The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pupil Responses
研究概览
简要总结
After a head injury, many people find that exposure to light causes them increased discomfort. By measuring how the pupil in the eye constricts to flashes of red and blue light, this study will investigate whether this phenomenon is due to a change in the eye's sensitivity to light.
详细描述
The pupils inside the eyes constrict in response to light stimulation. Different classes of cells within the human retina initiate this response. Recent research suggests that one of the ganglion cell types involved in this pupil response also plays a role in the photophobia experienced by migraine sufferers. The main aim of this study is to determine whether this type of ganglion cell becomes 'hypersensitive' after traumatic brain injury, thereby contributing to symptoms of increased photosensitivity experienced by many of these individuals.
In the first session of this study, subjects will be asked questions about their sensitivity to light and the reaction of their eyes' pupils to flashing red and blue lights will be measured. The subjects will be given a full eye examination to rule out other causes of increased photosensitivity.
In some cases, subjects will be asked to attend a second session roughly two weeks later. They will be asked to wear a watch that measures their daily activity/sleep rhythms and light exposure during this inter-session period. During the second session, further testing of the pupil responses to blue and red flickering light will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18+ years old
- •reports a previous head injury that occurred at least 6 months ago
- •score of 2 or 3 (mild TBI) on OSU-TBI ID Survey
- •best-corrected visual acuity of at least 20/30 in both eyes
- •reliable visual field
排除标准
- •pregnancy
- •significant afferent pupillary defect
- •previous history of neurodegenerative disease
- •intraocular pressure more than 21 mm Hg
- •significant visual field defect
- •active corneal pathology
- •history of retinal or optic nerve disease
- •strabismus (eye turn)
结局指标
主要结局
Pupil Responses
时间窗: 2 weeks
The pupil fluctuation evoked by blue and red flickering lights will be measured in patients with a prior brain injury and compared to matched controls.
次要结局
- Light Exposure(2 weeks)
- Photosensitivity Symptoms(Single visit - one day)
- Sleep Rhythms(2 weeks)
研究者
Andrew Hartwick
Assistant Professor
Ohio State University