{"doc_desc":{"title":"\u00c9tude longitudinale sur de patients souffrant d'hypertension oculaire trait\u00e9e et de glaucome primaire \u00e0 angle ouvert","idno":"FRESH-PEF73206-fr","producers":[{"name":"Florent APTEL","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73206-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73206"},{"agency":"FReSH","code":"FRESH-PEF73206"}]},"title":"\u00c9tude longitudinale sur de patients souffrant d'hypertension oculaire trait\u00e9e et de glaucome primaire \u00e0 angle ouvert","alternate_title":"ProgF"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Florent;APTEL","firstname":"Florent","lastname":"APTEL","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/041rhpw39","role":"organisation id"},{"title":"SIREN","uri":"263800302","role":"organisation id"}],"email":"","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE","PILabo":"CHU Grenoble","isContact":false}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/041rhpw39","role":"sponsor id"},{"title":"SIREN","uri":"263800302","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/041rhpw39"},{"title":"SIREN","uri":"263800302"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"glaucome - hypertension oculaire - lanalyse des tendances - progression du champ visuel"}],"topics":[{"topic":"Ophtalmologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/621ef1ce-2ebd-43d9-a6c7-ecd962d27269"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009885"}]},{"topic":"Hypertension oculaire","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/535283437","title":"CIM-11"}]},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"}],"purpose":"Observer la progression du champ visuel de patients souffrant d'hypertension oculaire ou de glaucome primaire","abstract":"","coll_dates":[{"start":"1998-01-01","end":"2013-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes','Ile-de-France']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Tous les patients atteints de glaucome suivis dans l'Unit\u00e9 de glaucome du CHU de Grenoble et de l'h\u00f4pital militaire du Val-de-Gr\u00e2ce ayant subi un examen ophtalmologique complet y compris les examens du champ visuel au moins tous les 6 mois\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"228"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"25-08-2015","lastUpdatedAuto":null,"lastUpdatedManual":"13-09-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/26095771"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Donn\u00e9es receuillies \u00e0 partir d'un syt\u00e8me informatique automatis\u00e9","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Grenoble, Paris"},"dataTypes":{"clinicalDataDetails":"Nom, sexe, date de naissance, l'origine ethnique, l'\u0153il (droite ou gauche), la classification de diagnostic de glaucome, l'histoire syst\u00e9mique de l'\u00e9tat de sant\u00e9, l'histoire de l'\u00e9tat ophtalmique (yeux, la date, la description), les chirurgies ophtalmiques (\u0153il, la date, la description), traitement laser ophtalmique (oeil, date, description), traitement syst\u00e9mique et ophtalmique m\u00e9dicale (nom, l'indication, la route, la dose, la fr\u00e9quence, l'\u0153il le cas \u00e9ch\u00e9ant, date d'ouverture, date d'ach\u00e8vement ou en cours), l'\u00e9paisseur corn\u00e9enne centrale, la r\u00e9fraction objective, le statut de l'objectif (phakique, pseudophake, aphake), meilleure acuit\u00e9 visuelle corrig\u00e9e, la PIO, les indices de fiabilit\u00e9 de la p\u00e9rim\u00e9trie automatis\u00e9e standard, \u00e9cart moyen (MD), le motif \u00e9cart type, index du champ visuel (VFI)","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}