Intraoperative Non-invasive Eye Movement Monitoring

Study Overview
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Brief Summary
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For procedures involving proximity to the nerves responsible for eye movement, the need to monitor eye movement exists. The current solution is to place needles in the muscles surrounding the eye. The Investigators have invented a non-invasive electrode and software designed to monitor eye movements non-invasively. The electrode is placed on the skin on the corner of the eye and using the natural dipole of the eye, detects the horizontal and vertical movements of the eye. The Investigators would like to prove efficacy compared to the standard monitoring.

Official Title
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Intraoperative Non-invasive Eye Movement Monitoring

Conditions
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Surgery

Intervention / Treatment
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* Device: EEG Electrode Patch
* Device: Standard Needles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Subject will be undergoing surgery involved of the nerves controlling the eye Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EEG Electrode Patch<br>The additional electrodes are modified EEG electrodes (used in clinical practice on the head already) placed in a silicone molding. These are placed lateral to the eye with the patient asleep. These are then wired to the same recording apparatus that is commonly used for recording. | Device: EEG Electrode Patch<br>* The additional electrodes are modified EEG electrodes (used in clinical practice on the head already) placed in a silicone molding. These are placed lateral to the eye with the patient asleep. These are then wired to the same recording apparatus that we would commonly use for recording.<br>|
| Standard Needles<br>The current solution to monitor eye movement during surgery is to place standard needles in the muscles surrounding the eye. | Device: Standard Needles<br>* Needles are placed in the muscles surrounding the eye to measure eye movements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with greater than 95% concordance in signal between the standard needles and EEG electrode patch | The current method of measuring eye movement is to place needles in the muscles surrounding the eye. For the non-invasive method, the electrode is placed on the skin on the corner of the eye and using the natural dipole of the eye, detects horizontal and vertical movements of the eye. The signal comparison for the two methods would be a biphasic dipole representing eye movements compared to the compound muscle action potential of the invasive method. | approximately 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG electrodes