Stulting R Doyle, John Maurice E, Maloney Robert K, Assil Kerry K, Arrowsmith Peter N, Thompson Vance M
Department of Ophthalmology, Emory University, Atlanta, Georgia 30342, USA.
Ophthalmology. 2008 Mar;115(3):464-472.e1. doi: 10.1016/j.ophtha.2007.08.039. Epub 2007 Nov 26.
To assess the safety and efficacy of the Artisan/Verisyse phakic intraocular lens (IOL) for the correction of high myopia.
Prospective, open-label, noncomparative, multicenter clinical trial.
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.
Implantation of the Artisan/Verisyse phakic intraocular lens.
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.
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.
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.
评估Artisan/Verisyse有晶状体眼人工晶状体（IOL）矫正高度近视的安全性和有效性。
前瞻性、开放标签、非对照、多中心临床试验。
共纳入684例轴向近视度数在-4.5屈光度（D）至-22 D之间的成年人：662例纳入主要分析组，22例根据同情用药方案扩展纳入。疗效数据基于662只首次植入的眼。
植入Artisan/Verisyse有晶状体眼人工晶状体。
疗效指标包括未矫正远视力（UCVA）、屈光预测性和稳定性、患者满意度及对比敏感度。安全指标为最佳矫正视力（BSCVA）、眼压、裂隙灯检查、内皮细胞密度（ECD）、并发症及不良事件。
3年时，首次植入眼的UCVA在84.0%（194/231）的眼中达到20/40或更好，在51.9%（120/231）的眼中达到20/25或更好。首次植入眼在6个月及以后，71.7%至76.7%的眼屈光度数在目标屈光度的±0.50 D范围内，93.1%至95.0%的眼在±1.0 D范围内。从1个月随访至3年，99%至100%的首次植入眼的最佳矫正视力达到20/40或更好。3年时，54%的首次植入眼的BSCVA提高了≥1行，7.5%的眼降低了≥1行。ECD从基线至3年的平均变化为-4.8%±7.8%；2至3年期间细胞丢失率为2.4%。一个中心的平均细胞丢失率为-5.0%（P = 0.023），其他中心合并的平均细胞丢失率为1.7%±5.4%。对于一组有所有随访ECD数据的57只眼，3年期间从基线的平均变化为-3.8%±9.8%。约一半（31/59）不良事件和预防性重新定位发生在各研究者所做前10例手术中。
Artisan/Verisyse有晶状体眼人工晶状体提供了优异的屈光效果；3年期间内皮细胞平均丢失率为5.0%以内（即每年1.8%），并发症较少。
