Traumatic Brain Injury Clinical Trial
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | January 1, 2028 |
Est. primary completion date | January 1, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Health Care | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Randy Kardon |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 Day | |
Primary | 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. | 1 Day | |
Secondary | 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. | 1 Day | |
Secondary | 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). | 1 Day |
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