Tear Proteins, Conjunctival Cells and Imaging Eyes in Rheumatoid Arthritis and Systemic Lupus Erythematosus Patients
Analysing Tear Protein, Conjunctival Cells, and Imaging Eyes in Patients With Rheumatoid Arthritis and Systemic Lupus Erythematosus
2 other identifiers
observational
80
1 country
1
Brief Summary
Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE) are chronic systemic autoimmune diseases that have been reported to affect the ocular surface of patients \[1,2\]. However, the nature of the disturbances of the ocular surface immunity and their relationship to systemic disease severity are poorly understood. This study aims to profile the ocular surface inflammation of RA and SLE patients by a., analysing levels of tear cytokine, and b., investigating conjunctival cells, and c. clinical imaging for conjunctival redness and tear stability. 20 consecutive RA patients and 20 consecutive SLE patients will be recruited from the Singapore General Hospital Rheumatology clinic. 20 age matched controls for SLE and another 20 age matched controls for RA will be recruited. All participants will undergo
- 1.Tear collection with Schirmer strips
- 2.EyePRIMTM (Opia Technologies) Impression Cytology Device for conjunctival sampling
- 3.Clinical ocular surface assessment with Oculus Keratograph 5M
- 4.Collection of blood via venipuncture (optional)
- 5.Retrieval of Clinical Information of participants
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 9, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedNovember 18, 2015
June 1, 2014
1.3 years
June 9, 2014
November 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Profile tear cytokines
the inflammatory cytokines concentration
1 day
Secondary Outcomes (1)
Profile immune response
1 day
Eligibility Criteria
Rheumatoid Arthriris, Systemic Lupus Erythematosus and healthy normal volunteers will be recruited.
You may qualify if:
- Clinically diagnosed with Rheumatoid Arthritis or Systemic Lupus Erythematosus
You may not qualify if:
- Known history of thyroid disorders (diagnosed by physician).
- No ocular surgery within the last 3 months and LASIK within 1 year.
- Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos.
- Any other specified reason as determined by clinical investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Singapore Eye Research Institute
Singapore, Singapore, 168751, Singapore
Biospecimen
Tear samples will be collected from the schimers strips for protein analysis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinician-Scientist, Senior Consultant
Study Record Dates
First Submitted
June 9, 2014
First Posted
August 15, 2014
Study Start
June 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
November 18, 2015
Record last verified: 2014-06