NCT07227714

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40,000 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

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.

Conditions

• Cataract Surgery
• Eye Care
• Glasses
• Primary Eye Care
• Vision Center
• Eyecare Visits

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-06-01
• Completion: 2028-09-01
• First posted: 2025-11-13
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States