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Completed

NCT Number: NCT02554084

Optical Coherence Tomography of Tear Film Dynamics In-Vivo

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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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14627, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

optical coherence tomography

Other

Digital images of tear film

Primary outcomes

  1. Thickness of lipid layers on patient cornea (nm)

    Time frame: 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.

  2. Thickness of aqueous layers on patient cornea (um)

    Time frame: 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 outcomes

  1. Thickness maps dynamics

    Time frame: participants will be seen once within a one year period, on average within 1 month

    Measured through optical coherence tomography

  2. Optical aberrations

    Time frame: participants will be seen once within a one year period, on average within 1 month

    Measured through optical coherence tomography

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 18, 2015
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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