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临床试验/NCT00379275
NCT00379275已完成不适用

Ocular and Immuno-Genetic Manifestations of Sarcoidosis

National Eye Institute (NEI)1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1

研究概览

简要总结

This study will evaluate patients with sarcoidosis to understand how the disease affects the body. Sarcoidosis is a disease that results from inflammation of body tissues. The lungs, lymph nodes in the chest, skin and eyes are most commonly affected. As the disease progresses, small lumps, or granulomas, appear in the affected tissues. In most cases, the granulomas clear up, but in cases where they do not heal and disappear, the tissues tend to remain inflamed. Eye inflammation (uveitis) associated with sarcoidosis can cause various eye diseases, sometimes leading to blindness. This study will examine the clinical, immunological and genetic features of ocular sarcoidosis.

Patients 6 years of age and older with sarcoidosis may be eligible for this study. Candidates are screened with the following procedures:

  • Completion of a questionnaire with medical, social and demographic information
  • Blood draw for laboratory tests
  • Complete eye examination, including measurement of eye pressure and dilation of the pupils to examine the back of the eye. Fluorescein angiography may be done. This test involves injecting a dye into a vein in the arm. The dye travels to the blood vessels in the eyes. A camera flashes a blue light into the eye and takes pictures of the retina that show whether the dye has leaked from the blood vessels into the retina. Other photographs of the eye may also be taken using a special camera.

Participants are followed in conjunction with their local eye doctor as required by the status of their disease. Patients whose disease is stable are seen for an initial examination and followed every 12 months for 3 years.

详细描述

BACKGROUND

Sarcoidosis is a multi-systemic granulomatous disease. The lungs, thoracic lymph nodes, the skin and the eyes are the most commonly affected organs. Most patients with sarcoidosis present with respiratory symptoms. Sarcoid uveitis is usually suspected when ocular inflammation is found in conjunction with suggestive serological and radiological studies. Currently, the diagnosis of sarcoidosis requires the demonstration of non-caseating granulomas on biopsy; but even this is not always diagnostic; more sensitive and specific noninvasive tools are needed.

Ophthalmic involvement has been reported in as many as 40% of patients with sarcoidosis, but most series report ophthalmic findings in approximately 25% of patients who develop chronic, systemic sarcoidosis. Uveitis associated with sarcoidosis can be very diverse, including: acute non-granulomatous or chronic granulomatous iridocyclitis, vitritis, retinal vasculitis, choroiditis with choroidal granulomas and papillitis secondary to optic nerve granulomas; and it can cause ocular morbidity due to a high incidence of glaucoma and cataracts. Other ophthalmic findings include lacrimal gland enlargement, secondary Sjogren's disease, scleritis, orbital gland involvement, secondary proliferative retinopathy, subretinal neovascularization, and optic neuropathy.

To better evaluate and diagnose patients, we also need to improve our ability to predict susceptibility and prognosis, especially among African-Americans. Current epidemiologic studies of sarcoidosis indicate that in the United States, African Americans have about a threefold higher age-adjusted annual incidence, 35.5/100,000, compared with Caucasians, 10.9/100,000. In addition, African Americans with chronic sarcoidosis are more likely to develop ocular manifestations than whites. The study of ocular sarcoidosis is important because it is a leading inflammatory cause of blindness and ocular morbidity. In large surveys of patients with uveitis, approximately 5% of patients were found to have ocular sarcoidosis, and approximately 10% of these patients become blind in at least one eye.

AIMS:

研究设计

研究类型
Observational

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih

研究点 (1)

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