STABLE trial of spectacle provision and driving safety among myopic motorcycle users in Vietnam: study protocol for a stepped-wedge, cluster randomised trial
Vinh Chi Le,
Kien Gia To,
Van Dat Le,
Le Nguyen,
Graeme MacKenzie,
Lovemore Nyasha Sigwadhi,
Prabhath Piyasena,
Mai Tran,
Ving Fai Chan,
Rohit C. Khanna,
Mike Clarke,
Lynne Lohfeld,
Heather Dickey,
Augusto Azuara-Blanco,
Asha Latha Mettla,
Sridevi Rayasam,
Han Thi Ngoc Doan,
Dung Van Do,
Phuoc Hong Le,
Charlie Klauer,
Richard Hanowski,
Zeb Bowden,
Lynn Murphy,
Joanne Thompson,
Susan McMullan,
Cliona McDowell,
Raja Narayanan,
Julie-Anne Little,
Huong Thu Ha,
Sangchul Yoon,
Rahul Goel,
Lan Luong,
Xuan Nguyen,
Nathan Congdon
Affiliations
Vinh Chi Le
Centre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen’s University Belfast
Kien Gia To
Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City
Van Dat Le
Transport Development and Strategy Institute
Le Nguyen
Asia Injury Prevention Foundation
Graeme MacKenzie
Riemann Limited
Lovemore Nyasha Sigwadhi
Hyderabad Eye Research Foundation, L V Prasad Eye Institute
Prabhath Piyasena
Vision and Eye Research Institute, Anglia Ruskin University
Mai Tran
Asia Injury Prevention Foundation
Ving Fai Chan
Centre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen’s University Belfast
Rohit C. Khanna
Hyderabad Eye Research Foundation, L V Prasad Eye Institute
Mike Clarke
Centre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen’s University Belfast
Lynne Lohfeld
Centre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen’s University Belfast
Heather Dickey
Centre for Health Research at the Management School Economics, Queen’s University Belfast
Augusto Azuara-Blanco
Centre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen’s University Belfast
Asha Latha Mettla
Hyderabad Eye Research Foundation, L V Prasad Eye Institute
Sridevi Rayasam
Hyderabad Eye Research Foundation, L V Prasad Eye Institute
Han Thi Ngoc Doan
Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City
Dung Van Do
Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City
Phuoc Hong Le
Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City
Charlie Klauer
Virginia Tech Transportation Institute
Richard Hanowski
Virginia Tech Transportation Institute
Zeb Bowden
Virginia Tech Transportation Institute
Lynn Murphy
Northern Ireland Clinical Trials Unit
Joanne Thompson
Northern Ireland Clinical Trials Unit
Susan McMullan
Northern Ireland Clinical Trials Unit
Cliona McDowell
Northern Ireland Clinical Trials Unit
Raja Narayanan
Hyderabad Eye Research Foundation, L V Prasad Eye Institute
Julie-Anne Little
Centre of Optometry and Vision Science, School of Biomedical Sciences, Ulster University
Huong Thu Ha
Hanoi Medical University
Sangchul Yoon
Department of Medical Humanities and Social Sciences, Yonsei University College of Medicine
Rahul Goel
Transportation Research and Injury Prevention Centre, Indian Institute of Technology
Lan Luong
Eye Care Foundation
Xuan Nguyen
Eye Care Foundation
Nathan Congdon
Centre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen’s University Belfast
Abstract Background Traffic crashes are the leading cause of death globally for people aged 5–29 years, with 90% of mortality occurring in low- and middle-income countries (LMICs). The STABLE (Slashing Two-wheeled Accidents by Leveraging Eyecare) trial was designed to determine whether providing spectacles could reduce risk among young myopic motorcycle users in Vietnam. Methods This investigator-masked, stepped-wedge, cluster randomised naturalistic driving trial will recruit 625 students aged 18–23 years, driving ≥ 50 km/week, with ≥ 1-year driving experience and using motorcycles as their primary means of transport, in 25 clusters of 25 students in Ho Chi Minh City, Vietnam. Motorcycles of consenting students who have failed self-testing on the WHOeyes app will be fitted with Data Acquisition Systems (DAS) with video cameras and accelerometers. Video clips (± 30 s) of events flagged by the accelerometer will be reviewed for crash and near-crash events per 1000 km driven (main outcome). Five clusters of 25 students will be randomly selected every 12 weeks to undergo ocular examination and an estimated 40% of these will have bilateral spherical equivalent < − 0.5 D, and better-eye presenting distance visual acuity < 6/12, correctable bilaterally to ≥ 6/7.5. They will be given free distance spectacles and their driving data before receiving spectacles will be analysed as the control condition and subsequent data as the intervention condition. Secondary outcomes include visual function, cost-effectiveness and self-reported crash events. Discussion STABLE will be the first randomised trial of vision interventions and driving safety in a LMIC. Trial registration ClinicalTrials.gov, NCT05466955 . Initial registration: 20 July 2022, most recent update: 9 July 2024.
