Choudhari Nikhil S, George Ronnie, Baskaran Mani, Vijaya Lingam, Dudeja Namrata
Medical Research Foundation, Sankara Nethralaya, Chennai, India.
Ophthalmology. 2009 Jan;116(1):3-8. doi: 10.1016/j.ophtha.2008.06.020. Epub 2008 Aug 16.
To determine the frequency and possible origins of calibration errors of the Goldmann applanation tonometer and to investigate intraobserver and interobserver agreement in the measurement of such calibration errors.
Evaluation of diagnostic test or technology.
One hundred thirty-two slit-lamp-mounted Haag-Streit Goldmann tonometers (Model AT 900 C/M; Haag-Streit, Bern, Switzerland).
Calibration error testing was performed using the standard calibration error check weight bar. A single observer tested 25 instruments on 2 consecutive days. Two observers independently measured calibration errors of another 40 instruments. A single observer performed prospective testing of the remaining Haag-Streit Goldmann tonometers, 6 months after their annual calibration by the bioengineering department of the hospital. Four months later, the same observer retested the instruments that were found to be faulty earlier.
Goldmann applanation tonometer calibration error.
Only 4% of Goldmann tonometers were found to be within the manufacturer's recommended calibration error tolerance (+/-0.5 mmHg) at 20 mmHg. Twenty-eight percent of instruments had calibration errors of more than +/-2 mmHg at the 20-mmHg testing level. An additional 12.12% had calibration errors of more than +/-2 mmHg at the 0- or 60-mmHg testing levels, or both. Four months after the initial testing and repair of the 53 faulty instruments, 20.75% again were found to have calibration errors of more than +/-2 mmHg at any one or more testing level(s). Intraclass correlation coefficients for intraobserver agreement at 20 mmHg were 0.57 (95% confidence interval [CI], 0.25-0.78) for positive error, 0.82 (95% CI, 0.65-0.92) for negative error, and for interobserver agreement at 20 mmHg, 0.83 (95% CI, 0.70-0.90) for positive error and 0.83 (95% CI, 0.70-0.90) for negative error.
The authors found good agreement in measurement of Goldmann applanation tonometer calibration error. A significant number of instruments had clinically unacceptable calibration errors. A more frequent calibration error testing and automation of calibration error check is desirable.
FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any materials discussed in this article.
确定Goldmann压平眼压计校准误差的频率及可能来源，并研究在测量此类校准误差时观察者内和观察者间的一致性。
诊断试验或技术评估。
132台安装在裂隙灯上的Haag-Streit Goldmann眼压计（型号AT 900 C/M；Haag-Streit，瑞士伯尔尼）。
使用标准校准误差检查配重杆进行校准误差测试。一名观察者在连续两天内测试了25台仪器。两名观察者独立测量了另外40台仪器的校准误差。一名观察者对其余的Haag-Streit Goldmann眼压计进行前瞻性测试，这些眼压计在医院生物工程部门进行年度校准6个月后进行测试。四个月后，同一名观察者对早期发现有故障的仪器重新进行测试。
Goldmann压平眼压计校准误差。
在20 mmHg时，仅4%的Goldmann眼压计在校准误差上处于制造商推荐的公差范围内（±0.5 mmHg）。在20 mmHg测试水平下，28%的仪器校准误差超过±2 mmHg。另外12.12%的仪器在0或60 mmHg测试水平或两者都有超过±2 mmHg的校准误差。在对53台有故障的仪器进行初始测试和维修四个月后，再次发现20.75%的仪器在任何一个或多个测试水平上校准误差超过±2 mmHg。在20 mmHg时，观察者内一致性的组内相关系数，正误差为0.57（95%置信区间[CI]，0.25 - 0.78），负误差为0.82（95% CI，0.65 - 0.92）；在20 mmHg时，观察者间一致性的组内相关系数，正误差为0.83（95% CI，0.70 - 0.90），负误差为0.83（95% CI，0.70 - 0.90）。
作者发现Goldmann压平眼压计校准误差测量中一致性良好。大量仪器存在临床上不可接受的校准误差。需要更频繁地进行校准误差测试并实现校准误差检查自动化。
作者对本文中讨论的任何材料均无所有权或商业利益。
