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Corneal Nerve Structure in Sjogren's

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03203382
Enrollment
100
Registered
2017-06-29
Start date
2015-09-30
Completion date
2017-04-30
Last updated
2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren's Syndrome, Vitamin D Deficiency

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.

Interventions

None listed

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Corneal Nerve Morphologyone time examHeidelberg Retina Tomograph with the Rostock Cornea Module
Vitamin D Levelone time exam at baseline, day 1serum

Secondary

MeasureTime frameDescription
vital dye stainingone time exam at baseline, day 1corneal staining

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026