An observational study in Healthy Subjects, sponsored by University Hospital Tuebingen. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-03.
Sponsored by University Hospital Tuebingen · Observational
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.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 37 observational studies indexed under Lacerations.
Browse Lacerations studies →University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.
Counted across the registry records on this site, refreshed daily.
healthy volunteers without any eye condition and normal anterior surface
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
comprehensive eye exam, Schirmer test, break-up time, tear sampling
concentration of analytes (lipids, proteins/amino acids)
level of analytes (ng/ml)
Time frame: 3 days per patient
number of detecatable analytes
number of analytes (lipds, proteins/amino acids)
Time frame: 3 days per patient
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2013 to primary completion in Dec 2016, 37 months.
Of 20 observational studies under Lacerations, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's 37 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University Hospital Tuebingen →