CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
SightSaver Visual Stimulatordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02563028
NCT02563028N/ACompleted

A Novel Method for Capturing the Visual Evoked Potential (VEP) During Single-Level Lumbar Spine Decompression/Fusion Under Total Intravenous Anesthesia (TIVA)

Hospital for Special Surgery, New York·interventional·Posted Sep 29, 2015·Updated May 11, 2022

In Brief

A clinical study evaluating SightSaver Visual Stimulator for Evoked Potentials, Visual. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 29, 2015
Enrollment StartOct 1, 2015
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 10.8 years ago

Interventions

SightSaver Visual Stimulatordevice

Evoked response photic stimulator