120 Participants Needed

Diagnostic Monitoring Techniques for Light Sensitivity

JF
JN
Overseen ByJulie Nellis, BSN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses tools to measure how a person's face, eyes, and nerves react to light. It targets people with light sensitivity and headaches, including those with traumatic brain injuries and migraines. By understanding these reactions, doctors aim to develop better treatments for these conditions.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially those that affect pupil size or are sedatives, like benzodiazepines or opioids, as they could interfere with the study measurements.

Is visual electrophysiological testing safe for humans?

Visual electrophysiological techniques like electroretinography (ERG) and visual evoked potentials (VEP) are used to assess the safety of drugs and their effects on the eyes, indicating they are generally considered safe for evaluating visual system side effects.12345

How does this treatment for light sensitivity differ from other treatments?

This treatment uses electrophysiological techniques like electroretinography (ERG) and visual evoked potentials (VEP) to objectively assess and monitor retinal and visual pathway function, which is unique compared to other treatments that may rely on subjective assessments or imaging alone. These methods can detect specific dysfunctions in the retina and visual system, providing a detailed understanding of light sensitivity issues.678910

What data supports the effectiveness of this treatment for light sensitivity?

Electrophysiology tests like ERG and VEP are used to detect visual dysfunctions and can help identify issues in the visual pathway, which may be related to light sensitivity. These tests are standardized to ensure consistent quality, which supports their reliability in diagnosing and monitoring conditions related to light sensitivity.56101112

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 18-80 who have had a normal eye exam in the past year. It's designed to help those with traumatic brain injury and associated light sensitivity or migraines by objectively measuring their response to light.

Inclusion Criteria

Healthy individuals with normal eye exam in the previous year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Assessment

Objective measurement of facial features, pupil responses, retinal electrical responses, and autonomic nerve responses to light

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after assessment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Electrophysiology
  • Ocular Coherence Tomography (OCT)
  • Pupillography
  • Videography
  • Wrist-watch sensor device
Trial Overview The study tests new methods like videography, ocular coherence tomography (OCT), wrist-watch sensor devices, pupillography, and electrophysiology to diagnose and monitor treatment of light sensitivity and headaches in patients.
How Is the Trial Designed?
5Treatment groups
Active Control
Group I: TBI patients with photosensitivityActive Control5 Interventions
Group II: TBI Patients without photosensitivityActive Control5 Interventions
Group III: Migraine patients without photosensitivityActive Control5 Interventions
Group IV: Migraine patients with photosensitivityActive Control5 Interventions
Group V: Healthy Control subjectsActive Control5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Randy Kardon

Lead Sponsor

Trials
4
Recruited
1,100+

Published Research Related to This Trial

Understanding photometry is crucial for accurate electrophysiological testing of the visual system, particularly in clinical settings like ERG (electroretinography) and VEP (visual evoked potential) testing.
The technical note emphasizes the importance of factors such as pupil size, flash stimulus specifications, and the spectral composition of visual stimuli, all of which are essential for adhering to ISCEV standards in clinical electrophysiology.
Essentials of photometry for clinical electrophysiology of vision.McCulloch, DL., Hamilton, R.[2021]
The 2010 EOG Standard from ISCEV provides updated guidelines for conducting electro-oculogram tests, which assess the function of the outer retina and retinal pigment epithelium, ensuring consistency in testing across clinical centers.
While the testing protocol remains unchanged from the 2006 version, the updated document emphasizes technical requirements and practical issues to enhance the quality of EOG testing and result reporting.
ISCEV standard for clinical electro-oculography (2010 update).Marmor, MF., Brigell, MG., McCulloch, DL., et al.[2022]
The study identified specific pupillary light reflex parameters that differ significantly between individuals with and without photosensitivity, suggesting these could serve as objective biomarkers for photosensitivity.
In individuals with mild traumatic brain injury (mTBI), distinct differences in pupil response were observed, including larger baseline diameter and faster recovery times, indicating that pupillometry could help assess photosensitivity in this population.
Objective Pupillary Correlates of Photosensitivity in the Normal and Mild Traumatic Brain Injury Populations.Truong, JQ., Ciuffreda, KJ.[2017]

Citations

Essentials of photometry for clinical electrophysiology of vision. [2021]
ISCEV standard for clinical electro-oculography (2010 update). [2022]
Objective Pupillary Correlates of Photosensitivity in the Normal and Mild Traumatic Brain Injury Populations. [2017]
[Electrophysiology in ophthalmology]. [2018]
ISCEV Standard for clinical electro-oculography (2017 update). [2018]
An overview of drug development with special emphasis on the role of visual electrophysiological testing. [2018]
Steady-state electroretinograms and pattern electroretinograms in pigs. [2019]
Retrospective evaluation of pre-surgical electroretinography results in a mixed-breed canine population presented for cataract removal surgery. [2023]
Retinal phototoxicity: a review of standard methodology for evaluating retinal optical radiation hazards. [2022]
[Information conveyed by electroretinography (author's transl)]. [2019]
[Do We Still Need Electrophysiology in Ophthalmology?] [2017]
Electroretinography and visual evoked responses in paediatric practice. [2014]
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