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临床试验/NCT02225119
NCT02225119已完成不适用

The Focal Electro-Oculogram in Macular Disease

National Eye Institute (NEI)1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2015年2月6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
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

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

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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