Validity and Reliability of a Novel Handheld Osmolarity System for Measurement of a National Institute of Standards Traceable Solution

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

doi:10.1097/ico.0000000000001653

Cited by 16 publications

(29 citation statements)

References 12 publications

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“…A study including moderate to severe DED cases would be better able to determine the clinical feasibility of I-PEN measurements. Second, osmolarity measurements obtained using the I-PEN system may not be accurate, although Chan et al reported that the I-PEN system yielded rapid and accurate measurements of tear osmolarity in their “simulated testing setting” [ 23 ]. In contrast, some studies comparing different osmolarity measurement systems reported inferior repeatability of I-PEN measurements compared to those of other instruments [ 24 , 25 ].…”

Section: Discussionmentioning

confidence: 99%

Tear Film Osmolarity Measurement in Japanese Dry Eye Patients Using a Handheld Osmolarity System

Shimazaki

Sakata²,

Den

et al. 2020

Diagnostics

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We studied the efficacy and safety of a handheld osmolarity measurement system (I-PEN) in Japanese patients with dry eye disease (DED) and non-DED subjects. In this prospective, multicenter study, tear osmolarity was examined using the I-PEN in a total of 122 eyes divided into DED (n = 71) and non-DED (n = 51) groups. Subjective symptoms were assessed using the Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire. Ocular surface condition was evaluated in terms of fluorescein tear breakup time (FBUT) and tear breakup pattern (TBUP), and by fluorescein staining and Schirmer’s test. The I-PEN measurements were performed safely in the majority of cases. There was no statistically significant difference in mean tear film osmolarity between the DED and non-DED groups (294.76 ± 16.39 vs. 297.76 ± 16.72 mOsms/L, respectively, p = 0.32). No significant correlations were observed between osmolarity values and DEQS score, FBUT, or the Schirmer score. Osmolarity did not differ among TBUP subgroups. This prospective clinical study found no correlations between the tear film osmolarity values obtained with the I-PEN system and any subjective or objective parameters of DED. Further studies are required to determine the utility of the I-PEN system in other settings.

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Section: Discussionmentioning

confidence: 99%

Tear Film Osmolarity Measurement in Japanese Dry Eye Patients Using a Handheld Osmolarity System

Shimazaki

Sakata²,

Den

et al. 2020

Diagnostics

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“…The meiboscore (0–3 for each eyelid), which reflects the disruption of meibomian gland morphology, was determined with a noncontact meibography system (Topcon, Tokyo, Japan), 26 the volume of tear fluid was measured using the Schirmer test performed without the administration of anesthetic, 27 and tear osmolarity was measured at the palpebral conjunctiva with an I-PEN Osmolarity System (I-MED Pharma, QC, Canada). 28 All participants in the azithromycin group were evaluated for drug side effects on the basis of a diary in which they were asked to record such potential adverse events during the treatment period.…”

Section: Methodsmentioning

confidence: 99%

Efficacy of Azithromycin Eyedrops for Individuals With Meibomian Gland Dysfunction–Associated Posterior Blepharitis

Arita

Fukuoka

2020

Eye &Amp; Contact Lens: Science &Amp; Clinical Practice

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Purpose: To examine the safety and efficacy of azithromycin eyedrops in Japanese individuals with meibomian gland dysfunction (MGD)-associated posterior blepharitis. Methods: Individuals with MGD-associated posterior blepharitis who visited the Itoh Clinic, Saitama, Japan, were randomly assigned to receive azithromycin (1%) eyedrops (AZM group, 16 eyes of 16 patients) or preservative-free artificial tears (control group, 20 eyes of 20 patients) for 2 weeks. All subjects also applied a warming eyelid compress twice per day. Subjective symptoms (Standardized Patient Evaluation of Eye Dryness [SPEED] score), lipid layer thickness (LLT) and interferometric pattern of the tear film, plugging and vascularity of the lid margin, noninvasive break-up time of the tear film (NIBUT) and fluorescein-based break-up time of the tear film (TBUT), corneal–conjunctival fluorescein staining score, tear meniscus height, meibum grade, meiboscore, tear osmolarity, and Schirmer test value were determined before and after treatment. Side effects of treatment were also recorded. Results: In the AZM group, SPEED score, LLT, interferometric pattern, plugging and vascularity of the lid margin, NIBUT, TBUT, meibum grade, and tear osmolarity were significantly improved after treatment compared with baseline. The SPEED score, interferometric pattern, plugging, vascularity, meibum grade, and tear osmolarity were also significantly improved after treatment in the AZM group compared with the control group. Common side effects in the AZM group were transient eye irritation and blurred vision. Conclusion: Azithromycin eyedrops improved eyelid inflammation, the quality and quantity of the lipid layer of the tear film, and tear film stability. Such eyedrops thus seem to be a safe and effective treatment for MGD-associated posterior blepharitis.

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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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Validity and Reliability of a Novel Handheld Osmolarity System for Measurement of a National Institute of Standards Traceable Solution

Cited by 16 publications

References 12 publications

Tear Film Osmolarity Measurement in Japanese Dry Eye Patients Using a Handheld Osmolarity System

Tear Film Osmolarity Measurement in Japanese Dry Eye Patients Using a Handheld Osmolarity System

Efficacy of Azithromycin Eyedrops for Individuals With Meibomian Gland Dysfunction–Associated Posterior Blepharitis

Tränenfilmosmolarität gesunder Probanden: Vergleichbarkeit zweier Osmometer

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