[Goldmann applanation tonometry and dynamic contour tonometry. Comparison of intraocular pressure measurements in the course of product certification according to EN ISO 8612:2001].
BACKGROUND
The aim of the study was to compare intraocular pressure (IOP) measurements between Goldmann applanation tonometry (GAT) and dynamic contour tonometry (DCT) during product certification according to the international requirements for ophthalmic instruments (tonometers, ISO 8612:2001).


METHODS
The study included 160 eyes of 80 subjects. IOP measurements were performed four times consecutively on each instrument in randomized order. The difference of mean IOP measurements between GAT and DCT was analyzed. Furthermore, Bland and Altman analysis was performed to assess agreement between the instruments.


RESULTS
The mean difference between DCT and GAT IOP measurements was 0.30+/-2.18 mmHg. At low to normal IOP values of 7-16 mmHg and higher IOP values of > or =23 mmHg, the difference between DCT IOP measurements and GAT IOP measurements increased in the opposite direction (1.44+/-1.59 mmHg and -1.47+/-2.57 mmHg). The Bland and Altman analysis revealed a fixed bias of -0.4+/-2.0 mmHg.


CONCLUSIONS
The test tonometer DCT exceeds the requirements for the international standard for tonometers ISO 8612:2001. The results are valid for a central corneal thickness of 540+/-40 microm.
Hoffmann
E M
EM
Augenklinik und Poliklinik, Universität Mainz. ehoffman@mail.uni-mainz.de
Pfeiffer
N
N
Barleon
L
L
Grus
F H
FH
D002138:Calibration; D003257:Consumer Product Safety; D003936:Diagnosis, Computer-Assisted / Q000295:instrumentation*; D004867:Equipment Design; D005901:Glaucoma / Q000175:diagnosis*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology*; D008365:Manometry / Q000295:instrumentation*; D009798:Ocular Hypertension / Q000175:diagnosis* / Q000503:physiopathology; D012680:Sensitivity and Specificity