A Study to Test the Potential of Brillouin Microscopy for Biomechanical Properties Measurements in Human Cornea
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
- 是
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
Seok Hyun Yun
Professor
Massachusetts General Hospital
