{
  "FullStudy":{
    "Rank":217714,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517789",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CHUBX 2011/09"
          },
          "Organization":{
            "OrgFullName":"University Hospital, Bordeaux",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways",
          "OfficialTitle":"Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways",
          "Acronym":"VISUOPEV"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 20, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 4, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 5, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University Hospital, Bordeaux",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"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.\n\nIn 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.",
          "DetailedDescription":"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.\n\nIn 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.\n\nDuring the intervention, VEPs associated to an electroretinogram will be performed by a neurosurgeon trained to the use of these tools by Metrovision company:\n\nUnder general anaesthesia, but before any surgery.\nDuring 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)."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Surgery",
              "Optic Nerve and Pathway Injury"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Surgery",
              "Optic Nerve and Pathway Injury",
              "visual event-related potential"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"40",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Patients",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®",
                "InterventionDescription":"Visual assessment (visual field, visual acuity, pattern visual evoked potential) are realised before and after surgery.\n\nFlash and steady state visual evoked potential are measured during the surgical procedure at different times.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Patients"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Evolution of visual function six months after surgery.",
                "PrimaryOutcomeDescription":"Visual function : visual field and visual acuity six months after surgery.",
                "PrimaryOutcomeTimeFrame":"Month 6 after surgery"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Score of the visual field.",
                "SecondaryOutcomeTimeFrame":"Month 6 after surgery"
              },{
                "SecondaryOutcomeMeasure":"Score of visual acuity",
                "SecondaryOutcomeTimeFrame":"Month 6 after surgery"
              },{
                "SecondaryOutcomeMeasure":"Average diameter of the optic nerve fibers measured with Optical coherence tomography",
                "SecondaryOutcomeTimeFrame":"Month 6 after surgery"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with lesion compressing or near the optical pathways\n\nExclusion Criteria:\n\nPatients with photic epilepsy",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"13 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Daniel LAGUERRE, Dr",
                "OverallOfficialAffiliation":"University Hospital, Bordeaux, France",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Paul PEREZ, Dr",
                "OverallOfficialAffiliation":"University Hospital, Bordeaux, France",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"CHU Bordeaux - hôpital Pellegrin",
                "LocationCity":"Bordeaux",
                "LocationZip":"33000",
                "LocationCountry":"France"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000020221",
                "ConditionMeshTerm":"Optic Nerve Injuries"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000020209",
                "ConditionAncestorTerm":"Cranial Nerve Injuries"
              },{
                "ConditionAncestorId":"D000003389",
                "ConditionAncestorTerm":"Cranial Nerve Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009901",
                "ConditionAncestorTerm":"Optic Nerve Diseases"
              },{
                "ConditionAncestorId":"D000006259",
                "ConditionAncestorTerm":"Craniocerebral Trauma"
              },{
                "ConditionAncestorId":"D000020196",
                "ConditionAncestorTerm":"Trauma, Nervous System"
              },{
                "ConditionAncestorId":"D000005128",
                "ConditionAncestorTerm":"Eye Diseases"
              },{
                "ConditionAncestorId":"D000014947",
                "ConditionAncestorTerm":"Wounds and Injuries"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M20631",
                "ConditionBrowseLeafName":"Optic Nerve Injuries",
                "ConditionBrowseLeafAsFound":"Optic Nerve and Pathway Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5188",
                "ConditionBrowseLeafName":"Cranial Nerve Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11415",
                "ConditionBrowseLeafName":"Optic Nerve Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7932",
                "ConditionBrowseLeafName":"Craniocerebral Trauma",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20607",
                "ConditionBrowseLeafName":"Trauma, Nervous System",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6854",
                "ConditionBrowseLeafName":"Eye Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC11",
                "ConditionBrowseBranchName":"Eye Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC26",
                "ConditionBrowseBranchName":"Wounds and Injuries"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}