Point of Care Testing of Inflammatory Markers in Tears

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Other: Without eye inflammation; Other: Eye inflammation

• Registration Number: NCT02315079
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-11
• Study Start: 2015-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Without eye inflammation	Without eye inflammation	This group will have a regular eye exam with the collection of tears.
Eye inflammation	Eye inflammation	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.

Primary Outcome Measures

Name	Time	Method
Measurement of matrix metalloproteinase-9 in tears	Baseline

Trial Locations

Locations (1)

University of Florida, Department of Ophthalmology; 🇺🇸 Gainesville, Florida, United States