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CompletedNCT03203382Updated Aug 4, 2021

Corneal Nerve Structure in Sjogren's

An observational study in Sjogren's Syndrome and Vitamin D Deficiency, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-04.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sjogren's Syndrome
  • Vitamin D Deficiency
03

In context

Sjogren's Syndrome

371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.

This study's enrollment of 100 is below the median of 114 across 113 observational studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Suspected or confirmed Sjogren's patients

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any condition that in the opinion of the investigator may confound study results or cause concerns for safety
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Corneal Nerve Morphology

    Heidelberg Retina Tomograph with the Rostock Cornea Module

    Time frame: one time exam

  2. Vitamin D Level

    serum

    Time frame: one time exam at baseline, day 1

Secondary outcomes

  1. vital dye staining

    corneal staining

    Time frame: one time exam at baseline, day 1

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Study locations

1 site
  • Scheie Eye Institute of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03203382
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Jun 29, 2017
Start date
Sep 2015
Primary completion
Apr 2017
Completion
Apr 2017
Last update
Aug 4, 2021

Study contacts

Giacomina Massaro-Giordano
principal investigator · Scheie Eye Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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