Study of Eye Tissue for Sarcoidosis
Immunologic Assay of Conjunctiva and Lacrimal Gland for Sarcoidosis
2 other identifiers
observational
30
1 country
1
Brief Summary
The purpose of this study is to develop a relatively simple, accurate method of diagnosing sarcoidosis. Sarcoidosis is a disease in which granulomas (nodules of inflamed tissue) develop in various organs, such as the lungs, liver, skin and eyes. Disease symptoms vary depending on the tissues involved. Many patients develop uveitis (eye inflammation). Tissue biopsy-often a costly and difficult invasive procedure-is currently the only definitive diagnostic test for sarcoidosis. Other tests, such as blood and urine tests, do not provide definitive results. Patients with uveitis that is 1) known to be due to sarcoidosis; 2) suspected to be due to sarcoidosis based on specific diagnostic criteria; and 3) known not to be due to sarcoidosis may be enrolled in this study. Participants will undergo an eye examination, blood tests, chest X-ray, and skin test for tuberculosis and other infections. Small tissue samples from the conjunctiva (the thin lining covering the outside of the eye and the inside of the eyelid) and the lacrimal (tear) gland will be taken after the eye is numbed with anesthetic drops and injection. Investigators will examine and compare levels of certain proteins in the biopsied tissues from the three patient groups to see if elevated levels of these substances may indicate granuloma formation. Development of a new, relatively simple diagnostic test for sarcoidosis based on these findings may permit doctors to start appropriate therapy earlier in the course of disease without invasive biopsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 1991
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1991
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2001
CompletedFirst Posted
Study publicly available on registry
December 10, 2002
CompletedMarch 4, 2008
May 1, 2000
November 3, 1999
March 3, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Biopsy proven sarcoidosis with intraocular inflammatory eye disease.
- Intraocular inflammatory eye disease with suspected sarcoidosis based on age, race and characteristic granulomatous intraocular inflammation.
- Inflammatory eye disease of a known etiology other than sarcoidosis.
- Age greater than 18 years.
- Can not have known bleeding diathesis, ocular infection, known allergy to local anesthetic agent or current treatment with a monoamine oxidase inhibitor, or vision worse than 20/400 in either eye.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Eye Institute (NEI)
Bethesda, Maryland, 20892, United States
Related Publications (2)
Chan CC, Wetzig RP, Palestine AG, Kuwabara T, Nusenblatt RB. Immunohistopathology of ocular sarcoidosis. Report of a case and discussion of immunopathogenesis. Arch Ophthalmol. 1987 Oct;105(10):1398-402. doi: 10.1001/archopht.1987.01060100100036.
PMID: 3478042BACKGROUNDMoller DR, Konishi K, Kirby M, Balbi B, Crystal RG. Bias toward use of a specific T cell receptor beta-chain variable region in a subgroup of individuals with sarcoidosis. J Clin Invest. 1988 Oct;82(4):1183-91. doi: 10.1172/JCI113715.
PMID: 2459159BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 3, 1999
First Posted
December 10, 2002
Study Start
May 1, 1991
Study Completion
April 1, 2001
Last Updated
March 4, 2008
Record last verified: 2000-05