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OpenTrials
Completed

NCT Number: NCT02315079

Point of Care Testing of Inflammatory Markers in Tears

To evaluate the use of a point of care device to measure markers of inflammation in various eye conditions. In particular, matrix metalloproteinase-9 (MMP-9) will be measured. MMP-9 is an enzyme that plays a role in inflammation. The value obtained with the point of care device will be correlated with values obtained using gel electrophoresis to measure MMP-9 from the same sample. These data will be compared to clinical exam findings and questionnaires to help the investigators better understand the role of this marker of inflammation in eye diseases and possibly improve diagnostic abilities.

Completed

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida, Department of Ophthalmology

Gainesville, Florida, 32610, United States

About this study

As a participant in the study a sample of tears will be collected in a non-invasive manner by sitting comfortably at the slit lamp (a slit lamp is the standard device used to examine the eye and merely requires the participant to sit upright and place their chin on a chin rest and their forehead up against the slit lamp apparatus). The participant will then be asked to look upwards and while gently lowering the lower eyelid, a sterile blunt glass pipette will be used to collect tears from the natural tear lake (the tear lake is a reservoir of tears that sits on the surface of the eye and above the lower eyelid). Collected tears will then be taken for analysis of inflammatory markers.

In addition, a survey to evaluate the symptoms and the symptoms impact daily life (Ocular Surface Disability Index Survey of National Eye Institute Visual Functioning Questionnaire- 25).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients that present to clinic for evaluation. Patients with and without evidence of eye inflammation will be eligible for this study.

Exclusion criteria

  • Patients outside the age limits will not be eligible for the study

Treatment and study plan

Eye inflammation

Other

This group will have a regular eye exam with the collection of tears. In addition, a the Ocular Surface Disability Index Survey of National Eye Institute Visual Functioning Questionnaire- 25 may be administered.

Without eye inflammation

Other

This group will have a regular eye exam with the collection of tears.

Primary outcomes

  1. Measurement of matrix metalloproteinase-9 in tears

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2014
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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