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Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways

Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01517789
Acronym
VISUOPEV
Enrollment
40
Registered
2012-01-25
Start date
2012-01-01
Completion date
2014-09-01
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optic Nerve and Pathway Injury, Surgery

Keywords

Surgery, Optic Nerve and Pathway Injury, visual event-related potential

Brief 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. 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).

Interventions

DEVICEVisual 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.

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with lesion compressing or near the optical pathways

Exclusion criteria

* Patients with photic epilepsy

Design outcomes

Primary

MeasureTime frameDescription
Evolution of visual function six months after surgery.Month 6 after surgeryVisual function : visual field and visual acuity six months after surgery.

Secondary

MeasureTime frame
Score of the visual field.Month 6 after surgery
Score of visual acuityMonth 6 after surgery
Average diameter of the optic nerve fibers measured with Optical coherence tomographyMonth 6 after surgery

Countries

France

Contacts

PRINCIPAL_INVESTIGATORDaniel LAGUERRE, Dr

University Hospital, Bordeaux, France

STUDY_CHAIRPaul PEREZ, Dr

University Hospital, Bordeaux, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026