New methods to diagnose and monitor light sensitivity
Use of Facial Feature to Objectively Diagnose and Monitor Treatment of Light Sensitivity
This study is testing new ways to diagnose and track light sensitivity and headaches in people with conditions like traumatic brain injury and migraines using advanced technology.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT03694626 on ClinicalTrials.gov |
What this trial studies
This project aims to create a new framework for diagnosing and monitoring light sensitivity and headaches through objective measurements. It utilizes advanced techniques such as videography, pupil response assessments, retinal electrical responses, and autonomic nerve responses to light. Patients' responses will be recorded using surface electrodes and portable devices, allowing for real-time monitoring of their physiological reactions. The goal is to better understand the mechanisms behind light sensitivity and improve treatment strategies for conditions like traumatic brain injury and migraines.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals aged 18-80 and TBI patients without photosensitivity or headaches.
Not a fit: Patients with a history of eye or systemic disorders affecting the retina or those who are light sensitive or suffer from migraines may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a reliable method for diagnosing and managing light sensitivity and related headaches.
How similar studies have performed: While similar approaches have been explored, this specific methodology for diagnosing and monitoring light sensitivity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Iowa City, Iowa
- University of Iowa Health Care — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Study coordinator: Julie Nellis, BSN
- Email: julie-nellis@uiowa.edu
- Phone: 319-356-2780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.