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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 patients with dry eye syndrome | Other | Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria |
|
| 20 healthy control subjects | Other | age- and sex-matched controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of tear film osmolarity with the TearLab® instrument | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of variation of tear film osmolarity after repeated measurements | Measurement of tear film osmolarity 3 times daily within 30 minutes for 3 consecutive days |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective symptoms assessed using the OSDI test | on the screening day | |
| Tear break up time | on 3 consecutive study days once a day | |
| Schirmer I test |
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Inclusion Criteria:
Patients with dry eye syndrome (DES):
Healthy control group:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | State of Vienna | 1090 | Austria |
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| Schirmer I test |
| Other |
|
| Tear break up time | Other |
|
| Optical Quality Analysis System | Device | Measurement of the objective scattering index (OSI) |
|
| Ocular Surface Disease Index | Other |
|
| on 3 consecutive study days once a day |
| OSI (Objective Scattering Index) | on 3 consecutive study days once a day |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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