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Toric phakic IOL safe, effective for ametropia with astigmatism
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The Artisan Toric Phakic IOL is safe and effective at 6 months for correction of myopia or hyperopia with astigmatism, according to a multicenter study.
Seventy eyes with a preoperative spherical equivalent between +6.5 D and –21.25 D and cylinder between 1.5 D and 7.25 D were enrolled in the prospective, nonrandomized European multicenter clinical trial. Patients ranged in age from 22 to 59, with a mean age of 35. All eyes underwent implantation of the Artisan Toric Phakic IOL (Ophtec). The lens has an optical zone of 5 mm. The dioptric power of the IOL was calculated by considering refraction, keratometry and anterior chamber depth.
Myopes in the study had an average spherical equivalent of –8.9 D, and hyperopes had an average spherical equivalent of +3.25 D.
No eyes experienced a loss of best corrected visual acuity (BCVA), and 46 eyes gained 1 or more lines from their preoperative BCVA. Uncorrected visual acuity of 20/40 or better was achieved in 62 eyes (89%). There was a significant reduction in spherical error and astigmatism in all eyes after surgery. All eyes were within 1 D of target refraction, and 51 eyes (73%) were within 0.5 D of target refraction.
Two eyes required a secondary intervention: one eye had a postop wound leak and another required lens repositioning at 1 week postop. No potentially sight-threatening complications were reported during the 6-month follow-up. Three patients reported mild photic phenomena after surgery, one patient reported moderate glare, and no patients reported severe photic phenomena.
On a scale from 1 to 10, with 10 being “excellent,” mean subjective overall patient satisfaction was 8.98 under bright light conditions, 9.19 under normal light conditions and 8.89 under dark conditions.
The study is published in the January issue of Ophthalmology.