NCT03475173招募中不适用
New Non-invasive Modalities for Assessing Retinal Structure and Function:Preliminary Investigation
Randy Kardon2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年5月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Ocular Blood Flow
研究概览
简要总结
This study investigates a new technology to assess the structure and function inside the eye. Retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal structure and function compared to other visual function tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal eye exam in last 2 years
排除标准
- •Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay. Any abnormalities of the retina or optic nerve that could affect metabolism of the retina outside of normal.
- •Subjects with Inner Retina Defect:
- •Defined structural defect to include those with Ischemic optic neuropathy, branch retinal artery occlusion (BRAO), hemianopia or visual field defect that respects the vertical meridian, inherited mitochondrial optic neuropathies such as Leber's and Dominant Optic Neuropathy, other retinopathies or optic neuropathies.
- •Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- •Subjects with Outer Retinal Defect:
- •AZOOR (acute zonal occult outer retinopathy) or other focal or diffuse outer photoreceptor loss of function
- •Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay.
- •The 450 total is to allow for exclusion of some subjects or in the event that the enrolled subject blinks too much or cannot fixate on a visual target adequately to maintain the same eye position during the short imaging interval. We hope to have a total of 450 (50 controls and 400 patients)
研究组 & 干预措施
Laser Speckle Blood Flow Group
Experimental
干预措施: LSFG-NAVI (Device)
结局指标
主要结局
Ocular Blood Flow
时间窗: 1 day
imaging the movement of blood through blood vessels in retina and optic nerve
次要结局
未报告次要终点
研究者
Randy Kardon
Dr. Randy Kardon M.D. Ph.D Professor and Director of Neuro-ophthalmology
University of Iowa
研究点 (2)
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