Myopia Research Today is a free monthly online journal that collates and summarizes the latest research about Myopia, including details on treatment, prevention, causes, correction. | ||||||||
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Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States Food And Drug Administration clinical trial.Stulting RD, John ME, Maloney RK, Assil KK, Arrowsmith PN, Thompson VM, Department of Ophthalmology, Emory University, Atlanta, Georgia 30342, USA. ophtrds@emory.edu OBJECTIVE: To assess the safety and efficacy of the Artisan/Verisyse phakic intraocular lens (IOL) for the correction of high myopia. DESIGN: Prospective, open-label, noncomparative, multicenter clinical trial. PARTICIPANTS: A total of 684 adults with axial myopia from -4.5 diopters (D) to -22 D were enrolled: 662 in the primary analysis group and 22 under compassionate use protocol expansion. Efficacy data are based on the 662 first eyes implanted. INTERVENTION: Implantation of the Artisan/Verisyse phakic intraocular lens. MAIN OUTCOME MEASURES: Efficacy measures included uncorrected distance visual acuity (UCVA), refractive predictability and stability, patient satisfaction, and contrast sensitivity. Safety measures were best spectacle-corrected visual acuity (BSCVA), intraocular pressure, slit-lamp observations, endothelial cell density (ECD), complications, and adverse events. RESULTS: At 3 years, UCVAs for first eyes were 20/40 or better in 84.0% (194/231) and 20/25 or better in 51.9% (120/231). Of first eyes, 71.7% to 76.7% were within 0.50 D of target refraction and 93.1% to 95.0% were within 1.0 D at 6 months and later. Best spectacle-corrected visual acuity was 20/40 or better for 99% to 100% of first eyes from the 1-month visit through 3 years. At 3 years, 54% of first eyes gained >/=1 lines of BSCVA, and 7.5% lost >/=1 lines of BSCVA. The mean change in ECD from baseline to 3 years was -4.8%+/-7.8%, with a 2.4% loss between 2 and 3 years. One site had a mean cell loss of -5.0% (P = 0.023), and the others combined had a mean cell loss of 1.7%+/-5.4%. For a cohort of 57 eyes with ECD data for all visits, the mean change from baseline was -3.8%+/-9.8% over 3 years. Approximately half (31/59) of the adverse events and preventative repositionings were among the first 10 cases performed by each investigator. CONCLUSIONS: The Artisan/Verisyse phakic IOL provides excellent refractive outcomes; endothelial cell loss within a mean of 5.0% over 3 years, or 1.8% per year; and few complications. Published 5 March 2008 in Ophthalmology, 115(3): 464-472.e1.
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