[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475134":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":41,"responsibleParty":65,"collaborators":68,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":18,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":44,"whyStopped":18,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Queen's University, Belfast","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Free eye glasses for un or under-corrected myopia","EXPERIMENTAL","Free eyeglasses for the correction of uncorrected myopia will be provided to participants at the time of enrolment into the intervention group.",[13],"Device: Free eye glasses for un or under-corrected myopia",{"label":15,"type":16,"description":17,"interventionNames":18},"Control-No treatment","NO_INTERVENTION","Participants in the control period will not have glasses but the SW-CRT design means that all trial participants with uncorrected myopia will receive free glasses by the trials' completion, and no participant will have glasses withheld after being diagnosed with un- or under-corrected myopia.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","All participants randomised to the intervention group will be provided with free eye glasses",[9],[25],{"name":26,"affiliation":27,"role":28},"Tô Gia Kiên, PhD","University of Medicine and Pharmacy at Ho Chi Minh City Vietnam","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Nathan G Congdon, MD, MPH","CONTACT","+44(0)289097","8929","n.congdon@qub.ac.uk",{"name":37,"role":32,"phone":38,"phoneExt":39,"email":40},"Rohit C Khanna, MPH","91403522","5600","rohit@lvpei.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University of Medicine and Pharmacy at Ho Chi Minh City","RECRUITING","Ho Chi Minh City","Hong Bang Ward 11","217","Vietnam","VN",{"type":51,"coordinates":52},"Point",[53,54],106.62965,10.82302,{"lat":54,"lon":53},[57,61],{"name":58,"role":32,"phone":59,"phoneExt":18,"email":60},"Kien To Gia, PhD","+84 90 78 57 370","togiakien@ump.edu.vn",{"name":62,"role":32,"phone":63,"phoneExt":18,"email":64},"Mai Tran, MPH","(84-28) 6299 1409","mai.tran@aipf-vietnam.org",{"type":28,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Nathan Congdon","Professor",[69,71,72,75,77,79,81],{"name":70,"class":6},"L.V. Prasad Eye Institute",{"name":43,"class":6},{"name":73,"class":74},"Asia Injury Prevention Foundation","UNKNOWN",{"name":76,"class":6},"Clearly",{"name":78,"class":6},"Belfast Health and Social Care Trust",{"name":80,"class":74},"Transport Development and Strategy Institute, Ministry of Transport, Vietnam",{"name":82,"class":74},"EyeCare Foundation","100475134","slashing-two-wheeled-accidents-by-leveraging-eyecare-100475134",false,"NCT05466955","Slashing Two-wheeled Accidents by Leveraging Eyecare","Slashing Two-wheeled Accidents by Leveraging Eyecare: a Stepped-wedge Cluster Randomised Controlled Trial to Assess Impact of Spectacles on Reducing Crash and Near-crash Events Among Myopic Motorcycle Drivers in Ho Chi Minh City Vietnam","STABLE","Inclusion Criteria:\n\nInclusion criteria for DAS fitting\n\nStudents from selected universities will be eligible to participate if they:\n\n* are aged 18 to 23 years\n* have at least one year or more years of driving experience\n* are the sole user of their motorcycle\n* use their motorcycle as their primary means of transport\n* drive at least 25 km per week (self-report)\n* hold a valid driving license if their motorcycle has an engine capacity \\>50cc\n\nInclusion criteria for assignment to Intervention group\n\nParticipants will be eligible for assignment to transition into the intervention group if, during the STABLE clinical examination, they are found to have:\n\n* presenting distance visual acuity \\\u003C= 6\u002F12 in the better-seeing eye due to un- or under-corrected myopia,\n* vision correctable to 6\u002F7.5 or better in both eyes\n* at least 0.5 Dioptre of myopia\n\nExclusion Criteria:\n\nIndividuals with any ocular or systemic abnormalities affecting vision will be ineligible to participate.","ALL","18 Years","23 Years",{"count":95,"type":96},625,"ESTIMATED","INTERVENTIONAL",[99],"NA","STABLE is a stepped-wedge cluster randomised controlled trial and its primary aim is to determine whether the provision of spectacles for the correction of myopia can reduce the average number of crash-near-crash (CNC) events among eligible motorcycle drivers in Vietnam as measured under naturalistic driving conditions with the Data Acquisition System (DAS).\n\nSTABLE is designed to assess the impact of vision correction on the safety of road users in a a Low and Middle income countries (LMIC) setting. A positive trial outcome would demonstrate the safety benefits of vision correction and would create pressure for tighter regulation of drivers' vision and the promotion of vision correction.\n\nThe study will be conducted in the peri-urban universities in Ho Chi Minh City, Vietnam and 625 students from five universities will be recruited into the trial.\n\nBefore conducting the main trial, a pilot of 35 students will be recruited to test DAS and build CNC dictionary.\n\nDuration of the trial is 33 months from enrolment to completion of primary analysis, with 18 months for data collection.\n\nStudy participants can be both male and female motorcycle drivers aged 18 to 23 years years with at least one year of driving experience; they must use their motorcycle as their primary means of transport; drive at least 25 km per week and present with un- or under-corrected myopia that can be corrected with spectacles.\n\nParticipants with any ocular or systemic abnormality affecting vision, other than un-or under-corrected myopia will be excluded from the trial.\n\nSTABLE's primary outcome is CNC events per 1,000 km driven the DAS mounted to the motorcycles of trial participants. An interim analysis of the primary outcome will take place 9 months after data collection begins. The interim analysis will be reviewed by the trial's Data Monitoring and Ethics Committee. Unless a change is needed because of this review, the trial's primary analysis will take place 18 months after the DAS units are fitted to participants' motorcycle).\n\nCompliance with study glasses; self-reported visual function (driving-adapted Visual Function Questionnaire-25 \\[VFQ-25\\]); Dula Dangerous Driving Index (DDDI), for all crashes; self-reported CNC events for comparison with recorded CNC events and total delivery cost per CNC event avoided with the intervention (indicator of cost-effectiveness).",[102],"Myopia",[104,105,106,107],"crash events","near-crash events","myopia","motorcycle drivers","2025-07-14",{"date":110,"type":111},"2025-07-17","ACTUAL",{"date":113,"type":111},"2024-09-22",{"date":115,"type":96},"2027-12",{"name":5,"class":6},1]