Objectively Diagnose and Monitor Treatment of Light Sensitivity

Last updated: May 15, 2024
Sponsor: Randy Kardon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blurred Vision

Eye Disease

Neurologic Disorders

Treatment

Videography

Electrophysiology

Wrist-watch sensor device

Clinical Study ID

NCT03694626
201604763
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion

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 Design

Total Participants: 120
Treatment Group(s): 5
Primary Treatment: Videography
Phase:
Study Start date:
July 11, 2019
Estimated Completion Date:
January 01, 2028

Study Description

Using objecting measurement of facial features, pupil responses, retinal electrical responses and autonomic nerve responses to light this project aims to provide a new framework for diagnosing and monitoring treatment of light sensitivity. The patient's responses will be measured with videography facial muscle electrical responses Electromyogram (EMG) measured from surface skin electrodes and retinal electrical responses (EMG) or electroretinogram (ERG) recorded from a portable hand-held device). Simultaneously, patient's will have their heart rate and skin conductance objectively monitored using wristwatch devices (E4, Empatica). If successful, this will open an immediate new way to objectively assess the mechanisms that lead to light sensitivity, and provide an approach to effectively treat, and manage the symptoms of light sensitivity and headache from different causes, including traumatic brain injury (TBI) and migraine.

Connect with a study center

  • University of Iowa Health Care

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

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