Point of Care Testing of Inflammatory Markers in Tears

NCT02315079 | Completed

• 1 other identifier: IRB201400775
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndrome

Keywords

Ocular Inflammation; Matrix Metalloproteinase 9

Outcome Measures

Primary Outcomes (1)

• Measurement of matrix metalloproteinase-9 in tears

  Baseline

Study Arms (2)

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

Without eye inflammation

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

Other: Without eye inflammation

Interventions

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.

Eye inflammation

Without eye inflammation OTHER

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

Without eye inflammation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida, Department of Ophthalmology

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

de-identified tear samples

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Sonal Tuli, MD

  University of Florida, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 11, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

US (1)