ArticleFrontiers in public health2026
Development, validation, and cost-effectiveness analysis of an AI-assisted three-tiered glaucoma screening model in a community-based setting: protocol for a cluster randomized controlled trial.
Article in Frontiers in public health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Introduction: Glaucoma is the leading irreversible blinding eye disease worldwide and the global prevalence of glaucoma for individuals aged 40-80 years is estimated as 3.54%. Early screening and prevention wherever possible are essential interventions of chronic disease management for glaucoma, but there is currently a lack of a recognized glaucoma screening model for Chinese population. Therefore, this study intends to construct and validate an artificial intelligence (AI)-assisted three-tiered glaucoma screening model based on the community population and assess its cost-effectiveness. Methods and analysis: This is a community population-based cluster randomized controlled trial with a minimum of 6-year follow-up. A three-tiered glaucoma screening strategy appropriate for Chinese individuals will be established, including a high-risk model questionnaire (primary screening), ophthalmic examinations (secondary screening, combined with physician-based and AI-assisted image interpretation), and definitive diagnosis by tertiary hospitals (tertiary screening). The participants of each community will be randomly divided into three groups (simple cluster randomization): no screening group, routine screening group, and tiered screening group. Participants in the no screening group will receive regular glaucoma-related health education, structured annual follow-up for symptom monitoring and recording of external ophthalmology visits, and a comprehensive ophthalmic screening at the end of the study to compensate for the absence of regular screening. A total of 28,275 participants (9,425 per group) will be recruited, allowing for an anticipated loss-to-follow-up rate of 20%. All primary outcome measures will be analyzed on a per-participant basis. The main endpoint is the glaucoma detection rate, with sensitivity and specificity of the screening as additional primary outcomes. Secondary outcomes involve comparative analyses of the cost-effectiveness of different screening strategies and the diagnostic accuracy of physician-based versus AI-assisted image interpretation. Ethics and dissemination: The protocol has been approved by the Biomedical Ethics Review Committee, West China Hospital of Sichuan University [2025(1021)]. All the participants will be required to afford signed informed consent. The study results will be presented at scientific meetings and published in a peer-reviewed journal. Clinical trial registration: https://www.chictr.org.cn/showproj.html?proj=281642, identifier (ChiCTR2500107852).
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