{
  "FullStudy":{
    "Rank":218256,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510691",
          "OrgStudyIdInfo":{
            "OrgStudyId":"VE-Oxygen-28062010"
          },
          "Organization":{
            "OrgFullName":"Medical University of Vienna",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Vitrectomy Retinal Oxygenation",
          "OfficialTitle":"The Influence of Retinal Oxygenation on the Clinical Outcomes in Eyes With Different Vitreoretinal Pathologies After a Successful Vitrectomy"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2015",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 14, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 15, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Stefan Sacu",
            "ResponsiblePartyInvestigatorTitle":"Ass Prof Priv Doz Dr",
            "ResponsiblePartyInvestigatorAffiliation":"Medical University of Vienna"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Stefan Sacu",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"Vitrectomy is the common treatment for patients with macular edema secondary to epiretinal membrane. Recently, in eyes with diabetic macular edema or persistent macular edema following retinal vein occlusion, vitrectomy will be increasingly performed as an additional treatment modality. In eyes with impaired oxygen situation vitrectomy may improve the retinal oxygen saturation. However, little information is available about the oxygenation and the blood flow of the retinal vessels after vitroretinal surgery.\n\nHypoxia is a the major trigger of vascular endothelial growth factor (VEGF), which is in turn the most important factor for the development of macular edema. It is a major issue to improve the oxygen situation and the blood flow of the retina and there are just a few not satisfactory procedures available to overcome this problem. However, vitrectomy would be an adequate therapy for many of these diseases, and it would be an appreciated side effect of the treatment in almost every case.\n\nTo investigate the influence of oxygenation and blood flow of the retina on clinical outcomes after a successfully 23 gauge vitrectomy in eyes with epiretinal membrane, persistent macular edema following diabetic retinopathy or retinal vein occlusion."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Diabetic Macular Edema"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Oxygenation of the retinal vessels",
              "vitroretinal surgery"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"7",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Epiretinal membrane"
              },{
                "ArmGroupLabel":"diabetic macular edema"
              },{
                "ArmGroupLabel":"vein occlusion"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Clinical Data",
                "PrimaryOutcomeDescription":"Visus, OCT",
                "PrimaryOutcomeTimeFrame":"6 months"
              },{
                "PrimaryOutcomeMeasure":"Blood Flow Data",
                "PrimaryOutcomeDescription":"Oxygenation of retinal blood vessles and retinal blood flow",
                "PrimaryOutcomeTimeFrame":"6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nmale or female, at least 18 years of age.\nophthalmoscopic evidence of epiretinal membrane scheduled for vitrectomy and membrane peeling.\npersistent diabetic macular edema\nwritten informed consent\nfemale patients of childbearing potential must have a negative urine pregnancy test.\n\nExclusion Criteria:\n\nuncontrolled systemic disease\nsymptoms of a clinically relevant illness in the 3 weeks before the first study day\nany ocular condition that in the opinion of the investigator would be a contraindication for the surgical procedure\nhistory of glaucoma, aphakie or presence of anterior chamber intraocular lens, choroidal neovascularisation, significant cataract, any ocular infection, - history of pars plana vitrectomy.\ncontraindication to pupil dilation.\nneed for silicon oil or gas after the surgery\nadvanced diabetic retinopathy with vitreoretinal tear and/or bleeding",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Group 1: 20 patients with macular edema following epiretinal membrane Group 2: 20 patients with persistent diabetic macular edema. Group 3: 20 patients with persistent macular edema following retinal vein occlusion",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Department of Opthalmology/Clinical Pharmacology",
                "LocationCity":"Vienna",
                "LocationZip":"1090",
                "LocationCountry":"Austria"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008269",
                "ConditionMeshTerm":"Macular Edema"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000008268",
                "ConditionAncestorTerm":"Macular Degeneration"
              },{
                "ConditionAncestorId":"D000012162",
                "ConditionAncestorTerm":"Retinal Degeneration"
              },{
                "ConditionAncestorId":"D000012164",
                "ConditionAncestorTerm":"Retinal Diseases"
              },{
                "ConditionAncestorId":"D000005128",
                "ConditionAncestorTerm":"Eye Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9844",
                "ConditionBrowseLeafName":"Macular Edema",
                "ConditionBrowseLeafAsFound":"Macular Edema",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M6240",
                "ConditionBrowseLeafName":"Edema",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9843",
                "ConditionBrowseLeafName":"Macular Degeneration",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13580",
                "ConditionBrowseLeafName":"Retinal Degeneration",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13582",
                "ConditionBrowseLeafName":"Retinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6854",
                "ConditionBrowseLeafName":"Eye Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC11",
                "ConditionBrowseBranchName":"Eye Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}