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Artisan IOL may provide better vision than LASIK, two studies indicate.
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The Artisan phakic IOL is a safe and accurate method of correcting high myopia that may produce better subjective quality of vision compared to LASIK, two recently published studies suggest. Both studies, one in Europe and one in the United States, are published in the September issue of Ophthalmology.
European researchers conducted a prospective, randomized trial comparing the refractive performance of the Artisan phakic IOL (Ophtec BV) to LASIK in 25 patients with myopia ranging from –8 D to –12 D. One eye of each patient was randomly assigned to treatment with LASIK or implantation with an Artisan lens.
One month following surgery, the mean spherical equivalent refraction, which was the main outcome measure, in the LASIK eyes was –0.28 ± 0.71 D. The Artisan-implanted eyes had a mean spherical equivalent refraction of –1.07 ± 0.59 D. At 1 year follow-up, the mean spherical equivalent refraction in the LASIK eyes was –0.74 ± 0.67 D. This compared to –0.95 ± 0.45 D in the Artisan eyes.
According to the study, the Artisan group fared better in regard to change of two or more lines of visual acuity (P <.05).
Sixty-four percent (64%) of the LASIK eyes and 60% of the Artisan eyes were within 1 D of intended correction, and both surgeries had similar predictability. The authors noted the best corrected visual acuity and subjective evaluation of vision quality were better in the Artisan-implanted group.
In a separate study in the United States, researchers concluded that short-term results suggest the Artisan is a safe and accurate method for correcting high myopia. The authors noted that surgical skill is important to avoid lens opacities and that longer-term data is needed to assess the effect the lens has on the endothelium, the crystalline lens and the iris.
The researchers conducted the nonrandomized, prospective and multicenter study under Food and Drug Administration trials of the lens. One hundred and fifty-five eyes of 155 patients with myopia ranging from –5.5 D to –22.5 D were included. Eyes were followed for 6 months.
According to the report, the mean spherical equivalent manifest refraction stabilized on the first postoperative day. The mean difference between attempted and achieved correction at 2 months was –0.32 ± 0.95 D.At 6 months, 95% of eyes were within 1 D of attempted correction, and 85% of eyes had uncorrected visual acuity of 20/40 or better.
Refractive astigmatism increased in 4.8% of eyes but decreased in 17% of eyes at 6 months.
At 2 months, six eyes lost at least two lines of best corrected acuity. However, by 6 months, no eyes lost two or more lines of best corrected visual acuity.
Endothelial cell counts were unchanged at 6 months. Nonprogressive lens opacities attributed to surgical trauma developed in four eyes. No chronic inflammation, angle closure or glaucoma was detected in any eyes.