Budo C, Hessloehl J C, Izak M, Luyten G P, Menezo J L, Sener B A, Tassignon M J, Termote H, Worst J G
J Cataract Refract Surg. 2000 Aug;26(8):1163-71. doi: 10.1016/s0886-3350(00)00545-9.
To assess the Artisan intraocular lens to correct myopia in phakic eyes.
European multicenter study sponsored by Ophtec BV, Groningen, The Netherlands.
In this prospective multicenter clinical study, the Artisan lens was implanted in 518 eyes between September 1991 and October 1999. The power of the lenses ranged from -5.0 to -20.0 diopters (D). Follow-up examinations were performed at 6 months and 1, 2, and 3 years. Follow-up ranged from 6 months (n = 454) to 3 years (n = 249). The preoperative uncorrected visual acuity (UCVA) was not recorded but was estimated to be worse than 0.1. The preoperative mean best spectacle-corrected visual acuity (BSCVA) was 0.67 +/- 0.26 (SD). Endothelial cell counts were done at 6 months and 1, 2, and 3 years in a subgroup of 129 eyes.
A UCVA of 20/40 or better was observed in 76.8% of eyes regardless of the postoperative goal. A BSCVA of 20/40 or better was observed in 93.9% of eyes and remained stable throughout the follow-up. Of the eyes with extremely high myopia (>-15.0 D), 63.3% gained 2 or more lines of BSCVA; of those with moderate myopia (-5.0 to -10.0 D), 23.5% gained 2 or more lines. The mean endothelial cell density change was 4.8% at 6 months, 2.4% at 1 year, 1.7% at 2 years, and 0.7% at 3 years. The incidence of persistent adverse events at 3 years was relatively low. Secondary surgical interventions included repositioning of the lens because of poor initial placement and lens exchange because of preoperative power calculation errors. Glare and halo effects during night driving were noted and were related to large pupils in young patients.
The Artisan lens is a safe, stable, efficacious, and predictable method to correct -5.0 to -20.0 D of myopia. This study suggests that the corneal endothelial cell loss is stabilized to the physiologically normal level after 3 years.
评估Artisan人工晶状体用于矫正有晶状体眼近视的效果。
由荷兰格罗宁根的Ophtec BV公司赞助的欧洲多中心研究。
在这项前瞻性多中心临床研究中，1991年9月至1999年10月期间，518只眼睛植入了Artisan人工晶状体。晶状体的屈光度范围为-5.0至-20.0屈光度（D）。在术后6个月、1年、2年和3年进行随访检查。随访时间从6个月（n = 454）到3年（n = 249）。术前未矫正视力（UCVA）未记录，但估计低于0.1。术前平均最佳矫正视力（BSCVA）为0.67±0.26（标准差）。在129只眼睛的亚组中，于术后6个月、1年、2年和3年进行内皮细胞计数。
无论术后目标如何，76.8%的眼睛UCVA达到20/40或更好。93.9%的眼睛BSCVA达到20/40或更好，且在整个随访期间保持稳定。在高度近视（>-15.0 D）的眼睛中，63.3%的眼睛BSCVA提高了2行或更多；在中度近视（-5.0至-10.0 D）的眼睛中，23.5%的眼睛BSCVA提高了2行或更多。内皮细胞密度的平均变化在术后6个月为4.8%，1年为2.4%，2年为1.7%，3年为0.7%。3年时持续性不良事件的发生率相对较低。二次手术干预包括因初始放置不佳而重新定位晶状体以及因术前屈光度计算错误而更换晶状体。注意到夜间驾驶时的眩光和光晕效应，且与年轻患者的大瞳孔有关。
Artisan人工晶状体是矫正-5.0至-20.0 D近视的一种安全、稳定、有效且可预测的方法。本研究表明，3年后角膜内皮细胞损失稳定在生理正常水平。
