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Study of Eye Tissue for Sarcoidosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001278
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition
Sarcoidosis

Study Type: Observational
Official Title: Immunologic Assay of Conjunctiva and Lacrimal Gland for Sarcoidosis

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 30
Study Start Date: May 1991
Estimated Study Completion Date: April 2001
Detailed Description:
The purpose of this study is to develop a method of diagnosing sarcoidosis in patients with presumed sarcoid uveitis. We plan to test conjunctival and lacrimal gland biopsy specimens from three groups of patients: patients with known, biopsy proven sarcoidosis, patients with suspected sarcoidosis, and patients with uveitis of an etiology other than sarcoidosis. Specimens will be tested for presence of cytokines, cell surface markers, and specific T cell receptor gene elements with immunohistochemical techniques using monoclonal antibodies. It has been shown that the diagnostic value of conjunctival and lacrimal gland biopsy looking for the presence of non-caseating granuloma in the absence of discrete nodules is low. Assaying for cytokines, cell surface markers, and specific T cell receptor gene elements may provide a more sensitive and specific diagnostic test for sarcoidosis in patients with presumed sarcoid eye disease.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001278


Locations
United States, Maryland
National Eye Institute (NEI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001278     History of Changes
Other Study ID Numbers: 910139
91-EI-0139
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: May 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
Conjunctival Biopsy
Lacrimal Gland Biopsy
Sarcoid Uveitis
Sarcoidosis
Conjunctiva
Inflammatory Eye Disease

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases