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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry Eye Disease | Confocal Imaging - In vivo confocal microscopy (IVCM) Ophthalmic Examination:
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| |
| Control | Confocal Imaging - In vivo confocal microscopy (IVCM) Ophthalmic Examination:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In vivo confocal microscopy (IVCM) | Other | IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Corneal Immune cell Status by IVCM | Peripheral Corneal Immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells | Visit 1 |
| Bulbar conjunctival immune cell Status by IVCM | Bulbar conjunctival immune cell Status by IVCM • Density of dendritic immune cells • Density of non-dendritic immune cells • Morphology of immune cells | Visit 1 |
| Measure | Description | 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 |
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For Dry Eye Disease Participants
Inclusion Criteria:
For Age-Match Controls
Inclusion Criteria:
For Dry Eye Disease Participants
Exclusion Criteria:
For Age-Match Controls
Exclusion Criteria:
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Patients with and without Dry Eye Disease
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| Name | Affiliation | Role |
|---|---|---|
| Pedram Hamrah, MD | MEEI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| 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 |