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A Novel Method for Capturing the Visual Evoked Potential During Spine Surgery Under Total Intravenous Anesthesia

NCT02563028 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-05-11

Study results available
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Summary

Spine surgery in the prone position (which involves lying face down) is associated with various visual changes, ranging from temporary changes in acuity (or sharpness) to permanent blindness. Known risk factors include low blood count (anemia) and long surgical times in the prone position under general anesthesia. While blindness is a rare outcome of this surgery, it is devastating and incompletely prevented by controlling known risk factors. Thus, improved monitoring and detection of visual injury during surgery is necessary. The purpose of this study is to determine whether a novel, non-invasive monitoring device can reliably record visual responses during spine surgery. The first phase of this study is completed and involved patients undergoing microdiscectomy surgery. The second phase of this study involves patients undergoing single-level lumbar spine decompression/fusion surgery.

Conditions

  • Evoked Potentials, Visual

Interventions

DEVICE

SightSaver Visual Stimulator

Evoked response photic stimulator

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • James Beckman, MD · Hospital for Special Surgery, New York

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

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 NCT02563028 on ClinicalTrials.gov