An observational study in Sjogren's Syndrome, Dry Eye and Neurotrophic Keratitis, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Johns Hopkins University · Observational
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:
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.
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
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.
Diagnostic Test: Eye Exam
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
Diagnostic Test: Eye Exam
Age-matched healthy controls with no known history of ocular surface diseases or dry eye or any underlying autoimmune disease
Diagnostic Test: Eye Exam
* Symptom Questionnaires (OSDI, eye dryness VAS, visual fatigue VAS, eye discomfort VAS) * Pain scale questionnaire \[Wong-Baker Faces Pain Rating Scale and Ocular Pain Assessment Survey * Best spectacle-corrected visual acuity (BSCVA) as measured by Snellen chart followed by Mars contrast sensitivity test. * Corneal esthesiometer for measurement of corneal sensation * Schirmer's without topical anesthesia * Corneal epithelial thickness sand endothelial cell count using Anterior Segment Optical Coherence Tomography (AS-OCT) * Staining for dry eye: * Tear film break-up time (BUT) using fluorescein. * Fluorescein staining (National Eye Institute (NEI) and Ocular staining score (OSS)) * Lissamine green staining (OSS and Oxford) * Non-contact confocal biomicroscopy for morphology of the ocular surface
Corneal Epithelium health
Measuring epithelial staining score and epithelial thickness map using anterior segment Optical coherence tomography (OCT)
Time frame: 1 Day
Corneal Nerve health
Corneal sensation using non-contact esthesiometer and corneal nerve density and morphology using non-contact confocal biomicroscopy
Time frame: 1 Day
Correlations Between Corneal Staining Score
Correlations between corneal staining score with visual parameters, epithelial thickness map, corneal nerve density and morphology, and corneal sensation
Time frame: 1 Day
Correlations Between Patient Symptoms
Correlations between the patient symptoms and above corneal findings using Ocular Surface Disease Index (OSDI), Visual Acuity Scale (VAS), and pain scale questionnaire
Time frame: 1 Day
Plan to share: No
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This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University