University of California, San Francisco
San Francisco, California, 94158, United States
NCT Number: NCT07227714
This cluster-randomized trial aims to evaluate the effect of vision centers on access to eye care and eye health outcomes in South Asia. The main questions it aims to answer are:
1. Do vision centers improve effective refractive error coverage? 2. Do vision centers increase eye care center utilization? 3. Do vision centers improve population visual acuity?
Researchers will compare outcomes in communities randomized to immediate versus delayed establishment of a vision center. Outcomes will be assessed through population-based surveys at baseline and after two years as well as through hospital records collected throughout the study period.
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Interventional
Not applicable
San Francisco, California, 94158, United States
The vast majority of visual impairment and blindness is preventable or treatable with existing interventions. Nearly all of this burden is faced by those living in low- and middle-income countries. Access to eye care is a key challenge in these settings, particularly in rural and remote areas.
Vision centers (VCs) have been developed to increase access to primary eye care in such underserved settings. VCs typically involve establishment of a fixed center staffed by a mid-level ophthalmic technician who offers refraction, spectacles, diagnosis and treatment of basic eye conditions, and referrals for more complex care. VCs have become a common approach to increase access to care in many low- and middle-income country settings, yet little rigorous evidence exists on their impact on eye health in the communities they serve. A recent literature review was unable to identify randomized controlled trials on the impact of vision centers on eye health outcomes in real world settings. While the observational research that exists suggests VCs improve eye health in the communities they serve, the existing evidence is prone to bias.
The investigators propose a cluster-randomized trial to evaluate the effect of VCs on access to eye care and eye health outcomes in South Asia. The trial will leverage VCs planned by the Seva Foundation and partners Bangladesh, India, and Nepal and will monitor outcomes via population-based surveys and hospital network records over 2 years. The investigators expect to provide rigorous evidence on VC impact in real-world settings that can be used to influence programmatic decision making and policy.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The establishment of a vision center includes building a fixed center, and equipping it with a trained vision technician to provide basic eye care services such as refractive error correction, spectacle dispensing, basic diagnosis for common conditions, as well as referrals for advanced care at base hospitals. The establishment of VCs will be actively publicized in the neighboring communities through promotion by local stakeholders, teachers, community workers, village leaders, health workers, and radio announcements prior to establishment. Additional outreach activities include posters and loudspeaker announcements in the communities the day before operations begin.
Time frame: 2 years
Proportion of survey participants with met need for distance refractive error correction with good quality vision of 6/12 or better in the better seeing eye among the total number of people in need (met need + undermet need + unmet need).
Time frame: 1 year
Prevalence of eyecare visits completed in the past one year, defined for each cluster as the number of individuals self-reporting having completed at least one visit in the past year divided by the total number of individuals surveyed.
Time frame: 2 years
Mean presenting and pinhole visual acuity (logMAR) as assessed during the survey.
Time frame: 2 years
Proportion of survey participants with met need for near vision correction with good quality vision of N6 or better among the total number of people in need of near vision correction (met need + undermet neet + unmet need)
Time frame: 2 years
Proportion of survey participants with met need for cataract surgery with a good-quality outcome of presenting visual acuity 6/12 or better among the total number of people who have had or are in need of cataract surgery
Time frame: 2 years.
Prevalence of current spectacle ownership assessed during the population-based survey.
Time frame: 2 years
Prevalence of spectacle wearing as assessed during the survey.
Time frame: 2 years
Visual impairment is defined as presenting visual acuity worse than logMAR 0.54 in the better-seeing eye as assessed during the population-based survey.
Time frame: 2 years
Blindness is defined as presenting visual acuity worse than logMAR 1.30 in the better-seeing eye as assessed during the population-based survey.
Time frame: 2 years
Prevalence of employment as assessed during the population-based survey.
Time frame: 2 years
Prevalence of individuals with caregiving responsibilities for visually impaired household members assessed during the population-based survey.
Contact information is provided by the study sponsor or research team.
Angela S Cheng, Masters of Public Health
CONTACT
Kieran O'Brien, PhD, MPH
CONTACT
University of California, San Francisco
Other
A Cluster-Randomized Trial Evaluating the Effect of Vision Centers on Access to Eye Care and Eye Health Outcomes in South Asia
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