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 Vision Institute, Los Angeles, California. Jules Stein Eye Institute, Los Angeles, California. John-Kenyon Eye Center, Jeffersonville, Indiana,USA.
Robert K
RK
Maloney
Lien H
LH
Nguyen
Maurice E
ME
John
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