Metabolites of Tear Fluid (Metabol-T)
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|ClinicalTrials.gov Identifier: NCT03389282|
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
|Condition or disease||Intervention/treatment|
|Healthy Subjects||Diagnostic Test: Tear Sampling|
The variability of tear film metabolites should be investigated in a sample of ophthalmologists in preparation for a pilot study in patients eye diseases.
The easy accessibility of the tear fluid and the lack of invasiveness of the study make it promising and sensible to determine the concentration of various tear film metabolites. Because attention has so far focused primarily on the quantitative and qualitative analysis of tear film proteins, many metabolites have so far only been shown to be contained in tears.
However, before the suitability of the measured values as a predictive parameter of the ocular surface for pathologies can be examined and assessed, it is necessary to determine the scattering variables in a sample of healthy volunteers. Thus, reference areas are to be defined for later investigations in order to enable reliable case number planning thereafter.
Repeated determinations at different times and on different days make it possible in particular to detect a time-dependent relationship in view of the dynamic variability of the tear film. The functional significance of certain metabolites can not yet be assessed in the establishment phase. However, the data may provide important information for the interpretation of a later, planned feasibility study with diseased patients or the influence of applied eye drops.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Metabolites of Tear Fluid - Evaluation in a Clinical Pilot Study|
|Actual Study Start Date :||November 1, 2013|
|Actual Primary Completion Date :||December 1, 2016|
|Estimated Study Completion Date :||April 1, 2018|
- Diagnostic Test: Tear Sampling
comprehensive eye exam, Schirmer test, break-up time, tear sampling
- concentration of analytes (lipids, proteins/amino acids) [ Time Frame: 3 days per patient ]level of analytes (ng/ml)
- number of detecatable analytes [ Time Frame: 3 days per patient ]number of analytes (lipds, proteins/amino acids)
Biospecimen Retention: Samples Without DNA
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): NCT03389282
|Contact: Focke Ziemssen, MD||+49 7071 29 firstname.lastname@example.org|
|Contact: Sascha Dammeier, PhD||+49 7071 29 email@example.com|
|University Eye Hospital||Recruiting|
|Tuebingen, BW, Germany, 72076|
|Contact: Focke Ziemssen, MD 0049 7071 29 84761 Focke.Ziemssen@med.uni-tuebingen.de|
|Principal Investigator: Focke Ziemssen, MD|
|Principal Investigator:||Focke Ziemssen, MD||Center for Ophthalmology, University of Tuebingen|