[Tear Film Osmolarity in Normal Individuals: Comparison of Two Osmometers].

Abstract:

INTENTION:The hyperosmolarity of the tear film is an important clinical sign of dry eye disease. It is the most important diagnostic parameter. In addition to the TearLab osmometer (TearLab Corp, San Diego, CA), which has been available for several years, the I-Pen osmometer (I-MED Pharma Inc, Dollard-des-Ormeaux, Quebec, Canada) has been recently marketed. The intention of our study was to compare tear film osmolarities in normal individuals as measured by TearLab and I-Pen. METHODS:51 healthy subjects (mean age 40.6 years, range 17 - 63 years, 66.7% females) without dry eye disease (ocular surface disease index < 13, tear film break-up time > 7 s, normal Schirmer test > 10 mm/5 min) were included in this study. Tear film osmolarity was measured in the tear meniscus (TearLab) and the palpebral conjunctiva (I-Pen) with a 30 min interval. The osmolarity testing techniques were alternated. Statistical analysis was performed using Wilcoxon tests and Spearman correlations. RESULTS:Mean TearLab osmolarities were 295.1 mosmol/l (right eye), 294.0 mosmol/l (left eye), and 294.6 mosmol/l (mean of both eyes) with a range of 268 to 394 mosmol/l. I-Pen measured mean osmolarites of 301.6 mosmol/l (right eye), 302.5 mosmol/l (left eye), and 302.1 mosmol/l (mean of both eyes) with a range of 276 to 394 mosmol/l. There was a significant difference in tear film osmolarities for the two techniques for both single eyes (p < 0.02) and the mean value of both eyes (p < 0.001). TearLab and I-Pen measurements did not correlate significantly in any eye (r = 0.27 and r = 0.08 for right and left eye, respectively). With a cut-off value of 308 mosmol/l (as suggested for TearLab), 98.0% of TearLab values and 68.6% of I-Pen values were in the normal range. CONCLUSIONS:I-Pen measured significantly higher tear film osmolarities than TearLab. The location of the measurement site in the palpebral conjunctiva could be responsible for this difference. Our results indicate that cut-off values should be changed when using I-Pen for evaluation of tear film osmolarity. Further examinations and studies with greater cohorts of healthy subjects and patients suffering from dry eye disease are necessary. HINTERGRUND:Die Hyperosmolarität des Tränenfilms gilt als bedeutendes klinisches Zeichen des trockenen Auges und als wichtigster singulärer diagnostischer Parameter. Neben dem seit einigen Jahren verfügbaren Ocusense TearLab-Osmometer (TearLab Corp, San Diego, CA) ist seit Kurzem auch das I-Pen-Osmometer (I-MED Pharma Inc., Dollard-des-Ormeaux, Quebec, Kanada) verfügbar. Das Ziel unserer Studie war die Vergleichbarkeit der mittels TearLab- und I-Pen-Osmometer erhobenen Tränenfilmosmolarität bei gesunden Probanden zu untersuchen. MATERIAL UND METHODEN:51 gesunde Probanden (mittleres Alter 40,6 Jahre, Altersspanne 17 – 63 Jahre, 66,7% weiblich) ohne Beschwerden und Zeichen eines trockenen Auges (Ocular Surface Disease Index < 13, Tränenfilmaufrisszeit > 7 s, unauffälliger Schirmer-Test > 10 mm/5 min) wurden eingeschlossen. Die Tränenfilmosmolarität wurde im Tränenfilmmeniskus (TearLab) und an der subtarsalen Bindehaut (I-Pen) mit einem Zeitintervall von 30 min erhoben. Die Reihenfolge der beiden Osmolaritätsuntersuchungen erfolgte im alternierenden Wechsel. Die statistische Analyse erfolgte mittels Wilcoxon- und Spearman-Tests. ERGEBNISSE:Die mittlere TearLab-Osmolarität war 295,1 mosmol/l (rechtes Auge), 294,0 mosmol/l (linkes Auge) sowie 294,6 mosmol/l (bilateral) mit einer Variationsbreite von 268 – 394 mosmol/l. Mittels I-Pen-Osmometer erhobene mittlere Osmolaritätswerte lagen bei 301,6 mosmol/l (rechtes Auge), 302,5 mosmol/l (linkes Auge) und 302,1 mosmol/l bilateral mit einer Variationsbreite von 276 – 394 mosmol/l. Es zeigte sich ein signifikanter Unterschied in den erhobenen Tränenfilmosmolaritäten mit den beiden Techniken für beide Augen einzeln (p < 0,02) und beim Mittelwert beider Augen (p < 0,001). Die Messungen mit beiden Geräten korrelierten nicht signifikant (r = 0,27 rechts und r = 0,08 links). Bei einem – wie von TearLab vorgeschlagenen – Grenzwert von 308 mosmol/l lagen 98,0% der TearLab-Werte, aber nur 68,6% der I-Pen-Werte im Normbereich. SCHLUSSFOLGERUNG:Die mittels I-Pen gemessenen Osmolaritätswerte zeigten sich signifikant höher im Vergleich zu den mit TearLab erhobenen Messwerten. Für diesen Unterschied verantwortlich könnte u. a. die Lokalisation der Messung an der subtarsalen Konjunktiva mit dem I-Pen im Vergleich zur Messung im Tränenfilmmeniskus mit dem TearLab sein. Es könnte daher notwendig sein, den Grenzwert zur Unterscheidung pathologischer Werte von physiologischen Werten bei Messungen der Tränenfilmosmolarität mit dem I-Pen-Osmometer zu ändern. Weiterführende Untersuchungen an einer größeren Kohorte von Normalprobanden sowie bei Patienten mit trockenem Auge sind hierfür notwendig.

journal_name

Klin Monbl Augenheilkd

authors

König S,Priglinger S,Schaumberger M,Messmer EM

doi

10.1055/a-1155-6468

subject

Has Abstract

pub_date

2020-05-01 00:00:00

pages

649-654

issue

5

eissn

0023-2165

issn

1439-3999

journal_volume

237

pub_type

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