{
  "FullStudy":{
    "Rank":218226,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511094",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Gonio-32"
          },
          "Organization":{
            "OrgFullName":"Federal University of Minas Gerais",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications",
          "OfficialTitle":"Goniocurettage as First Choice of Surgical Treatment in Chronic Open-Angle Glaucoma: Outcomes and Complications",
          "Acronym":"GC"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"June 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2010",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2012",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"October 14, 2011",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 17, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 18, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Tiago Tomaz de Souza",
            "ResponsiblePartyInvestigatorTitle":"Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"Federal University of Minas Gerais"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Federal University of Minas Gerais",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The study has the purpose to evaluate the effectiveness and safety of the goniocurettage as a first choice of surgical treatment for primary open-angle glaucoma (POAG) in patients with good vision.",
          "DetailedDescription":"A prospective study in 33 eyes (32 patients) with uncontrolled open angle glaucoma under clinical treatment. The trabecular tissue was scraped away from the angle (goniocurettage) in about 100 degrees by means of an instrument similar to a microchalazion curette. The goniocurettage was done under direct visualization of the angle through a gonioscopy lens (Swan-Jacob) and a surgical microscope. Using the 17.0 SPSS software the investigators compared the intraocular pressure, the numbers of antiglaucomatous medications, the best correct visual acuity, the development of cataract, the central corneal thickness,the impact on the visual field, the impact on the optic nerve head and the central corneal endothelial cell density before and after the goniocurettage, and the intra and post operative complications."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Open-Angle Glaucoma",
              "Surgery"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "ab-interno trabeculectomy,",
              "intraocular pressure,",
              "open angle glaucoma",
              "trabeculectomy",
              "Goniocurettage",
              "Non-Filtering Surgery"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2",
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"32",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Eye Surgery",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Goniocurettage was used to treat open angle glaucoma patients",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Goniocurettage"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Goniocurettage",
                "InterventionDescription":"Ab interno surgery consisting on scraped away the trabecular tissue from the angle (goniocurettage) removing segments of pathologically altered trabecular meshwork from the scleral sulcus",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Eye Surgery"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Ab interno glaucoma precedure",
                    "Open angle glacuoma surgery",
                    "Non filtering glaucoma procedure"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Intra Ocular Pressure",
                "PrimaryOutcomeDescription":"The mean of at least three measures at 8:00 am two weeks before surgery. After intervention, the Intra Ocular Pressure was measured on the day after, one week after, two weeks after and every month at the same time until the end of the study (an expected average of 20 months).",
                "PrimaryOutcomeTimeFrame":"Change from Baseline in Intra Ocular Pressure at 20 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Central Corneal Thickness",
                "SecondaryOutcomeTimeFrame":"Two weeks before, six months after and one year after intervention"
              },{
                "SecondaryOutcomeMeasure":"Central corneal endothelial cell density",
                "SecondaryOutcomeTimeFrame":"Two weeks before, six months after intervention and one year after intervention"
              },{
                "SecondaryOutcomeMeasure":"Best correct visual acuity",
                "SecondaryOutcomeTimeFrame":"Two weeks before, six months after and one year after intervention"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nDisc and/or visual field findings consistent with Primary Open Angle Glaucoma\nUncontrolled intraocular pressure (≥21 mm Hg) or progressive glaucomatous neuropathy despite maximum tolerated medical therapy\n40 years old or over\nVisual acuity higher than 0.2\nOpen angles (greater or equal to Shaffer grade II)\n\nExclusion Criteria:\n\nPrevious ocular surgery\nHistory of glaucoma laser treatment\nHistory of ocular trauma\nCyclodestructive procedures\nCorneal edema or opacities\nEndothelial decompensation\nHistory of uveitis\nSecondary glaucoma\nneovascularization of the iris or angle\nCongenital anterior segment abnormalities\nAnatomically confusing angles without clear definition of the scleral spur or meshwork and inability to maintain follow-up",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"40 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Tiago T Souza, MD",
                "OverallOfficialAffiliation":"Federal University of Minas Gerais",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Sebastiao Cronemberger, PhD",
                "OverallOfficialAffiliation":"Federal University of Minas Gerais",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Federal University of Minas Gerais",
                "LocationCity":"Belo Horizonte",
                "LocationState":"Minas Gerais",
                "LocationZip":"30130-100",
                "LocationCountry":"Brazil"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"9215060",
                "ReferenceType":"background",
                "ReferenceCitation":"Jacobi PC, Dietlein TS, Krieglstein GK. Technique of goniocurettage: a potential treatment for advanced chronic open angle glaucoma. Br J Ophthalmol. 1997 Apr;81(4):302-7."
              },{
                "ReferencePMID":"10334341",
                "ReferenceType":"background",
                "ReferenceCitation":"Jacobi PC, Dietlein TS, Krieglstein GK. Goniocurettage for removing trabecular meshwork: clinical results of a new surgical technique in advanced chronic open-angle glaucoma. Am J Ophthalmol. 1999 May;127(5):505-10."
              },{
                "ReferencePMID":"10080211",
                "ReferenceType":"background",
                "ReferenceCitation":"Jacobi PC, Dietlein TS, Krieglstein GK. Microendoscopic trabecular surgery in glaucoma management. Ophthalmology. 1999 Mar;106(3):538-44."
              },{
                "ReferencePMID":"11219641",
                "ReferenceType":"background",
                "ReferenceCitation":"Johnson DH, Johnson M. How does nonpenetrating glaucoma surgery work? Aqueous outflow resistance and glaucoma surgery. J Glaucoma. 2001 Feb;10(1):55-67. Review."
              },{
                "ReferencePMID":"17471324",
                "ReferenceType":"background",
                "ReferenceCitation":"Minckler D, Baerveldt G, Ramirez MA, Mosaed S, Wilson R, Shaarawy T, Zack B, Dustin L, Francis B. Clinical results with the Trabectome, a novel surgical device for treatment of open-angle glaucoma. Trans Am Ophthalmol Soc. 2006;104:40-50."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000005901",
                "ConditionMeshTerm":"Glaucoma"
              },{
                "ConditionMeshId":"D000005902",
                "ConditionMeshTerm":"Glaucoma, Open-Angle"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009798",
                "ConditionAncestorTerm":"Ocular Hypertension"
              },{
                "ConditionAncestorId":"D000005128",
                "ConditionAncestorTerm":"Eye Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M7596",
                "ConditionBrowseLeafName":"Glaucoma",
                "ConditionBrowseLeafAsFound":"Glaucoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M7597",
                "ConditionBrowseLeafName":"Glaucoma, Open-Angle",
                "ConditionBrowseLeafAsFound":"Open Angle Glaucoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8607",
                "ConditionBrowseLeafName":"Hypertension",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11314",
                "ConditionBrowseLeafName":"Ocular Hypertension",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6854",
                "ConditionBrowseLeafName":"Eye Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T4577",
                "ConditionBrowseLeafName":"Pigment-dispersion Syndrome",
                "ConditionBrowseLeafAsFound":"Open Angle Glaucoma",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC11",
                "ConditionBrowseBranchName":"Eye Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}