Village Integrated Eye Worker Trial (VIEW)
Corneal ulceration is a leading cause of visual impairment globally, with a disproportionate burden occurring in developing countries. While antimicrobial treatment is generally effective in eradicating infection, “successful” treatment is often associated with a poor visual outcome. The scarring that accompanies the resolution of infection leaves many eyes blind. Moreover, it has been difficult to discern differences in clinical outcomes like visual acuity between different antimicrobials in randomized controlled trials. Thus, prevention of corneal ulceration may be our best opportunity to reduce morbidity associated with corneal ulceration. In fact, previous non-randomized prevention studies in South Asia suggested that antibiotic ointment applied promptly after a corneal abrasion could reduce the incidence of corneal ulcers.
The Village Integrated Eye Worker Trial was designed to determine whether we can prevent corneal ulcers on a large scale. In this community-randomized trial, we are comparing villages randomized to receive an intervention that trains community health volunteers to provide antimicrobial ointment after corneal abrasion to control villages in rural Nepal. This study is funded by the National Eye Institute (U10EY02280).
Village Integrated Eye Worker Trial II (VIEW II)
To address the global burden of avoidable blindness, eye care systems must determine optimal strategies for identifying people with or at risk for visual impairment beyond opportunistic screening. After cataract and uncorrected refractive error, the leading causes of visual impairment globally are glaucoma, diabetic retinopathy (DR), corneal opacity, and age-related macular degeneration (AMD). Glaucoma, DR, and AMD are theoretically amenable to screening as they are treatable and initially asymptomatic. Mass screening for eye disease is currently not recommended as prior studies have been unable to demonstrate that screening improves visual acuity in the community. However, the available evidence is largely from resource-rich settings and limited by small sample sizes and considerable loss to follow-up.
The Village Integrated Eye Worker Trial II is a cluster-randomized trial that builds on the infrastructure developed for the first Village Integrated Eye Worker Trial (VIEW) to assess the effectiveness of a community-based screening program employing optical coherence tomography, intraocular pressure measurement, and enhanced linkage-to-care in reducing visual impairment in Nepal. To isolate the effect of screening for glaucoma, DR, and AMD, cases of cataract and refractive error are identified identically in both study arms during a baseline census. This study is funded by the National Eye Institute (UG1EY028097).
For more information, the complete Manual of Procedures, Statistical Analysis Plan, and data sharing statement are available at https://osf.io/fgvrt/.
Nepal Elimination of Trachoma Study (NETS)
Trachoma is a neglected tropical disease and is the most common cause of blindness from an infectious disease worldwide. The WHO aims to eliminate trachoma as a public health concern (control) by the year 2020. Clinical trachoma is poorly correlated with infection by the causative agent (C. trachomatis) in some situations, especially following mass antibiotic treatment. Mass antibiotic treatment with azithromycin is an essential element of the WHO’s trachoma elimination strategy. The common wisdom is that everyone in a community should be treated. There are several reasons why mass antibiotic treatments may be adequate to eliminate chlamydial infection although it is unclear if treatments can be stopped. If this approach is successful with ocular Chlamydia, it may be a valuable strategy against a variety of bacterial diseases. It is unknown if repeated treatments should continue or can be stopped thereby minimizing side effects and the high cost of medicine distribution.
The general research objective of Nepal Elimination of Trachoma Study is to define and certify elimination of ocular infection with Chlamydia trachomatis at the district level in Nepal and to evaluate whether repeated mass distributions of antibiotics are effective and safe through a randomized clinical trial.
Mycotic Ulcer Treatment Trial (MUTT)
Infectious keratitis is a leading cause of vision loss globally. Fungal keratitis accounts for as many as half of all corneal ulcers in certain tropical regions and can be more difficult to treat than bacterial corneal ulcers, often with worse outcomes. Though natamycin is the only topical antifungal approved by the United States Food and Drug Administration for topical ophthalmic use, expert surveys indicated that the majority of corneal specialists would prefer to use voriconazole. The Mycotic Ulcer Treatment Trials (MUTT) are two separate randomized, placebo-controlled, masked clinical trials funded by the National Eye Institute (NEI) and the National Institutes of Health (NIH). In the first trial (MUTT I), we compared voriconaozle to natamycin in the treatment of filamentous fungal keratitis and found that natamycin results in improved visual outcomes. The ongoing second trial (MUTT II) compares whether the addition of oral voriconazole to topical voriconazole leads to improved outcomes for severe filamentous fungal keratitis in patients treated with natamycin. These studies are a collaboration between the F.I. Proctor Foundation at UCSF, the Aravind Eye Care System in South India, Lumbini Eye Institute and Bharatpur Eye Hospital in Nepal, and Dartmouth Medical School. For further information about these trials, please see: