Point of Care Testing of Inflammatory Markers in Tears

NCT ID: NCT02315079

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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).

Conditions

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Dry Eye Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Eye inflammation

Intervention Type 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

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

Without eye inflammation

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Without eye inflammation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sonal Tuli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida, Department of Ophthalmology

Locations

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University of Florida, Department of Ophthalmology

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201400775

Identifier Type: -

Identifier Source: org_study_id

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