Intraoperative Non-invasive Eye Movement Monitoring

Completed

• Conditions: Surgery
• Interventions: Device: EEG Electrode Patch; Device: Standard Needles

• Registration Number: NCT03046615
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-05
• Study First Posted: 2017-02-08
• Study Start: 2017-02-13
• Primary Completion: 2018-08-31
• Study Completion: 2019-01-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-24
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Subject will be undergoing surgery involved of the nerves controlling the eye

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EEG Electrode Patch	EEG Electrode Patch	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.
Standard Needles	Standard Needles	The current solution to monitor eye movement during surgery is to place standard needles in the muscles surrounding the eye.

Primary Outcome Measures

Name	Time	Method
Number of subjects with greater than 95% concordance in signal between the standard needles and EEG electrode patch	approximately 30 minutes	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States