Dry Eye Disease
Conditions
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.
Interventions
OTHEROptical Coherence Tomography
Digital images of tear film
Sponsors
University of Rochester
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed