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Evoked Potentials, VisualVEPNCT02563028

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

A study testing SightSaver Visual Stimulator in people with Evoked Potentials, Visual, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Evoked Potentials, Visual
What is being tested?
SightSaver Visual Stimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Oct 2015to Oct 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any patient presenting for single-level microdiscectomy (first phase only)
  • Any patient presenting for single-level lumbar spine decompression/fusion (second phase only)
  • Any patient suitable for total intravenous anesthesia (TIVA)
  • Age >18

Who cannot join

  • Neurologic or demyelinating disease expected to be associated with impaired VEPs
  • Eye disease, including blindness, glaucoma, macular degeneration, diabetic retinopathy, or conditions expected to be associated with impaired VEPs
  • Patients with a known history of seizures

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hospital for Special Surgery

    New York, New York, 10021

Other trials in United States

About this study

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

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.

Read the detailed description

Spine surgery is associated with a variety of post-operative visual complications, ranging from mild, transient deficits in acuity to full visual loss. Known risk factors for visual loss include anemia, hypotension, and long surgical times in the prone position under general anesthesia. Despite recognition and control of risk factors, the prevalence of visual loss after prone spine surgery is estimated at approximately 0.1-1% . The pathophysiology of visual loss most often reflects posterior ischemic optic neuropathy, but anterior ischemic optic neuropathy and posterior reversible encephalopathy syndrome have also been described.

These reports suggest that the entire pathway from retina to visual cortex is vulnerable to injuries causing post-operative visual deficits. The potential for severe injury during spine surgery mandates improved detection of evolving optic tract injury during prone spine surgery.

Theoretically, the flash visual evoked potential (VEP) represents a useful intraoperative tool to monitor global visual system function. However, its application to spine surgery has been limited due to challenges in acquiring and interpreting signals intraoperatively. Several devices for intraoperative VEP-recording have been described . However, most of these have been trialed with patients in the supine or beach chair position, undergoing neurosurgical procedures. Goggle or eyepatch-designed devices have the potential to move during surgery, changing the relationship between the goggle and globe. The goggle itself may potentially compress the globe, producing inconsistent illumination to the retina or causing mechanical injury. These are particular liabilities during changes in position from supine to prone, as is required for many spine surgeries. Additionally, VEPs are extremely variable and exquisitely sensitive to anesthetics- particularly inhaled agents. Consistent with this, intravenous (rather than inhaled) agents have been associated with successful intraoperative VEP monitoring patients, particularly in patients without baseline visual impairment. Nonetheless, there are multiple reports in the literature showing poor correlation/prediction of postoperative visual status by intraoperative VEP measurements. A novel technology for capturing VEPs has recently been developed and may address several of the liabilities described above. The device is constructed from soft foam padding in a "ski mask" design, which we hypothesize may add a measure of protection to the eyes compared to traditional VEP goggles or patches. This design may also provide stability during changes in patient positioning from supine to prone. The front of the mask consists of an opaque circuit board with six bright light emitting diodes positioned in front of each eye, allowing illumination of the retina through closed, protected eyes. Opaque foam separates right and left sides of the mask, allowing each eye to be stimulated individually. To date, the mask has not been tested for sensitivity to elicit and record VEPs in patients under anesthesia. In this pilot study, we tested the feasibility of using the mask during prone spine surgery. Specifically, we asked if VEPs can be detected throughout spine surgeries of varying complexity and duration, whether the signals change with changes in patient positioning and anesthetic conditions, and whether the mask was associated with any adverse effects. Here we show that intraoperative VEPs can be recorded throughout spine surgery using this device. We also describe effects of several anesthetic agents on VEP stability, and ask if there is any qualitative relationship between changes in VEPs and SSEPs recorded simultaneously.

Being tested
SightSaver Visual Stimulator
Keywords
Visual Evoked Potentials, Microdiscectomy, SightSaver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SightSaver Visual StimulatorDevice

    Evoked response photic stimulator

Study groups in NCT02563028
Study groupRoleWhat they receive
SightSaver Visual StimulatorExperimentalA SightSaver Visual Stimulator mask will be applied during surgery. Baseline VEPs will be recorded prior to prone positioning. At the end of surgery, after supine positioning, the SightSaver Visual Stimulator mask will be removed and discarded.
Receives: Device: SightSaver Visual Stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Presence of VEPs

    The primary outcome will be the presence of VEPs during spine surgery. This outcome will be measured in realtime, intraoperatively. Outcome measure: Visual evoked potential morphology, varying in amplitude (µV) and latency.

    Measured: Duration of surgery (approximately 3 hours)

Secondary outcomes (3)
  1. Number of Participants With Change in VEP Signal Strength

    Number of participants with change in VEP signal strength. This outcome will be measured in realtime, intraoperatively.

    Measured: Duration of surgery (approximately 3 hours)

  2. Correlation of Change in VEPs With Identifiable Intraoperative Event

    Whether changes in VEPs vary with any identifiable intraoperative change in patient condition (including hypotension, hypertension, tachycardia, bradycardia, arrhythmias, oxygen saturation, CO2 level, hypothermia and hyperthermia), surgical event (including sudden or ongoing hemorrhage, neurological injury), or anesthetic change (including increasing/decreasing doses of anesthetics, depth of anesthesia and use of vasoactive drugs). This outcome will be measured in realtime, intraoperatively. Number of participants with change in VEPs associated with increases or decreases of isoflurane and nitrous oxide are reported.

    Measured: Duration of surgery (approximately 3 hours)

  3. Number of Participants With Intolerance to the SightSaver Visual Stimulator

    Whether the SightSaverTM Visual Stimulator is well tolerated by patients. This outcome will be assessed in the PACU will comprise a clinical exam of the periorbital structures and a patient questionnaire

    Measured: Postoperatively, after recovery from anesthesia (approximately 3 hours after surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02563028
Sponsor's protocol ID
2015-272
Acronym
VEP
Status last verified
Apr 2022
First submitted
28 Sep 2015
Last updated
11 May 2022
Data monitoring committee
No

Publications

  • Soffin EM, Emerson RG, Cheng J, Mercado K, Smith K, Beckman JD. A pilot study to record visual evoked potentials during prone spine surgery using the SightSaver photic visual stimulator. J Clin Monit Comput. 2018 Oct;32(5):889-895. doi: 10.1007/s10877-017-0092-1. Epub 2017 Dec 20.

    PubMed 29264762

Questions about this trial

What is this clinical trial studying?

A study testing SightSaver Visual Stimulator in people with Evoked Potentials, Visual, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Presence of VEPs (time frame: Duration of surgery (approximately 3 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02563028, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.

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