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: 40,000
• Locations: 1 country
• Sites: 1

Brief 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. 1.Do vision centers increase visits to eyecare centers?
2. 2.Do vision centers increase spectacle ownership and wearing?
3. 3.Do vision centers improve visual acuity of the population?

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of eyecare visits

  The primary outcome is the prevalence of eyecare visits completed in the past one year, defined for each cluster as the number of individuals having completed at least one visit in the past year divided by the total number of individuals surveyed.

  1 year

Secondary Outcomes (17)

• Total number of visits to any eyecare provider

  1 year

• Prevalence of current spectacle ownership

  2 years.

• Effective refractive error coverage

  2 years

• Prevalence of spectacle wearing

  2 years

• Mean presenting and pinhole visual acuity

  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 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.

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

Related Publications (8)

• Khanna RC, Sabherwal S, Sil A, Gowth M, Dole K, Kuyyadiyil S, Chase H. Primary eye care in India - The vision center model. Indian J Ophthalmol. 2020 Feb;68(2):333-339. doi: 10.4103/ijo.IJO_118_19.

  PMID: 31957722 BACKGROUND

• Rao GN, Khanna RC, Athota SM, Rajshekar V, Rani PK. Integrated model of primary and secondary eye care for underserved rural areas: the L V Prasad Eye Institute experience. Indian J Ophthalmol. 2012 Sep-Oct;60(5):396-400. doi: 10.4103/0301-4738.100533.

  PMID: 22944748 BACKGROUND

• Misra V, Vashist P, Malhotra S, Gupta SK. Models for primary eye care services in India. Indian J Community Med. 2015 Apr-Jun;40(2):79-84. doi: 10.4103/0970-0218.153868.

  PMID: 25861167 BACKGROUND

• Vision Loss Expert Group of the Global Burden of Disease Study; GBD 2019 Blindness and Vision Impairment Collaborators. Global estimates on the number of people blind or visually impaired by cataract: a meta-analysis from 2000 to 2020. Eye (Lond). 2024 Aug;38(11):2156-2172. doi: 10.1038/s41433-024-02961-1.

  PMID: 38461217 BACKGROUND

• Vision Loss Expert Group of the Global Burden of Disease Study; GBD 2019 Blindness and Vision Impairment Collaborators. Global estimates on the number of people blind or visually impaired by Uncorrected Refractive Error: a meta-analysis from 2000 to 2020. Eye (Lond). 2024 Aug;38(11):2083-2101. doi: 10.1038/s41433-024-03106-0. Epub 2024 Jul 4.

  PMID: 38965322 BACKGROUND

• GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Trends in prevalence of blindness and distance and near vision impairment over 30 years: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e130-e143. doi: 10.1016/S2214-109X(20)30425-3. Epub 2020 Dec 1.

  PMID: 33275950 BACKGROUND

• GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e144-e160. doi: 10.1016/S2214-109X(20)30489-7. Epub 2020 Dec 1.

  PMID: 33275949 BACKGROUND

• Burton MJ, Ramke J, Marques AP, Bourne RRA, Congdon N, Jones I, Ah Tong BAM, Arunga S, Bachani D, Bascaran C, Bastawrous A, Blanchet K, Braithwaite T, Buchan JC, Cairns J, Cama A, Chagunda M, Chuluunkhuu C, Cooper A, Crofts-Lawrence J, Dean WH, Denniston AK, Ehrlich JR, Emerson PM, Evans JR, Frick KD, Friedman DS, Furtado JM, Gichangi MM, Gichuhi S, Gilbert SS, Gurung R, Habtamu E, Holland P, Jonas JB, Keane PA, Keay L, Khanna RC, Khaw PT, Kuper H, Kyari F, Lansingh VC, Mactaggart I, Mafwiri MM, Mathenge W, McCormick I, Morjaria P, Mowatt L, Muirhead D, Murthy GVS, Mwangi N, Patel DB, Peto T, Qureshi BM, Salomao SR, Sarah V, Shilio BR, Solomon AW, Swenor BK, Taylor HR, Wang N, Webson A, West SK, Wong TY, Wormald R, Yasmin S, Yusufu M, Silva JC, Resnikoff S, Ravilla T, Gilbert CE, Foster A, Faal HB. The Lancet Global Health Commission on Global Eye Health: vision beyond 2020. Lancet Glob Health. 2021 Apr;9(4):e489-e551. doi: 10.1016/S2214-109X(20)30488-5. Epub 2021 Feb 16. No abstract available.

  PMID: 33607016 BACKGROUND

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: March 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 6 months after the study ends.
• Access Criteria: General public

Locations

US (1)