NCT01640236已完成不适用
Flare Measurements in Human Radiation Therapy Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Ocular flare in radiotherapy patients
研究概览
简要总结
This is a longitudinal Feasibility Study of a novel non-invasive device in assessing radiation dose exposure in humans. All patients receiving whole body irradiation therapy and meeting all other inclusion/exclusion criteria will receive ocular flare meter measurements and slit-lamp examinations on up to eleven occasions starting prior to the first fractional dose of irradiation.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be scheduled to receive whole body irradiation in a dose range from 1.5 to 12Gy.
- •Subjects must not have received ocular surgery for at least three months prior to study enrolment.
- •Subjects must not have a history of uveitis.
- •Subjects must have at least one eye free of cataracts
- •Subject age must be greater than 18 years
- •Subjects must have the ability to understand and willingness to sign a written informed consent document.
排除标准
- •Inability to give informed consent
- •Cataracts in both eyes
- •Subject has received ocular surgery within the prior three months
- •Subject has a history of uveitis
结局指标
主要结局
Ocular flare in radiotherapy patients
时间窗: Daily measurements for the duration of radiotherapy treatment (expected up to four days from start of treatment)
Determine if ocular flare meter spectra and/or a slit-lamp eye exam can assess radiation dose exposure in individual human radiotherapy patients.
次要结局
未报告次要终点
研究者
研究点 (1)
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