Schwenteck T, Harnisch J-P, Galanski M, Draeger J
Physikalisch-Technische Bundesanstalt, Berlin.
Klin Monbl Augenheilkd. 2006 Oct;223(10):808-12. doi: 10.1055/s-2006-926861.
There is a continuous process of development of new tonometer types following different measurement principles on the tonometer market. A new tonometer working on the dynamic contour measurement principle is currently available for ophthalmologists. This device has special properties, since it determines the intraocular pressure as well as the ocular pulse amplitude. So far, clinical comparison measurements exist between the new tonometer Pascal and the applanation tonometer by Goldmann albeit without any reference to a standard. Besides, these measurements cover only a small pressure range between 7 mmHg and 23 mmHg which is not sufficient for medical diagnosis.
This new tonometer was investigated by clinical comparison measurements according to the currently valid international standard for human eye tonometers (ISO 8612). The tested tonometer determines the intraocular pressure without fluorescein. In an ophthalmogical hospital in Berlin the clinical comparison measurements were carried out by ophthalmologists on 127 patients according to the methods and criteria of the above-mentioned standard. A calibrated AT 870 from the Haag-Streit company served as reference tonometer.
The different cornea surface geometries of individual eyes, the variation of tear liquid volume, and also the different elastic properties of the human eye due to a large variation in rigidity led to measurements of intraocular pressure by this tonometer with an excessively high number of outliers p (i) (i = 1, ..., 3) per group (p (1) = 16.28 %, p (2) = 8.85 %, p (3) = 15.69 %, 5.0 % outliers per group only are permitted for the differences method), which do not correspond to the requirements of the international standard for tonometers ISO 8612. This is also shown by application of total method of least squares of regression line (slope a = 0.964, interception b = 2.868 mmHg, standard deviation s (y) = 2.628 mmHg).
The test of conformity of results of clinical comparison measurements to the international standard for tonometers ISO 8612 is the target of this work. The measurement results of the investigated tonometer are analysed and discussed according to this standard. Statements about the medical application of this medical measurement device for ophthalmologists are presented. According to the presented investigations the requirements of this international standard are not fulfilled by the tonometer Pascal.
眼压计市场上，基于不同测量原理的新型眼压计不断涌现。目前，眼科医生可使用一种基于动态轮廓测量原理的新型眼压计。该设备具有特殊性能，它不仅能测定眼压，还能测定眼脉搏振幅。到目前为止，虽然没有任何标准作为参考，但已存在新型眼压计帕斯卡与戈德曼压平眼压计之间的临床对比测量。此外，这些测量仅覆盖7 mmHg至23 mmHg的小压力范围，这对于医学诊断来说是不够的。
根据目前有效的人眼眼压计国际标准（ISO 8612），通过临床对比测量对这种新型眼压计进行了研究。被测眼压计无需荧光素即可测定眼压。在柏林的一家眼科医院，眼科医生根据上述标准的方法和标准，对127名患者进行了临床对比测量。来自哈格 - 施特雷公司的校准AT 870作为参考眼压计。
个体眼睛不同的角膜表面几何形状、泪液体积的变化，以及由于硬度变化很大导致人眼不同的弹性特性，使得用这种眼压计测量眼压时，每组的异常值p（i）（i = 1, ..., 3）数量过多（p（1） = 16.28％，p（2） = 8.85％，p（3） = 15.69％，差异法每组仅允许5.0％的异常值），这不符合眼压计国际标准ISO 8612的要求。回归线的最小二乘法应用也表明了这一点（斜率a = 0.964，截距b = 2.868 mmHg，标准差s（y） = 2.628 mmHg）。
这项工作的目标是检验临床对比测量结果是否符合眼压计国际标准ISO 8612。根据该标准对被测眼压计的测量结果进行了分析和讨论。给出了关于这种眼科医疗测量设备在医学应用方面的陈述。根据所呈现的研究，帕斯卡眼压计未满足该国际标准的要求。
