Table 2.
Data category | Information |
Primary registry and trial identifying number | ClinicalTrials.gov NCT01969786 |
Date of registration in primary registry | 25 October 2013 |
Secondary identifying numbers | U10EY022880 |
Source(s) of monetary or material support | National Eye Institute-National Institutes of Health |
Primary sponsor | National Eye Institute-National Institutes of Health |
Secondary sponsor(s) | |
Contact for queries | Thomas M Lietman, MD (tom.lietman@ucsf.edu) |
Title | Village Integrated Eye Worker trial |
Countries of recruitment | Nepal |
Health condition(s) or problem(s) studied | Corneal ulcer prevention |
Intervention(s) | Intervention: training volunteer community health workers to diagnose corneal abrasions and provide antimicrobial ointment to prevent corneal ulcers Control: no intervention |
Key eligibility criteria | Community-level eligibility criteria (Village Development Committee): located within the catchment area of Bharatpur Eye Hospital, Population≥15 000 according to the 2001 national census Individual-level eligibility criteria: resident of eligible Village Development Committee |
Study type | Cluster-randomised trial |
Date of first enrolment | January 2014 |
Target sample size | 24 Village Development Committees, 216 000 individuals |
Recruitment status | Recruiting |
Primary outcome(s) | Incidence of corneal ulcer (time frame: 3 years) |
Key secondary outcomes | Trial-based cost-effectiveness analysis |