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NCT03203382 Clinical Trial

Corneal Nerve Structure in Sjogren's

Vitamin D Deficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03203382
Other study ID # 823009
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date April 2017

Study information
Verified date August 2021
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Scheie Eye Institute of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corneal Nerve Morphology Heidelberg Retina Tomograph with the Rostock Cornea Module one time exam
Primary Vitamin D Level serum one time exam at baseline, day 1
Secondary vital dye staining corneal staining one time exam at baseline, day 1
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