Optical Coherence Tomography of Tear Film Dynamics In-Vivo

Dry Eye Disease Clinical Trial

Official title:

Optical Coherence Tomography of Tear Film Dynamics In-Vivo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554084
• Other study ID #: 52165
• Status: Completed
• Phase: N/A
• First received: November 24, 2014
• Last updated: April 18, 2018
• Start date: November 2014
• Est. completion date: September 2017

Study information

• Verified date: April 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye Disease
• Eye Diseases

Intervention

Other:
• Optical Coherence Tomography
Digital images of tear film

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Thickness maps dynamics	Measured through optical coherence tomography	participants will be seen once within a one year period, on average within 1 month
Secondary	Optical aberrations	Measured through optical coherence tomography	participants will be seen once within a one year period, on average within 1 month