Table 2

Trial registration data and protocol summary

Data categoryInformation
Primary registry and trial identifying numberClinicalTrials.gov NCT01969786
Date of registration in primary registry25 October 2013
Secondary identifying numbersU10EY022880
Source(s) of monetary or material supportNational Eye Institute-National Institutes of Health
Primary sponsorNational Eye Institute-National Institutes of Health
Secondary sponsor(s)
Contact for queriesThomas M Lietman, MD (tom.lietman@ucsf.edu)
TitleVillage Integrated Eye Worker trial
Countries of recruitmentNepal
Health condition(s) or problem(s) studiedCorneal 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 criteriaCommunity-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 typeCluster-randomised trial
Date of first enrolmentJanuary 2014
Target sample size24 Village Development Committees, 216 000 individuals
Recruitment statusRecruiting
Primary outcome(s)Incidence of corneal ulcer (time frame: 3 years)
Key secondary outcomesTrial-based cost-effectiveness analysis