SurgeryVISUOPEVNCT01517789
Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways
A study testing Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera® in people with Surgery and Optic Nerve and Pathway Injury, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Visual morbidity (visual acuity and/or visual field deficit) must be taken into account during neurosurgical procedures for lesions near the optical pathways. Part of this morbidity is due to surgical manipulation. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Surgery, Optic Nerve and Pathway Injury
- What is being tested?
- Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with lesion compressing or near the optical pathways
Who cannot join
- Patients with photic epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Visual morbidity (visual acuity and/or visual field deficit) must be taken into account during neurosurgical procedures for lesions near the optical pathways. Part of this morbidity is due to surgical manipulation. There is no validated tool for intraoperative visual monitoring and few publications have studied this issue.
In a preliminary work based on analysis of these publications, we defined technical, anaesthetic and analytical parameters in order to optimise intraoperative visual evoked potentials monitoring. These parameters are special devices used for transpalpebral stimulation, complete intravenous anaesthesia without halogen or nitrous oxide, and pertinent analysis criteria of visual evoked potential (VEP). We suppose that these improvements will increase reliability of intraoperative VEP.
Read the detailed description
This genuine optimised monitoring in France, set up in association with Metrovision company, should help increasing intraoperative VEP reliability as a monitoring tool for visual pathways function.
In this study, we assess the predictive value of relevant intraoperative variations of VEP (more than 50% variation of latency and amplitude) on the visual prognosis at six months after surgery The visual assessment consisting of a visual field, a visual acuity, and the performance of pattern transient VEP, will be performed by an ophthalmologist before surgery, and at three and six months after surgery. An electroencephalogram with photostimulatory lighting will be used in pre-operative and will validate the absence of photo-induced epilepsy risk.
During the intervention, VEPs associated to an electroretinogram will be performed by a neurosurgeon trained to the use of these tools by Metrovision company:
- Under general anaesthesia, but before any surgery.
- During the surgery, at predetermined surgical times (while performing the craniotomy or the sphenoid opening, at various times during the perioptic lesion dissection, after the lesion resection, when closing).
- Conditions
- Surgery, Optic Nerve and Pathway Injury
- Being tested
- Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®
- Keywords
- Surgery, Optic Nerve and Pathway Injury, visual event-related potential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®Device
Visual assessment (visual field, visual acuity, pattern visual evoked potential) are realised before and after surgery.
Flash and steady state visual evoked potential are measured during the surgical procedure at different times.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Device: Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of visual function six months after surgery.
Visual function : visual field and visual acuity six months after surgery.
Measured: Month 6 after surgery
Secondary outcomes (3)
Score of the visual field.
Measured: Month 6 after surgery
Score of visual acuity
Measured: Month 6 after surgery
Average diameter of the optic nerve fibers measured with Optical coherence tomography
Measured: Month 6 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel LAGUERRE, Dr, Principal investigator, University Hospital, Bordeaux, FrancePaul PEREZ, Dr, Study chair, University Hospital, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517789
- Sponsor's protocol ID
- CHUBX 2011/09
- Other IDs
- 2011-A01220-41
- Acronym
- VISUOPEV
- Status last verified
- Mar 2015
- First submitted
- 20 Jan 2012
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways
- ClinicalTrials.gov ID
- NCT01517789
- Acronym / sponsor ID
- VISUOPEV / CHUBX 2011/09
- Conditions
- Surgery, Optic Nerve and Pathway Injury
- Keywords
- Surgery, Optic Nerve and Pathway Injury, visual event-related potential
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Visual morbidity (visual acuity and/or visual field deficit) must be taken into account during neurosurgical procedures for lesions near the optical pathways. Part of this morbidity is due to surgical manipulation. There is no validated tool for intraoperative visual monitoring and few publications have studied this issue.
In a preliminary work based on analysis of these publications, we defined technical, anaesthetic and analytical parameters in order to optimise intraoperative visual evoked potentials monitoring. These parameters are special devices used for transpalpebral stimulation, complete intravenous anaesthesia without halogen or nitrous oxide, and pertinent analysis criteria of visual evoked potential (VEP). We suppose that these improvements will increase reliability of intraoperative VEP.
Detailed description
This genuine optimised monitoring in France, set up in association with Metrovision company, should help increasing intraoperative VEP reliability as a monitoring tool for visual pathways function.
In this study, we assess the predictive value of relevant intraoperative variations of VEP (more than 50% variation of latency and amplitude) on the visual prognosis at six months after surgery The visual assessment consisting of a visual field, a visual acuity, and the performance of pattern transient VEP, will be performed by an ophthalmologist before surgery, and at three and six months after surgery. An electroencephalogram with photostimulatory lighting will be used in pre-operative and will validate the absence of photo-induced epilepsy risk.
During the intervention, VEPs associated to an electroretinogram will be performed by a neurosurgeon trained to the use of these tools by Metrovision company:
- Under general anaesthesia, but before any surgery.
- During the surgery, at predetermined surgical times (while performing the craniotomy or the sphenoid opening, at various times during the perioptic lesion dissection, after the lesion resection, when closing).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera® |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with lesion compressing or near the optical pathways
Key exclusion criteria (1 listed)
- Patients with photic epilepsy
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 |
|---|---|---|
| Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®Visual assessment (visual field, visual acuity, pattern visual evoked potential) are realised before and after surgery. Flash and steady state visual evoked potential are measured during the surgical procedure at different times. | Device | Patients |
Primary outcome
Evolution of visual function six months after surgery.
Time frame: Month 6 after surgery
Visual function : visual field and visual acuity six months after surgery.
3 secondary outcomes
Score of the visual field.
Time frame: Month 6 after surgery
Score of visual acuity
Time frame: Month 6 after surgery
Average diameter of the optic nerve fibers measured with Optical coherence tomography
Time frame: Month 6 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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.
Daniel LAGUERRE, Dr principal investigator
University Hospital, Bordeaux, France
Paul PEREZ, Dr study chair
University Hospital, Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera® in people with Surgery and Optic Nerve and Pathway Injury, run by University Hospital, Bordeaux at 1 site in France.
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 1 inclusion and 1 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 1 Jun 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evolution of visual function six months after surgery. (time frame: Month 6 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2026.