A Study to Test the Potential of OCT Vibrography for Measuring Biomechanical Properties of Tissues
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.
研究概览
简要总结
The overall goal of this study is to develop OCT Vibrography (aka OCT elastography) as a novel tool for measuring biomechanical properties of human tissues in vivo.
详细描述
The overall goal of this study is to develop OCT Vibrography (aka OCT elastography) as a novel tool for measuring biomechanical properties of human tissues in vivo. The investigators aim to establish baseline data in healthy subjects, compare elastic moduli in different tissue types, and measure differences in elastic moduli between keratoconus and normal eyes. If successful, this project will provide useful, previously inaccessible elastic parameters and advance the investigators' understanding of the relationship between the bulk mechanical properties and the microstructure of the human tissue in vivo. This information can ultimately be used to improve the diagnosis and treatment of keratoconus, inflammatory skin diseases, and inflammatory gingiva diseases. More broadly, the technologies developed in this project will have relevance to other potential applications beyond the tissues in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria:
- •Subjects with healthy eyes (age 18 - 75, N = 50)
排除标准
- •Subjects with history of eye diseases, and previous eye surgeries.
- •Subjects with diabetes, glaucoma family history
- •Subjects allergic to anesthetic eyedrop, especially proparacaine
- •Subjects with severe allergy
- •Subjects who have difficulty biting
- •Subjects who have recurrent corneal erosion
- •Inclusion criteria:
- •Subjects with healthy skin (age 18 - 75, N = 10)
- •Exclusion criteria:
- •Subjects with open cuts/sores on the skin, skin infection, or any contagious skin condition
- •Inclusion criteria:
- •Subjects with healthy gingiva (age 18 - 75, N = 10)
- •Exclusion criteria:
- •Subjects with open cuts/sores on the gingiva, gingiva infection, or any contagious gingiva condition
- •Inclusion criteria:
- •Mild or moderate keratoconus subjects (age 18 - 40, N = 20)
- •Exclusion criteria:
- •Subjects with K-max above 60 diopters (Pentacam imaging) are excluded
研究组 & 干预措施
Healthy gingiva
Optical imaging of the gingiva in healthy subjects
干预措施: Optical imaging of the tissues (Device)
Keratoconus cornea
Optical imaging of the cornea in mild and moderate keratoconus
干预措施: Optical imaging of the tissues (Device)
Healthy cornea
Optical imaging of the cornea in healthy subjects
干预措施: Optical imaging of the tissues (Device)
Healthy skin
Optical imaging of the skin in healthy subjects
干预措施: Optical imaging of the tissues (Device)
结局指标
主要结局
Number of subjects to successfully complete OCT Vibrography without serious unanticipated adverse events related to application of the device.
时间窗: 1 year
Frequency and severity of all treatment-related adverse events
次要结局
未报告次要终点
研究者
Seok Hyun Yun
Professor of Dermatology
Massachusetts General Hospital