Brezna Wolfgang, Lux Kirsten, Dragostinoff Nikolaus, Krutzler Christian, Plank Nicole, Tobisch Rainer, Boltz Agnes, Garhöfer Gerhard, Told Reinhard, Witkowska Katarzyna, Schmetterer Leopold
ACMIT Gmbh, Wiener Neustadt, Austria.
Department of Clinical Pharmacology, Medical University Vienna, Austria.
Transl Vis Sci Technol. 2016 Oct 17;5(5):13. doi: 10.1167/tvst.5.5.13. eCollection 2016 Oct.
The visual performance of monofocal, bifocal, and trifocal intraocular lenses was evaluated by human individuals using a vision simulator device. This allowed investigation of the visual impression after cataract surgery, without the need actually to implant the lenses.
The randomized, double-masked, three-way cross-over study was conducted on 60 healthy male and female subjects aged between 18 and 35 years. Visual acuity (Early Treatment Diabetic Retinopathy Study; ETDRS) and contrast sensitivity tests (Pelli-Robson) under different lighting conditions (luminosities from 0.14-55 cd/m, mesopic to photopic) were performed at different distances.
Visual acuity tests showed no difference for corrected distance visual acuity data of bi- and trifocal lens prototypes ( 0.851), but better results for the trifocal than for the bifocal lenses at distance corrected intermediate ( 0.021) and distance corrected near visual acuity ( 0.044). Contrast sensitivity showed no differences between bifocal and trifocal lenses at the distant ( = 0.984) and at the near position ( 0.925), but better results for the trifocal lens at the intermediate position ( 0.043). Visual acuity and contrast sensitivity showed a strong dependence on luminosity ( 0.001).
At all investigated distances and all lighting conditions, the trifocal lens prototype often performed better, but never worse than the bifocal lens prototype.
The vision simulator can fill the gap between preclinical lens development and implantation studies by providing information of the perceived vision quality after cataract surgery without implantation. This can reduce implantation risks and promotes the development of new lens concepts due to the cost effective test procedure.
使用视觉模拟器设备对单焦点、双焦点和三焦点人工晶状体的视觉性能进行人体评估。这使得在无需实际植入晶状体的情况下,能够研究白内障手术后的视觉感受。
对60名年龄在18至35岁之间的健康男性和女性受试者进行了随机、双盲、三交叉研究。在不同距离下,于不同光照条件(亮度从0.14 - 55 cd/m²,由中间视觉到明视觉)下进行视力(早期糖尿病视网膜病变研究;ETDRS)和对比敏感度测试(佩利 - 罗布森)。
视力测试显示,双焦点和三焦点晶状体原型的矫正远视力数据无差异(0.851),但在矫正中距离视力(0.021)和矫正近视力(0.044)方面,三焦点晶状体比双焦点晶状体的结果更好。对比敏感度在远距( = 0.984)和近距位置(0.925)时,双焦点和三焦点晶状体之间无差异,但在中距位置,三焦点晶状体的结果更好(0.043)。视力和对比敏感度显示出对亮度的强烈依赖性(0.001)。
在所有研究的距离和所有光照条件下,三焦点晶状体原型的表现通常更好,但从不比双焦点晶状体原型差。
视觉模拟器可以通过提供白内障手术后未植入时的感知视觉质量信息,填补临床前晶状体开发与植入研究之间的空白。由于测试程序具有成本效益,这可以降低植入风险并促进新晶状体概念的发展。