Intraoperative Non-invasive Eye Movement Monitoring

NCT ID: NCT03046615

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-13

Study Completion Date

2019-01-31

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.

Detailed Description

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Conditions

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Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

EEG Electrode Patch

Intervention Type DEVICE

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.

Standard Needles

The current solution to monitor eye movement during surgery is to place standard needles in the muscles surrounding the eye.

Standard Needles

Intervention Type DEVICE

Needles are placed in the muscles surrounding the eye to measure eye movements.

Interventions

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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 we would commonly use for recording.

Intervention Type DEVICE

Standard Needles

Needles are placed in the muscles surrounding the eye to measure eye movements.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- Subject will be undergoing surgery involved of the nerves controlling the eye

Exclusion Criteria

\- None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jamie J. Van Gompel

Associate Professor of Neurosurgery and Otolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jamie J Van Gompel, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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16-010266

Identifier Type: -

Identifier Source: org_study_id

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