Metabolites of Tear Fluid - Evaluation in a Clinical Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Subjects
- Sponsor
- University Hospital Tuebingen
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- concentration of analytes (lipids, proteins/amino acids)
- Last Updated
- 8 years ago
Overview
Brief Summary
The pilot trial evaluates the use of modified Schirmer strips and is designed to evaluate inter-individual range of metabolites in tear film.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •healthy subjects at age \> 18 years
Exclusion Criteria
- •in the case of subjects with a mental disability or legal guardianship, due to possible conflicts for the caregivers, a data evaluation and recording should in principle be dispensed with.
- •subjects who have had any eye drops within the last 4 weeks, e.g. lubricants were used
- •subjects undergoing clinical examination for symptoms of wetting disorder or morphological changes related to eye disease
Outcomes
Primary Outcomes
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)