[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600719":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":24,"responsibleParty":44,"collaborators":24,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":24,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":24,"overallStatus":66,"whyStopped":24,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":24},{"fullName":5,"class":6},"Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"Qualitative Phase","The \"Qualitative\" phase, estimated to last six months, will be conducted on a panel of up to 30 patients with hight myopia for the purpose of conducting semi-structured interviews and pre-tests to calibrate the Perf Outcome parameters.",[12,13,14],"Other: Quality of life questionnaire","Other: Performance Outcomes (PerfO)","Other: Semi-structured interviews",{"label":16,"type":6,"description":17,"interventionNames":18},"Exploratory Phase","The \"Exploratory\" phase, estimated to last 18 months, will be conducted on a panel of 70 patients with hight myopia in order to explore the validity of Perf Outcome.",[12,13],[20,25,29],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Quality of life questionnaire","The NEI-RQL-42 (National Eye Institute Refractive Quality of Life) questionnaire will be self-administered via a secure online platform to assess the impact of pathological myopia on quality of life.",[16,9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Performance Outcomes (PerfO)","Three tests are planned to assess the impact of high myopia on critical aspects of mobility and safety, with the possibility of adjusting their scope based on pilot data.\n\n* The first test involves an assessment of driving on a simulator, designed to evaluate the performance of detecting pedestrians in peripheral vision, with and without glare.\n* The second test focuses on assessing mobility and obstacle avoidance under six levels of brightness.\n* The third test evaluates visual search ability. It consists of finding spheres in everyday scenes in an apartment with six levels of contrast tested.",[16,9],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":24},"Semi-structured interviews","Semi-structured interviews will only be offered to patients recruited in Phase 1 Qualitative and aim to further explore the information gathered from the NEI-RQL-42 questionnaire responses and the difficulties encountered during the performance tasks in the laboratory, by exploring in more detail the limitations encountered by patients with pathological myopia in their daily activities. These interviews will help identify the specific causes of the difficulties encountered, as well as the environmental conditions that may create discomfort or increased hardship.",[9],[34],{"name":35,"affiliation":36,"role":37},"Elise PHILIPPAKIS, MD","Hôpital Fondation Adolphe de Rothschild","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":24,"email":43},"Nabil BROUK","CONTACT","00 33 1 40 02 11 44","nbrouk@15-20.fr",{"type":45,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100600719","100-high-myopia-patient-reported-outcomes-pro-and-performance-outcomes-perfo-100600719",false,"NCT07101146","100 High Myopia Patient-reported Outcomes (PRO) and Performance Outcomes (PERFO)","Pathological Myopia and Quality of Life: An Exploratory Study of Patient Outcomes and Perceptions","PPO100","Inclusion Criteria:\n\nPatients with pathological myopia and diffuse choroidal atrophy (DCA, Cat. 2 Meta PM)\n\n* Age ≥ 18 years and ≤ 55 years;\n* Patient consenting to be included in the study;\n* Examination and follow-up in at least one of the participating centers;\n* Severe pathological myopia with an axial length ≥ 26.5 mm in both eyes;\n* Presence of diffuse atrophy (category 2 of the Meta-PM classification) in the better eye;\n* Affiliated with or covered by a social security system.\n\nPathological myopic patients with patch choroidal atrophy (PCA,\n\nCat. 3 Meta PM):\n\n* Age ≥ 18 years and ≤ 55 years;\n* Patients who consent to be included in the study;\n* Examination and follow-up at least one of the participating centers;\n* High myopia with an axial length ≥ 26.5 mm in both eyes;\n* Presence of patch atrophy (category 3 of the Meta-PM classification) in the better eye;\n* Affiliated with or beneficiary of a social security system.\n\nExclusion Criteria:\n\n* Identified genetic syndromic myopia, including Stickler syndromes type 1 and 2 (collagen 2A1 and 11A1), Marfan syndrome (fibrillin), Ehler-Danlos syndrome type 4 (lysyl-protocollagen hydroxylase), and Knobloch syndrome (collagen 18A).\n* Patient unwilling to participate or be followed up at one of the participating centers.\n* Binocular visual acuity ≥ 1 logMar (\\\u003C0.1 on the decimal scale).\n* Media opacities preventing quality imaging, including cataracts.\n* Patients benefiting from legal protection measures.\n* Pregnant or breastfeeding women.\n* Individuals who may not be able to tolerate the driving simulator.","ALL","18 Years","55 Years",{"count":58,"type":59},100,"ESTIMATED","INTERVENTIONAL",[62],"NA","Prospective, longitudinal, interventional, exploratory, non-randomized, single-center study including patients with pathological myopia .",[65],"High Myopia","NOT_YET_RECRUITING","2025-08-01",{"date":69,"type":70},"2025-08-03","ACTUAL",{"date":72,"type":59},"2025-10",{"date":74,"type":59},"2028-11-30",{"name":5,"class":6}]