Optical Coherence Tomography of Tear Film Dynamics In-Vivo

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

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-09-30

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.

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dry Eye Disease

Optical Coherence Tomography

Group Type EXPERIMENTAL

Optical Coherence Tomography

Intervention Type OTHER

Digital images of tear film

Normals

Optical Coherence Tomography

Group Type ACTIVE_COMPARATOR

Optical Coherence Tomography

Intervention Type OTHER

Digital images of tear film

Interventions

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Optical Coherence Tomography

Digital images of tear film

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes