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R. U. Desai, A. Jain, E. E. Manche, Artisan Hyperopia Lens Study Group; Long-Term Results of the Artisan Phakic IOL for the Correction of Severe and Extreme Hyperopia in the United States: A Prospective Multi-Center Study. Invest. Ophthalmol. Vis. Sci. 2008;49(13):5646.
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Our study describes the results of a Phase III United States FDA investigation on the Artisan phakic intraocular lens (PIOL) for the correction of hyperopia up to +12.0 D. The endpoints focused on refraction efficacy, predictability, stability, and safety.
The Artisan hyperopic PIOL is fabricated from ultraviolet-absorbing polymethylmethacrylate. It was implanted in 95 eyes of 60 subjects at 13 participating trial sites located throughout the United States. Inclusion criteria included endothelial cell counts (ECC) of at least 2000 cells/mm2 and anterior chamber depth (ACD) of at least 3.2 mm. The goal of all surgeries was emmetropia. 46 eyes were followed for 3 years.
Implant diopter strength averaged 7.55 ± 2.04 D (range +4.0 to +12.0 D). Pre-operative ACD averaged 3.40 ± 0.17 mm. The pre-operative mean spherical equivalent (MSE) averaged +5.47 ± 1.45 D, while the third post-operative year MSE averaged -0.56 ± 0.65 D. By this third post-operative year, 65.5% of eyes were within ± 0.5 D and 98.2% were within ± 1.0 D of the intended correction. Pre-operative best corrected visual acuity (BCVA) was 20/20 or better for 75.8% of eyes and 20/40 or better for all of eyes, while at the third post-operative year, 21.4% of eyes achieved uncorrected visual acuity (UCVA) of 20/20 or better, and 85.5% of eyes achieved 20/40 or better. By the third post-operative year, 72.7% of eyes achieved a BCVA of 20/20 or better with all eyes achieving a BCVA of 20/40 or better. ECC decreased by 4.3% over three years from 2588 to 2400 cell/mm2 (p < 0.01).
The Artisan PIOL provides effective and predictable correction of hyperopia up to +12.0 D.
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