Randomized comparison of in vivo performance of two point-of-care tear film osmometers

Jerry Nolfi, Barbara Caffery Toronto Eye Care Optometric Clinic, Toronto, ON, Canada Purpose: To compare the in vivo precision of two commercially available point-of-care osmometers among normal subjects with no dry eye disease. Methods: Twenty healthy adults with healthy ocular surfaces were eval...

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Autores principales:	Nolfi J, Caffery B
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	Tear Osmolarity TearLab Osmolarity System i-Pen Osmolarity Precision Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/4205a9bf4ce443c8a47660fd93ef6454
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spelling	oai:doaj.org-article:4205a9bf4ce443c8a47660fd93ef64542021-12-02T06:27:03ZRandomized comparison of in vivo performance of two point-of-care tear film osmometers1177-5483https://doaj.org/article/4205a9bf4ce443c8a47660fd93ef64542017-05-01T00:00:00Zhttps://www.dovepress.com/randomized-comparison-of-in-vivo-performance-of-two-point-of-care-tear-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Jerry Nolfi, Barbara Caffery Toronto Eye Care Optometric Clinic, Toronto, ON, Canada Purpose: To compare the in vivo precision of two commercially available point-of-care osmometers among normal subjects with no dry eye disease. Methods: Twenty healthy adults with healthy ocular surfaces were evaluated by licensed eye care practitioners. All subjects had low Ocular Surface Disease Index score (<5), normal tear breakup time (>10 seconds), and no evidence of corneal fluorescein staining. Five consecutive measurements of tear osmolarity were measured on each eye using each of the two osmometers: the TearLab Osmolarity System (TearLab) and the I-Med i-Pen (i-Pen), for a total of 200 measurements per device. Performance of the osmometers was determined by specificity, estimated by the percentage of osmolarity data at or below the clinical cutoff (308 mOsm/L) and precision, and represented by the standard deviation per subject. In addition, to assess analytical performance, on each day of patient testing, standardized osmolarity quality control solutions (338 mOsm/L) were tested on the TearLab per manufacturer instructions. i-Pen manufacturer instructions do not neither provide for, nor recommend quality control procedures. Results: The mean age of the 20 subjects was 27±8 years (range: 19–48 years, 16 females, four males). Over 2 months of testing, the TearLab reported analytical performance on quality control solutions of 335.8±4.2 mOsm/L with a coefficient of variation of 1.3%. In the subject cohort, 90.9% of TearLab measurements were in the normal range ≤308 mOsm/L. The i-Pen reported 37.5% of all measurements in the normal range. The average intra-subject osmolarity of the TearLab was 295.4±8.6 mOsm/L, which was significantly lower and less variable than the i-Pen, which reported an average of 319.4±20.3 mOsm/L (P<0.001). When the measurements were grouped by subject, the TearLab accurately identified 100% of subjects as normal while the i-Pen accurately identified only 15% of subjects as normal. Conclusion: In this randomized comparative study of two point-of-care osmometers among normal, healthy non-dry eye subjects, the TearLab Osmolarity System demonstrated accuracy, precision, and agreement with clinical interpretation in line with the manufacturer claims. The i-Pen lacked sufficient performance to delineate subjects with and without dry eye disease. Keywords: tear osmolarity, TearLab osmolarity system, i-Pen osmolarity, precisionNolfi JCaffery BDove Medical PressarticleTear OsmolarityTearLab Osmolarity Systemi-Pen OsmolarityPrecisionOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 11, Pp 945-950 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Tear Osmolarity TearLab Osmolarity System i-Pen Osmolarity Precision Ophthalmology RE1-994
spellingShingle	Tear Osmolarity TearLab Osmolarity System i-Pen Osmolarity Precision Ophthalmology RE1-994 Nolfi J Caffery B Randomized comparison of in vivo performance of two point-of-care tear film osmometers
description	Jerry Nolfi, Barbara Caffery Toronto Eye Care Optometric Clinic, Toronto, ON, Canada Purpose: To compare the in vivo precision of two commercially available point-of-care osmometers among normal subjects with no dry eye disease. Methods: Twenty healthy adults with healthy ocular surfaces were evaluated by licensed eye care practitioners. All subjects had low Ocular Surface Disease Index score (<5), normal tear breakup time (>10 seconds), and no evidence of corneal fluorescein staining. Five consecutive measurements of tear osmolarity were measured on each eye using each of the two osmometers: the TearLab Osmolarity System (TearLab) and the I-Med i-Pen (i-Pen), for a total of 200 measurements per device. Performance of the osmometers was determined by specificity, estimated by the percentage of osmolarity data at or below the clinical cutoff (308 mOsm/L) and precision, and represented by the standard deviation per subject. In addition, to assess analytical performance, on each day of patient testing, standardized osmolarity quality control solutions (338 mOsm/L) were tested on the TearLab per manufacturer instructions. i-Pen manufacturer instructions do not neither provide for, nor recommend quality control procedures. Results: The mean age of the 20 subjects was 27±8 years (range: 19–48 years, 16 females, four males). Over 2 months of testing, the TearLab reported analytical performance on quality control solutions of 335.8±4.2 mOsm/L with a coefficient of variation of 1.3%. In the subject cohort, 90.9% of TearLab measurements were in the normal range ≤308 mOsm/L. The i-Pen reported 37.5% of all measurements in the normal range. The average intra-subject osmolarity of the TearLab was 295.4±8.6 mOsm/L, which was significantly lower and less variable than the i-Pen, which reported an average of 319.4±20.3 mOsm/L (P<0.001). When the measurements were grouped by subject, the TearLab accurately identified 100% of subjects as normal while the i-Pen accurately identified only 15% of subjects as normal. Conclusion: In this randomized comparative study of two point-of-care osmometers among normal, healthy non-dry eye subjects, the TearLab Osmolarity System demonstrated accuracy, precision, and agreement with clinical interpretation in line with the manufacturer claims. The i-Pen lacked sufficient performance to delineate subjects with and without dry eye disease. Keywords: tear osmolarity, TearLab osmolarity system, i-Pen osmolarity, precision
format	article
author	Nolfi J Caffery B
author_facet	Nolfi J Caffery B
author_sort	Nolfi J
title	Randomized comparison of in vivo performance of two point-of-care tear film osmometers
title_short	Randomized comparison of in vivo performance of two point-of-care tear film osmometers
title_full	Randomized comparison of in vivo performance of two point-of-care tear film osmometers
title_fullStr	Randomized comparison of in vivo performance of two point-of-care tear film osmometers
title_full_unstemmed	Randomized comparison of in vivo performance of two point-of-care tear film osmometers
title_sort	randomized comparison of in vivo performance of two point-of-care tear film osmometers
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/4205a9bf4ce443c8a47660fd93ef6454
work_keys_str_mv	AT nolfij randomizedcomparisonofinvivoperformanceoftwopointofcaretearfilmosmometers AT cafferyb randomizedcomparisonofinvivoperformanceoftwopointofcaretearfilmosmometers
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Randomized comparison of in vivo performance of two point-of-care tear film osmometers

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