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Optical Coherence Tomography of Tear Film Dynamics In-Vivo

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optical Coherence Tomography
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Eye Disease

Normals

Arm Description

Optical Coherence Tomography

Optical Coherence Tomography

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Thickness maps dynamics
Measured through optical coherence tomography
Optical aberrations
Measured through optical coherence tomography

Full Information

First Posted
November 24, 2014
Last Updated
April 18, 2018
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT02554084
Brief Title
Optical Coherence Tomography of Tear Film Dynamics In-Vivo
Official Title
Optical Coherence Tomography of Tear Film Dynamics In-Vivo
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Eye Disease
Arm Type
Experimental
Arm Description
Optical Coherence Tomography
Arm Title
Normals
Arm Type
Active Comparator
Arm Description
Optical Coherence Tomography
Intervention Type
Other
Intervention Name(s)
Optical Coherence Tomography
Intervention Description
Digital images of tear film
Primary Outcome Measure Information:
Title
Thickness of lipid layers on patient cornea (nm)
Description
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.
Time Frame
participants will be seen once within a one year period, on average within 1 month
Title
Thickness of aqueous layers on patient cornea (um)
Description
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.
Time Frame
participants will be seen once within a one year period, on average within 1 month
Secondary Outcome Measure Information:
Title
Thickness maps dynamics
Description
Measured through optical coherence tomography
Time Frame
participants will be seen once within a one year period, on average within 1 month
Title
Optical aberrations
Description
Measured through optical coherence tomography
Time Frame
participants will be seen once within a one year period, on average within 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jannick Rolland, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States

12. IPD Sharing Statement

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Optical Coherence Tomography of Tear Film Dynamics In-Vivo

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