Corneal Nerve Structure in Sjogren's
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Vitamin D Level
Study Overview
Brief Summary
Patients who are suspected of or diagnosed with Sjogren's disease will be evaluated for ocular symptoms and corneal nerve morphology. We are specifically interested in the relationship between Vitamin D level and aberrations in the morphology of the corneal nerves.
Detailed Description
Patients with either suspected or confirmed diagnosis of Sjogren's disease will be recruited to participate. Participation will involve the completion of a brief survey (the OSDI), corneal evaluation with an aesthesiometer, corneal staining with fluorescein and lissamine green, and finally measurement of tear-film breakup time. In addition, participants will have their corneal nerve morphology evaluated with the Heidelberg confocal microscope and finally they will have a blood draw performed to assess vitamin D level.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Suspected or confirmed Sjogren's syndrome
- •18+ years of age
Exclusion Criteria
- •Any condition that in the opinion of the investigator may confound study results or cause concerns for safety
Outcomes
Primary Outcomes
Vitamin D Level
Time Frame: one time exam at baseline, day 1
serum
Corneal Nerve Morphology
Time Frame: one time exam
Heidelberg Retina Tomograph with the Rostock Cornea Module
Secondary Outcomes
- vital dye staining(one time exam at baseline, day 1)