Dry Eye Disease
Conditions
Keywords
Dry Eye
Brief summary
In vivo confocal microscopy (IVCM) is a sensitive imaging tool for detecting dry eye-associated subclinical inflammation. Studies have previously shown that IVCM provides an in vivo metric to measure inflammatory changes in the central cornea. The objective of the current study is to assess inflammatory response changes in the peripheral cornea and the conjunctiva by analyzing epithelial immune cell density and morphology in these areas and then correlating the IVCM findings to clinical signs and symptoms to establish novel objective imaging biomarkers.
Interventions
IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.
Sponsors
Tufts Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For Dry Eye Disease Participants Inclusion Criteria: * Age \>18 * Ability to consent to study * Symptoms of dry eye disease for at least 6 months, such foreign body sensation, burning, stinging, light sensitivity * Positive vital dye staining of the cornea * At least one of the following objective signs: (Schirmer I \<10 mm at 5 minutes), decreased (\<0.2 mm) tear meniscus, decreased tear breakup time (TBUT) of \<10 seconds, positive vital dye staining of the conjunctiva For Age-Match Controls Inclusion Criteria: * Between the ages of 18-89 * The ability to provide informed consent for study inclusion * Clear, healthy cornea * Normal tear meniscus (\> 0.3 mm) For Dry Eye Disease Participants
Exclusion criteria
* History of contact lens wear in the past 3 months * History of ocular surgery in the past 6 months * Active ocular allergies * History of ocular infection in the past 3 months * History of diabetes * History of topical or systemic anti-inflammatory therapy in the past 1 month For Age-Match Controls
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Corneal Immune cell Status by IVCM | Visit 1 | Peripheral Corneal Immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells |
| Bulbar conjunctival immune cell Status by IVCM | Visit 1 | Bulbar conjunctival immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Parameter: Ocular Surface Disease Index (OSDI) | Visit 1 |
| Clinical Parameter: Schirmer's II test | Visit 1 |
| Clinical Parameter: Conjunctival staining with lissamine green | Visit 1 |
| Clinical Parameter: Corneal staining with fluorescein | Visit 1 |
| Clinical Parameter: Tear Break Up Time (TBUT) | Visit 1 |
| Clinical Parameter: Conjunctival redness | Visit 1 |
Countries
United States
Outcome results
None listed