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

NCT07227714 | Not Yet Recruiting

• 1 other identifier: 25-45086
• Study Type: interventional
• Target: 150,000
• Locations: 1 country
• Sites: 1

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. 1.Do vision centers improve effective refractive error coverage?
2. 2.Do vision centers increase eye care center utilization?
3. 3.Do vision centers improve population visual acuity?

Conditions

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

Keywords

vision center; primary eye care; cataract surgery; glasses; glassess ownership; spectacle ownership; cluster-randomized trial; eyecare visits

Outcome Measures

Primary Outcomes (1)

• Effective refractive error coverage

  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).

  2 years

Secondary Outcomes (10)

• Prevalence of eyecare visits

  1 year

• Mean presenting and pinhole visual acuity

  2 years

• Near vision effective refractive error coverage

  2 years

• Effective cataract surgical coverage

  2 years

• Prevalence of current spectacle ownership

  2 years.

Study Arms (2)

Immediate establishment of a vision center

EXPERIMENTAL

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

Delayed establishment of a vision center

NO INTERVENTION

The control arm will receive standard of care during the study period. The establishment of a vision center will occur after endline data collection, if hospital interest and resources remain adequate.

Interventions

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.

Immediate establishment of a vision center

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Seva Foundation: collaborator
• Proctor Foundation: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Study Officials

• Kieran O'Brien, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kieran O'Brien, PhD, MPH

CONTACT

415-514-2163; Kieran.OBrien@ucsf.edu

Angela S Cheng, Masters of Public Health

CONTACT

650-287-5150; angela.cheng@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 13, 2025
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared at the time of publication
• Access Criteria: General public

Locations

US (1)