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临床试验/NCT03220529
NCT03220529已完成不适用

A Study to Test the Potential of Brillouin Microscopy for Biomechanical Properties Measurements in Human Cornea

Massachusetts General Hospital3 个研究点 分布在 2 个国家目标入组 85 人开始时间: 2016年11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
85
试验地点
3
主要终点
Brillouin frequency shift of corneal stroma

研究概览

简要总结

The purpose of this research study is to find out if the new Brillouin Ocular Scanner can measure the variation (difference) of the corneal elastic changes involved in the onset of corneal ectasia, induced by LASIK surgery and cornea collagen crosslinking (CXL) treatment. Ectasia refers to the thinning and bulging of the cornea and results in severe vision degradation (loss), which may occur because of a progressive disease (keratoconus) or because of LASIK surgery. It is believed that the structural weakening of the cornea plays a major role in developing ectasia. CXL is a treatment that is able to halt the progression of ectasia.

The Brillouin Ocular Scanner is a technique based on the principles used in the laser speed measuring of a car (radar gun). When laser light illuminates a moving sample, a portion of the light slightly changes color. In our body, e.g in eye and corneal tissue, very weak sound waves are naturally present and they can induce a similar color shift. Measuring this color shift with a sensitive light color meter (spectrometer), we will measure the sound speed in the tissue.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with healthy cornea
  • Patients with mild, moderate, or advanced keratoconus
  • Subjects diagnosed with PMD
  • Patients before and after LASK surgery
  • Patients with keratoconus before and after collagen crosslinking treatment

排除标准

  • Normal volunteer group: presbyopia and/or cataract
  • Keratoconus subjects group: corneas with scars developed, received any ocular surgery, such as laser vision correction surgeries or CXL treatment
  • Subjects diagnosed with PMD: excludes corneas received any ocular surgery, such as laser vision correction or CXL treatment
  • Patients before and after LASK surgery Corneas received priori ocular surgeries, taking any ocular medications except season allergy medicine such as artificial tears

结局指标

主要结局

Brillouin frequency shift of corneal stroma

时间窗: at time of measurement

Brillouin frequency shift of corneal stroma in normal corneas and corneas diagnosed with keratoconus and pellucid marginal degeneration

Change of Brillouin frequency shift from base line in corneas received crosslinking treatment

时间窗: 3 days, 1 month, 3 months, 6 months

Brillouin frequency shift in corneas before and after receiving crosslinking surgery

Change of Brillouin frequency shift from base line in corneas received LASIK surgery

时间窗: 1 day and 4-8 weeks

Brillouin frequency shift in corneas before and after receiving LASIK surgery

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

Seok Hyun Yun

Professor

Massachusetts General Hospital

研究点 (3)

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