{"doc_desc":{"title":"Longitudinal study of patients with treated ocular hypertension and primary open-angle glaucoma","idno":"FRESH-PEF73206-en","producers":[{"name":"Florent APTEL","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73206-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73206"},{"agency":"FReSH","code":"FRESH-PEF73206"}]},"title":"Longitudinal study of patients with treated ocular hypertension and primary open-angle glaucoma","alternate_title":"ProgF"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Florent;APTEL","PILabo":"CHU Grenoble","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE","extlink":[{"title":"ORCID","uri":"0000-0003-1537-9992","role":"pi id"},{"title":"IdRef","uri":"139872213","role":"pi id"},{"title":"SIREN","uri":"263800302","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"glaucoma"},{"keyword":"trend analysis"},{"keyword":"visual field progression"},{"keyword":"ocular hypertension"}],"topics":[{"topic":"Ophthalmology","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":"Ocular hypertension","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/535283437","title":"CIM-11"}]}],"purpose":"Observe the progression of the visual field of patients with ocular hypertension or primary glaucoma","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"All patients with glaucoma monitored in the glaucoma unit of the CHU Grenoble and the h\u00f4pital militaire du Val-de-Gr\u00e2ce having undergone a complete ophthalmological examination including visual field examinations at least every 6 months\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"228"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"25-08-2015","lastUpdatedAuto":null,"lastUpdatedManual":"13-09-2017","isContributorPI":"No","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":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Data collected from an automated computer system","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Grenoble, Paris"},"dataTypes":{"clinicalDataDetails":"Name, sex, date of birth, ethnic origin, the eye (right or left), classification of glaucoma diagnosis, systemic history of state of health, ophthalmic history (eyes, date, description), ophthalmic surgeries (eye, date, description), ophthalmic laser treatment (eye, date, description), systemic and medical ophthalmic treatment (name, indication, route of administration, dose, frequency, the eye if need be, opening date, completion date or ongoing) central corneal thickness, objective refraction, lens status (phakia, pseudophakia, aphakia), best corrected visual acuity, IOP, the reliability indices of the standard automated perimetry, mean deviation (MD), the pattern standard deviation, the visual field index (VFI)","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}