Randomized, masked, in vitro comparison of three commercially available tear film osmometers
Authors Rocha G, Gulliver E, Borovik A, Chan CC
Received 8 November 2016
Accepted for publication 10 January 2017
Published 27 January 2017 Volume 2017:11 Pages 243—248
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Yang Liu
Peer reviewer comments 3
Editor who approved publication: Dr Scott Fraser
Guillermo Rocha,1 Eric Gulliver,1 Armand Borovik,2 Clara C Chan2
1Department of Ophthalmology, University of Manitoba, Winnipeg, 2Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada
Purpose: The purpose of this study was to compare the precision and accuracy of commercially available tear film osmometers.
Methods: Contrived tear solution target values representing the physiological range of tear osmolarity (normal eyes 297 mOsm/L, moderately dry eyes 342 mOsm/L, and severe dry eyes 383 mOsm/L) were constructed using a mix of mono- and divalent electrolytes, metabolites, serum albumin, and pH balanced to 7.4. Solution values were randomized and masked from the investigators during testing. Osmometers (Wescor 5520 Vapro Pressure Osmometer: device A, TearLab Osmolarity System: device B, and i-Med Pharma i-Pen: device C) were calibrated according to manufacturer instructions. Each level was tested 64× on each osmometer across two sites. Accuracy was reported as a correlation coefficient against expected linear dilutions, precision was calculated as percent coefficient of variation.
Results: Device A reported a correlation with known solutions of r2=0.98, with averages of 305.6±4.0, 352.2±5.5, and 389.8±4.0 mOsm/L, and coefficient of variations (CVs) of 1.3%, 1.6%, and 1.0%, respectively. Device B reported an r2=0.96, with averages of 300.6±3.7, 341.4±7.9, and 376.8±5.1 mOsm/L, and CVs of 1.2%, 2.3%, and 1.4%, respectively. Device C reported an r2=0.03, with averages of 336.4±21.5, 342.0±20.7, and 345.7±22.0 mOsm/L, and CVs of 6.4%, 6.1%, and 6.4%, respectively.
Conclusion: In this randomized, masked, in vitro study, device A and device B had significantly better accuracy and precision in measuring osmolarity of contrived tear solutions of known target values compared to device C. Device C showed insufficient performance to accurately and precisely delineate osmolarity levels in the physiological range. Furthermore, in vivo studies would be required to compare performance in human subjects.
Keywords: tear osmolarity, TearLab Osmometer, i-Pen Osmometer, electrical impedance, Wescor Osmometer, precision
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Published Date: 22 May 2017