Correlation of Different Signs for Assessment of Dry Eye Syndrome
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|ClinicalTrials.gov Identifier: NCT01753687|
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : November 27, 2013
Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory response of the ocular surface. Common symptoms include ocular discomfort, visual impairment and instability of the tear film with potential damage to the ocular surface.
The rationale of the present study is to compare signs as assessed with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film with well established methods for assessment of the severity of DES (Break up time, staining of the cornea with fluorescein). Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndrome||Other: Ocular scattering of the tear film Other: Optical Coherence Tomography (OCT) Other: Measurement of tear film osmolarity||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Correlation of Different Signs for Assessment of Dry Eye Syndrome|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||September 2013|
|50 patients with dry eye syndrome||
Other: Ocular scattering of the tear film
Other Name: OQAS, Visometrics, SpainOther: Optical Coherence Tomography (OCT)
Tear film thickness as measured with OCTOther: Measurement of tear film osmolarity
Other Name: TearLab®, OcuSens Inc, San Diego, USA
- Break up time [ Time Frame: once on the study day ]break up time of the tear film measured in seconds
- Tear film thickness as measured with optical coherence tomography (OCT) [ Time Frame: once on the study day ]tear film thickness measured in micrometers
- Visual Acuity [ Time Frame: once on the study day ]Total number of letters read using ETDRS Charts
- Tear film osmolarity [ Time Frame: once on the study day ]Tear film osmolarity measured in mosmol/l
- OSI (Objective Scattering Index) [ Time Frame: once on the study day ]The objective scattering index will be measured using the OQAS system (Visiometrics, Spain)
- Staining of the cornea with fluorescein [ Time Frame: once on the study day ]The cornea will be divided into 5 regions (central, inferior, nasal, temporal, inferior) and each region will be graded from 0-4 in 0.5 steps as described in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) study.
- Impression cytology [ Time Frame: once on the study day ]After topical anesthesia of the eye, filter material is placed on the conjunctiva to obtain cytological samples, which will be prepared and evaluated.
- Tear cytokines/chemokines [ Time Frame: once on the study day ]Samples of 40 µl tears will be taken with a glass capillary and stored in vials. The concentrations of several cytokines and chemokines will be evaluated.
- Subjective symptoms of dry eye syndrome [ Time Frame: once on the study day ]a questionaire will be used
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753687
|Department of Clinical Pharmacology, Medical University of Vienna|
|Vienna, Austria, 1090|