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Point of Care Testing of Inflammatory Markers in Tears

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ClinicalTrials.gov Identifier: NCT02315079
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Dry Eye Syndrome Other: Eye inflammation Other: Without eye inflammation

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).


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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Point of Care Testing of Inflammatory Markers in Tears
Study Start Date : January 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort Intervention/treatment
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.
Other: 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.

Without eye inflammation
This group will have a regular eye exam with the collection of tears.
Other: Without eye inflammation
This group will have a regular eye exam with the collection of tears.




Primary Outcome Measures :
  1. Measurement of matrix metalloproteinase-9 in tears [ Time Frame: Baseline ]

Biospecimen Retention:   Samples Without DNA
de-identified tear samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18-90 years of age that present to our North Central Florida Tertiary Referral University Eye Clinics for evaluation. Patients with and without evidence of eye inflammation will be eligible for this study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315079


Locations
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United States, Florida
University of Florida, Department of Ophthalmology
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Sonal Tuli, MD University of Florida, Department of Ophthalmology

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02315079     History of Changes
Other Study ID Numbers: IRB201400775
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

Keywords provided by University of Florida:
Ocular Inflammation
Matrix Metalloproteinase 9

Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases