Effect of Vision Centers on Access to Eye Care and Eye Health Outcomes
NCT ID: NCT07227714
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40000 participants
INTERVENTIONAL
2026-03-01
2028-09-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 outside the 20-100 km distance range from the base hospital.
* Sites with existing major primary eye care services within a 10 km radius.
ALL
Yes
Sponsors
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Seva Foundation
OTHER
Proctor Foundation
UNKNOWN
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Kieran O'Brien, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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25-45086
Identifier Type: -
Identifier Source: org_study_id