Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia
研究概览
详细说明
A growing number of clinicians are regularly using fixation training, in which patients undergo daily sessions fixating on colored light targets on light boxes, to treat symptoms including photophobia associated with traumatic brain injury (TBI). While fixation training using various colored light targets is reported, blue light targets specifically appear to be used in this patient population more often than other light target colors. The College of Syntonic Optometry (www.csovision.org) estimates that there are roughly 500 practicing optometrists that utilize fixation training in the USA alone. However, evidence supporting this approach is primarily anecdotal, and there are no controlled, masked clinical trials published that evaluate the efficacy of this therapy against a control group.
Therefore, the goal of this study is to assess whether daily 20 min fixation training sessions using a blue light target alleviates symptoms of light sensitivity and alters pupil response more than daily 20 min fixation training sessions using red light targets in a masked cross-over clinical trial involving participants with chronic TBI-associated photophobia. In addition, we will determine if any improvement in symptomology correlates to any changes in pupil responses to red, blue and white light pulses and potential changes in other standard clinical measures of visual function. In short, this study will compare the effect of fixation training using a blue light target to the effect of fixation training using a red light target in participants with chronic TBI-associated photophobia.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Andrew Hartwick, OD, PhD
- 电话号码:16146888308
- 邮箱:HARTWICK.4@osu.edu
学习地点
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Ohio
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Columbus、Ohio、美国、43210
- 招聘中
- College of Optometry
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接触:
- Andrew Hartwick, OD, PhD
- 电话号码:614-688-8308
- 邮箱:HARTWICK.4@osu.edu
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 18 to 80 years old and subjects able to consent for themselves
- Completion of first session in entirety (participants who cannot complete the entire first visit will be considered as a screen fail)
- Best-corrected visual acuity of at least 20/32 in both the right and left eyes, and 20/25 using both eyes
- Prior head injury with current photophobia - A mild or moderate TBI occurring at least 3 months prior to visit, verified by a score of 2, 3 or 4 on OSU-TBI survey, and participant reports having experienced greater light sensitivity since their head injury
Exclusion Criteria:
- Pregnancy or suspected pregnancy - based on self-report
- Previous history of neurodegenerative disease (e.g. Alzheimer's, Parkinson's, multiple sclerosis, myasthenia gravis, seizures)
- History of pathology of the retina and optic nerve (includes retinal tears, diabetic retinopathy, glaucoma, macular degeneration, optic nerve atrophy)
- Currently on cholinergic medications, which affect pupil responses
- Prior participation in fixation training sessions within the past 2 years
- Experiencing a migraine during visit
- Prior history of severe TBI (score of 5 or 6 on OSU-TBI survey)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Red light first, blue light second
Red light first, blue light second for the colored target used in the fixation training
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Red versus blue targets in light boxes used for fixation training
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实验性的:Blue light first, red light second
Blue light first, red light second for the colored target used in the fixation training
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Red versus blue targets in light boxes used for fixation training
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pupil Responses
大体时间:From baseline visit to the end of 3 months of fixation training with each light color
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Pupil responses to red, blue and white light stimuli
|
From baseline visit to the end of 3 months of fixation training with each light color
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Symptom Survey
大体时间:From baseline visit to the end of 3 months of fixation training with each light color
|
Symptom survey
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From baseline visit to the end of 3 months of fixation training with each light color
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Vergence facility
大体时间:From baseline visit to the end of 3 months of fixation training with each light color
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Measurement of vergence range (how well eyes work together) with loose prisms
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From baseline visit to the end of 3 months of fixation training with each light color
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Stereopsis
大体时间:From baseline visit to the end of 3 months of fixation training with each light color
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Measurement of local stereopsis (depth perception) with Randot test
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From baseline visit to the end of 3 months of fixation training with each light color
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Phoria magnitude
大体时间:From baseline visit to the end of 3 months of fixation training with each light color
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Measure of phorias (how well eyes are aligned) using cover test and loose prisms
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From baseline visit to the end of 3 months of fixation training with each light color
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|
Near Point of Convergence
大体时间:From baseline visit to the end of 3 months of fixation training with each light color
|
Measure of ability for eyes to converge (how well eyes turn in when reading up close)
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From baseline visit to the end of 3 months of fixation training with each light color
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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