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NCT Number: NCT07227714

Effect of Vision Centers on Access to Eye Care and Eye Health Outcomes

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Establishment of a vision center

Other

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.

Primary outcomes

  1. Effective refractive error coverage

    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).

Secondary outcomes

  1. Prevalence of eyecare visits

    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.

  2. Mean presenting and pinhole visual acuity

    Time frame: 2 years

    Mean presenting and pinhole visual acuity (logMAR) as assessed during the survey.

  3. Near vision effective refractive error coverage

    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)

  4. Effective cataract surgical coverage

    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

  5. Prevalence of current spectacle ownership

    Time frame: 2 years.

    Prevalence of current spectacle ownership assessed during the population-based survey.

  6. Prevalence of spectacle wearing

    Time frame: 2 years

    Prevalence of spectacle wearing as assessed during the survey.

  7. Prevalence of visual impairment

    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.

  8. Prevalence of blindness

    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.

  9. Prevalence of employment

    Time frame: 2 years

    Prevalence of employment as assessed during the population-based survey.

  10. Prevalence of individuals with caregiving responsibilities for visually impaired household members

    Time frame: 2 years

    Prevalence of individuals with caregiving responsibilities for visually impaired household members assessed during the population-based survey.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela S Cheng, Masters of Public Health

CONTACT

[email protected]

650-287-5150

Kieran O'Brien, PhD, MPH

CONTACT

[email protected]

415-514-2163

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Proctor Foundation
  • Seva Foundation

Registry information

Official study title

A Cluster-Randomized Trial Evaluating the Effect of Vision Centers on Access to Eye Care and Eye Health Outcomes in South Asia

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 13, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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