NCT02225119已完成不适用
The Focal Electro-Oculogram in Macular Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- develop method for recording focal EOG
研究概览
简要总结
Background:
- Maculopathies are eye conditions that affect the center of the retina. Retina health depends on the retinal pigment epithelium (RPE), a layer behind the retina. A new test may measure the health of the central retina and RPE.
Objective:
- To use the focal electro-oculogram (EOG) test to understand how the central retina and RPE are affected in maculopathies.
Eligibility:
- People at least 10 years old with a maculopathy.
- Healthy volunteers with visual acuity of 20/20 or better in at least one eye.
Design:
- Participants will be screened with medical and eye history and an eye exam. Pictures will be taken of the eyes.
- Their eyes may be dilated.
- They may have a field test. They will look into a lens and press a button when they see a light. First, they may sit in the dark for 40 minutes.
- Participants will have 1-7 visits over 18 months.
- Their vision will be tested and eye pressure measured.
- Their pupils will be dilated with eye drops and researchers may take pictures of the retina and the inside of the eye, and measure the thickness of the retina.
- Participants will have an electro-oculogram. They will look at a 2 LED lights and follow them back and forth for 10 seconds once per minute. Participants will be in darkness for 15 minutes and in light for 20 minutes. One skin electrode will be placed on the nose and one next to the eye.
- Participants with maculopathy will also have:
- Field test.
- Electroretinogram. Participants will get numbing eye drops and special contact lenses. A small metal electrode will be taped to the forehead. Participants will watch flashing lights and try not to blink. First, they may sit in the dark for 40 minutes.
详细描述
OBJECTIVE:
The objective of this protocol is to investigate the local response of the retinal pigment epithelium (RPE) across the posterior pole of the eye by recording the focal electrooculogram (EOG) in participants with macular disease.
STUDY POPULATION:
Up to 50 healthy volunteers and 80 participants, age 10 or older, with macular disorders affecting the retina/retinal pigment epithelium complex. Examples of such macular disorders include Stargardt s disease and age-related macular degeneration (AMD).
DESIGN:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 100 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
develop method for recording focal EOG
时间窗: up to 6 months
to develop a method for recording the focal EOG in response to a central light stimulus
次要结局
- establish the normal range for the focal EOG and determine the inter-session and intra-session variabilities of this test(up to 18 months)
研究者
研究点 (1)
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