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Metabolites of Tear Fluid

Metabolites of Tear Fluid - Evaluation in a Clinical Pilot Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03389282
Acronym
Metabol-T
Enrollment
30
Registered
2018-01-03
Start date
2013-11-01
Completion date
2018-04-01
Last updated
2018-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

Tear, Metabolite

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.

Interventions

DIAGNOSTIC_TESTTear Sampling

comprehensive eye exam, Schirmer test, break-up time, tear sampling

Sponsors

Institute of Ophthalmic Research Tuebingen
CollaboratorUNKNOWN
Institute for Clinical Epidemiology and Applied Biometry Tuebingen
CollaboratorUNKNOWN
University Hospital Tuebingen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
concentration of analytes (lipids, proteins/amino acids)3 days per patientlevel of analytes (ng/ml)
number of detecatable analytes3 days per patientnumber of analytes (lipds, proteins/amino acids)

Countries

Germany

Contacts

Primary ContactFocke Ziemssen, MD
focke.ziemssen@med.uni-tuebingen.de+49 7071 29 84762
Backup ContactSascha Dammeier, PhD
sascha.dammeier@uni-tuebingen.de+49 7071 29 84955

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026