Ocular Surface Immune Response in Dry Eye Disease

Study Overview
=================
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.

Official Title
-----------------
Ocular Surface Immune Response in Dry Eye Disease: Analysis of Conjunctival and Peripheral Corneal Immune Cell Alterations by In Vivo Confocal Microscopy and Clinical Correlation

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Other: In vivo confocal microscopy (IVCM)


Participation Criteria
=================
Eligibility 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 Exclusion Criteria: History of ocular or eyelid surgery within the past 12 months History of herpetic or other infectious keratitis or other inflammatory eye disease History of any other acute ocular disease Current use of topical medications (not including artificial tears) Current use of contact lenses History of ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy History of cancer elsewhere in the body which is currently under systemic chemotherapy Current glaucoma disease requiring use of glaucoma drops History of Diabetes mellitus Current diagnosis of dry eye disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dry Eye Disease<br>Confocal Imaging - In vivo confocal microscopy (IVCM) Ophthalmic Examination: Tear Break Up Time (TBUT) Ocular Surface Disease Index (OSDI) Schirmer's II test Conjunctival staining with lissamine green Corneal staining with fluorescein Conjunctival redness assessment | Other: In vivo confocal microscopy (IVCM)<br>* IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.<br>|
| Control<br>Confocal Imaging - In vivo confocal microscopy (IVCM) Ophthalmic Examination: TBUT OSDI Schirmer's II test Conjunctival staining with lissamine green Corneal staining with fluorescein Conjunctival redness assessment | Other: In vivo confocal microscopy (IVCM)<br>* IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye