Condition: Myopia · Sponsor: Queen's University, Belfast
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). STABLE 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. The 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. Before conducting the main trial, a pilot of 35 students will be recruited to test DAS and build CNC dictionary. Duration of the trial is 33 months from enrolment to completion of primary analysis, with 18 months for data collection. Study 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. Participants with any ocular or systemic abnormality affecting vision, other th…
This description comes directly from the study's public registry record.
Nathan G Congdon, MD, MPH · +44(0)289097 · n.congdon@qub.ac.uk
Rohit C Khanna, MPH · 91403522 · rohit@lvpei.org
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| University of Medicine and Pharmacy at Ho Chi Minh City | Ho Chi Minh City, Hong Bang Ward 11, Vietnam | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05466955