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Objectively Diagnose and Monitor Treatment of Light Sensitivity

Primary Purpose

Photophobia, Traumatic Brain Injury, Migraine

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pupillography

Ocular Coherence Tomography (OCT)

Wrist-watch sensor device

Videography

Electrophysiology

About this trial

This is an interventional screening trial for Photophobia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Iowa Health CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Arm Label

Healthy Control subjects

TBI Patients without photosensitivity

Migraine patients without photosensitivity

Migraine patients with photosensitivity

TBI patients with photosensitivity

Arm Description

Outcomes

Primary Outcome Measures

Correlation of facial responses to light sensitivity

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

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

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

Secondary Outcome Measures

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

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.

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

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).

Full Information

NCT ID

NCT03694626

First Posted

July 17, 2018

Last Updated

September 14, 2023

Sponsor

Randy Kardon

1. Study Identification

Unique Protocol Identification Number

NCT03694626

Brief Title

Objectively Diagnose and Monitor Treatment of Light Sensitivity

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 11, 2019 (Actual)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Randy Kardon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Photophobia, Traumatic Brain Injury, Migraine

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Control subjects

Arm Type

Active Comparator

Arm Title

TBI Patients without photosensitivity

Arm Type

Active Comparator

Arm Title

Migraine patients without photosensitivity

Arm Type

Active Comparator

Arm Title

Migraine patients with photosensitivity

Arm Type

Active Comparator

Arm Title

TBI patients with photosensitivity

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Pupillography

Other Intervention Name(s)

Reteval, LKC

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Ocular Coherence Tomography (OCT)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Wrist-watch sensor device

Other Intervention Name(s)

(E4, Empatica)

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Videography

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Electrophysiology

Intervention Description

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 Outcome Measure Information:

Title

Correlation of facial responses to light sensitivity

Description

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

Time Frame

1 Day

Title

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

Description

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

Time Frame

1 Day

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

1 Day

Title

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

Description

Time Frame

1 Day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julie Nellis, BSN

Phone

319-356-2780

julie-nellis@uiowa.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jan Full, BSN

Phone

3193562780

jan-full@uiowa.edu

Facility Information:

Facility Name

University of Iowa Health Care

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

We will determine a plan to share IPD closer to time of completion of the study.

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Objectively Diagnose and Monitor Treatment of Light Sensitivity

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