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.
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
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.
- Conditions
- Evoked Potentials, Visual
- 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 group | Role | What they receive |
|---|---|---|
| SightSaver Visual Stimulator | Experimental | A 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.
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)
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)
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)
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.
- First posted29 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evoked Potentials, VisualStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Beckman, MD, Principal investigator, Hospital for Special Surgery, New York
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Method for Capturing the Visual Evoked Potential (VEP) During Single-Level Lumbar Spine Decompression/Fusion Under Total Intravenous Anesthesia (TIVA)
- ClinicalTrials.gov ID
- NCT02563028
- Acronym / sponsor ID
- VEP / 2015-272
- Conditions
- Evoked Potentials, Visual
- Keywords
- Visual Evoked Potentials, Microdiscectomy, SightSaver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Posted 30 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SightSaver Visual Stimulator | Experimental | Device: SightSaver Visual StimulatorA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SightSaver Visual StimulatorEvoked response photic stimulator | Device | SightSaver Visual Stimulator |
Primary outcome
Number of Participants With Presence of VEPs
Time frame: Duration of surgery (approximately 3 hours)
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.
3 secondary outcomes
Number of Participants With Change in VEP Signal Strength
Time frame: Duration of surgery (approximately 3 hours)
Correlation of Change in VEPs With Identifiable Intraoperative Event
Time frame: Duration of surgery (approximately 3 hours)
Number of Participants With Intolerance to the SightSaver Visual Stimulator
Time frame: Postoperatively, after recovery from anesthesia (approximately 3 hours after surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29264762Soffin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Beckman, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
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.