PhotophobiaNCT03694626
Objectively Diagnose and Monitor Treatment of Light Sensitivity
A study testing Pupillography, Ocular Coherence Tomography (OCT) and Wrist-watch sensor device in people with Photophobia and Traumatic Brain Injury, run by Randy Kardon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Photophobia, Traumatic Brain Injury, Migraine
- What is being tested?
- Pupillography, Ocular Coherence Tomography (OCT) and Wrist-watch sensor device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals with normal eye exam in the previous year
- Age 18-80
- Age 18-80
- Traumatic Brain Injury (TBI)
Who cannot join
- 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:
- 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)
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- 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)
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
About this study
Official title: Use of Facial Feature to Objectively Diagnose and Monitor Treatment of Light Sensitivity
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.
Read the 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.
- Conditions
- Photophobia, Traumatic Brain Injury, Migraine
- Being tested
- Pupillography, Ocular Coherence Tomography (OCT), Wrist-watch sensor device, Videography, Electrophysiology
- Medical subject headings
- Photophobia, Brain Injuries, Traumatic, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PupillographyDevice
Also called Reteval, LKC
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.
Ocular Coherence Tomography (OCT)Device
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.
Wrist-watch sensor deviceDevice
Also called (E4, Empatica)
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).
VideographyDevice
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.
ElectrophysiologyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control subjects | Active comparator | Not described Receives: Device: Pupillography; Device: Ocular Coherence Tomography (OCT); Device: Wrist-watch sensor device; Device: Videography; Device: Electrophysiology |
| TBI Patients without photosensitivity | Active comparator | Not described Receives: Device: Pupillography; Device: Ocular Coherence Tomography (OCT); Device: Wrist-watch sensor device; Device: Videography; Device: Electrophysiology |
| Migraine patients without photosensitivity | Active comparator | Not described Receives: Device: Pupillography; Device: Ocular Coherence Tomography (OCT); Device: Wrist-watch sensor device; Device: Videography; Device: Electrophysiology |
| Migraine patients with photosensitivity | Active comparator | Not described Receives: Device: Pupillography; Device: Ocular Coherence Tomography (OCT); Device: Wrist-watch sensor device; Device: Videography; Device: Electrophysiology |
| TBI patients with photosensitivity | Active comparator | Not described Receives: Device: Pupillography; Device: Ocular Coherence Tomography (OCT); Device: Wrist-watch sensor device; Device: Videography; Device: Electrophysiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of facial responses to light sensitivity
Hand held pupillography/videography, electroretinogram, and electrophysiology measurements are correlated to develop of an objective biological marker of light sensitivity.
Measured: 1 Day
Difference in objective biological markers of light sensitivity between light sensitive and normal subjects
The correlation of facial responses to light sensitivity is compared between groups to test whether the measure can accurately distinguish light sensitivity.
Measured: 1 Day
Secondary outcomes (2)
Correlation of objective biological marker of light sensitivity to optic nerve structures
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.
Measured: 1 Day
Correlation of objective biological marker of light sensitivity to macula (structure found in the back of the eye).
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).
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start11 Jul 2019
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotophobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Randy Kardon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Randy Kardon, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694626
- Sponsor's protocol ID
- 201604763
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2018
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We will determine a plan to share IPD closer to time of completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Facial Feature to Objectively Diagnose and Monitor Treatment of Light Sensitivity
- ClinicalTrials.gov ID
- NCT03694626
- Acronym / sponsor ID
- 201604763
- Conditions
- Photophobia, Traumatic Brain Injury, Migraine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Randy KardonUniversity, hospital or other
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Control subjects | Active comparator | Device: Pupillography, Device: Ocular Coherence Tomography (OCT), Device: Wrist-watch sensor device, Device: Videography, Device: Electrophysiology |
| TBI Patients without photosensitivity | Active comparator | Device: Pupillography, Device: Ocular Coherence Tomography (OCT), Device: Wrist-watch sensor device, Device: Videography, Device: Electrophysiology |
| Migraine patients without photosensitivity | Active comparator | Device: Pupillography, Device: Ocular Coherence Tomography (OCT), Device: Wrist-watch sensor device, Device: Videography, Device: Electrophysiology |
| Migraine patients with photosensitivity | Active comparator | Device: Pupillography, Device: Ocular Coherence Tomography (OCT), Device: Wrist-watch sensor device, Device: Videography, Device: Electrophysiology |
| TBI patients with photosensitivity | Active comparator | Device: Pupillography, Device: Ocular Coherence Tomography (OCT), Device: Wrist-watch sensor device, Device: Videography, Device: Electrophysiology |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy individuals with normal eye exam in the previous year
- Age 18-80
- Age 18-80
- Traumatic Brain Injury (TBI)
Key exclusion criteria (16 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PupillographyAlso: Reteval, LKCA 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 | Healthy Control subjects, Migraine patients with photosensitivity, Migraine patients without photosensitivity, TBI Patients without photosensitivity, TBI patients with photosensitivity |
| 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 | Healthy Control subjects, Migraine patients with photosensitivity, Migraine patients without photosensitivity, TBI Patients without photosensitivity, TBI patients with photosensitivity |
| Wrist-watch sensor deviceAlso: (E4, Empatica)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 | Healthy Control subjects, Migraine patients with photosensitivity, Migraine patients without photosensitivity, TBI Patients without photosensitivity, TBI patients with photosensitivity |
| VideographyThe 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 | Healthy Control subjects, Migraine patients with photosensitivity, Migraine patients without photosensitivity, TBI Patients without photosensitivity, TBI patients with photosensitivity |
| ElectrophysiologyNext, 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. | Device | Healthy Control subjects, Migraine patients with photosensitivity, Migraine patients without photosensitivity, TBI Patients without photosensitivity, TBI patients with photosensitivity |
Primary outcome
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.
2 secondary outcomes
Correlation of objective biological marker of light sensitivity to optic nerve structures
Time frame: 1 Day
Correlation of objective biological marker of light sensitivity to macula (structure found in the back of the eye).
Time frame: 1 Day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided. We will determine a plan to share IPD closer to time of completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pupillography, Ocular Coherence Tomography (OCT) and Wrist-watch sensor device in people with Photophobia and Traumatic Brain Injury, run by Randy Kardon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Nellis, BSN (319-356-2780, julie-nellis@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of facial responses to light sensitivity (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.