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
Centre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, BT12 6BA, UK.
Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City, 217 Hong Bang Street, District 5, Ho Chi Minh City, Vietnam.
Trials. 2024 Dec 18;25(1):825. 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 ≥ 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.
STABLE will be the first randomised trial of vision interventions and driving safety in a LMIC.
ClinicalTrials.gov, NCT05466955 . Initial registration: 20 July 2022, most recent update: 9 July 2024.
交通事故是全球5至29岁人群的主要死因，90%的死亡发生在低收入和中等收入国家（LMICs）。STABLE（通过利用眼保健减少两轮事故）试验旨在确定提供眼镜是否可以降低越南年轻近视摩托车使用者的风险。
这项研究者设盲、阶梯楔形、整群随机自然驾驶试验将在越南胡志明市的25个整群中招募625名年龄在18至23岁之间、每周驾驶≥50公里、有≥1年驾驶经验且以摩托车为主要交通工具的学生。在WHOeyes应用程序上自我测试未通过的同意参与学生的摩托车将安装带有摄像头和加速度计的数据采集系统（DAS）。每1000公里驾驶里程中，将对加速度计标记的事件的视频片段（±30秒）进行审查，以确定碰撞和险些碰撞事件（主要结局）。每12周将随机选择5个由25名学生组成的整群进行眼部检查，预计其中约40%的学生双眼等效球镜度数＜-0.5D，较好眼的远视力＜6/12，双眼矫正后≥6/7.5。将为他们提供免费的远用眼镜，并将他们在接受眼镜之前的驾驶数据作为对照条件进行分析，后续数据作为干预条件进行分析。次要结局包括视觉功能、成本效益和自我报告的碰撞事件。
STABLE将是低收入和中等收入国家首次进行的视力干预与驾驶安全的随机试验。
ClinicalTrials.gov，NCT05466955。初始注册：2022年7月20日，最新更新：2024年7月9日。
