About this trial
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 than un-or under-corrected myopia will be excluded from the trial.
STABLE'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).
Compliance 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
are aged 18 to 23 years
have at least one year or more years of driving experience
are the sole user of their motorcycle
use their motorcycle as their primary means of transport
Disqualifiers
None
Trial design
Crossover
Treatments tested in this trial
Free eye glasses for un or under-corrected myopia
DeviceAll participants randomised to the intervention group will be provided with free eye glasses
Treatment groups
Trial outcomes
Primary outcomes
Crash and near-crash (CNC) events per 1,000 km driven
CNC events as measured by Global Positioning System (GPS) and a gyroscopic sensor-video data-acquisition system (DAS) mounted to the motorcycles of trial participants.
Secondary outcomes
Cost-effectiveness
Total delivery cost per CNC event avoided with the intervention is the indicator of cost-effectiveness
Self-reported crashes
self- reported crashes compared with Data Aquisition System reported crashes and injuries are assessed using the questionnaire (Crash and Injury Self-Report Questionnaire \[CI SRQ\]).
Spectacle compliance
Glasses wear compliance will be assessed throughout the trial using a driver-facing camera mounted on the motorcycle's handlebars.
Visual Function
Visual Function is assessed by self-reported visual function (driving-adapted Visual Function Questionnaire-25 \[VFQ-25\]).
Sponsors and contacts
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Queen's University, Belfast
Lead sponsor
L.V. Prasad Eye Institute
Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City
Collaborator
Asia Injury Prevention Foundation
Collaborator
Clearly
Collaborator
Belfast Health and Social Care Trust
Collaborator
Transport Development and Strategy Institute, Ministry of Transport, Vietnam
Collaborator
EyeCare Foundation
Collaborator