Slashing Two-wheeled Accidents by Leveraging Eyecare

NCT05466955 | Recruiting DMC

• 1 other identifier: MHLS 22_68
• Study Type: interventional
• Target: 625
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Myopia

Keywords

crash events; near-crash events; myopia; motorcycle drivers

Outcome Measures

Primary Outcomes (1)

• 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.

  up to18 months

Secondary Outcomes (4)

• Cost-effectiveness

  18 months, Collected at the end of the trial.

• Self-reported crashes

  up to 18 months

• Spectacle compliance

  up to 18 months

• Visual Function

  VFQ-25 is administered at baseline and one month after receiving glasses.

Study Arms (2)

Free eye glasses for un or under-corrected myopia

EXPERIMENTAL

Free eyeglasses for the correction of uncorrected myopia will be provided to participants at the time of enrolment into the intervention group.

Device: Free eye glasses for un or under-corrected myopia

Control-No treatment

NO INTERVENTION

Participants in the control period will not have glasses but the SW-CRT design means that all trial participants with uncorrected myopia will receive free glasses by the trials' completion, and no participant will have glasses withheld after being diagnosed with un- or under-corrected myopia.

Interventions

Free eye glasses for un or under-corrected myopia DEVICE

All participants randomised to the intervention group will be provided with free eye glasses

Free eye glasses for un or under-corrected myopia

Eligibility Criteria

• Age: 18 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Students from selected universities will be eligible to participate if they:
• 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
• drive at least 25 km per week (self-report)
• hold a valid driving license if their motorcycle has an engine capacity \>50cc
• Participants will be eligible for assignment to transition into the intervention group if, during the STABLE clinical examination, they are found to have:
• presenting distance visual acuity \<= 6/12 in the better-seeing eye due to un- or under-corrected myopia,
• vision correctable to 6/7.5 or better in both eyes
• at least 0.5 Dioptre of myopia

You may not qualify if:

• Individuals with any ocular or systemic abnormalities affecting vision will be ineligible to participate.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• 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

Study Sites (1)

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Hong Bang Ward 11, 217, Vietnam

RECRUITING

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• Le VC, To KG, Le VD, Nguyen L, MacKenzie G, Sigwadhi LN, Piyasena P, Tran M, Chan VF, Khanna RC, Clarke M, Lohfeld L, Dickey H, Azuara-Blanco A, Mettla AL, Rayasam S, Doan HTN, Van Do D, Le PH, Klauer C, Hanowski R, Bowden Z, Murphy L, Thompson J, McMullan S, McDowell C, Narayanan R, Little JA, Ha HT, Yoon S, Goel R, Luong L, Nguyen X, Congdon N. STABLE trial of spectacle provision and driving safety among myopic motorcycle users in Vietnam: study protocol for a stepped-wedge, cluster randomised trial. Trials. 2024 Dec 18;25(1):825. doi: 10.1186/s13063-024-08644-2.

  PMID: 39695859 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Tô Gia Kiên, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City Vietnam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan G Congdon, MD, MPH

CONTACT

+44(0)289097; n.congdon@qub.ac.uk

Rohit C Khanna, MPH

CONTACT

91403522; rohit@lvpei.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The trial will be investigator-masked, but not participant-masked, because all participants who are eligible for eye glasses will be given them. The study's outcomes, including Crash and near Crash (CNC) events per 1,000 km, self-reported visual function (Visual Function Questionnaire (VFQ-25), and CI SRQ Crash and Injury Self report Questionnaire for all crashes, Dula Dangerous Driving Index (DDDI) will be masked from assessors. All care will be taken to ensure that the study team are kept masked and the trial team do not foresee conditions that will require emergency unmasking.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: STABLE is a naturalistic driving trial with a Stepped Wedge-Cluster Randomised Trial (SW-CRT) design. The unit of randomisation in STABLE is the cluster: five universities in Ho Chi Minh City, Vietnam. The design involves random, sequential crossover of clusters from control to intervention until all clusters are exposed to the study intervention. The stepped-wedge cohort design with exchangeable correlation structure will comprise six sequences (steps) of an estimated seven myopic participants per cluster, and five clusters per sequence. The duration of each sequence is 12 weeks. Participants will not be masked to whether they are in the control or intervention period but investigators assessing study outcomes will be masked to this.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 20, 2022
• Study Start: September 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: All deidentified IPD will be available from February 2023 (anticipated Trial start date) to December 2025 (inclusive of analysis, publication and archival).
• Access Criteria: STABLE's research team will not provide any government with direct and unfettered access to trial participant data. Government authorities seeking access to trial data must follow applicable legal processes and supply a warrant, court order for content or a subpoena for trial data.

Locations

VN (1)