NCT01744457

Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Dry Eye Syndrome (DES) is a common condition that affects approximately 20% of adults aged 45 and older. Although several clinical tests for the diagnosis and monitoring of DES are available, currently no gold standard for the assessment of DES exists. It has, however, been hypothesized that the assessment of tear film osmolarity may be a new and promising approach of an objective and non-invasive method for diagnosis and monitoring of treatment success. Recently, a new commercially available instrument (TearLab®, OcuSens Inc, San Diego, USA) for the assessment of tear film osmolarity has been introduced. This instrument allows for the easy and non-invasive determination of tear film osmolarity. Unfortunately, no data about reproducibility are yet available. Consequently, the current study sets out to investigate the short time reproducibility of tear film osmolarity measurements using the TearLab® instrument.

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DEVICE	Measurement of tear film osmolarity with the TearLab® instrument
OTHER	Schirmer I test
OTHER	Tear break up time
DEVICE	Optical Quality Analysis System	Measurement of the objective scattering index (OSI)
OTHER	Ocular Surface Disease Index

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-02-01
• Completion: 2012-06-01
• First posted: 2012-12-06
• Last updated: 2012-12-06

Locations

1 site across 1 country: Austria