Healthy Subjects Clinical Trial
Official title:
Metabolites of Tear Fluid - Evaluation in a Clinical Pilot Study
The pilot trial evaluates the use of modified Schirmer strips and is designed to evaluate inter-individual range of metabolites in tear film.
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.
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