STABLE trial of spectacle provision and driving safety among myopic motorcycle users in Vietnam: study protocol for a stepped-wedge, cluster randomised trial

• Published in: Trials 2024, Vol.25 (1)
• Main Authors: Le, Vinh Chi, To, Kien Gia, Le, Van Dat, Nguyen, Le, MacKenzie, Graeme, Sigwadhi, Lovemore Nyasha, Piyasena, Prabhath, Tran, Mai, Chan, Ving Fai, Khanna, Rohit C, Clarke, Mike, Lohfeld, Lynne, Dickey, Heather, Azuara-Blanco, Augusto, Mettla, Asha Latha, Rayasam, Sridevi, Doan, Han Thi Ngoc, Van Do, Dung, Le, Phuoc Hong, Klauer, Charlie, Hanowski, Richard, Bowden, Zeb, Murphy, Lynn, Thompson, Joanne, McMullan, Susan, McDowell, Cliona, Narayanan, Raja, Little, Julie-Anne, Ha, Huong Thu, Yoon, Sangchul, Goel, Rahul, Luong, Lan, Nguyen, Xuan, Congdon, Nathan
• Format: Report
• Language: English
• Subjects: Health aspects; Motorcycles
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-024-08644-2

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. This investigator-masked, stepped-wedge, cluster randomised naturalistic driving trial will recruit 625 students aged 18-23 years, driving [greater than or equal to] 50 km/week, with [greater than or equal to] 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 [greater than or equal 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. STABLE will be the first randomised trial of vision interventions and driving safety in a LMIC.