Summary

Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Kieran O'Brien, PhD, MPH (ucsf)

Description

Summary

The goal of this clinical trial is 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 increase visits to eyecare centers?
  2. Do vision centers increase spectacle ownership and wearing?
  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.

Official Title

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

Details

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.

We 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. We expect to provide rigorous evidence on VC impact in real-world settings that can be used to influence programmatic decision making and policy.

Keywords

Cataract Surgery, Eye Care, Glasses, Primary Eye Care, Vision Center, Eyecare Visits, glassess ownership, spectacle ownership, cluster-randomized trial, Establishment of a vision center, Immediate establishment of a vision center

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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.

Location

  • University of California, San Francisco
    San Francisco 5391959 California 5332921 94158 United States

Lead Scientist at University of California Health

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07227714
Study Type
Interventional
Participants
Expecting 40000 study participants
Last Updated