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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.

Abstract：

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.

journal_name

Ophthalmology

journal_title

Ophthalmology

authors

Stulting RD,John ME,Maloney RK,Assil KK,Arrowsmith PN,Thompson VM,U.S. Verisyse Study Group.

doi

10.1016/j.ophtha.2007.08.039

subject

Has Abstract

pub_date

2008-03-01 00:00:00

pages

464-472.e1

issue

eissn

0161-6420

issn

1549-4713

pii

S0161-6420(07)00957-8

journal_volume

115

pub_type

杂志文章,多中心研究

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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.