate the safety and efficiency of the Artisan iris-supported phakic intraocular lens (Ophtec BV, Groningen, Netherlands) for the correction of high myopia.


METHODS
Nonrandomized, prospective, multicenter trial conducted under a United States Food and Drug Administration (FDA) Investigational Device Exemption.


METHODS
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.


METHODS
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.
Maloney
Robert K
RK
Maloney Vision Institute, Los Angeles, California. Jules Stein Eye Institute, Los Angeles, California. John-Kenyon Eye Center, Jeffersonville, Indiana,USA.
Nguyen
Lien H
LH
John
Maurice E
ME
D000328:Adult; D002452:Cell Count; D002983:Clinical Competence; D004728:Endothelium, Corneal / Q000166:cytology; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007429:Intraocular Pressure; D019654:Lens Implantation, Intraocular / Q000379:methods*; D007908:Lens, Crystalline / Q000502:physiology; D007910:Lenses, Intraocular; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000601:surgery*; D011183:Postoperative Complications; D011446:Prospective Studies; D012029:Refraction, Ocular; D012449:Safety; D014792:Visual Acuity