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NCT Number: NCT03694626

Objectively Diagnose and Monitor Treatment of Light Sensitivity

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pupillography

Device

A hand-held pupillometer/electroretinogram device (RETeval, LKC) will be held in front of the subject's eye, but will not touch the eye. The device will provide a brief, a series of brief light stimuli and then record the pupil response and the elicited electrical response from the retina from a surface skin patch (electrode) placed below each eye, from the light as a measure of whether the inherent sensitivity of the eye in the retina is normal. The investigators will repeat this in the left eye. The visible light stimulus is safe and is given at an intensity experienced in normal daily light exposures. The test takes about 2 minutes per eye.

Other names: Reteval, LKC

Ocular Coherence Tomography (OCT)

Device

The thickness of the optic nerve and macula will also be measured inside of the eye using a special camera that forms an image of the layers of the retina without pupil dilation. The imaging is harmless and measures the structural health of the optic nerve and retinal layers. This test takes 5-10 minutes per eye.

Wrist-watch sensor device

Device

A wrist-watch sensor device (E4, Empatica) will be place on each wrist to measure skin conductance, heart rate, skin temperature and arm movement during testing. These wrist-watch devices are being used to monitor changes in sympathetic nerve activity to light intensity, (the sympathetic nerves supply the blood vessels to the skin and heart).

Other names: (E4, Empatica)

Videography

Device

The subject will sit comfortably in front of miniature combination infrared/visible light video cameras and infrared diode light source located within 1 meter to provide video recording of the face during testing with light and during darkness, described next.

After the 10 minutes of dark-adapting, the subject will put his/her chin on a chin rest in front of the video cameras and a light emitting diode (LED) array give diffuse red, blue, and white stimuli over a range of intensities. None of the stimuli are as bright as a flash from a camera and are in the range of intensities normally experienced during daily activities.

At the end of the test the investigators will add filters over the glasses: orange (blue-blocking) filters and neutral density filters. Subjects will grade independently, both the brightness and discomfort they feel from each light stimulus intensity.

Electrophysiology

Device

Next, electrodes will be placed above, below and to the side of the test eye to record the electromyogram (EMG) for measuring eyelid opening and blink rate.

Primary outcomes

  1. Correlation of facial responses to light sensitivity

    Time frame: 1 Day

    Hand held pupillography/videography, electroretinogram, and electrophysiology measurements are correlated to develop of an objective biological marker of light sensitivity.

  2. Difference in objective biological markers of light sensitivity between light sensitive and normal subjects

    Time frame: 1 Day

    The correlation of facial responses to light sensitivity is compared between groups to test whether the measure can accurately distinguish light sensitivity.

Secondary outcomes

  1. Correlation of objective biological marker of light sensitivity to optic nerve structures

    Time frame: 1 Day

    Bio marker score will be correlated to optic nerve structure measurements made using Optical Coherence Tomography (OCT) to evaluate structural loss of the optic nerve.

  2. Correlation of objective biological marker of light sensitivity to macula (structure found in the back of the eye).

    Time frame: 1 Day

    Bio marker score will be correlated to macula structure measurements made using Optical Coherence Tomography (OCT) to examine to evaluate structural loss of the macula (structure found in the back of the eye).

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Full, BSN

CONTACT

[email protected]

3193562780

Julie Nellis, BSN

CONTACT

[email protected]

319-356-2780

Sponsors and collaborators

Lead sponsor

Randy Kardon

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Oct 3, 2018
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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