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Objectively Diagnose and Monitor Treatment of Light Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694626
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Randy Kardon, University of Iowa

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Photophobia Traumatic Brain Injury Migraine Device: Pupillography Device: Ocular Coherence Tomography (OCT) Device: Wrist-watch sensor device Device: Videography Device: Electrophysiology Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Use of Facial Feature to Objectively Diagnose and Monitor Treatment of Light Sensitivity
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Healthy Control subjects 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.
Other Name: Reteval, LKC

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).
Other Name: (E4, Empatica)

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.

Active Comparator: TBI Patients without photosensitivity 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.
Other Name: Reteval, LKC

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).
Other Name: (E4, Empatica)

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.

Active Comparator: Migraine patients without photosensitivity 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.
Other Name: Reteval, LKC

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).
Other Name: (E4, Empatica)

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.

Active Comparator: Migraine patients with photosensitivity 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.
Other Name: Reteval, LKC

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).
Other Name: (E4, Empatica)

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.

Active Comparator: TBI patients with photosensitivity 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.
Other Name: Reteval, LKC

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).
Other Name: (E4, Empatica)

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694626


Contacts
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Contact: Julie Nellis, BSN 319-356-2780 julie-nellis@uiowa.edu
Contact: Jan Full, BSN 3193562780 jan-full@uiowa.edu

Locations
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United States, Iowa
University of Iowa Health Care Recruiting
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Randy Kardon

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Responsible Party: Randy Kardon, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03694626    
Other Study ID Numbers: 201604763
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will determine a plan to share IPD closer to time of completion of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Photophobia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms