Objectively Diagnose and Monitor Treatment of Light Sensitivity
Recruiting · NCT03694626 · Interventional (participants receive a specific treatment) · Lead sponsor: Randy Kardon
View the official record on ClinicalTrials.gov →Interventions studied
ElectrophysiologyOcular Coherence Tomography (OCT)PupillographyVideographyWrist-watch sensor device
What this trial is about
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 take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Iowa Health Care - Iowa City, Iowa, United States