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The study was prematurely closed to enrollment due to the principal investigator's departure from the institution (Johns Hopkins University).
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| Name | Class |
|---|---|
| Dompé, US, Inc. | INDUSTRY |
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In this study the investigators plan to enroll three groups of patients: non-Sjogren's dry eye, Sjogren's dry eye and controls. The study has the following primary goals:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sjogren's related dry-eye | Patients over the age of 18 years with known dry eye with underlying Sjogren's syndrome. Includes a previous diagnosis of dry eye made by an eye care specialist and a previous diagnosis of Sjogren's made according to the 2016 revised Sjogren's classification criteria. |
| |
| non-Sjogren's related dry-eye | Patients over the age of 18 years with known dry eye without underlying Sjogren's syndrome. Includes a previous diagnosis of dry eye made by an eye care specialist and a previous diagnosis of Sjogren's according to the 2016 revised Sjogren's classification criteria was definitively excluded |
| |
| Control | Age-matched healthy controls with no known history of ocular surface diseases or dry eye or any underlying autoimmune disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye Exam | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Epithelium health | Measuring epithelial staining score and epithelial thickness map using anterior segment Optical coherence tomography (OCT) | 1 Day |
| Corneal Nerve health | Corneal sensation using non-contact esthesiometer and corneal nerve density and morphology using non-contact confocal biomicroscopy | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Correlations Between Corneal Staining Score | Correlations between corneal staining score with visual parameters, epithelial thickness map, corneal nerve density and morphology, and corneal sensation | 1 Day |
| Correlations Between Patient Symptoms |
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Inclusion Criteria:
Male or female aged 18 or older
Capacity to give informed consent
Self-reported literacy
Best corrected visual acuity at distance 20/40 in each eye
Signed Institutional Review Board (IRB)-approved consent agreeing to the terms of the study For Sjogren's-related dry eye, the below inclusion criteria will be required
Exclusion Criteria:
● Age less than 18 years
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Adults aged 18 years or older, with and without Sjogren's-related dry eye, and no previous diagnosis of dry eye or other ocular surface disease.
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| Name | Affiliation | Role |
|---|---|---|
| Esen K Akpek, MD | Johns Hopkins Hospital Wilmer Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital Wilmer Eye Institute | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Correlations between the patient symptoms and above corneal findings using Ocular Surface Disease Index (OSDI), Visual Acuity Scale (VAS), and pain scale questionnaire
| 1 Day |
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |