Schwartz Daniel M
University of California, San Francisco, USA.
Trans Am Ophthalmol Soc. 2003;101:417-36.
First, to determine whether a silicone light-adjustable intraocular lens (IOL) can be fabricated and adjusted precisely with a light delivery device (LDD). Second, to determine the biocompatibility of an adjustable IOL and whether the lens can be adjusted precisely in vivo.
After fabrication of a light-adjustable silicone formulation, IOLs were made and tested in vitro for cytotoxicity, leaching, precision of adjustment, optical quality after adjustment, and mechanical properties. Light-adjustable IOLs were then tested in vivo for biocompatibility and precision of adjustment in a rabbit model. In collaboration with Zeiss-Meditec, a digital LDD was developed and tested to correct for higher-order aberrations in light-adjustable IOLs.
The results establish that a biocompatible silicone IOL can be fabricated and adjusted using safe levels of light. There was no evidence of cytotoxicity or leaching. Testing of mechanical properties revealed no significant differences from commercial controls. Implantation of light-adjustable lenses in rabbits demonstrated- excellent biocompatibility after 6 months, comparable to a commercially available IOL. In vivo spherical (hyperopic and myopic) adjustment in rabbits was achieved using an analog light delivery system. The digital light delivery system was tested and achieved correction of higher-order aberrations.
A silicone light-adjustable IOL and LDD have been developed to enable postoperative, noninvasive adjustment of lens power. The ability to correct higher-order aberrations in these materials has broad potential applicability for optimization of vision in patients undergoing cataract and refractive surgery.
第一,确定是否可以制造出一种硅酮光可调人工晶状体(IOL),并使用光传输装置(LDD)进行精确调整。第二,确定可调节IOL的生物相容性,以及该晶状体在体内是否可以精确调整。
制备出一种光可调硅酮制剂后,制造IOL并在体外测试其细胞毒性、浸出、调整精度、调整后的光学质量和机械性能。然后在兔模型中对光可调IOL进行体内生物相容性和调整精度测试。与蔡司医疗技术公司合作,开发并测试了一种数字LDD,以校正光可调IOL中的高阶像差。
结果表明,可以使用安全水平的光制造并调整生物相容性硅酮IOL。没有细胞毒性或浸出的证据。机械性能测试显示与商业对照无显著差异。在兔子体内植入光可调晶状体6个月后显示出优异的生物相容性,与市售IOL相当。使用模拟光传输系统在兔子体内实现了球面(远视和近视)调整。对数字光传输系统进行了测试,并实现了高阶像差的校正。
已开发出一种硅酮光可调IOL和LDD,以实现术后非侵入性地调整晶状体屈光力。校正这些材料中高阶像差的能力对于优化白内障和屈光手术患者的视力具有广泛的潜在适用性。