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Analysis of Eye Tissue

Primary Purpose

Eye Disease, Inflammation, Uveitis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Eye Disease focused on measuring Ocular Inflammatory Disease, Cataracts, Vitrectomy, Extracapsular, Cataract Surgery, Uveitis, Lenticular Opacity, Vitreal Opacity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patients of either sex will be admitted to this study. All patients should have a previous history of uveitis. The patient must have lenticular or vitreal opacities which are significantly impairing their vision and for which surgical removal of the opacity has a reasonable chance of improving the vision. Patients should have vision of 20/80 or worse. Patients may have any of the following syndromes: anterior uveitis, including HLA-B27-associated iritis and juvenile rheumatoid arthritis, ocular sarcoid, intermediate uveitis and pars planitis, birdshot retinochoroidopathy, Behcet's disease, Vogt-Koyanagi-Harada's syndrome, sympathic ophthalmia and idiopathic posterior uveitis.

Sites / Locations

  • National Eye Institute (NEI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001224
Brief Title
Analysis of Eye Tissue
Official Title
Immunologic Analysis of Intra-Ocular Tissue
Study Type
Observational

2. Study Status

Record Verification Date
September 2002
Overall Recruitment Status
Completed
Study Start Date
July 1987 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

5. Study Description

Brief Summary
The purpose of this investigation is to better understand the inflammatory process that occurs in uveitis (eye inflammation) through study of eye tissues. Patients with uveitis sometimes develop cataracts (clouding of the lens of the eye) or clouding of the vitreous-the gel-like material behind the lens-that can impair eyesight. Those who require cataract surgery or vitrectomy are eligible for this study. Samples of eye tissue and fluid normally removed during standard surgical procedures for these conditions will be given to researchers instead of discarded, as is usually done. Before surgery, patients will undergo routine preoperative tests, including chest X-ray, electrocardiogram, blood tests and urinalysis. They will also have an eye examination and photographs taken of the retina. Other tests that may be performed include fluorescein angiography to evaluate the blood vessels of the retina; ultrasound to examine the back of the eye; and a gallium scan to evaluate inflammation. Immune cells in the blood and eye tissue will be compared and categorized by disease. The eye fluid will be examined for substances involved in the inflammatory process. These studies may provide information that will lead to improved methods of diagnosis and treatment.
Detailed Description
The purpose of this project is to evaluate intra-ocular tissue such as iris or vitreous from uveitis patients in order to analyze the type and character of the inflammatory response. Patients with a history of uveitis who require cataract surgery or vitreous surgery because of the clinical complications of inflammation, will be entered in this study. The lymphocyte subsets in the peripheral blood and ocular tissue will be compared and categorized by disease. The presence of soluble lymphokines in the intra-ocular fluid will be analyzed. Long term cell cultures of vitreal cells will be attempted to define the T-cell receptors. In addition, a portion of iris tissue or vitreous cells will be frozen to establish a tissue library of uveitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Disease, Inflammation, Uveitis
Keywords
Ocular Inflammatory Disease, Cataracts, Vitrectomy, Extracapsular, Cataract Surgery, Uveitis, Lenticular Opacity, Vitreal Opacity

7. Study Design

Enrollment
150 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients of either sex will be admitted to this study. All patients should have a previous history of uveitis. The patient must have lenticular or vitreal opacities which are significantly impairing their vision and for which surgical removal of the opacity has a reasonable chance of improving the vision. Patients should have vision of 20/80 or worse. Patients may have any of the following syndromes: anterior uveitis, including HLA-B27-associated iritis and juvenile rheumatoid arthritis, ocular sarcoid, intermediate uveitis and pars planitis, birdshot retinochoroidopathy, Behcet's disease, Vogt-Koyanagi-Harada's syndrome, sympathic ophthalmia and idiopathic posterior uveitis.
Facility Information:
Facility Name
National Eye Institute (NEI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3523359
Citation
Chan CC, Nussenblatt RB, Fujikawa LS, Palestine AG, Stevens G Jr, Parver LM, Luckenbach MW, Kuwabara T. Sympathetic ophthalmia. Immunopathological findings. Ophthalmology. 1986 May;93(5):690-5. doi: 10.1016/s0161-6420(86)33694-7.
Results Reference
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PubMed Identifier
9298057
Citation
Whitcup SM, Stark-Vancs V, Wittes RE, Solomon D, Podgor MJ, Nussenblatt RB, Chan CC. Association of interleukin 10 in the vitreous and cerebrospinal fluid and primary central nervous system lymphoma. Arch Ophthalmol. 1997 Sep;115(9):1157-60. doi: 10.1001/archopht.1997.01100160327010.
Results Reference
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PubMed Identifier
9381369
Citation
George RK, Chan CC, Whitcup SM, Nussenblatt RB. Ocular immunopathology of Behcet's disease. Surv Ophthalmol. 1997 Sep-Oct;42(2):157-62. doi: 10.1016/s0039-6257(97)00026-x.
Results Reference
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Analysis of Eye Tissue

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