Study of Eye Tissue for Sarcoidosis

March 3, 2008 updated by: National Eye Institute (NEI)

Immunologic Assay of Conjunctiva and Lacrimal Gland for Sarcoidosis

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Eye Institute (NEI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Eye Institute (NEI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1991

Study Completion

April 1, 2001

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

May 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 910139
  • 91-EI-0139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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