Optical Coherence Tomography of Tear Film Dynamics In-Vivo

Not Applicable

Completed

• Conditions: Dry Eye Disease
• Interventions: Other: Optical Coherence Tomography

• Registration Number: NCT02554084
• Lead Sponsor: University of Rochester

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-18
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normals	Optical Coherence Tomography	Optical Coherence Tomography
Dry Eye Disease	Optical Coherence Tomography	Optical Coherence Tomography

Primary Outcome Measures

Name	Time	Method
Thickness of lipid layers on patient cornea (nm)	participants will be seen once within a one year period, on average within 1 month	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.
Thickness of aqueous layers on patient cornea (um)	participants will be seen once within a one year period, on average within 1 month	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.

Secondary Outcome Measures

Name	Time	Method
Thickness maps dynamics	participants will be seen once within a one year period, on average within 1 month	Measured through optical coherence tomography
Optical aberrations	participants will be seen once within a one year period, on average within 1 month	Measured through optical coherence tomography

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States