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临床试验/NCT03230981
NCT03230981已完成不适用

Age-dependency of Cornea Biomechanics Measured by OCT Vibrography: A Pilot Study

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年8月1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
46
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 aim of this pilot study is to assess the ability of a new optical coherence tomography system to obtain information on biomechanics of the cornea.

详细描述

The cornea, the clear front window of the eye, consists of finely intertwined collagen fibers, which give the cornea a microstructure that provides mechanical integrity necessary to maintain its typical dome-shape against the intraocular pressure (IOP). Changes in the biomechanical properties can lead to an abnormal corneal shape and refractive errors. As a result, light is not perfectly focused onto the retina and the vision is affected. A typical example of alterations in the cornea's biomechanical properties is found in patients with an eye disorder called Keratoconus, which leads to progressive thinning of the cornea. Numerous studies have shown that promising interventions like collagen crosslinking (CXL) can slow down an arrest progression of ectatic eye diseases. Keratoconus, as a typical example, although it cannot be cured, could be at least halted by CXL. Therefore, early diagnosis of ectasia is crucial for the patient. Current diagnostic methods of ectasia are based on morphological rather than biomechanical analysis. The irregular patterns of the cornea can be detected by pachymetry and topography before clinical signs occur, but these tests cannot reliably differentiate truly weak or keratoconic corneas from atypical normal ones.

These are compelling needs for improved diagnostic methods. More recently, and triggered by those unmet needs, an interest in the mechanical properties of the cornea has emerged. Typical examples of mechanical properties are elastic modulus and corneal stiffness.

In this pilot study the investigators will test the ability of a new OCT Vibrography system to determine cornea material parameters. More precisely, the investigators will study the oscillation response in human corneas in-vivo using a stimulus mechanism used to induce vibrations by touching the surface of the cornea. A localized vibration source paired together with phase-sensitive OCT to measure the frequency response function of the human cornea and to analyze the dependency of the frequency response function on age. Additionally the investigators will use Brillouin Microscopy data for computer simulations to validate OCT Vibrography results.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female subjects between the ages of 18 to 79 years
  • Healthy normal subjects with no significant eye disease and no significant refractive errors

排除标准

  • Volunteers with implanted intraocular lenses
  • Volunteers with LASIK or any other eye surgery, and monocular volunteers
  • Volunteers with restricted mobility, who cannot stand up, walk or sit still on a chair without a back
  • Subjects who do not or cannot understand the instructions for imaging
  • Subjects with diabetes, glaucoma family history
  • Subjects who are pregnant and/or breastfeeding.

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

  • Validation of OCT Vibrography data by means of Brillouin microscopy measurements of the in-vivo cornea(1 year)

研究者

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

Seok Hyun Yun

Professor of Dermatology

Massachusetts General Hospital

研究点 (2)

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