Cataract Surgery, Eye Care, Eyecare Visits, Glasses, Primary Eye Care, Vision Center
Conditions
Keywords
vision center, primary eye care, cataract surgery, glasses, glassess ownership, spectacle ownership, cluster-randomized trial, eyecare visits
Brief summary
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.
Detailed description
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.
Interventions
OTHEREstablishment of a vision center
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.
Sponsors
University of California, San Francisco
Seva Foundation
Proctor Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Survey data collectors and data analysts conducting the primary analyses will be masked. This will be achieved by not informing survey data collectors of arm assignment and by having an unmasked team member conceal arm assignment before primary analyses.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* The catchment area of the proposed VC site is predominantly rural. * The proposed VC site is located within 20-100 km of the base hospital. * There are no major primary eye care services within 10 km of the proposed site. * Care at sites randomized to establish VCs immediately is accessible to anyone.
Exclusion criteria
* Sites located in non-rural or urban catchment areas. * Sites outside the 20-100 km distance range from the base hospital. * Sites with existing major primary eye care services within a 10 km radius.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective refractive error coverage | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of eyecare visits | 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. |
| Mean presenting and pinhole visual acuity | 2 years | Mean presenting and pinhole visual acuity (logMAR) as assessed during the survey. |
| Near vision effective refractive error coverage | 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) |
| Effective cataract surgical coverage | 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 |
| Prevalence of current spectacle ownership | 2 years. | Prevalence of current spectacle ownership assessed during the population-based survey. |
| Prevalence of spectacle wearing | 2 years | Prevalence of spectacle wearing as assessed during the survey. |
| Prevalence of visual impairment | 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. |
| Prevalence of blindness | 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. |
| Prevalence of employment | 2 years | Prevalence of employment as assessed during the population-based survey. |
| Prevalence of individuals with caregiving responsibilities for visually impaired household members | 2 years | Prevalence of individuals with caregiving responsibilities for visually impaired household members assessed during the population-based survey. |
Countries
United States
Contacts
CONTACTKieran O'Brien, PhD, MPH
CONTACTAngela S Cheng, Masters of Public Health
PRINCIPAL_INVESTIGATORKieran O'Brien, PhD, MPH
University of California, San Francisco
Outcome results
None listed