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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Other: Optical Coherence Tomography

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14627
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Eye Disease; Optical Coherence Tomography	Other: Optical Coherence Tomography; Digital images of tear film
Active Comparator: Normals; Optical Coherence Tomography	Other: Optical Coherence Tomography; Digital images of tear film

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Jannick Rolland, PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 52165

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No