跳至主要内容
临床试验/NCT01695629
NCT01695629已完成不适用

In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy

University of Michigan1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
changes between control and diabetic patients

研究概览

简要总结

Clinical in vivo confocal microscopy (IVCM) is a relatively new technique of corneal evaluation that permits non-invasive imaging of corneal structures on the cellular level. Precise anatomic characterization of corneal structures, including corneal nerves, can be rapidly performed with high resolution.

详细描述

Evaluation of the corneal nerve layer with IVCM provides a method of direct visualization of peripheral small fiber nerves and a quantifiable assessment of nerve abnormalities in a low risk, non-invasive manner. Therefore, our goal is to develop a non-invasive diagnostic protocol as a quantitative tool for the evaluation of DPN. The protocol and the tool we seek to develop could ultimately be used in large-scale clinical trials and in clinical practice to assess DPN severity and progression.

We hypothesize that in vivo confocal imaging of the corneal nerve layer is a clinically viable method to assess and quantify systemic peripheral nerve health. We emphasize that this imaging method can be used in both humans and animal models to provide quantifiable, longitudinal data on the same live individual to advance our understanding of the development and progression of DPN, and to evaluate treatment effectiveness.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • 未提供

排除标准

  • history of laser eye surgery, corneal disease, multiple sclerosis, Parkinson's disease, or any known systemic neuropathy.

结局指标

主要结局

changes between control and diabetic patients

时间窗: 12 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roni Shtein

Assistant Professor, Department of Ophthalmology

University of Michigan

研究点 (1)

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