Corneal Nerve Structure in Sjogren's

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.

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Key information

Conditions

Sjogren's Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avitaminosis Connective Tissue Diseases Deficiency Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Malnutrition Mouth Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Rheumatic Diseases Salivary Gland Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Vitamin D Deficiency Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scheie Eye Institute of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Corneal Nerve Morphology

Time frame: one time exam

Heidelberg Retina Tomograph with the Rostock Cornea Module
Vitamin D Level

Time frame: one time exam at baseline, day 1

serum

Secondary outcomes

vital dye staining

Time frame: one time exam at baseline, day 1

corneal staining

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Jun 29, 2017
Registry last updated: Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed