- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01517789
Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways (VISUOPEV)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33000
- CHU Bordeaux - Hôpital Pellegrin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with lesion compressing or near the optical pathways
Exclusion Criteria:
- Patients with photic epilepsy
Study Plan
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Patients
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Month 6 after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score of the visual field.
Time Frame: Month 6 after surgery
|
Month 6 after surgery
|
Score of visual acuity
Time Frame: Month 6 after surgery
|
Month 6 after surgery
|
Average diameter of the optic nerve fibers measured with Optical coherence tomography
Time Frame: Month 6 after surgery
|
Month 6 after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel LAGUERRE, Dr, University Hospital, Bordeaux, France
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2011/09
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