Objectively Diagnose and Monitor Treatment of Light Sensitivity

NCT ID
NCT03694626
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Randy Kardon
Conditions
Migraine, Photophobia, Traumatic Brain Injury

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Use of Facial Feature to Objectively Diagnose and Monitor Treatment of Light Sensitivity

Enrollment: 120 participants (Estimated).

What is being studied

  • Device: Electrophysiology
  • Device: Ocular Coherence Tomography (OCT)
  • Device: Pupillography
  • Device: Videography
  • Device: Wrist-watch sensor device

Who may be eligible

Ages
18 Years to 80 Years
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Iowa, United States: 1

Sample of listed locations

  • University of Iowa Health Care — Iowa City, Iowa, 52242, United States — Recruiting

Study details

Start date
July 11, 2019
Primary completion date
January 1, 2028
Completion date
January 1, 2028
First posted
October 3, 2018

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT03694626
Registry last updated
September 8, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT03694626 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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