A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
A Brillouin ocular analyzer uses a low-power near infrared laser light to probe the viscoelastic properties of the cornea and crystalline lens in the eye. The study hypothesis is that the instrument can measure the Brillouin light scattering spectra from the eye safely and effectively from human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 20-60
- •No refractional abnormalities
- •Clear enough cornea and media to permit imaging
排除标准
- •Occludable narrow angles (without a patent peripheral iridotomy)
- •Other ocular or systemic pathology, which precludes safe eye dilation
- •LASIK eye surgery
- •Allergies to the dilation medication
- •Only one healthy eye
- •Pregnant women or expected pregnancy within the timeframe of the study
- •Do not or cannot understand the instructions for the imaging
- •Restricted mobility
结局指标
主要结局
Number of patients with adverse events
时间窗: 6 months
Complete standard eye exam including medical and ocular history with manifest refraction, Amsler grid evaluation (macular test), color vision (Ishihara color plates), Scotopic pupil measurement (Colvard pupillometer), Slit lamp biomicroscopy of anterior segment, intraocular pressure measurement, dilated fundoscopic exam (2.5% phenylephrine and 0.5% tropicamide), and corneal topography (Pentacam).
次要结局
- Sensitivity and accuracy of Brillouin modulus measurement.(at time of imaging session)
研究者
Seok Hyun Yun
Associate Physicist / Associate Professor
Massachusetts General Hospital