Objectively Diagnose and Monitor Treatment of Light Sensitivity
Recruiting
N/AInterventional Study
PhotophobiaTraumatic Brain InjuryMigraine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Screening
Participants needed
120 (estimated)
Sponsor
Randy Kardon · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility 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…
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
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