Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 20 patients with dry eye syndrome Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria |
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
|
| Other: 20 healthy control subjects age- and sex-matched controls |
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
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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 [on 3 consecutive study days once a day]
- OSI (Objective Scattering Index) [on 3 consecutive study days once a day]
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients with dry eye syndrome (DES):
-
Men and Women aged between 45 and 80 years, with DES defined as a pathological Schirmer I test and / or a pathological break-up time test. Schirmer I test and break up time will be tested and analyzed according to the guidelines published in the Report of the International Dry EyeWorkShop (DEWS) 2007
-
normal findings in the ophthalmic examination other than DES
Healthy control group:
-
Men and Women aged between 45 and 80 years,
-
normal findings in the medical history and ophthalmic examination
Exclusion Criteria:
-
Abuse of drugs or alcoholic beverages
-
Participation in a clinical trial
-
Symptoms of a clinically relevant illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Clinical Pharmacology, Medical University of Vienna | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OPHT-161009