Corneal Nerve Structure in Sjogren's

August 3, 2021 updated by: University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Scheie Eye Institute of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Suspected or confirmed Sjogren's patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal Nerve Morphology
Time Frame: one time exam
Heidelberg Retina Tomograph with the Rostock Cornea Module
one time exam
Vitamin D Level
Time Frame: one time exam at baseline, day 1
serum
one time exam at baseline, day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vital dye staining
Time Frame: one time exam at baseline, day 1
corneal staining
one time exam at baseline, day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 823009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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