[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504564":3},{"organization":4,"outcomesModule":7,"designInfo":60,"detailedDescription":66,"studyPopulation":59,"armGroups":67,"interventions":74,"overallOfficials":79,"centralContacts":84,"locations":59,"responsibleParty":94,"collaborators":96,"id":100,"slug":59,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":59,"enrollmentInfo":108,"targetDuration":59,"studyType":111,"phases":112,"briefSummary":113,"conditions":114,"keywords":59,"overallStatus":116,"whyStopped":59,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":59},{"fullName":5,"class":6},"Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":52,"otherOutcomes":59},[9,13,16,19,22,25,28,31,34,37,40,43,46,49],{"measure":10,"description":11,"timeFrame":12},"Visual acuity","Using the ETDRS and the near vision scale (decimal scales converted to logMAR)","10 years",{"measure":14,"description":15,"timeFrame":12},"Refraction measures","Measure will be performed in diopter",{"measure":17,"description":18,"timeFrame":12},"Lens opacity","Measure will be performed in pixel units",{"measure":20,"description":21,"timeFrame":12},"Intraocular pressure and pachymetry","These measurements are respectively carried out in mmHg and in μm",{"measure":23,"description":24,"timeFrame":12},"Retinal sensitivity and fixation stability","Respectively Performed in decibels and by microperimetry",{"measure":26,"description":27,"timeFrame":12},"Central visual field deficits","by automatic perimetry in decibels",{"measure":29,"description":30,"timeFrame":12},"Axial length","Will be performed in mm",{"measure":32,"description":33,"timeFrame":12},"Quantitative data","On optical coherence tomography (OCT) and OCT-Angiography",{"measure":35,"description":36,"timeFrame":12},"qualitative data on OCT :","presence of any macular complications:\n\n* condition of the posterior vitreous\n* presence of inner or outer retinal alteration (fluid, layer disorganization, band interruption...).",{"measure":38,"description":39,"timeFrame":12},"Area of Rétinal atrophy","In autofluorescence (in mm²)",{"measure":41,"description":42,"timeFrame":12},"Characterization of the type of staphyloma","staphyloma classification",{"measure":44,"description":45,"timeFrame":12},"Vitreous status","Liquefaction, stage of posterior vitreous detachment",{"measure":47,"description":48,"timeFrame":12},"Excavation of the optic nerve and area","In mm² of peripapillary atrophy on color and autofluorescence images",{"measure":50,"description":51,"timeFrame":12},"Anterior segment status","Chamber measurement, corneal curvature (in mm)",[53,56],{"measure":54,"description":55,"timeFrame":12},"Macular ophthalmologic complications","Diffuse atrophy\u002Fpatch atrophy\u002Fmacular atrophy\n\n* Choroidal neovessel\n* Bruch's membrane rupture\n* Bulging macula\n* Papillary dysversion\n* Myopic staphyloma\n* Epiretinal membrane\n* Lamellar hole\n* Myopic foveoschisis\n* Macular hole",{"measure":57,"description":58,"timeFrame":12},"Non-macular ophthalmologic complications","* Glaucoma optic Neuropathy\n* Cataract\n* Retinal detachment",null,{"allocation":61,"interventionModel":62,"interventionModelDescription":63,"primaryPurpose":6,"observationalModel":59,"timePerspective":59,"maskingInfo":64},"NA","SINGLE_GROUP","Prospective, longitudinal, multicentric, non-randomized cohort study with constitution of a biological collection.\n\nThis study will include major and minor patients with high myopia",{"masking":65,"maskingDescription":59,"whoMasked":59},"NONE","This study allows to describe the evolution of different ophthalmological parameters of a population of strong myopes during their follow-up for 10 years using multimodal imaging techniques of the retina.\n\nProspective, longitudinal, multicentric, non-randomized cohort study with constitution of a biological collection.\n\nThis study will include major and minor patients with high myopia",[68],{"label":69,"type":70,"description":71,"interventionNames":72},"Hight Myopa","EXPERIMENTAL","Large Cohort of patients with hight Myopa",[73],"Other: Structural and fonctional phynotyping",[75],{"type":6,"name":76,"description":77,"armGroupLabels":78,"otherNames":59},"Structural and fonctional phynotyping","The additioan acts in this research are:\n\nFonctionnal phenotyping:Retinal sensitivity and fixation stability assessment using microperimetry, assessment of long-term fixation stability Structural Phenotyping: Anterior segment examination with OCT anterior Blood sample collection",[69],[80],{"name":81,"affiliation":82,"role":83},"Ramin TADAYONI, Pr","Hôpital Fondation Adolphe de Rothschild","PRINCIPAL_INVESTIGATOR",[85,90],{"name":86,"role":87,"phone":88,"phoneExt":59,"email":89},"Nabil BROUK","CONTACT","+331 40 02 11 26","nbrouk@15-20.fr",{"name":91,"role":87,"phone":92,"phoneExt":59,"email":93},"Hayet SERHANE","+331 40 02 11 44","hserhane@15-20.fr",{"type":95,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR",[97],{"name":98,"class":99},"Fondation Ophtalmologique Adolphe de Rothschild","NETWORK","100504564",false,"NCT05849974","Large Cohort of 1000 Patients With Severe Myopia","MyoCo1000","Inclusion Criteria:\n\n* Age ≥ 6 years\n* Severe myopia in at least one eye, defined as\n\n  * a refractive error ≤ -6.00 diopters OR\n  * an axial length ≥ 26.50 mm\n* Follow-up performed at at least one of the participating centers\n* Express consent to participate in the study\n* If age \\\u003C 18 years: express consent of the person(s) exercising parental authority\n* Affiliated or beneficiary of a health insurance\n\nExclusion Criteria:\n\n* Visual acuity \\\u003C 5 letters on the ETDRS (equivalent to \"finger count\" or less) in both eyes\n* Disorders of the transparent media in both eyes with opacities that may affect image quality\n* Syndromic myopia of genetic origin (Stickler syndrome type 1 and 2, Marfan syndrome, Ehler-Danlos disease type 4, Knobloch syndrome) or inherited retinal dystrophy (X-linked retinitis pigmentosa, congenital stationary night blindness of Schubert-Bornshein type, Bornholm eye disease)\n* Patient who does not wish to continue to be followed in one of the participating centers\n* Patient benefiting from a legal protection measure\n* Pregnant or breastfeeding woman","ALL","6 Years",{"count":109,"type":110},1000,"ESTIMATED","INTERVENTIONAL",[61],"The prevalence of myopia and severe myopia are increasing and will affect 50% and 10% of the population respectively. Severe myopia exposes an increased risk of glaucoma, cataract, retinal detachment and myopic maculopathy, a source of visual impairment.\n\nTo date, no European cohort study has been conducted to estimate the rate of these complications and to study the predictive parameters.",[115],"Myopia, Severe","NOT_YET_RECRUITING","2023-05-22",{"date":119,"type":120},"2023-05-23","ACTUAL",{"date":122,"type":110},"2023-06",{"date":124,"type":110},"2038-05",{"name":5,"class":6}]