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Corneal Nerve Structure in Sjogren's

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT03203382
Collaborator
(none)
100
Enrollment
1
Location
19
Actual Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Sep 1, 2015
    Actual Primary Completion Date :
    Apr 1, 2017
    Actual Study Completion Date :
    Apr 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Corneal Nerve Morphology [one time exam]

      Heidelberg Retina Tomograph with the Rostock Cornea Module

    2. Vitamin D Level [one time exam at baseline, day 1]

      serum

    Secondary Outcome Measures

    1. vital dye staining [one time exam at baseline, day 1]

      corneal staining

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scheie Eye Institute of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    • Principal Investigator: Giacomina Massaro-Giordano, Scheie Eye Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT03203382
    Other Study ID Numbers:
    • 823009
    First Posted:
    Jun 29, 2017
    Last Update Posted:
    Aug 4, 2021
    Last Verified:
    Aug 1, 2021
    Additional relevant MeSH terms:
    Sjogren's Syndrome
    Vitamin D Deficiency

    Study Results

    No Results Posted as of Aug 4, 2021