Effects of Standardized Near Activities on Retinal and Choroidal Structure, Microcirculation, and Visual Outcomes in Children with Anisometropic Amblyopia: Study Protocol for a Prospective Controlled Trial

Effects of Standardized Near Activities on Retinal and Choroidal Structure, Microcirculation, and Visual Outcomes in Children with Anisometropic Amblyopia: Study Protocol for a Prospective Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Effects of Standardized Near Activities on Retinal and Choroidal Structure, Microcirculation, and Visual Outcomes in Children with Anisometropic Amblyopia: Study Protocol for a Prospective Controlled Trial Xiyu Zhao, Di Cao, Yanan Guo, Boteng Gong, Jingjing Jiang, Li Li This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8946729/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 5 You are reading this latest preprint version Abstract Background Anisometropic amblyopia is a major cause of visual impairment in children. Although near activities are commonly recommended alongside first-line treatments, the immediate effects on retinal and choroidal structure and microcirculation in amblyopic eyes are not well understood. Furthermore, it is unclear whether these short-term changes are linked to later outcomes in best-corrected visual acuity (BCVA) and binocular function. This trial aims to investigate these questions within the context of standard pediatric amblyopia care. Methods This is a prospective, single-center, open-label, randomized controlled trial. Eighty children with hyperopic anisometropic amblyopia will be enrolled and randomly assigned to either an intervention group or a control group, with 40 participants in each group. All participants will receive full refractive correction and standard patching. At baseline, children in the intervention group will perform a standardized 15-minute near-activity task using a unified amblyopia training device. Optical coherence tomography (OCT) and OCT angiography (OCTA) scans of the amblyopic and fellow eyes will be obtained within 10 minutes before the task and immediately afterward. Subsequently, the intervention group will repeat the same task at home 5 days per week in addition to patching, while the control group will continue patching alone. Best-corrected visual acuity (BCVA), axial length (AL), and binocular visual function will be assessed at baseline and during follow-up visits at approximately 5 (± 1), 8 (± 1), and 17 (± 1) weeks. OCT/OCTA scans will be repeated at around 8 (± 1) weeks to quantify structural and microvascular changes and to compare outcomes between groups. Discussion By combining standardized near activities with detailed imaging assessments and medium-term follow-up, this trial is expected to provide new evidence for the biological effects and clinical role of near activities in anisometropic amblyopia and provide a reference for optimizing future amblyopia treatment strategies. Trial registration Chinese Clinical Trial Registry (ChiCTR), ChiCTR2600118894; registered 12 February 2026. URL: https://www.chictr.org.cn/showproj.html?proj=305915 Anisometropic amblyopia Near activity Visual Acuity Full Text Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 09 May, 2026 Reviewers invited by journal 04 May, 2026 Editor assigned by journal 08 Apr, 2026 Submission checks completed at journal 26 Feb, 2026 First submitted to journal 24 Feb, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8946729","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":637482322,"identity":"b9c5bf67-df8e-4540-b15f-bb35e9618caf","order_by":0,"name":"Xiyu Zhao","email":"","orcid":"","institution":"Department of Ophthalmology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Key Laboratory of Major Diseases in Children, Ministry of 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