Objectively Diagnose and Monitor Treatment of Light Sensitivity

赞助:

合作者:

信息的提供 (责任方):

Randy Kardon，University of Iowa

追踪信息

首次提交日期 ^ICMJE

July 17, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

October 15, 2018

预计主要完成日期

July 1, 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Correlation of facial responses to light sensitivity[ Time Frame: 1 Day ]

Hand held pupillography/videography, electroretinogram, and electrophysiology measurements are correlated to develop of an objective biological marker of light sensitivity.

Difference in objective biological markers of light sensitivity between light sensitive and normal subjects[ Time Frame: 1 Day ]

The correlation of facial responses to light sensitivity is compared between groups to test whether the measure can accurately distinguish light sensitivity.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Correlation of objective biological marker of light sensitivity to optic nerve structures[ Time Frame: 1 Day ]
Bio marker score will be correlated to optic nerve structure measurements made using Optical Coherence Tomography (OCT) to evaluate structural loss of the optic nerve.
Correlation of objective biological marker of light sensitivity to macula (structure found in the back of the eye).[ Time Frame: 1 Day ]
Bio marker score will be correlated to macula structure measurements made using Optical Coherence Tomography (OCT) to examine to evaluate structural loss of the macula (structure found in the back of the eye).

描述性信息

简略标题 ^ICMJE

Objectively Diagnose and Monitor Treatment of Light Sensitivity

正式标题 ^ICMJE

Use of Facial Feature to Objectively Diagnose and Monitor Treatment of Light Sensitivity

简要概况

The purpose of this project is to provide a new framework for diagnosing and monitoring treatment of light sensitivity and headache by objective measurement of facial features, pupil responses, retinal electrical responses and autonomic nerve responses to light.

详细说明

Using objecting measurement of facial features, pupil responses, retinal electrical responses and autonomic nerve responses to light this project aims to provide a new framework for diagnosing and monitoring treatment of light sensitivity. The patient's responses will be measured with videography facial muscle electrical responses Electromyogram (EMG) measured from surface skin electrodes and retinal electrical responses (EMG) or electroretinogram (ERG) recorded from a portable hand-held device). Simultaneously, patient's will have their heart rate and skin conductance objectively monitored using wristwatch devices (E4, Empatica). If successful, this will open an immediate new way to objectively assess the mechanisms that lead to light sensitivity, and provide an approach to effectively treat, and manage the symptoms of light sensitivity and headache from different causes, including traumatic brain injury (TBI) and migraine.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Non-Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Screening

适用条件 ^ICMJE

干预项目 ^ICMJE

Device: Pupillography
A hand-held pupillometer/electroretinogram device (RETeval, LKC) will be held in front of the subject's eye, but will not touch the eye. The device will provide a brief, a series of brief light stimuli and then record the pupil response and the elicited electrical response from the retina from a surface skin patch (electrode) placed below each eye, from the light as a measure of whether the inherent sensitivity of the eye in the retina is normal. The investigators will repeat this in the left eye. The visible light stimulus is safe and is given at an intensity experienced in normal daily light exposures. The test takes about 2 minutes per eye.
Device: Ocular Coherence Tomography (OCT)
The thickness of the optic nerve and macula will also be measured inside of the eye using a special camera that forms an image of the layers of the retina without pupil dilation. The imaging is harmless and measures the structural health of the optic nerve and retinal layers. This test takes 5-10 minutes per eye.
Device: Wrist-watch sensor device
A wrist-watch sensor device (E4, Empatica) will be place on each wrist to measure skin conductance, heart rate, skin temperature and arm movement during testing. These wrist-watch devices are being used to monitor changes in sympathetic nerve activity to light intensity, (the sympathetic nerves supply the blood vessels to the skin and heart).
Device: Videography
The subject will sit comfortably in front of miniature combination infrared/visible light video cameras and infrared diode light source located within 1 meter to provide video recording of the face during testing with light and during darkness, described next. After the 10 minutes of dark-adapting, the subject will put his/her chin on a chin rest in front of the video cameras and a light emitting diode (LED) array give diffuse red, blue, and white stimuli over a range of intensities. None of the stimuli are as bright as a flash from a camera and are in the range of intensities normally experienced during daily activities. At the end of the test the investigators will add filters over the glasses: orange (blue-blocking) filters and neutral density filters. Subjects will grade independently, both the brightness and discomfort they feel from each light stimulus intensity.
Device: Electrophysiology
Next, electrodes will be placed above, below and to the side of the test eye to record the electromyogram (EMG) for measuring eyelid opening and blink rate.

研究工具

Active Comparator: Healthy Control subjects
Active Comparator: TBI Patients without photosensitivity
Active Comparator: Migraine patients without photosensitivity
Active Comparator: Migraine patients with photosensitivity
Active Comparator: TBI patients with photosensitivity

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

120

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

January 1, 2021

预计主要完成日期

July 1, 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Healthy Control subjects: Inclusion Criteria - Healthy individuals with normal eye exam in the previous year - Age 18-80 Exclusion Criteria - History of eye or systemic disorder that affect the retina, optic nerve, visual pathway, or pupil defect: including glaucoma, optic neuropathy, or retinal disease, diabetes and/or hypertension that are not well controlled, history of head trauma, concussion, or TBI, history of cervical or spinal injury/surgery - Medications or eyedrops that would confound measuring the pupil light reflex and EMG: including topical autonomic drugs that could influence pupil size, ocular pharmacologic agents, sedative agents (e.g. benzodiazepines or barbiturates), opioid narcotics - Must not be light sensitive or get migraine headaches TBI patients without photosensitivity or headache: Inclusion Criteria - Age 18-80 - Traumatic Brain Injury (TBI) Exclusion Criteria - History of eye or systemic disorder that affect the retina, optic nerve, visual pathway, or pupil defect: including glaucoma, optic neuropathy, or retinal disease, diabetes and/or hypertension that are not well controlled - Medications or eyedrops that would confound measuring the pupil light reflex and EMG: including topical autonomic drugs that could influence pupil size, ocular pharmacologic agents, sedative agents (e.g. benzodiazepines or barbiturates), opioid narcotics - Must not be light sensitive or get migraine headaches (use headache criteria from Ana if we are including headaches) Patients with photosensitivity from non-TBI causes Inclusion Criteria - Age 18-80 - Photosensitivity: determined by patient reporting symptoms and there may or may not be an identified cause associated with their light sensitivity (i.e. history of uveitis, childhood exotropia, meningitis, radiation, tumor) Exclusion Criteria - History of eye or systemic disorder that affect the retina, optic nerve, visual pathway, or pupil defect: including glaucoma, optic neuropathy, or retinal disease, diabetes and/or hypertension that are not well controlled, history of head trauma, concussion, or TBI, history of cervical or spinal injury/surgery - Medications or eyedrops that would confound measuring the pupil light reflex and EMG: including topical autonomic drugs that could influence pupil size, ocular pharmacologic agents, sedative agents (e.g. benzodiazepines or barbiturates), opioid narcotics TBI patients with photosensitivity Inclusion Criteria - Age 18-80 - Photosensitivity: determined by patient reporting symptoms and cause associated with their light sensitivity is post TBI - TBI Exclusion Criteria - History of eye or systemic disorder that affect the retina, optic nerve, visual pathway, or pupil defect: including glaucoma, optic neuropathy, or retinal disease, diabetes and/or hypertension that are not well controlled

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：80 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: Yes

IPD 共享声明

计划分享 IPD:

责任方

Randy Kardon，University of Iowa

研究赞助商 ^ICMJE

Randy Kardon

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

University of Iowa

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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