Point of Care Testing of Inflammatory Markers in Tears

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02315079
Collaborator
(none)
63
1
24
2.6

Study Details

Study Description

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 Phase
  • 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).

Study Design

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 :
Jan 1, 2015
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Measurement of matrix metalloproteinase-9 in tears [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Florida, Department of Ophthalmology Gainesville Florida United States 32610

Sponsors and Collaborators

  • University of Florida

Investigators

  • Principal Investigator: Sonal Tuli, MD, University of Florida, Department of Ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT02315079
Other Study ID Numbers:
  • IRB201400775
First Posted:
Dec 11, 2014
Last Update Posted:
Jul 24, 2019
Last Verified:
Jul 1, 2019
Keywords provided by University of Florida
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 24, 2019