Optical Coherence Tomography of Tear Film Dynamics In-Vivo

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a new instrument that takes digital images of tear film (a thin film that coats the eye that is made up of oil and water). The investigators are interested in measuring how the thickness of the tear film varies through time. The goal is to develop a technique that may enable non-invasive evaluation of Dry Eye Disease for future clinical diagnosis.

Official Title
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Optical Coherence Tomography of Tear Film Dynamics In-Vivo

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Other: Optical Coherence Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically diagnosed Dry Eye Disease Normal individuals (those without a dry eye diagnosis and without eye abnormalities) Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions that are deemed confounding to the data as determined by the PI) Ability to give informed consent Willing to spend time for the study Either gender Any racial or ethnic origin Exclusion Criteria: Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the study visit Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to blepharitis and ocular allergy Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract surgery less than one year ago Use of soft or hard contact lenses 6 hours prior to visit Female subjects may not be pregnant or lactating (subjects will be asked to self-report these conditions) Infectious diseases (for example, hepatitis, tuberculosis) or an immuno-suppressive disease (for example, HIV) (subjects will be asked to self-report these conditions)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry Eye Disease<br>Optical Coherence Tomography | Other: Optical Coherence Tomography<br>* Digital images of tear film<br>|
| Active Comparator: Normals<br>Optical Coherence Tomography | Other: Optical Coherence Tomography<br>* Digital images of tear film<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of lipid layers on patient cornea (nm) | Multiple measures taken within one eye blink, through optical coherence tomography, to map thickness. Each individual measure taken contributes to a computed map of lipid-layer thickness. | participants will be seen once within a one year period, on average within 1 month | 
| Thickness of aqueous layers on patient cornea (um) | Multiple measures taken within one eye blink, through optical coherence tomography, to map thickness. Each individual measure taken contributes to a computed map of aqueous-layer thickness. | participants will be seen once within a one year period, on average within 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness maps dynamics | Measured through optical coherence tomography | participants will be seen once within a one year period, on average within 1 month | 
| Optical aberrations | Measured through optical coherence tomography | participants will be seen once within a one year period, on average within 1 month |