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临床试验/NCT01866371
NCT01866371招募中不适用

High Resolution Retinal Imaging

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2013年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
2
主要终点
high-resolution images of retina

研究概览

简要总结

Studying the morphology and function of the normal and diseased retina in vivo is needed for advancing the detection, diagnosis, and treatment of retinal disease. This protocol uses an adaptive optics scanning laser ophthalmoscope (AOSLO) to image the normal and diseased retina with individual cellular resolution non-invasively. The primary objective of this study is to obtain and analyze high-resolution images of the retina, in particular by imaging the cone photoreceptor mosaic, the retinal vasculature and other retinal layers. The study design will involve case-control studies, where cases are followed over time. Subjects age 7 and older may be invited to participate. The main research procedure involves retinal imaging with the AOSLO. The primary endpoint is the observation of differences in retinal images between subjects with and without retinal diseases. These changes will be quantified by examining the cell density, size, spacing and regularity of the cone photoreceptor mosaic, as well as examining the differences between other retinal layers.

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
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females age 7 years or older.
  • Parental/guardian permission (informed consent) and if appropriate, child assent. Child subjects age 7-17 must give assent.
  • Reasonable compliance with an imaging protocol as determined by the study personnel.

排除标准

  • Individuals that are at risk to acute glaucoma.
  • Individuals that are photophobic and experience adverse psychological reactions to flashes of light.
  • Ocular opacities, high refractive error, and high frequency of nystagmus as determined by the study team.

研究组 & 干预措施

Retinal degeneration

This group will include patients with retinal degeneration and vision abnormalities. The group will participate in retinal imaging procedures including adaptive optics imaging, optical coherence tomography and fundus photography. Vision may be assessed using microperimetry, visual fields, and visual acuity.

干预措施: Retinal imaging (Procedure)

Normal control

This group will include individuals without retinal degeneration. The group will participate in retinal imaging procedures including adaptive optics imaging, optical coherence tomography and fundus photography. Vision may be assessed using microperimetry, visual fields, and visual acuity.

干预措施: Retinal imaging (Procedure)

结局指标

主要结局

high-resolution images of retina

时间窗: 1 day (initial visit)

The primary objective of this study is to obtain and analyze high-resolution images of the retina in normal and diseased eyes non-invasively.

次要结局

  • Cone mosaic parameters(1 day (initial visit))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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