Objectively Diagnose and Monitor Treatment of Light Sensitivity (NCT03694626) | Clinical Trial Compass
RecruitingNot Applicable
Objectively Diagnose and Monitor Treatment of Light Sensitivity
United States120 participantsStarted 2019-07-11
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hea…
What they're measuring
1
Correlation of facial responses to light sensitivity
Timeframe: 1 Day
2
Difference in objective biological markers of light sensitivity between light sensitive and normal subjects