Grossman L W, Igel D A, Faaland R W
Office of Science and Technology, Food and Drug Administration, Rockville, Maryland 20857.
J Cataract Refract Surg. 1991 Mar;17(2):168-74. doi: 10.1016/s0886-3350(13)80247-7.
Intraocular lenses (IOLs) from 15 U.S. firms were tested for conformance to the requirements of the American National Standards Institute Z80.7 standard for IOLs. A total of 162 IOLs were tested for resolution, astigmatism, and accuracy of labeled power. Average resolving power was 78% of the diffraction limit, much better than the ANSI minimum requirement which is typically equivalent to 30% of the diffraction limit. This suggests that the ANSI Z80.7 requirement could be significantly tightened with little effect on current production practices. Only one IOL exhibited astigmatism in excess of 0.25 diopter. Differences between measured and labeled power in excess of 0.50 diopter were found in 22 lenses, indicating that accuracy of refractive power may be the most commonly missed optical requirement of the standard.
对来自15家美国公司的人工晶状体(IOL)进行了测试,以确定其是否符合美国国家标准学会Z80.7人工晶状体标准的要求。总共对162个人工晶状体进行了分辨率、散光和标注屈光度准确性的测试。平均分辨能力为衍射极限的78%,远优于美国国家标准学会的最低要求,该要求通常相当于衍射极限的30%。这表明可以大幅提高美国国家标准学会Z80.7的要求,而对当前的生产实践几乎没有影响。只有一个人工晶状体的散光超过0.25屈光度。在22个晶状体中发现测量屈光度与标注屈光度的差异超过0.50屈光度,这表明屈光力的准确性可能是该标准中最常被忽视的光学要求。