NCT03694626 Objectively Diagnose and Monitor Treatment of Light Sensitivity
| NCT ID | NCT03694626 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Randy Kardon |
| Condition | Photophobia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2019-07-11 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2019-07-11 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03694626 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Photophobia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03694626 currently recruiting?
Yes, NCT03694626 is actively recruiting participants. Contact the research team at julie-nellis@uiowa.edu for enrollment information.
Where is the NCT03694626 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT03694626 clinical trial?
NCT03694626 is sponsored by Randy Kardon. The trial plans to enroll 120 participants.