Studies of the Natural History, Pathogenesis and Outcome of Ocular Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- No formal outcomes will be measured; however, the clinical assessments of enrolled participants can be used to measure the response to standard treatment.
研究概览
简要总结
Background:
The National Eye Institute (NEI) wants to evaluate and provide standard treatment to people with eye diseases.
Objective:
To examine and treat people with eye diseases and learn more about eye diseases and how they are inherited.
Eligibility:
People with eye diseases who can give consent or have a guardian who can consent for them. Asymptomatic first-degree relatives willing to provide a blood sample may also be enrolled for the purpose of genetic testing.
Design:
Participants will be screened with an eye exam.
Participants will have 1-12 visits per year depending on their eye disease for up to 5 years. Visits last about 4 hours and could include:
Medical and family history
Physical exam
Eye exam and photography.
Oculography: They put on contact lenses or goggles. They watch spots on a computer
screen for 20-30 minutes.
Electrooculography: Small metal disks are placed on the skin next to both eyes. They look left
and right in the dark and light for about 30 minutes.
Electroretinography: They sit in the dark with their eyes patched. A small metal disk is taped
to the forehead. After 30 minutes, the patches are removed and contact lenses put in. They
watch flashing lights.
Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is
injected through the tube and travels up the blood vessels in the eyes. Pictures are taken of the
eyes.
Immunosuppressive treatment
Eye cell sample: Samples are obtained from swabbing, pressing paper on, or taking a small
biopsy sample from the surface of the eye.
Blood tests
Skin, tear, urine, saliva, stool, or hair sample
Exam under anesthesia for some children
At each visit participants could get medications, eye drops, eye injections, laser treatments, or surgery.
详细描述
The National Eye Institute (NEI) is conducting a study to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed ocular conditions.
Objective
The primary objective of this protocol is to collect data and specimens generated
through clinical care procedures. Through this primary objective, the secondary objectives (establish a resource of patients with ocular conditions to facilitate recruitment into new research protocols at the NEI, gain additional knowledge about the course of specific ocular diseases and characterize the natural history of such diseases (to generate hypotheses for future clinical research studies), and evaluate the effects of standard of care treatments) may be achieved.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Month 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •To be eligible, the following inclusion criteria must be met, where applicable.
- •Have a diagnosed, undiagnosed or suspected eye disease.
- •Have the ability to understand and sign an informed consent or have a parent/legal guardian do so if they are minor children or a legally authorized representative to provide consent for adults without consent capacity.
排除标准
- •A participant is not eligible if any of the following exclusion criteria are present.
- •Are unwilling to give informed consent or assent when applicable.
- •Are unwilling or unable to be followed as clinically indicated.
- •Have a systemic disease that compromises the ability of NEI clinicians to provide adequate ophthalmologic examination or treatment.
研究组 & 干预措施
Participants
subjects with diagnosed or undiagnosed ocular conditions and/or their first-degree relatives
结局指标
主要结局
No formal outcomes will be measured; however, the clinical assessments of enrolled participants can be used to measure the response to standard treatment.
时间窗: ongoing
response to standard care of treatment
次要结局
未报告次要终点