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

May 15, 2026 updated by: University of California, San Francisco

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

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 visual acuity of the population?

Researchers will compare outcomes in communities randomized to have a vision center is established with communities randomized to delay 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate establishment of a vision center
The intervention arm will include the establishment of a fixed vision center equipped with trained vision technicians to provide basic eye care services and referrals to higher care.
Other: Establishment 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.
No Intervention: Delayed establishment of a vision center
The control arm will receive no intervention during the study period. The establishment of a vision center will occur after endline data collection, if hospital interest and resources remain adequate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective refractive error coverage
Time Frame: 2 years
Defined as the proportion of survey participants with met need for refractive error correction with good quality vision of 6/12 or better in the better seeing eye divided by the total number of people in need (met need + undermet need + unmet need).
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of current spectacle ownership
Time Frame: 2 years.
Prevalence of current spectacle ownership assessed during the population-based survey among all age groups.
2 years.
Prevalence of spectacle wearing
Time Frame: 2 years
Prevalence of spectacle wearing as assessed during the survey among all age groups.
2 years
Mean presenting and pinhole visual acuity
Time Frame: 2 years
Mean presenting and pinhole visual acuity (logMAR) as assessed during the survey among adults 50 years and older, among children younger than 18 years, and among all ages.
2 years
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, for adults aged 50 years and older, children younger than 18 years, and all ages.
2 years
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, for adults aged 50 years and older, children younger than 18 years, and all ages.
2 years
Prevalence of employment
Time Frame: 2 years
Prevalence of employment as assessed during the population-based survey among adults 18 years and older.
2 years
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.
2 years
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Seva Foundation
Proctor Foundation

Investigators

  • Principal Investigator: Kieran O'Brien, PhD, MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 10, 2025

First Submitted That Met QC Criteria

November 10, 2025

First Posted (Actual)

November 13, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25-45086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified cluster-level data will be shared publicly via osf.io

IPD Sharing Time Frame

Data will be shared at the time of publication

IPD Sharing Access Criteria

General public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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