Randomized, masked, in vitro comparison of three commercially available tear film osmometers

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 acc...

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Autores principales:	Rocha G, Gulliver E, Borovik A, Chan CC
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	Tear Osmolarity TearLab Osmometer i-Pen Osmometer Electrical Impedance Wescor Osmometer Precision Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/83cd7925b63144978d129cf7306874c5
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spelling	oai:doaj.org-article:83cd7925b63144978d129cf7306874c52021-12-02T07:28:49ZRandomized, masked, in vitro comparison of three commercially available tear film osmometers1177-5483https://doaj.org/article/83cd7925b63144978d129cf7306874c52017-01-01T00:00:00Zhttps://www.dovepress.com/randomized-masked-in-vitro-comparison-of-three-commercially-available--peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Guillermo 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, precisionRocha GGulliver EBorovik AChan CCDove Medical PressarticleTear OsmolarityTearLab Osmometeri-Pen OsmometerElectrical ImpedanceWescor OsmometerPrecisionOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 11, Pp 243-248 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Tear Osmolarity TearLab Osmometer i-Pen Osmometer Electrical Impedance Wescor Osmometer Precision Ophthalmology RE1-994
spellingShingle	Tear Osmolarity TearLab Osmometer i-Pen Osmometer Electrical Impedance Wescor Osmometer Precision Ophthalmology RE1-994 Rocha G Gulliver E Borovik A Chan CC Randomized, masked, in vitro comparison of three commercially available tear film osmometers
description	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
format	article
author	Rocha G Gulliver E Borovik A Chan CC
author_facet	Rocha G Gulliver E Borovik A Chan CC
author_sort	Rocha G
title	Randomized, masked, in vitro comparison of three commercially available tear film osmometers
title_short	Randomized, masked, in vitro comparison of three commercially available tear film osmometers
title_full	Randomized, masked, in vitro comparison of three commercially available tear film osmometers
title_fullStr	Randomized, masked, in vitro comparison of three commercially available tear film osmometers
title_full_unstemmed	Randomized, masked, in vitro comparison of three commercially available tear film osmometers
title_sort	randomized, masked, in vitro comparison of three commercially available tear film osmometers
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/83cd7925b63144978d129cf7306874c5
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_version_	1718399412202373120

Randomized, masked, in vitro comparison of three commercially available tear film osmometers

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