Corneal Nerve Structure in Sjogren's

Completed

• Conditions: Vitamin D Deficiency; Sjogren's Syndrome

• Registration Number: NCT03203382
• Lead Sponsor: University of Pennsylvania

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2017-01-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Suspected or confirmed Sjogren's syndrome
• 18+ years of age

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Exclusion Criteria

• Any condition that in the opinion of the investigator may confound study results or cause concerns for safety

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitamin D Level	one time exam at baseline, day 1	serum
Corneal Nerve Morphology	one time exam	Heidelberg Retina Tomograph with the Rostock Cornea Module

Secondary Outcome Measures

Name	Time	Method
vital dye staining	one time exam at baseline, day 1	corneal staining

Trial Locations

Locations (1)

Scheie Eye Institute of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States