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

Rocha, Guillermo; Gulliver, Eric; Borovik, Armand; Chan, Clara C.

doi:10.2147/opth.s127035

Cited by 31 publications

(34 citation statements)

References 18 publications

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“…The results of this study reinforce a recent laboratory analysis of the TearLab and i-Pen 19. The data published by Rocha et al reported an average analytical CV of 1.6% for TearLab, which is essentially equivalent to the 1.3% CV for TearLab found in this study.…”

Section: Discussionsupporting

confidence: 91%

“…The i-Pen measures tear osmolarity via electrical impedance of the ocular tissues on the palpebral conjunctival membrane 18. Its utility has been questioned in the literature, as in vitro data suggest that the i-Pen provides insufficient performance to accurately and precisely delineate osmolarity levels in the physiological range 19. However, no data on the precision or performance of the device when testing tear fluid of human subjects, as per device labeling, is available in the peer-reviewed literature, and it may be that the technical implementation of the previous study did not accurately reflect the operative mechanism of the i-Pen device.…”

Section: Introductionmentioning

confidence: 99%

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

Nolfi¹,

Caffery²

2017

OPTH

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PurposeTo compare the in vivo precision of two commercially available point-of-care osmometers among normal subjects with no dry eye disease.MethodsTwenty 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.ResultsThe 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.ConclusionIn 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.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

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

Nolfi¹,

Caffery²

2017

OPTH

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“…Osmometers produced by various manufacturers are used for examining osmolarity of the lachrymal film. In comparison with certain other instruments of a similar type, the instrument TearLab™ Osmolarity System (TearLab Corp., San Diego, CA) has high precision of osmolarity measurement [11,14], and is often used for the detection of pathologies linked with dry eye syndrome, or in the case of other diseases linked with a change of tear osmolarity (e.g. lagophthalmos) - [12].…”

Section: Resultsmentioning

confidence: 99%

Change of tear osmolarity after refractive surgery

Kacerovská¹,

Kacerovsky²,

Hlaváčková³

et al. 2018

CSO

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To compare the influence of the LASIK and ReLEx SMILE refractive method on tear osmolarity Methods: Prospective non-randomized comparative study. We evaluated the results in two groups of patients who underwent binocular refractive surgery to remove myopia and possibly astigmatism in the eye clinic of Horní Počernice. In each group were 15 patients (30 eyes), patients of one group undergoing FS-LASIK refractive surgery, in the second group a ReLEx SMILE procedure. Bilateral measurement of the tear film osmolarity using the TearLab instrument on the day of surgery, the first day after surgery, one month and 3 months after surgery was performed on each patient. Results: The mean preoperative value of the osmolarity of the tear film was practically the same in both groups, in the ReLEx SMILE group 294.9 ± 13.4 mOsm/l and in the FS-LASIK group 296.4 ± 13.1. One and three months after the surgery in the ReLEx SMILE group, these values increased to 301.4 and 296.4 ± 13.3 mOsm/l respectively, the elevation of values one month after surgery was statistically significant. In the FS-LASIK group, one month after surgery, the osmolarity was 320.1 ± 14.7, three months postoperatively 306.5 ± 13.1 mOsm / l. Both of these values compared to the preoperative value were statistically significantly higher. The increase of the mean osmolarity was statistically significantly higher in the FS-LA-SIK group compared to the ReLEx SMILE. Three months after surgery, the difference between groups was not statistically significant. Conclusion: In our group of patients, after the FS-LASIK refraction procedure, we noted a higher mean osmolarity of tear film in comparison with patients after the ReLEx SMILE in all evaluated timepoints (1 day, 1 month and 3 months after surgery). We consider ReLEx SMILE as a method with less impact on the quality of tear film, with a faster return to original osmolarity and potentially higher patient comfort.

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“…Auch müssen viele andere Faktoren wie die Tageszeit, die Applikation von Augentropfen vor der Untersuchung wie auch klimatische Bedingungen bei der Bewertung der Ergebnisse berücksichtigt werden. Ebenso zeigt das neue I-Pen-Osmometer in durchgeführten Studien eine unterschiedlich gute Übereinstimmung der Osmolaritätsmessungen von vorbekannten Testlösungen [26,27]. Klinische Studien liegen mit diesem Gerät derzeit noch nicht vor.…”

Section: Diskussionunclassified

Tränenfilmosmolarität gesunder Probanden: Vergleichbarkeit zweier Osmometer

König

Priglinger

Schaumberger

et al. 2020

Klin Monbl Augenheilkd

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Zusammenfassung 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.

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

Cited by 31 publications

References 18 publications

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

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

Change of tear osmolarity after refractive surgery

Tränenfilmosmolarität gesunder Probanden: Vergleichbarkeit zweier Osmometer

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