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Intraoperative Continuous Flash Visual Evoked Potentials Monitoring During Endoscopic Skull Base Surgery

NCT04068220 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-09-18

No results posted yet for this study

Summary

Skull base surgeries performed in areas involving the visual pathway are associated with varying levels of postoperative visual dysfunction. The goal of intraoperative FVEP monitoring is to detect and prevent intraoperative visual pathway injury.

Conditions

  • Chiasmal; Lesion
  • Prechiasmal; Lesion

Interventions

OTHER

intraoperative FVEPs monitoring

During the surgery, a pair of goggles (similar to the swimming goggles) will be placed on patient's closed eyes. The goggles equipped with red LEDs will apply no pressure or minimal pressure on patient's closed eyes. Patient's left eye then right eye will be stimulated with flashing red light emitted by the goggles. Two subdermal needle electrodes will be placed under the skin behind patient's ears, and one subdermal needle electrode will be placed under the skin above the bridge of patient's nose. The two electrodes placed behind patient's ears, will record intraoperative flash visual evoked potentials (FVEPs) resulted from red light stimulation of patient's visual pathway through the eyes and the electrode above the bridge of the nose will record, at the same time, the activity of each eye's retina.

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    collaborator OTHER

  • Fahad AlKherayf

    lead OTHER

Principal Investigators

  • Fahad Alkherayf, MD MSc FRCSC · Ottawa Hospital Research Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04068220 on ClinicalTrials.gov