Effect of distant-image screen technology (DIST) on delaying myopia onset in pre-myopia children: study protocol for a 1-year randomized controlled trial

Effect of distant-image screen technology (DIST) on delaying myopia onset in pre-myopia children: study protocol for a 1-year randomized 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 Research Article Effect of distant-image screen technology (DIST) on delaying myopia onset in pre-myopia children: study protocol for a 1-year randomized controlled trial Liying Zou, Xiaoru Li, Jiawei Zhou, Meiping Xu This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6496580/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 11 Apr, 2026 Read the published version in Trials → Version 1 posted 4 You are reading this latest preprint version Abstract • Background : Myopia is an escalating global health issue, particularly among adolescents, and its increasing prevalence is associated with a rising burden of ocular complications that adversely affect quality of life and strain healthcare resources. Extensive evidence links prolonged near work to myopia progression, prompting the development of innovative control strategies. One promising approach is the distant-image screen (DIST), which transforms a nearby real image into a virtual one that appears much farther away, thereby reducing the accommodative stress typically induced by prolonged near work. This study is designed to evaluate the efficacy of DIST in delaying the onset of myopia among pre-myopic children. • Methods : This is a one-year, multi-arm randomized controlled trial involving 192 children, who will be randomly assigned in a 1:1:1 ratio to one of three groups: (1) a DIST group; (2) a Combined Intervention group, which will receive both DIST and an optical defocusing intervention and (3) a control group, engaging in regular near work without the use of DIST. The primary objective is to assess whether the use of DIST—alone or in combination with optical defocusing—can effectively delay the onset of myopia in pre-myopic children. The primary outcome is the proportion of myopia onset, and the secondary outcomes are the proportion of fast myopia progressors, change in spherical equivalent progression, and change in axial length at each follow-up point. • Discussion : The study aims to determine the independent efficacy of DIST as well as its potential synergistic benefits when combined with optical defocusing techniques. In the context of increasing academic demands and near-work exposure, DIST offers a space-efficient, practical solution that could alleviate visual strain without interfering with learning. By providing robust data on both refractive and ocular structural changes, the findings may inform personalized myopia prevention strategies. If successful, DIST could serve as a valuable adjunct to current myopia control methods, ultimately reducing the public health burden of myopia. • Trial registration : Chinese Clinical Trial Registry (ChiCTR), ChiCTR2400082078. Registered on 20 March 2024. https://www.chictr.org.cn/showproj.html?proj=221835 Myopia prevention Pre-myopia Distant-image screen technology Progression Axial length Figures Figure 1 Administrative information Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/). Title {1} Effect of distant-image screen technology (DIST) on delaying myopia onset in pre-myopia children: study protocol for a 1-year randomized controlled trial Trial registration {2a and 2b}. Chinese Clinical Trial Registry (ChiCTR), ChiCTR2400082078. Registered on 20 March 2024. https://www.chictr.org.cn/showproj.html?proj=221835 Protocol version {3} Protocol version 1. Protocol date: April 21, 2025 Funding {4} This investigator-initiated trial is sponsored by the Eye Hospital of Wenzhou Medical University, Zhejiang, China, which will provide all necessary medical instruments, examinations, and evaluation services free of charge. No external funding is involved, ensuring the study’s independence and impartiality. Author details {5a} Liying Zou 1,2 , Xiaoru Li 1,2 , Jiawei Zhou 1,2 and Meiping Xu 1,2* 1 School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, China 2 National Clinical Research Center for Ocular Disease, Wenzhou, Zhejiang, China *Corresponding author Name and contact information for the trial sponsor {5b} Eye Hospital of Wenzhou Medical University No. 270, College West Road, Wenzhou, Zhejiang, China Telephone: 0577-88068888 Email: [email protected] Role of sponsor {5c} The sponsor of this trial, Eye Hospital of Wenzhou Medical University, assumes overall responsibility for the initiation, management, and funding of the study. Specific roles and responsibilities include ethical and regulatory compliance, provision of resources, trial oversight, data management and integrity, independence of analysis. Introduction Background and rationale {6a} Myopia is a prevalent refractive error that significantly contributes to visual impairment worldwide. Over the past few decades, the global prevalence of myopia has risen sharply, with epidemiological studies predicting that by 2050, nearly half of the world’s population (approximately 4.758 billion individuals) will be myopic, including almost 1 billion affected by high myopia [ 1 ]. The high prevalence of myopia, especially among adolescents in certain populations (80–90%), has reached alarming levels [ 2 , 3 ]. Myopia has raised considerable public health concerns due to its associated risk of severe ocular complications, such as cataracts, glaucoma, and retinal detachment [ 4 – 7 ]. These complications not only impair vision but also impose substantial burden on patients’ quality of life and healthcare systems [ 8 , 9 ]. Moreover, myopia can adversely impact children's and adolescents' learning and daily lives, potentially leading to reduced self-esteem and social difficulties[ 10 – 12 ]. Consequently, the prevention and control of myopia have emerged as pressing global public health priorities. A growing body of evidence highlights the association between prolonged near work —such as reading or engaging in close-up tasks—and the onset and progression of myopia in children and adolescents[ 13 – 17 ]. Mechanistically, near work has been linked to alterations in choroidal thickness, a biomarker increasingly studied in the context of myopia development [ 18 ], suggesting that reducing near work exposure could mitigate myopia progression [ 19 ]. Furthermore, extended duration of near work has been shown to have an impact. This understanding has driven the innovation of novel technologies aimed at addressing the challenges of near work. The distance-image screen technology (DIST) is a novel myopia prevention and control approach developed in the past two years. DIST utilizes the “Birdbath” optical design principle and freeform mirror technology to project near scenes to a perceived distance beyond 3 meters. This innovation theoretically reduces the visual strain associated with near work while allowing children and adolescents to engage in tasks such as reading and note-taking. An previous clinical study have confirmed that using the DIST for reading does not compromise reading efficiency or increase visual fatigue, providing early support for its feasibility and safety in daily use[ 20 ]. In parallel, optical defocus has been widely recognized as an effective strategy for myopia control, with clinical applications such as peripheral defocus glasses and contact lenses [ 21 – 24 ]. While the potential synergistic effects of DIST and optical defocus technologies remain unexplored, their combination may represent a promising avenue for enhancing myopia control outcomes. This research aims to investigate whether DIST and integrating DIST with optical defocus principles can further optimize myopia prevention strategies, offering new insights into evidence-based myopia management. Objectives {7} Based on the aforementioned theories, our primary objective was to evaluate the efficacy of DIST and integrating DIST with optical defocus principles on delaying the onset of myopia, specifically in postponing the initial diagnosis of myopia in pre-myopic children. Additionally, we aimed to determine its impact on mitigating myopic refractive shift and slowing ocular axis elongation. We hypothesized that the DIST intervention would demonstrate superior efficacy in these outcomes compared to the control group, highlighting its potential as a targeted strategy for myopia prevention. Trial design {8} This study will be a randomized, superiority-controlled trial with a parallel-group design. 192 pre-myopic children will be randomly divided into three groups of 64 subjects in a 1:1:1 ratio. The three groups are no use of DIST, DIST alone (RIO-Max 2.0), and DIST optimized by combining the optical defocusing technique (RIO-Ultra 2.0). The complete study flowchart is shown in the figure (Fig. 1). The protocol and all study procedures are approved by the Medical Ethics Committee of the Affiliated Eye Hospital of Wenzhou Medical University (2024-016-K-015-05) and conducted following the ethical standards of the Declaration of Helsinki. The protocol has been registered with the Chinese Clinical Trial Registry (ChiCTR2400082078) and uses the SPIRIT reporting guidelines[ 25 ]. Subjects are required to sign an ethical informed consent form before participating in the experiment. Methods: Participants, interventions and outcomes Study setting {9} Participants in this study will be recruited from the Eye Hospital of Wenzhou Medical University. Screening and baseline examinations will be conducted in the outpatient clinic of the Eye Hospital, using advanced and comprehensive equipment to ensure accurate and complete data collection. Participants assigned to the two intervention groups using DIST will take the devices home. Follow-up supervision will be conducted by the researchers to ensure adherence to the study protocol and proper implementation of the intervention. Eligibility criteria {10} All subjects will undergo initial screening by ophthalmologists and investigators before enrolment. This screening will include inquiries about general health condition, family and disease history, allergies, and current medications. Potential subjects who meet these preliminary criteria will then be further assessed for ocular health and lifestyle habits based on the established inclusion and exclusion criteria. Inclusion criteria: (1) Age: 6–10 years old; (2) Spherical Equivalent (SE) in either eye:>-0.50D and ≤ + 0.75D (based on the average value of automatic refraction under cycloplegia); (3) Astigmatism in either eye: ≤1.50D; (4) At least 1 hour of near work every day, including non-learning (TV, games, etc.), learning (online learning, punching in), reading, etc.; (5) The naked visual acuity in either eye: ≥4.9, and the best corrected visual acuity: ≥5.0; (6) Never participated in any clinical trial of myopia control within 3 months or used myopia prevention methods, such as multi-point design defocus glasses, low concentration atropine, repeated low-level red light (RLRL), etc.; (7) No dominant strabismus was observed. Exclusion criteria: (1) Failure to comply with the protocol to obtain reliable study measurements; (2) There is any eye disease that can affect refractive development, such as retinal disease, cataract, and ptosis; (3) The existence of systemic or neurodevelopmental conditions that may affect refractive development; (4) Eye or systemic drugs known to affect the development of myopia or visual acuity through effects on retinal regulation amplitude or intraocular pressure are being used. Who will take informed consent? {26a} Each investigator will personally explain the informed consent form in detail to the subject and their guardian during the recruitment process. This includes providing clear information about the study’s purpose, procedures, potential risks, and benefits, and ensuring sufficient time for them to ask questions and consider their participation. No examinations or interventions will proceed until both the subject and their guardian have provided written informed consent. For children under the age of 8, the guardian will provide consent on their behalf, while verbal assent from the child will be sought whenever appropriate, in accordance with ethical guidelines. Additional consent provisions for collection and use of participant data and biological specimens {26b} N/A: This study does not involve additional data and biospecimens that require subjects' consent to be collected. Interventions Explanation for the choice of comparators {6b} The choice of comparators in this study was guided by the need to evaluate the efficacy of long-term use of DIST and its potential enhancement when combined with the optical defocusing technique in delaying the onset of myopia. This group (daily near work without DIST) serves as the baseline comparator, reflecting typical daily activities that involve prolonged near work without specific interventions. Prolonged near work is a well-documented risk factor for myopia development, but its role in the absence of compensatory measures, such as DIST, remains an important baseline for understanding the natural progression of myopia onset. This control group enables the evaluation of whether DIST alone provides a protective effect against myopia development. By maintaining their habitual near work activities, participants in this group help establish a reference for comparing the effectiveness of interventions. Intervention description {11a} There are two intervention groups in our study: the DIST Group (use of DIST alone) and the Combined Intervention Group (DIST and Optical Defocusing Technique). Participants in these two groups will be asked to use the device during near work, including online learning, playing online games, reading, and similar tasks, with a minimum daily usage of one hour. The DIST group is included to investigate whether projecting near scenes into the distance can effectively delay the onset of myopia. This group is critical for isolating the specific effect of DIST as a standalone intervention, independent of other factors. The use of DIST aligns with emerging evidence suggesting that increasing outdoor-like visual experiences or reducing accommodative stress may mitigate myopia progression. The Combined Intervention group (DIST and Optical Defocusing Technique) evaluates the synergistic effect of combining DIST with an optical defocusing technique, a method designed to induce controlled peripheral defocus, which has been shown in prior studies to slow myopia progression. By comparing this group with the DIST-only group, we aim to determine whether the addition of optical defocus provides a measurable advantage in delaying myopia onset. This comparison also informs the potential development of optimized multi-modal strategies for myopia prevention. This design enables a comprehensive evaluation of DIST’s efficacy both as a standalone intervention and in combination with optical defocus. By systematically comparing the outcomes across these groups, we aim to identify the most effective and practical strategy using DIST for delaying myopia onset. This evidence can directly inform clinical recommendations and public health strategies for myopia prevention. We recognize the potential for variability in participants’ adherence to the interventions. To mitigate this, detailed instructions will be provided, and adherence will be monitored through regular follow-ups. Criteria for discontinuing or modifying allocated interventions {11b} Participants may discontinue or have their allocated intervention modified during the trial based on the following criteria: Adverse events or safety concerns. The occurrence of adverse events related to the intervention, such as visual discomfort, eye strain, or other unexpected side effects, that compromise the participant's safety or well-being. Non-compliance with protocol. Persistent non-compliance with the study protocol, including failure to adhere to the prescribed use of DIST or participation in required follow-up visits, despite reasonable efforts to ensure adherence. Participant or guardian decision. Withdrawal of consent by the participant or their guardian for any reason, including personal preferences or perceived lack of benefit from the intervention. Investigator’s discretion. Determination by the investigator that continuing the intervention is not in the participant’s best interest, based on clinical judgment or unforeseen circumstances affecting the study’s integrity. Participants who discontinue or modify their allocated interventions will remain in the study unless they explicitly request withdrawal. Their data will be included in the Intention-to-Treat analysis to ensure a comprehensive evaluation of the intervention’s efficacy. Strategies to improve adherence to interventions {11c} To enhance participant adherence, each participant will be assigned a dedicated research assistant who will maintain regular contact with the participant’s family through a dedicated WeChat group. The research assistants will offer support by addressing any questions, troubleshooting equipment issues, and sending reminders to ensure timely completion of the intervention and follow-up activities. For experimental groups using DIST, the research team will monitor the device's usage through backend records once a week to verify adherence to the required usage duration. If any irregular usage patterns are detected, the research assistants will promptly inform the participant's family and provide personalized guidance to ensure consistent adherence. Relevant concomitant care permitted or prohibited during the trial {11d} Clearly defining permitted and prohibited concomitant care is essential to preserving the integrity of its intervention, protecting participant health and minimizing confounding factors. Permitted concomitant care primarily includes recommendations for healthy visual habits, such as ensuring appropriate reading distance, adequate lighting, and regular outdoor activities. These practices are permitted and encouraged, as they align with standard myopia prevention guidelines. In contrast, the following are strictly prohibited as concomitant care. First are alternative myopia control interventions. Participants are not allowed to use other myopia control strategies, such as atropine eye drops or other optical interventions (e.g., defocus lenses), during the trial period. Second is experimental therapies. Enrollment in other clinical trials or use of investigational devices or drugs targeting myopia management is prohibited to avoid confounding effects. Last but most important is device modifications. Any unauthorized adjustments or modifications to the DIST device or its usage protocol are also strictly prohibited. To ensure adherence, all concomitant care received by participants must be reported to the research team and documented during follow-up visits. Any potential impact on study outcomes will be evaluated, and all such data will be recorded in the case report forms (CRFs). Participants and their families will be instructed to notify the study team of any changes in care or new treatments initiated during the trial. Provisions for post-trial care {30} All interventions in our study are considered safe, with no anticipated harm under normal circumstances. However, in the unlikely event that a participant sustains an injury or adverse effect related to the study interventions, the research sponsor will provide comprehensive post-trial care. This includes covering all associated medical expenses and providing appropriate financial compensation based on an assessment conducted by a qualified ophthalmologist. Outcomes {12} Primary outcome Concealment mechanism {16b} A sealed, opaque, and consecutively envelope will be prepared for each participant. Each envelope will contain the group assignment determined by the randomization sequence. The envelopes will be opened sequentially only after a participant is deemed eligible and has provided informed consent, ensuring that the allocation remains concealed until the point of assignment. This approach prevents foreknowledge of group assignments and minimizes selection bias. Implementation {16c} The randomization sequence was generated by the statistical team of the clinical research center of the eye hospital of Wenzhou medical university. Specialized ophthalmologists in the outpatient clinic will recruit potential participants and conduct baseline assessments. Once participants confirm their enrollment, researchers will assign the corresponding envelope based on the order of participant enrollment. The envelope will then be opened by an independent research assistant, who will use the random number inside the envelope to determine the group assignment. Assignment of interventions: Blinding Who will be blinded {17a} Due to the nature of the intervention, blinding of participants and intervention providers is not feasible. However, to minimize potential bias, the examination equipment is relatively objective and blinding will be implemented for outcome assessors, data collectors, and data analysts. Outcome Assessors: Independent examiners conducting refraction and AL measurements will be blinded to the participants’ group assignments. They will not be involved in intervention delivery or participant interactions beyond data collection. Data Collectors: Personnel responsible for recording and entering study data will be blinded to group allocation to prevent unconscious bias in data handling. Data Analysts: Statistical analysts will receive a coded dataset without group identifiers, ensuring that data analysis remains objective. Blinding procedures will be strictly maintained throughout the study to enhance the reliability and validity of the findings. Procedure for unblinding if needed {17b} N/A. Data collection and management Plans for assessment and collection of outcomes {18a} At baseline and during each follow-up, researchers will provide paper-based questionnaires for guardians to complete, and the results will be entered into a spreadsheet for analysis. All other clinical assessments will be performed by experienced clinicians using relevant measuring instruments (as specified in item 12). Measurements will be repeated to ensure the reliability and validity of the data collection. Meanwhile, patients’ general information, medical history, baseline and follow-up results, adverse event reports, and trial summaries will be recorded in the CRFs by researchers on time. All researchers and clinicians will undergo training on participant recruitment, assessment, intervention, and data backup before participating in the study. Cycloplegic autorefraction will be performed using the Topcon KR800 autorefractor unit following the cycloplegia regimen of 1% cyclopentolate (Cyclogyl, AlconConvreur). Spherical equivalent is calculated as spherical power plus half of the cylinder power. Cycloplegic measurements will be performed at baseline, the 6-month follow-up, and the 12-month follow-up to assess the primary outcome. Ocular AL will be measured on a Zeiss IOL Master 700 (Carl Zeiss Meditec Inc.) using noncontact partial coherence interferometry. Perform six measurements of total AL, anterior chamber length, and corneal curvatures. At least three measurements are identical or almost identical. The ChT will be measured using Wevis OCT (Wevis Imaging Technology Co., Ltd.) in the Angio 6x6 512 R4 mode. An individual's visual function and comfort will be assessed through questionnaires during near work, screening for visual fatigue, accommodation abnormalities, convergence/divergence issues, and other visual impairments. Additionally, evaluating the time spent on outdoor activities and near work provides insights into myopia risk associated with lifestyle habits. Plans to promote participant retention and complete follow-up {18b} To ensure high participant retention and complete follow-up throughout the study, a comprehensive strategy will be implemented. This strategy will focus on maintaining participant engagement, minimizing dropout rates, and addressing potential challenges that may arise during the study. 1. Engagement and Retention Strategies Regular Communication: Participants will be regularly contacted via phone calls, text messages, or mobile applications to provide reminders of upcoming appointments and to maintain engagement. Flexible Scheduling: Follow-up visits will be scheduled at times convenient for the participants and their families, such as weekends and holidays. Incentives: To further encourage retention, participants will receive small incentives, such as gift cards or study-related materials, upon completion of key milestones (e.g., baseline, 6-month, and 12-month visits). 2. Handling Withdrawals or Treatment Modifications In the event that a participant decides to withdraw or is unable to complete the study, their outcome data up to the point of withdrawal will be collected. This ensures that even if they do not complete the entire study, the data they have contributed remains valuable. Reasons for Withdrawal: Participants who withdraw will be asked to provide the reason for their decision (e.g., personal, logistical, or health-related issues), which will be documented for further analysis and to inform potential improvements in future studies. Changes in Treatment Plan: If participants need to switch to an alternative treatment, the research team will collect relevant outcome data before the change is made, ensuring that the participant’s previous data remains part of the analysis. This will allow the study to account for the impact of treatment changes on the outcomes. 3. Follow-Up and Data Collection In the event of missing data or uncompleted follow-up visits, efforts will be made to contact participants to reschedule and collect the necessary data. If a participant cannot be reached for any follow-up visit, the last available data will be included in the analysis, and the participant will be considered as missing for subsequent follow-up points. By employing these strategies, we aim to minimize participant dropout, ensure high-quality follow-up data, and maximize the retention of participants throughout the one-year study period. Data management {19} Effective data management is critical for ensuring the integrity, security, and reliability of the data collected throughout the study. A comprehensive plan will be implemented for data entry, coding, confidentiality, and storage, with quality assurance measures to ensure accurate and complete data collection. Case report form: Case report forms, which will be in paper form, will be used to record clinical data in the trial, and case report. As original material, the CRFs will not be changed at will. The relevant information of all patients participating in the trial will be recorded timely and truthfully Data Entry: All data collected will be entered into an electronic data capture (WMU-EDC (Wenzhou Medical University, Wenzhou, Zhejiang, China) database. To prevent errors, double data entry will be used, where two separate team members will independently enter the data, and discrepancies will be resolved through a reconciliation process. Data Quality Control Measures Range Checks: To identify potential errors, automated range checks will be applied to the data during entry. For instance, measurements outside of predefined acceptable ranges (e.g., refraction values) will trigger a prompt for review. Consistency Checks: Periodic consistency checks will be conducted to detect any discrepancies or outliers in the dataset. These checks will compare newly entered data with historical data or other clinical parameters. Training for Data Collectors: All staff involved in data collection and entry will undergo standardized training on the study protocols, measurement techniques, and data entry processes to minimize human error and improve consistency. Data Security: Data will be stored on secure cloud servers with encrypted access. Hard copies of any records will be kept in locked file cabinets, accessible only to authorized personnel. Audit trail will be maintained for all data-related actions, including data entry, modifications, and access, ensuring full traceability and accountability. Data Access and Monitoring: Only authorized research staff will have access to the data, and data access permissions will be strictly controlled and documented. Regular internal audits will be conducted to ensure that data collection and management processes are being followed correctly. Data integrity will be routinely monitored, and any potential issues will be addressed promptly. By implementing these measures, we aim to ensure data accuracy, security, and confidentiality, while maintaining the highest standards of data quality throughout the study. Confidentiality {27} To ensure the confidentiality of participants' personal information throughout the study, a series of measures will be implemented to protect privacy during the pre-study phase, throughout the study, and after completion. These measures will govern the collection, sharing, and storage of personal data for both potential and enrolled participants. 1. Participant Informed Consent All participants will sign an informed consent form before entering the study, which will clearly explain how their personal information will be collected, used, stored, and shared. Participants will have the right to withdraw consent at any time and request the destruction of their personal data. The research team will ensure that participants fully understand how their personal data will be protected, and they will be given sufficient time and opportunity to ask questions or express concerns. 2. Data Collection and Storage During the study, all personal information related to participants will be stored using coding systems to ensure that identifying information is separate from study data. Each participant will be assigned a unique identification number, and only this number will be used to identify them. Personal identifying information (e.g., name, phone number, address) will be kept in separate files from the study data and will be accessible only to authorized personnel. Participant personal information will be stored in encrypted storage systems (e.g., cloud storage) with regular security updates and checks to maintain data protection. 3. Data Sharing and Access Only authorized researchers and relevant personnel will have access to participants' personal information, and this access will be granted strictly for research purposes. All access to data will be controlled through a permission-based system, ensuring that only necessary personnel can view sensitive information. Personal information will not be shared unless legally required or for specific research needs. When reporting results to external entities, all published data will be anonymized to prevent the disclosure of any personal identifiers. 4. Post-study Data Management After the study concludes, all personal information related to participants will continue to be handled according to confidentiality agreements, and will only be used for purposes directly related to the study (e.g., data analysis, final reporting). Original data will be retained for a specified period and then securely destroyed to ensure that no personal information is accessible or disclosed after the study's conclusion. If the data needs to be used for subsequent research or publications after the study has ended, participants will be re-consented, and appropriate confidentiality measures will be applied. Through these measures, we will ensure the protection of participants' privacy and comply with all relevant legal and ethical standards to safeguard the confidentiality of data and participants' rights Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} N/A: As indicated in the outcome measures (item 12), our study does not involve the collection of biological samples. Statistical methods Statistical methods for primary and secondary outcomes {20a} 1. Analysis of primary outcome In this participant-based study, the primary outcome is the proportion of myopia onset. This outcome is measured as a binary (nominal) variable. Participants are classified as either having experienced the onset of myopia (Yes) or not (No), based on whether their cycloplegic spherical equivalent refractive error reaches or exceeds − 0.50 D in either eye at the 1-year follow-up. This is a single endpoint measure, assessed once at the end of the 1-year follow-up period. It provides a proportion of participants who experience the onset of myopia. To test the effectiveness of DIST on the primary outcomes, logistic regression including trend analysis will be used, which can both examine the overall relationship and detect potential trends related to different treatments. In addition, covariates such as baseline spherical equivalent refractive error, age, gender, and study group (Intervention vs. Control) will be included to ensure a parsimonious logistic regression model while controlling for factors known to influence myopia onset and progression. The primary analysis will be conducted on the ITT population, which is defined as all randomized participants with at least one post-baseline measurement. For all analyses, the underlying model assumptions will be rigorously evaluated. For instance, when applying logistic regression to assess the binary primary outcome, we will verify the linearity of the logit for continuous covariates using methods such as the Box-Tidwell test, assess multicollinearity via variance inflation factors (VIF), and examine residuals and influence statistics (e.g., Cook’s distance) to identify any influential outliers. Missing data will be addressed using multiple imputations by chained equations under the assumption of data missing at random (MAR), with sensitivity analyses planned to assess the impact of outliers, nonadherence, and loss to follow-up. 2. Analysis of secondary outcomes The secondary outcomes are intended to capture aspects of the intervention effect that are not fully reflected by the primary outcome. For example, even if the primary outcome (myopia onset) does not show a statistically significant difference, significant changes in spherical equivalent or axial length may still be observed, thereby indicating a potential benefit of the intervention in slowing myopia progression. For the three secondary outcomes: (1) the proportion of fast progressors over 1 year, (2) changes in spherical equivalent progression, and (3) changes in AL (mm) at each follow-up point, the following statistical procedures will be employed: 1. Proportion of fast progressors (binary outcome) This endpoint will be analyzed using logistic regression. The model will estimate the odds of being classified as a fast progressor over one year, comparing the intervention group to the control group. Covariates to be included in the model are baseline spherical equivalent refractive error (continuous), age (continuous), and gender (categorical), as these factors have been shown in prior research to influence myopia progression. The study group (intervention vs. control) will be the primary factor of interest. These covariates are selected based on their theoretical relevance and empirical support, ensuring a parsimonious model that controls for potential confounding without overfitting. 2. Changes in spherical equivalent progression (continuous outcome) The change in spherical equivalent progression over time will be analyzed using a repeated measures mixed-effects model. This model will account for within-subject correlations across multiple follow-up points and will include fixed effects for the treatment group, time (as a categorical or continuous variable depending on the observed pattern), and the interaction between treatment and time. Baseline spherical equivalent refractive error, age, and gender will be included as covariates to adjust for initial differences and known predictors of refractive change. The rationale for these covariates is their established association with myopia progression, ensuring that the model is both explanatory and parsimonious. Model selection procedures, such as stepwise backward elimination based on the Akaike Information Criterion (AIC) or likelihood ratio tests, will be applied to refine the final model. 3. Changes in AL (mm) Similar to the spherical equivalent endpoint, changes in axial length (measured in mm) at each follow-up will be analyzed using a repeated measures mixed-effects model or an analysis of covariance (ANCOVA) for longitudinal data. The model will include fixed effects for treatment, time, and their interaction. Covariates will include baseline axial length, baseline spherical equivalent, age, and gender. These factors are chosen because they are known to influence ocular growth and, consequently, axial elongation. As with the other endpoints, a parsimonious model will be achieved by using stepwise selection methods or likelihood ratio tests to retain only covariates that contribute significantly to explaining the variation in axial length change. The results of these analyses will be presented as adjusted odds ratios with 95% confidence intervals for the binary outcome and as least-squares means (LSMEANS) with standard errors for the continuous outcomes. In addition, p-values will be reported to assess the statistical significance of the observed differences between intervention groups. 3. Analysis of exploratory outcomes 1. Time-to-Myopia Onset Analysis For comparing the time to myopia onset (time-to-event outcome) among 3 treatment groups, we'll create a number-at-risk table and use the Kaplan-Meier method to estimate survival curves, followed by the log-rank test to assess differences statistically. 2. Myopia Onset Associations A logistic regression model will be built with myopia onset as the dependent variable and near-work duration, device usage duration, and confounding factors as independent variables. Odds ratio (OR) and its 95% confidence interval will be estimated to determine associations while controlling for confounding. 3. Dose-Response Relationship Analysis We will group near-work and device usage durations (e.g., by quartiles). Use the Cochrance - Armitage trend test to analyze if there's a dose-response relationship. Curve fitting (such as polynomial regression) can also be used to further explore the non-linear relationship between them. 4. Choroidal Thickness Changes For exploring changes in choroidal thickness during different follow-up periods among three groups, repeated measures analysis of variance (ANOVA) will be used. If significant effects are found, post hoc tests (like Bonferroni or Tukey's) will determine specific differences. Interim analyses {21b} N/A Methods for additional analyses (e.g. subgroup analyses) {20b} Subgroup analysis will be conducted based on the total duration of near-work and the usage duration of devices in this study. The aim is to explore the impacts of these two factors on the AL growth and the incidence rate of myopia among the subjects. Firstly, we will divide the subjects into different subgroups according to specific criteria regarding the durations of near-work and device usage. Then, appropriate statistical methods will be employed for the analysis. To analyze the impact on the AL growth, which is a continuous variable, we will consider using analysis of variance (ANOVA) or regression analysis to compare the differences in AL changes among different subgroups and to determine whether there are significant associations between the durations of near-work/device usage and the AL growth. In this process, relevant covariates such as age, gender, baseline refractive status, and outdoor activity time will be adjusted to control for potential confounding effects. For the analysis of the impact on the incidence rate of myopia, which is a binary variable, logistic regression will be utilized. The myopia incidence will be set as the dependent variable, while the durations of near-work and device usage will be the main independent variables. Additionally, the same set of covariates as mentioned above will be included in the model to account for confounding factors and to obtain more accurate estimates of the odds ratios and their corresponding confidence intervals, which can reflect the strength and significance of the associations between these factors and the myopia incidence. Furthermore, interaction terms between the durations of near-work and device usage might be considered in the models to explore whether there are combined effects of these two factors on the outcomes of interest. Through this comprehensive subgroup analysis, we expect to gain a more detailed and in-depth understanding of how the durations of near-work and device usage influence the AL growth and the myopia incidence among the subjects. Subgroup Analysis of Secondary Outcomes Subgroup analyses will be conducted to investigate two primary factors among pre-myopic children: (1) the total duration of device usage, and (2) the duration of near-work. The objective is to determine how these factors affect key myopia prevention indicators—including the primary endpoint (proportion of myopia onset) and secondary outcomes (proportion of fast progressors, change in spherical equivalent progression, and change in axial length). Stratification and Definition: Participants will be stratified into subgroups based on predetermined thresholds for both device usage and near-work duration. For the purposes of this study, we will operationally define high-intensity near-work behavior as a daily at-home near-work duration of two hours or more, while near-work behavior lasting less than two hours per day will be classified as low-intensity . Similarly, daily device usage of 30 minutes or longer will be considered indicative of high adherence , whereas usage of less than 30 minutes per day will be classified as low adherence . These thresholds may be refined based on the statistical distribution of the relevant data at the end of the study. Statistical Procedures: Continuous Outcomes (Axial Length, Spherical Equivalent Change): For outcomes measured on a continuous scale (i.e., axial length growth and change in spherical equivalent), we will use analysis of variance (ANOVA) or linear regression models. In these models, the subgroup classifications (based on device usage and near-work duration) will be the main independent variables. Adjustments will be made for covariates such as age, gender, baseline refractive error, and outdoor activity time to control for potential confounding. Model selection will follow a strategy to achieve parsimony—incorporating only those covariates that are theoretically justified and empirically significant. Binary Outcomes (Myopia Incidence and Proportion of Fast Progressors): For binary outcomes, logistic regression will be utilized. Here, the dependent variable will be the incidence of myopia (or classification as a fast progressor), and the primary predictors will be the categorized durations of device usage and near-work. The same set of covariates (age, gender, baseline refractive error, outdoor activity time) will be included to adjust for confounding. Odds ratios with corresponding 95% confidence intervals will be calculated to quantify the associations. Interaction Analysis: Interaction terms between device usage duration and near-work duration will be incorporated into the regression models to explore potential synergistic effects on myopia prevention outcomes. Rationale and Interpretation: The independent analysis of these subgroups is designed to provide a deeper understanding of how both device usage and near-work independently and jointly influence myopia progression indicators. This analysis is not dependent on the primary endpoint results; rather, it is intended to complement the overall findings and help refine targeted intervention strategies for high-risk pre-myopic children. The results will be presented as adjusted means (for continuous outcomes) and adjusted odds ratios (for binary outcomes) along with their standard errors or 95% confidence intervals. This comprehensive subgroup analysis will yield insights that may inform future recommendations for reducing near-work-related visual stress and optimizing the use of the DIST device in myopia prevention. Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} To comprehensively assess the impact of the devices on delaying myopia onset, we will conduct data analyses using both the Intention-to-Treat (ITT) analysis as the primary result and the Per-Protocol (PP) analysis as the secondary result, along with appropriate handling of missing data in both processes. ITT Analysis (Primary Result) The ITT analysis will be carried out to reflect the real-world application effect of the devices in preventing myopia onset. In case a participant drops out or has missing data during the follow-up period, we will use the Last Observation Carried Forward (LOCF) method. This ensures that all randomly assigned participants are retained in the analysis, maintaining the integrity of the randomization and providing a comprehensive view of the overall effect of the devices in a real-life scenario. PP Analysis (Secondary Result) The PP analysis will be employed as a secondary result to focus on the effect among those participants who strictly adhered to the use of the devices and followed the study protocol precisely. Only those subjects who completed all the required procedures, used the devices as instructed (e.g., for the specified duration and frequency), and attended all the follow-up visits without any major deviations from the protocol will be included in this analysis. To maintain the purity of the analysis, we will use direct exclusion to hand the missing data. In conclusion, by utilizing both ITT and PP analyses with appropriate handling of missing data, we expect to obtain a comprehensive and in-depth understanding of the effect of the DIST on delaying myopia onset in pre-myopia children from different perspectives, which will contribute to a more robust and reliable evaluation of the efficacy of these devices in this context. Plans to give access to the full protocol, participant level-data and statistical code {31c} In our clinical research, we have well-defined plans for sharing important study materials to ensure transparency and reproducibility. Firstly, the full protocol of our study will be published in the Trials . Additionally, when the research is concluded and the corresponding article is published, the full protocol will also be attached as Supplementary materials at the end of the main text. Secondly, regarding the raw data, we will make it available on the data platform of our hospital's clinical research center. However, this will take place after the official publication of the research article. To access the raw data, interested parties are required to fill out a corresponding application form. They can then submit the application to the corresponding author for review. During this process, strict ethical and privacy safeguards are in place. The raw data will be anonymized to protect the identities of the participants by removing or encrypting personal identifiers such as names, addresses, and social security numbers. This ensures that while enabling the sharing of valuable data for further research and verification purposes, the privacy rights of the participants are duly respected. Oversight and monitoring Composition of the coordinating centre and trial steering committee {5d} In this single-center clinical trial, the coordinating center is the hospital's Clinical Research Center. The trial steering committee plays a key role, composed of 2 hospital senior ophthalmology experts, 3 statistics experts (1 external), the project leader, and the sponsor's leader. It's responsible for determining the full trial protocol, reviewing progress, and setting endpoints. The Ethics Committee safeguards ethical aspects. The Endpoint Adjudication Committee with 2 experts ensures endpoint accuracy. And the Data Management Team, having 2 admins and 2 quality control staff, maintains data quality. The project research team consists of clinical ophthalmologists, laboratory researchers, and research assistants from the sponsor. They jointly handle tasks like participant recruitment, intervention implementation, outcome evaluation, data management, and analysis. Each task has an experienced leader. The steering committee oversees the whole study, while the research team holds monthly meetings to discuss progress and solve trial-related issues. Together, these components work in harmony to support the trial's success and ensure its scientific integrity and high quality. Composition of the data monitoring committee, its role and reporting structure {21a} The Data Monitoring Committee (DMC) of the Clinical Trial Center at the Eye Hospital, Wenzhou Medical University, will be responsible for data monitoring and overseeing the entire study. The committee members are independent and do not include any personnel involved in this study, ensuring no conflicts of interest. All raw data will be stored with the Data Monitoring Committee and will not be made publicly available before the results are published. Adverse event reporting and harms {22} In our study, a meticulous approach is adopted for adverse event reporting and addressing potential harms. We utilize paper-based CRFs to record relevant information. During each follow-up visit, investigators will actively inquire about participants' ocular discomfort manifestations, such as visual fatigue, dry eyes, and foreign body sensation. Meanwhile, we also collect information on other unexpected reactions like having a cold or a fever, including details about the duration of these symptoms as well as the methods used for relief and cure. Based on the participants' reported reactions, investigators will carefully assess the correlation between these events and the trial. Appropriate handling plans will then be formulated accordingly. Moreover, participants are encouraged to contact our investigators immediately if they experience any ocular discomfort symptoms or unexpected reactions during the use of relevant items in the study. Our investigators will provide timely and correct handling solutions to ensure the well-being of the participants and minimize potential harms. Through such a comprehensive process, we strive to closely monitor and effectively manage adverse events and safeguard the health and safety of all participants involved in our study. Frequency and plans for auditing trial conduct {23} The trial steering committee regularly reviews the progress of the study (such as progress monitoring, decision modification, et al.) at intervals of every three months. It plays a crucial and pivotal role in our project It is independent from both the searchers and the sponsors. Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} Before the commencement of the study, specifically during the design stage, the research protocol needs to undergo multiple rounds of demonstration and modification before it can be implemented. During the implementation process, if there are contents that truly require adjustments, for example, regarding the age in the inclusion criteria of this study, which was originally set as 6–12 years old and has been changed to 6–10 years old, the hospital's Clinical Research Center has a clear process in place to determine whether such modifications will affect the scientific integrity, ethical considerations, and practical implementation of the study. This involves relevant parties such as the investigators, CRC, who participate in the trial and the trial registration institutions. Dissemination plans {31a} The researchers and sponsors have developed a comprehensive plan for disseminating the trial results to various audiences, including trial participants, healthcare practitioners, the general public, and other relevant groups. Firstly, the trial results may be shared at academic conferences and events. After we complete the whole trial and data analysis, the complete results of the trial will be published in scientific journals. Secondly, after publication, all raw data and statistical results will be made publicly available on the Chinese Clinical Trial Registry website. However, this data sharing will be carried out in compliance with ethical and legal requirements, ensuring that participant privacy is protected. Lastly, it should be noted that there may be certain publication restrictions. For example, if the study involves intellectual property rights or confidential agreements with collaborating partners, the dissemination of specific details may be limited until the relevant permissions are obtained. In such cases, we will ensure transparency by clearly communicating the reasons for these restrictions to the interested parties. Discussion The rising global prevalence of myopia has made its prevention and control a critical public health challenge, particularly among children and adolescents [ 27 – 30 ]. While managing myopia progression is important, preventing its onset is an even more valuable strategy. The International Myopia Institute (IMI) highlights the concept of "pre-myopia," which refers to a refractive state of ≤ + 0.75 D and >-0.50 D [ 31 ]. In this state, combined with baseline refractive error, age, and other quantifiable risk factors, the likelihood of developing myopia in the future is significantly high, warranting preventive intervention. Although some preventive measures are available, including optical interventions, time spent outdoors, and behavioural influences [ 23 , 32 ], the limitations of these methods underscore the need for innovative myopia prevention strategies. This study focuses on addressing the issue of near work in children, aiming to evaluate the effectiveness of DIST as a supplementary approach for pre-myopia interventions. Given that the participants are still pre-myopic children, we rationally include a control group that performed conventional near work to investigate whether DIST alone was effective in delaying the onset of myopia on the one hand and whether it would be better when combined with optical defocusing techniques on the other. The questionnaire is designed to capture critical factors influencing insufficient hyperopic reserve at this stage, such as parental myopia, the participants’ eye habits, and time spent in outdoor activities. We also introduced a near-work log card to record additional near-work duration at home, as near-work at school is currently unavoidable. This allows us to evaluate the potential impact of DIST during discretionary near-work periods. In addition, due to the lack of previous studies using similar equipment as a reference, the sample size calculation in our study may result in insufficient statistical power, potentially affecting the reliability of the results. However, our results could provide a foundation for future research. In the current educational situation, increasing academic pressure on children and adolescents has made it challenging to ensure sufficient outdoor activities and exposure to natural light. Compared to other devices that can reduce near-work, such as projectors or large-screen televisions, DIST requires only a small space and offers a more seamless integration with children’s near-task activities, allowing their eyes to relax by focusing on distant objects without interfering with their learning tasks, thereby reducing visual strain. If the effectiveness of DIST is demonstrated, it could serve as a promising supplementary strategy for myopia prevention. Moreover, if DIST proves to be more effective when combined with widely recognized optical defocusing techniques, it will open up opportunities for further individualization of optical defocus parameters to cater to patient-specific needs, unlocking greater clinical potential. Although we measured changes in choroidal thickness in an attempt to explore the underlying mechanisms, this study primarily discusses the clinical applicability of DIST intervention, further investigation and refinement are needed to fully elucidate the mechanisms. Trial status Version and date of this protocol: version 1, April 21, 2025 Recruitment schedule: started in March 2024 and complete in September 2025 Abbreviations DIST Distant-Image Screen Technology SE Spherical Equivalent RLRL Repeated low-level red light CRFs Case report forms AL Axis length ChT Choroidal thickness OCT Optical coherence tomography ITT Intent-to-Treat PP Per-protocol VIF Variance inflation factors MAR Missing at random AIC Akaike Information Criterion ANCOVA Analysis of covariance LSMEANS Least-squares means OR Odds ratio ANOVA Analysis of variance LOCF Last Observation Carried Forward DMC Data Monitoring Committee IMI International Myopia Institute Declarations Acknowledgements We sincerely appreciate the contributions of all the staff and participants involved in this study. Authors’ contributions {31b} MP and JZ designed the study. LZ drafted the manuscript and XL helped to plot the figures and tables. XL will collect the data and perform the statistical analysis. Funding {4} This investigator-initiated trial is sponsored by the Eye Hospital of Wenzhou Medical University, Zhejiang, China, which will provide all necessary medical instruments, examinations, and evaluation services free of charge. No external funding is involved, ensuring the study’s independence and impartiality. Availability of data and materials {29} Due to ethical restrictions, we cannot share the full dataset collected. However, the datasets used and analyzed in this study are available upon request from the corresponding author. Ethics approval and consent to participate {24} The protocol and all study procedures are approved by the Medical Ethics Committee of the Affiliated Eye Hospital of Wenzhou Medical University (2024-016-K-015-05) and conducted following the ethical standards of the Declaration of Helsinki. Subjects are required to sign an ethical informed consent form before participating in the experiment. For children under the age of 8, consent may be signed by their guardians on their behalf. Consent for publication {32} All authors have read and agreed to the final version of the manuscript Competing interests {28} The authors declare that they have no competing interests. Authors ’ information (optional) 1 School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, China 2 National Clinical Research Center for Ocular Disease, Wenzhou, Zhejiang, China References Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016;123(5):1036–42. Modjtahedi BS, Abbott RL, Fong DS, Lum F, Tan D, Ang M, et al. Reducing the Global Burden of Myopia by Delaying the Onset of Myopia and Reducing Myopic Progression in Children. Ophthalmology. 2021;128(6):816–26. You QS, Wu LJ, Duan JL, Luo YX, Liu LJ, Li X, et al. Factors associated with myopia in school children in China: the Beijing childhood eye study. PLoS ONE. 2012;7(12):e52668. Risk factors for idiopathic rhegmatogenous retinal detachment. The Eye Disease Case-Control Study Group. Am J Epidemiol. 1993;137(7):749–57. Liang YB, Friedman DS, Wong TY, Zhan SY, Sun LP, Wang JJ, et al. Prevalence and causes of low vision and blindness in a rural chinese adult population: the Handan Eye Study. Ophthalmology. 2008;115(11):1965–72. Kanthan GL, Mitchell P, Rochtchina E, Cumming RG, Wang JJ. Myopia and the long-term incidence of cataract and cataract surgery: the Blue Mountains Eye Study. Clin Exp Ophthalmol. 2014;42(4):347–53. Mitchell P, Hourihan F, Sandbach J, Wang JJ. The relationship between glaucoma and myopia: the Blue Mountains Eye Study. Ophthalmology. 1999;106(10):2010–5. Holy C, Kulkarni K, Brennan NA. Predicting Costs and Disability from the Myopia Epidemic–A Worldwide Economic and Social Model. Investig Ophthalmol Vis Sci. 2019;60(9):5466–5466. Sankaridurg P, Tahhan N, Kandel H, Naduvilath T, Zou H, Frick KD, et al. IMI Impact of Myopia. Invest Ophthalmol Vis Sci. 2021;62(5):2. Zhang W, Chang S, Jiang J, Yu M, Chen S, Hu Y, et al. Association between vision-related quality of life and mental health status in myopia children using various optical correction aids. Cont Lens Anterior Eye. 2024;47(5):102287. Goldstand S, Koslowe KC, Parush S. Vision, visual-information processing, and academic performance among seventh-grade schoolchildren: a more significant relationship than we thought? Am J Occup Ther. 2005;59(4):377–89. Dudovitz RN, Izadpanah N, Chung PJ, Slusser W. Parent, Teacher, and Student Perspectives on How Corrective Lenses Improve Child Wellbeing and School Function. Matern Child Health J. 2016;20(5):974–83. Enthoven CA, Tideman JWL, Polling JR, Yang-Huang J, Raat H, Klaver CCW. The impact of computer use on myopia development in childhood: The Generation R study. Prev Med. 2020;132:105988. Biswas S, El Kareh A, Qureshi M, Lee DMX, Sun CH, Lam JSH, et al. The influence of the environment and lifestyle on myopia. J Physiol Anthropol. 2024;43(1):7. Sivaraman V, Rizwana JH, Ramani K, Price H, Calver R, Pardhan S, et al. Near work-induced transient myopia in Indian subjects. Clin Exp Optom. 2015;98(6):541–6. Huang HM, Chang DST, Wu PC. The Association between Near Work Activities and Myopia in Children-A Systematic Review and Meta-Analysis. PLoS ONE. 2015;10(10):e0140419. Eppenberger LS, Grzybowski A, Schmetterer L, Ang M. Myopia Control: Are We Ready for an Evidence Based Approach? Ophthalmol Ther. 2024;13(6):1453–77. Liang X, Wei S, Zhao S, Li SM, An W, Sun Y, et al. Investigation of Choroidal Blood Flow and Thickness Changes Induced by Near Work in Young Adults. Curr Eye Res. 2023;48(10):939–48. Chhabra S, Rathi M, Sachdeva S, Rustagi IM, Soni D, Dhania S. Association of near work and dim light with myopia among 1400 school children in a district in North India. Indian J Ophthalmol. 2022;70(9):3369–72. Zhen Y, Zhang W, Shen J, Cheng D, Shen W, Wang NL. The clinical value of using a distant-image screen for reading and learning. Chin J Ophthalmol. 2022;58(12):1045–50. Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011;118(6):1152–61. Berntsen DA, Barr CD, Mutti DO, Zadnik K. Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses. Invest Ophthalmol Vis Sci. 2013;54(8):5761–70. Wildsoet CF, Chia A, Cho P, Guggenheim JA, Polling JR, Read S, et al. IMI - Interventions Myopia Institute: Interventions for Controlling Myopia Onset and Progression Report. Invest Ophthalmol Vis Sci. 2019;60(3):M106–31. Cho P, Cheung SW. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial. Invest Ophthalmol Vis Sci. 2012;53(11):7077–85. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346(jan08 15):e7586–7586. Fang PC, Chung MY, Yu HJ, Wu PC. Prevention of myopia onset with 0.025% atropine in premyopic children. J Ocul Pharmacol Ther. 2010;26(4):341–5. Dong L, Kang YK, Li Y, Wei WB, Jonas JB, PREVALENCE AND TIME TRENDS OF MYOPIA IN CHILDREN AND ADOLESCENTS IN CHINA. A Systemic Review and Meta-Analysis. Retina. 2020;40(3):399–411. Ding BY, Shih YF, Lin LLK, Hsiao CK, Wang IJ. Myopia among schoolchildren in East Asia and Singapore. Surv Ophthalmol. 2017;62(5):677–97. Yotsukura E, Torii H, Inokuchi M, Tokumura M, Uchino M, Nakamura K, et al. Current Prevalence of Myopia and Association of Myopia With Environmental Factors Among Schoolchildren in Japan. JAMA Ophthalmol. 2019;137(11):1233–9. Xiang F, He M, Zeng Y, Mai J, Rose KA, Morgan IG. Increases in the prevalence of reduced visual acuity and myopia in Chinese children in Guangzhou over the past 20 years. Eye (Lond). 2013;27(12):1353–8. Flitcroft DI, He M, Jonas JB, Jong M, Naidoo K, Ohno-Matsui K, et al. IMI - Defining and Classifying Myopia: A Proposed Set of Standards for Clinical and Epidemiologic Studies. Invest Ophthalmol Vis Sci. 2019;60(3):M20–30. Jonas JB, Ang M, Cho P, Guggenheim JA, He MG, Jong M, et al. IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci. 2021;62(5):6. Cite Share Download PDF Status: Published Journal Publication published 11 Apr, 2026 Read the published version in Trials → Version 1 posted Reviewers agreed at journal 19 Aug, 2025 Reviewers invited by journal 19 Aug, 2025 Editor assigned by journal 17 Jun, 2025 First submitted to journal 16 Jun, 2025 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-6496580","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":502382282,"identity":"ef12b8dc-6871-4705-9a6f-a740615e0456","order_by":0,"name":"Liying Zou","email":"","orcid":"","institution":"Wenzhou Medical University School of Optometry and Ophthalmology","correspondingAuthor":false,"prefix":"","firstName":"Liying","middleName":"","lastName":"Zou","suffix":""},{"id":502382283,"identity":"22f2be24-9c60-47b6-84d9-127c9be2571c","order_by":1,"name":"Xiaoru Li","email":"","orcid":"","institution":"Wenzhou Medical University School of Optometry and Ophthalmology","correspondingAuthor":false,"prefix":"","firstName":"Xiaoru","middleName":"","lastName":"Li","suffix":""},{"id":502382284,"identity":"ece8121f-04ff-4181-8f7c-8f2f7d71c3d9","order_by":2,"name":"Jiawei Zhou","email":"","orcid":"","institution":"Wenzhou Medical University School of Optometry and Ophthalmology","correspondingAuthor":false,"prefix":"","firstName":"Jiawei","middleName":"","lastName":"Zhou","suffix":""},{"id":502382285,"identity":"b725772e-e68c-4f2e-a61a-5d9c205e179f","order_by":3,"name":"Meiping Xu","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAz0lEQVRIiWNgGAWjYPACCTk2hsMHDnz4QbwWG2N+xmOJB2f2EK8lLXFm8xnjwxxsRKiVn5H+8HEBw2Fjg2NnPhxm4GGQ5xc7gF+LwY2EZOMZDIflDM6c3XC4wILBcObsBAJaJBKOSfOAbLkB1DKDhyHB4DYBLfIzEtt/A7Ukbrj/5sFhHjYitDDcSGZj5gF5v+EMA3FaDM48Y5bmMQAGMsMxA2AgSxD2i3x7+sPPPBXgqHz84cMPG3l+aUIOg9gFZ0kQo3wUjIJRMApGASEAAFKVRvYDqOXSAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0002-8755-3091","institution":"Wenzhou Medical University School of Optometry and Ophthalmology","correspondingAuthor":true,"prefix":"","firstName":"Meiping","middleName":"","lastName":"Xu","suffix":""}],"badges":[],"createdAt":"2025-04-21 13:41:01","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6496580/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6496580/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-026-09696-2","type":"published","date":"2026-04-11T15:58:01+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":90299088,"identity":"fc77e5c0-6df7-4b9b-affd-a10edfe3db8b","added_by":"auto","created_at":"2025-09-01 08:49:15","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":124957,"visible":true,"origin":"","legend":"\u003cp\u003eThe flowchart of the study\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-6496580/v1/a857fbb29571072ccce91cce.png"},{"id":106809189,"identity":"d46b992e-3c2c-45e9-874d-bd94f7443c09","added_by":"auto","created_at":"2026-04-13 16:07:56","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1572473,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6496580/v1/1d34bb14-434f-4c81-874b-cd773fcab854.pdf"}],"financialInterests":"","formattedTitle":"Effect of distant-image screen technology (DIST) on delaying myopia onset in pre-myopia children: study protocol for a 1-year randomized controlled trial","fulltext":[{"header":"Administrative information","content":"\u003cp\u003eNote: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"639\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTitle {1}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eEffect of distant-image screen technology (DIST) on delaying myopia onset in pre-myopia children: study protocol for a 1-year randomized controlled trial\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTrial registration {2a and 2b}.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eChinese Clinical Trial Registry (ChiCTR),\u0026nbsp;ChiCTR2400082078. Registered on 20 March 2024.\u0026nbsp;https://www.chictr.org.cn/showproj.html?proj=221835\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eProtocol version {3}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eProtocol version 1. Protocol\u0026nbsp;date:\u0026nbsp;April 21, 2025\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eFunding {4}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eThis investigator-initiated trial is sponsored by the Eye Hospital of Wenzhou Medical University, Zhejiang, China, which will provide all necessary medical instruments, examinations, and evaluation services free of charge. No external funding is involved, ensuring the study\u0026rsquo;s independence and impartiality.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAuthor details {5a}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eLiying Zou\u003csup\u003e1,2\u003c/sup\u003e, Xiaoru Li\u003csup\u003e1,2\u003c/sup\u003e,\u0026nbsp;Jiawei Zhou\u003csup\u003e1,2\u003c/sup\u003e and Meiping Xu\u003csup\u003e1,2*\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e1\u003c/sup\u003e School of Ophthalmology \u0026amp; Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, China\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e2\u003c/sup\u003e National Clinical Research Center for Ocular Disease, Wenzhou, Zhejiang, China\u003c/p\u003e\n \u003cp\u003e*Corresponding author\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eName and contact information for the trial sponsor {5b}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eEye Hospital of Wenzhou Medical University\u003c/p\u003e\n \u003cp\u003eNo. 270,\u0026nbsp;College West Road, Wenzhou, Zhejiang, China\u003c/p\u003e\n \u003cp\u003eTelephone:\u0026nbsp;0577-88068888\u003c/p\u003e\n \u003cp\u003eEmail:\u0026nbsp;\u003cu\[email protected]\u003c/u\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eRole of sponsor {5c}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eThe sponsor of this trial,\u0026nbsp;Eye Hospital of Wenzhou Medical \u0026nbsp; University,\u0026nbsp;assumes overall responsibility for the initiation, management, and funding of the study. Specific roles and responsibilities include\u0026nbsp;ethical and\u0026nbsp;regulatory\u0026nbsp;compliance, provision of resources, trial oversight, data management and integrity, independence of analysis.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Introduction","content":"\n\u003ch3\u003eBackground and rationale {6a}\u003c/h3\u003e\n\u003cp\u003eMyopia is a prevalent refractive error that significantly contributes to visual impairment worldwide. Over the past few decades, the global prevalence of myopia has risen sharply, with epidemiological studies predicting that by 2050, nearly half of the world\u0026rsquo;s population (approximately 4.758\u0026nbsp;billion individuals) will be myopic, including almost 1\u0026nbsp;billion affected by high myopia [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The high prevalence of myopia, especially among adolescents in certain populations (80\u0026ndash;90%), has reached alarming levels [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Myopia has raised considerable public health concerns due to its associated risk of severe ocular complications, such as cataracts, glaucoma, and retinal detachment [\u003cspan additionalcitationids=\"CR5 CR6\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. These complications not only impair vision but also impose substantial burden on patients\u0026rsquo; quality of life and healthcare systems [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Moreover, myopia can adversely impact children's and adolescents' learning and daily lives, potentially leading to reduced self-esteem and social difficulties[\u003cspan additionalcitationids=\"CR11\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Consequently, the prevention and control of myopia have emerged as pressing global public health priorities.\u003c/p\u003e\u003cp\u003eA growing body of evidence highlights the association between prolonged near work \u0026mdash;such as reading or engaging in close-up tasks\u0026mdash;and the onset and progression of myopia in children and adolescents[\u003cspan additionalcitationids=\"CR14 CR15 CR16\" citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Mechanistically, near work has been linked to alterations in choroidal thickness, a biomarker increasingly studied in the context of myopia development [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e], suggesting that reducing near work exposure could mitigate myopia progression [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Furthermore, extended duration of near work has been shown to have an impact. This understanding has driven the innovation of novel technologies aimed at addressing the challenges of near work.\u003c/p\u003e\u003cp\u003eThe distance-image screen technology (DIST) is a novel myopia prevention and control approach developed in the past two years. DIST utilizes the \u0026ldquo;Birdbath\u0026rdquo; optical design principle and freeform mirror technology to project near scenes to a perceived distance beyond 3 meters. This innovation theoretically reduces the visual strain associated with near work while allowing children and adolescents to engage in tasks such as reading and note-taking. An previous clinical study have confirmed that using the DIST for reading does not compromise reading efficiency or increase visual fatigue, providing early support for its feasibility and safety in daily use[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eIn parallel, optical defocus has been widely recognized as an effective strategy for myopia control, with clinical applications such as peripheral defocus glasses and contact lenses [\u003cspan additionalcitationids=\"CR22 CR23\" citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. While the potential synergistic effects of DIST and optical defocus technologies remain unexplored, their combination may represent a promising avenue for enhancing myopia control outcomes. This research aims to investigate whether DIST and integrating DIST with optical defocus principles can further optimize myopia prevention strategies, offering new insights into evidence-based myopia management.\u003c/p\u003e\n\u003ch3\u003eObjectives {7}\u003c/h3\u003e\n\u003cp\u003eBased on the aforementioned theories, our primary objective was to evaluate the efficacy of DIST and integrating DIST with optical defocus principles on delaying the onset of myopia, specifically in postponing the initial diagnosis of myopia in pre-myopic children. Additionally, we aimed to determine its impact on mitigating myopic refractive shift and slowing ocular axis elongation. We hypothesized that the DIST intervention would demonstrate superior efficacy in these outcomes compared to the control group, highlighting its potential as a targeted strategy for myopia prevention.\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eTrial design {8}\u003c/h2\u003e\u003cp\u003eThis study will be a randomized, superiority-controlled trial with a parallel-group design. 192 pre-myopic children will be randomly divided into three groups of 64 subjects in a 1:1:1 ratio. The three groups are no use of DIST, DIST alone (RIO-Max 2.0), and DIST optimized by combining the optical defocusing technique (RIO-Ultra 2.0). The complete study flowchart is shown in the figure (Fig.\u0026nbsp;1). The protocol and all study procedures are approved by the Medical Ethics Committee of the Affiliated Eye Hospital of Wenzhou Medical University (2024-016-K-015-05) and conducted following the ethical standards of the Declaration of Helsinki. The protocol has been registered with the Chinese Clinical Trial Registry (ChiCTR2400082078) and uses the SPIRIT reporting guidelines[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Subjects are required to sign an ethical informed consent form before participating in the experiment.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e"},{"header":"Methods: Participants, interventions and outcomes","content":"\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\n\u003ch2\u003eStudy setting {9}\u003c/h2\u003e\n\u003cp\u003eParticipants in this study will be recruited from the Eye Hospital of Wenzhou Medical University. Screening and baseline examinations will be conducted in the outpatient clinic of the Eye Hospital, using advanced and comprehensive equipment to ensure accurate and complete data collection. Participants assigned to the two intervention groups using DIST will take the devices home. Follow-up supervision will be conducted by the researchers to ensure adherence to the study protocol and proper implementation of the intervention.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eEligibility criteria {10}\u003c/h3\u003e\n\u003cp\u003eAll subjects will undergo initial screening by ophthalmologists and investigators before enrolment. This screening will include inquiries about general health condition, family and disease history, allergies, and current medications. Potential subjects who meet these preliminary criteria will then be further assessed for ocular health and lifestyle habits based on the established inclusion and exclusion criteria.\u003c/p\u003e\n\u003cp\u003eInclusion criteria:\u003c/p\u003e\n\u003cp\u003e(1) Age: 6\u0026ndash;10 years old;\u003c/p\u003e\n\u003cp\u003e(2) Spherical Equivalent (SE) in either eye:\u0026gt;-0.50D and \u0026le;\u0026thinsp;+\u0026thinsp;0.75D (based on the average value of automatic refraction under cycloplegia);\u003c/p\u003e\n\u003cp\u003e(3) Astigmatism in either eye: \u0026le;1.50D;\u003c/p\u003e\n\u003cp\u003e(4) At least 1 hour of near work every day, including non-learning (TV, games, etc.), learning (online learning, punching in), reading, etc.;\u003c/p\u003e\n\u003cp\u003e(5) The naked visual acuity in either eye: \u0026ge;4.9, and the best corrected visual acuity: \u0026ge;5.0;\u003c/p\u003e\n\u003cp\u003e(6) Never participated in any clinical trial of myopia control within 3 months or used myopia prevention methods, such as multi-point design defocus glasses, low concentration atropine, repeated low-level red light (RLRL), etc.;\u003c/p\u003e\n\u003cp\u003e(7) No dominant strabismus was observed.\u003c/p\u003e\n\u003cp\u003eExclusion criteria:\u003c/p\u003e\n\u003cp\u003e(1) Failure to comply with the protocol to obtain reliable study measurements;\u003c/p\u003e\n\u003cp\u003e(2) There is any eye disease that can affect refractive development, such as retinal disease, cataract, and ptosis;\u003c/p\u003e\n\u003cp\u003e(3) The existence of systemic or neurodevelopmental conditions that may affect refractive development;\u003c/p\u003e\n\u003cp\u003e(4) Eye or systemic drugs known to affect the development of myopia or visual acuity through effects on retinal regulation amplitude or intraocular pressure are being used.\u003c/p\u003e\n\u003ch3\u003eWho will take informed consent? {26a}\u003c/h3\u003e\n\u003cp\u003eEach investigator will personally explain the informed consent form in detail to the subject and their guardian during the recruitment process. This includes providing clear information about the study\u0026rsquo;s purpose, procedures, potential risks, and benefits, and ensuring sufficient time for them to ask questions and consider their participation. No examinations or interventions will proceed until both the subject and their guardian have provided written informed consent. For children under the age of 8, the guardian will provide consent on their behalf, while verbal assent from the child will be sought whenever appropriate, in accordance with ethical guidelines.\u003c/p\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n\u003ch2\u003eAdditional consent provisions for collection and use of participant data and biological specimens {26b}\u003c/h2\u003e\n\u003cp\u003eN/A: This study does not involve additional data and biospecimens that require subjects' consent to be collected.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eInterventions\u003c/h3\u003e\n\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\n\u003ch2\u003eExplanation for the choice of comparators {6b}\u003c/h2\u003e\n\u003cp\u003eThe choice of comparators in this study was guided by the need to evaluate the efficacy of long-term use of DIST and its potential enhancement when combined with the optical defocusing technique in delaying the onset of myopia. This group (daily near work without DIST) serves as the baseline comparator, reflecting typical daily activities that involve prolonged near work without specific interventions. Prolonged near work is a well-documented risk factor for myopia development, but its role in the absence of compensatory measures, such as DIST, remains an important baseline for understanding the natural progression of myopia onset. This control group enables the evaluation of whether DIST alone provides a protective effect against myopia development. By maintaining their habitual near work activities, participants in this group help establish a reference for comparing the effectiveness of interventions.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n\u003ch2\u003eIntervention description {11a}\u003c/h2\u003e\n\u003cp\u003eThere are two intervention groups in our study: the DIST Group (use of DIST alone) and the Combined Intervention Group (DIST and Optical Defocusing Technique). Participants in these two groups will be asked to use the device during near work, including online learning, playing online games, reading, and similar tasks, with a minimum daily usage of one hour.\u003c/p\u003e\n\u003cp\u003eThe DIST group is included to investigate whether projecting near scenes into the distance can effectively delay the onset of myopia. This group is critical for isolating the specific effect of DIST as a standalone intervention, independent of other factors. The use of DIST aligns with emerging evidence suggesting that increasing outdoor-like visual experiences or reducing accommodative stress may mitigate myopia progression.\u003c/p\u003e\n\u003cp\u003eThe Combined Intervention group (DIST and Optical Defocusing Technique) evaluates the synergistic effect of combining DIST with an optical defocusing technique, a method designed to induce controlled peripheral defocus, which has been shown in prior studies to slow myopia progression. By comparing this group with the DIST-only group, we aim to determine whether the addition of optical defocus provides a measurable advantage in delaying myopia onset. This comparison also informs the potential development of optimized multi-modal strategies for myopia prevention.\u003c/p\u003e\n\u003cp\u003eThis design enables a comprehensive evaluation of DIST\u0026rsquo;s efficacy both as a standalone intervention and in combination with optical defocus. By systematically comparing the outcomes across these groups, we aim to identify the most effective and practical strategy using DIST for delaying myopia onset. This evidence can directly inform clinical recommendations and public health strategies for myopia prevention. We recognize the potential for variability in participants\u0026rsquo; adherence to the interventions. To mitigate this, detailed instructions will be provided, and adherence will be monitored through regular follow-ups.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n\u003ch2\u003eCriteria for discontinuing or modifying allocated interventions {11b}\u003c/h2\u003e\n\u003cp\u003eParticipants may discontinue or have their allocated intervention modified during the trial based on the following criteria:\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eAdverse events or safety concerns. The occurrence of adverse events related to the intervention, such as visual discomfort, eye strain, or other unexpected side effects, that compromise the participant's safety or well-being.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNon-compliance with protocol. Persistent non-compliance with the study protocol, including failure to adhere to the prescribed use of DIST or participation in required follow-up visits, despite reasonable efforts to ensure adherence.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eParticipant or guardian decision. Withdrawal of consent by the participant or their guardian for any reason, including personal preferences or perceived lack of benefit from the intervention.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eInvestigator\u0026rsquo;s discretion. Determination by the investigator that continuing the intervention is not in the participant\u0026rsquo;s best interest, based on clinical judgment or unforeseen circumstances affecting the study\u0026rsquo;s integrity.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eParticipants who discontinue or modify their allocated interventions will remain in the study unless they explicitly request withdrawal. Their data will be included in the Intention-to-Treat analysis to ensure a comprehensive evaluation of the intervention\u0026rsquo;s efficacy.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n\u003ch2\u003eStrategies to improve adherence to interventions {11c}\u003c/h2\u003e\n\u003cp\u003eTo enhance participant adherence, each participant will be assigned a dedicated research assistant who will maintain regular contact with the participant\u0026rsquo;s family through a dedicated WeChat group. The research assistants will offer support by addressing any questions, troubleshooting equipment issues, and sending reminders to ensure timely completion of the intervention and follow-up activities. For experimental groups using DIST, the research team will monitor the device's usage through backend records once a week to verify adherence to the required usage duration. If any irregular usage patterns are detected, the research assistants will promptly inform the participant's family and provide personalized guidance to ensure consistent adherence.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\n\u003ch2\u003eRelevant concomitant care permitted or prohibited during the trial {11d}\u003c/h2\u003e\n\u003cp\u003eClearly defining permitted and prohibited concomitant care is essential to preserving the integrity of its intervention, protecting participant health and minimizing confounding factors.\u003c/p\u003e\n\u003cp\u003ePermitted concomitant care primarily includes recommendations for healthy visual habits, such as ensuring appropriate reading distance, adequate lighting, and regular outdoor activities. These practices are permitted and encouraged, as they align with standard myopia prevention guidelines.\u003c/p\u003e\n\u003cp\u003eIn contrast, the following are strictly prohibited as concomitant care. First are alternative myopia control interventions. Participants are not allowed to use other myopia control strategies, such as atropine eye drops or other optical interventions (e.g., defocus lenses), during the trial period. Second is experimental therapies. Enrollment in other clinical trials or use of investigational devices or drugs targeting myopia management is prohibited to avoid confounding effects. Last but most important is device modifications. Any unauthorized adjustments or modifications to the DIST device or its usage protocol are also strictly prohibited.\u003c/p\u003e\n\u003cp\u003eTo ensure adherence, all concomitant care received by participants must be reported to the research team and documented during follow-up visits. Any potential impact on study outcomes will be evaluated, and all such data will be recorded in the case report forms (CRFs). Participants and their families will be instructed to notify the study team of any changes in care or new treatments initiated during the trial.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\n\u003ch2\u003eProvisions for post-trial care {30}\u003c/h2\u003e\n\u003cp\u003eAll interventions in our study are considered safe, with no anticipated harm under normal circumstances. However, in the unlikely event that a participant sustains an injury or adverse effect related to the study interventions, the research sponsor will provide comprehensive post-trial care. This includes covering all associated medical expenses and providing appropriate financial compensation based on an assessment conducted by a qualified ophthalmologist.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\n\u003ch2\u003eOutcomes {12}\u003c/h2\u003e\n\u003cp\u003ePrimary outcome\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eConcealment mechanism {16b}\u003c/h3\u003e\n\u003cp\u003eA sealed, opaque, and consecutively envelope will be prepared for each participant. Each envelope will contain the group assignment determined by the randomization sequence. The envelopes will be opened sequentially only after a participant is deemed eligible and has provided informed consent, ensuring that the allocation remains concealed until the point of assignment. This approach prevents foreknowledge of group assignments and minimizes selection bias.\u003c/p\u003e\n\u003cdiv id=\"Sec31\" class=\"Section2\"\u003e\n\u003ch2\u003eImplementation {16c}\u003c/h2\u003e\n\u003cp\u003eThe randomization sequence was generated by the statistical team of the clinical research center of the eye hospital of Wenzhou medical university. Specialized ophthalmologists in the outpatient clinic will recruit potential participants and conduct baseline assessments. Once participants confirm their enrollment, researchers will assign the corresponding envelope based on the order of participant enrollment. The envelope will then be opened by an independent research assistant, who will use the random number inside the envelope to determine the group assignment.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec32\" class=\"Section2\"\u003e\n\u003ch2\u003eAssignment of interventions: Blinding\u003c/h2\u003e\n\u003cdiv id=\"Sec33\" class=\"Section3\"\u003e\n\u003ch2\u003eWho will be blinded {17a}\u003c/h2\u003e\n\u003cp\u003eDue to the nature of the intervention, blinding of participants and intervention providers is not feasible. However, to minimize potential bias, the examination equipment is relatively objective and blinding will be implemented for outcome assessors, data collectors, and data analysts.\u003c/p\u003e\n\u003cp\u003eOutcome Assessors: Independent examiners conducting refraction and AL measurements will be blinded to the participants\u0026rsquo; group assignments. They will not be involved in intervention delivery or participant interactions beyond data collection.\u003c/p\u003e\n\u003cp\u003eData Collectors: Personnel responsible for recording and entering study data will be blinded to group allocation to prevent unconscious bias in data handling.\u003c/p\u003e\n\u003cp\u003eData Analysts: Statistical analysts will receive a coded dataset without group identifiers, ensuring that data analysis remains objective.\u003c/p\u003e\n\u003cp\u003eBlinding procedures will be strictly maintained throughout the study to enhance the reliability and validity of the findings.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec34\" class=\"Section3\"\u003e\n\u003ch2\u003eProcedure for unblinding if needed {17b}\u003c/h2\u003e\n\u003cp\u003eN/A.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003ch3\u003eData collection and management\u003c/h3\u003e\n\u003cdiv id=\"Sec36\" class=\"Section2\"\u003e\n\u003ch2\u003ePlans for assessment and collection of outcomes {18a}\u003c/h2\u003e\n\u003cp\u003eAt baseline and during each follow-up, researchers will provide paper-based questionnaires for guardians to complete, and the results will be entered into a spreadsheet for analysis. All other clinical assessments will be performed by experienced clinicians using relevant measuring instruments (as specified in item 12). Measurements will be repeated to ensure the reliability and validity of the data collection. Meanwhile, patients\u0026rsquo; general information, medical history, baseline and follow-up results, adverse event reports, and trial summaries will be recorded in the CRFs by researchers on time. All researchers and clinicians will undergo training on participant recruitment, assessment, intervention, and data backup before participating in the study.\u003c/p\u003e\n\u003cp\u003eCycloplegic autorefraction will be performed using the Topcon KR800 autorefractor unit following the cycloplegia regimen of 1% cyclopentolate (Cyclogyl, AlconConvreur). Spherical equivalent is calculated as spherical power plus half of the cylinder power. Cycloplegic measurements will be performed at baseline, the 6-month follow-up, and the 12-month follow-up to assess the primary outcome.\u003c/p\u003e\n\u003cp\u003eOcular AL will be measured on a Zeiss IOL Master 700 (Carl Zeiss Meditec Inc.) using noncontact partial coherence interferometry. Perform six measurements of total AL, anterior chamber length, and corneal curvatures. At least three measurements are identical or almost identical. The ChT will be measured using Wevis OCT (Wevis Imaging Technology Co., Ltd.) in the Angio 6x6 512 R4 mode.\u003c/p\u003e\n\u003cp\u003eAn individual's visual function and comfort will be assessed through questionnaires during near work, screening for visual fatigue, accommodation abnormalities, convergence/divergence issues, and other visual impairments. Additionally, evaluating the time spent on outdoor activities and near work provides insights into myopia risk associated with lifestyle habits.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec37\" class=\"Section2\"\u003e\n\u003ch2\u003ePlans to promote participant retention and complete follow-up {18b}\u003c/h2\u003e\n\u003cp\u003eTo ensure high participant retention and complete follow-up throughout the study, a comprehensive strategy will be implemented. This strategy will focus on maintaining participant engagement, minimizing dropout rates, and addressing potential challenges that may arise during the study.\u003c/p\u003e\n\u003cp\u003e1. Engagement and Retention Strategies\u003c/p\u003e\n\u003cp\u003eRegular Communication: Participants will be regularly contacted via phone calls, text messages, or mobile applications to provide reminders of upcoming appointments and to maintain engagement.\u003c/p\u003e\n\u003cp\u003eFlexible Scheduling: Follow-up visits will be scheduled at times convenient for the participants and their families, such as weekends and holidays.\u003c/p\u003e\n\u003cp\u003eIncentives: To further encourage retention, participants will receive small incentives, such as gift cards or study-related materials, upon completion of key milestones (e.g., baseline, 6-month, and 12-month visits).\u003c/p\u003e\n\u003cp\u003e2. Handling Withdrawals or Treatment Modifications\u003c/p\u003e\n\u003cp\u003eIn the event that a participant decides to withdraw or is unable to complete the study, their outcome data up to the point of withdrawal will be collected. This ensures that even if they do not complete the entire study, the data they have contributed remains valuable.\u003c/p\u003e\n\u003cp\u003eReasons for Withdrawal: Participants who withdraw will be asked to provide the reason for their decision (e.g., personal, logistical, or health-related issues), which will be documented for further analysis and to inform potential improvements in future studies.\u003c/p\u003e\n\u003cp\u003eChanges in Treatment Plan: If participants need to switch to an alternative treatment, the research team will collect relevant outcome data before the change is made, ensuring that the participant\u0026rsquo;s previous data remains part of the analysis. This will allow the study to account for the impact of treatment changes on the outcomes.\u003c/p\u003e\n\u003cp\u003e3. Follow-Up and Data Collection\u003c/p\u003e\n\u003cp\u003eIn the event of missing data or uncompleted follow-up visits, efforts will be made to contact participants to reschedule and collect the necessary data. If a participant cannot be reached for any follow-up visit, the last available data will be included in the analysis, and the participant will be considered as missing for subsequent follow-up points.\u003c/p\u003e\n\u003cp\u003eBy employing these strategies, we aim to minimize participant dropout, ensure high-quality follow-up data, and maximize the retention of participants throughout the one-year study period.\u003c/p\u003e\n\u003cdiv id=\"Sec38\" class=\"Section3\"\u003e\n\u003ch2\u003eData management {19}\u003c/h2\u003e\n\u003cp\u003eEffective data management is critical for ensuring the integrity, security, and reliability of the data collected throughout the study. A comprehensive plan will be implemented for data entry, coding, confidentiality, and storage, with quality assurance measures to ensure accurate and complete data collection.\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eCase report form: Case report forms, which will be in paper form, will be used to record clinical data in the trial, and case report. As original material, the CRFs will not be changed at will. The relevant information of all patients participating in the trial will be recorded timely and truthfully\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eData Entry: All data collected will be entered into an electronic data capture (WMU-EDC (Wenzhou Medical University, Wenzhou, Zhejiang, China) database. To prevent errors, double data entry will be used, where two separate team members will independently enter the data, and discrepancies will be resolved through a reconciliation process.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eData Quality Control Measures\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eRange Checks: To identify potential errors, automated range checks will be applied to the data during entry. For instance, measurements outside of predefined acceptable ranges (e.g., refraction values) will trigger a prompt for review.\u003c/p\u003e\n\u003cp\u003eConsistency Checks: Periodic consistency checks will be conducted to detect any discrepancies or outliers in the dataset. These checks will compare newly entered data with historical data or other clinical parameters.\u003c/p\u003e\n\u003cp\u003eTraining for Data Collectors: All staff involved in data collection and entry will undergo standardized training on the study protocols, measurement techniques, and data entry processes to minimize human error and improve consistency.\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eData Security: Data will be stored on secure cloud servers with encrypted access. Hard copies of any records will be kept in locked file cabinets, accessible only to authorized personnel. Audit trail will be maintained for all data-related actions, including data entry, modifications, and access, ensuring full traceability and accountability.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eData Access and Monitoring: Only authorized research staff will have access to the data, and data access permissions will be strictly controlled and documented. Regular internal audits will be conducted to ensure that data collection and management processes are being followed correctly. Data integrity will be routinely monitored, and any potential issues will be addressed promptly.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eBy implementing these measures, we aim to ensure data accuracy, security, and confidentiality, while maintaining the highest standards of data quality throughout the study.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec39\" class=\"Section2\"\u003e\n\u003ch2\u003eConfidentiality {27}\u003c/h2\u003e\n\u003cp\u003eTo ensure the confidentiality of participants' personal information throughout the study, a series of measures will be implemented to protect privacy during the pre-study phase, throughout the study, and after completion. These measures will govern the collection, sharing, and storage of personal data for both potential and enrolled participants.\u003c/p\u003e\n\u003cp\u003e1. Participant Informed Consent\u003c/p\u003e\n\u003cp\u003eAll participants will sign an informed consent form before entering the study, which will clearly explain how their personal information will be collected, used, stored, and shared. Participants will have the right to withdraw consent at any time and request the destruction of their personal data. The research team will ensure that participants fully understand how their personal data will be protected, and they will be given sufficient time and opportunity to ask questions or express concerns.\u003c/p\u003e\n\u003cp\u003e2. Data Collection and Storage\u003c/p\u003e\n\u003cp\u003eDuring the study, all personal information related to participants will be stored using coding systems to ensure that identifying information is separate from study data. Each participant will be assigned a unique identification number, and only this number will be used to identify them.\u003c/p\u003e\n\u003cp\u003ePersonal identifying information (e.g., name, phone number, address) will be kept in separate files from the study data and will be accessible only to authorized personnel.\u003c/p\u003e\n\u003cp\u003eParticipant personal information will be stored in encrypted storage systems (e.g., cloud storage) with regular security updates and checks to maintain data protection.\u003c/p\u003e\n\u003cp\u003e3. Data Sharing and Access\u003c/p\u003e\n\u003cp\u003eOnly authorized researchers and relevant personnel will have access to participants' personal information, and this access will be granted strictly for research purposes. All access to data will be controlled through a permission-based system, ensuring that only necessary personnel can view sensitive information.\u003c/p\u003e\n\u003cp\u003ePersonal information will not be shared unless legally required or for specific research needs. When reporting results to external entities, all published data will be anonymized to prevent the disclosure of any personal identifiers.\u003c/p\u003e\n\u003cp\u003e4. Post-study Data Management\u003c/p\u003e\n\u003cp\u003eAfter the study concludes, all personal information related to participants will continue to be handled according to confidentiality agreements, and will only be used for purposes directly related to the study (e.g., data analysis, final reporting).\u003c/p\u003e\n\u003cp\u003eOriginal data will be retained for a specified period and then securely destroyed to ensure that no personal information is accessible or disclosed after the study's conclusion.\u003c/p\u003e\n\u003cp\u003eIf the data needs to be used for subsequent research or publications after the study has ended, participants will be re-consented, and appropriate confidentiality measures will be applied.\u003c/p\u003e\n\u003cp\u003eThrough these measures, we will ensure the protection of participants' privacy and comply with all relevant legal and ethical standards to safeguard the confidentiality of data and participants' rights\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eN/A: As indicated in the outcome measures (item 12), our study does not involve the collection of biological samples.\u003c/p\u003e\n\u003cdiv id=\"Sec40\" class=\"Section3\"\u003e\n\u003ch2\u003eStatistical methods\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods for primary and secondary outcomes {20a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1. Analysis of primary outcome\u003c/p\u003e\n\u003cp\u003eIn this participant-based study, the primary outcome is the proportion of myopia onset. This outcome is measured as a binary (nominal) variable. Participants are classified as either having experienced the onset of myopia (Yes) or not (No), based on whether their cycloplegic spherical equivalent refractive error reaches or exceeds \u0026minus;\u0026thinsp;0.50 D in either eye at the 1-year follow-up. This is a single endpoint measure, assessed once at the end of the 1-year follow-up period. It provides a proportion of participants who experience the onset of myopia. To test the effectiveness of DIST on the primary outcomes, logistic regression including trend analysis will be used, which can both examine the overall relationship and detect potential trends related to different treatments. In addition, covariates such as baseline spherical equivalent refractive error, age, gender, and study group (Intervention vs. Control) will be included to ensure a parsimonious logistic regression model while controlling for factors known to influence myopia onset and progression.\u003c/p\u003e\n\u003cp\u003eThe primary analysis will be conducted on the ITT population, which is defined as all randomized participants with at least one post-baseline measurement. For all analyses, the underlying model assumptions will be rigorously evaluated. For instance, when applying logistic regression to assess the binary primary outcome, we will verify the linearity of the logit for continuous covariates using methods such as the Box-Tidwell test, assess multicollinearity via variance inflation factors (VIF), and examine residuals and influence statistics (e.g., Cook\u0026rsquo;s distance) to identify any influential outliers. Missing data will be addressed using multiple imputations by chained equations under the assumption of data missing at random (MAR), with sensitivity analyses planned to assess the impact of outliers, nonadherence, and loss to follow-up.\u003c/p\u003e\n\u003cp\u003e2. Analysis of secondary outcomes\u003c/p\u003e\n\u003cp\u003eThe secondary outcomes are intended to capture aspects of the intervention effect that are not fully reflected by the primary outcome. For example, even if the primary outcome (myopia onset) does not show a statistically significant difference, significant changes in spherical equivalent or axial length may still be observed, thereby indicating a potential benefit of the intervention in slowing myopia progression.\u003c/p\u003e\n\u003cp\u003eFor the three secondary outcomes: (1) the proportion of fast progressors over 1 year, (2) changes in spherical equivalent progression, and (3) changes in AL (mm) at each follow-up point, the following statistical procedures will be employed:\u003c/p\u003e\n\u003cp\u003e1. Proportion of fast progressors (binary outcome)\u003c/p\u003e\n\u003cp\u003eThis endpoint will be analyzed using logistic regression. The model will estimate the odds of being classified as a fast progressor over one year, comparing the intervention group to the control group. Covariates to be included in the model are baseline spherical equivalent refractive error (continuous), age (continuous), and gender (categorical), as these factors have been shown in prior research to influence myopia progression. The study group (intervention vs. control) will be the primary factor of interest. These covariates are selected based on their theoretical relevance and empirical support, ensuring a parsimonious model that controls for potential confounding without overfitting.\u003c/p\u003e\n\u003cp\u003e2. Changes in spherical equivalent progression (continuous outcome)\u003c/p\u003e\n\u003cp\u003eThe change in spherical equivalent progression over time will be analyzed using a repeated measures mixed-effects model. This model will account for within-subject correlations across multiple follow-up points and will include fixed effects for the treatment group, time (as a categorical or continuous variable depending on the observed pattern), and the interaction between treatment and time. Baseline spherical equivalent refractive error, age, and gender will be included as covariates to adjust for initial differences and known predictors of refractive change. The rationale for these covariates is their established association with myopia progression, ensuring that the model is both explanatory and parsimonious. Model selection procedures, such as stepwise backward elimination based on the Akaike Information Criterion (AIC) or likelihood ratio tests, will be applied to refine the final model.\u003c/p\u003e\n\u003cp\u003e3. Changes in AL (mm)\u003c/p\u003e\n\u003cp\u003eSimilar to the spherical equivalent endpoint, changes in axial length (measured in mm) at each follow-up will be analyzed using a repeated measures mixed-effects model or an analysis of covariance (ANCOVA) for longitudinal data. The model will include fixed effects for treatment, time, and their interaction. Covariates will include baseline axial length, baseline spherical equivalent, age, and gender. These factors are chosen because they are known to influence ocular growth and, consequently, axial elongation. As with the other endpoints, a parsimonious model will be achieved by using stepwise selection methods or likelihood ratio tests to retain only covariates that contribute significantly to explaining the variation in axial length change.\u003c/p\u003e\n\u003cp\u003eThe results of these analyses will be presented as adjusted odds ratios with 95% confidence intervals for the binary outcome and as least-squares means (LSMEANS) with standard errors for the continuous outcomes. In addition, p-values will be reported to assess the statistical significance of the observed differences between intervention groups.\u003c/p\u003e\n\u003cp\u003e3. Analysis of exploratory outcomes\u003c/p\u003e\n\u003cp\u003e1. Time-to-Myopia Onset Analysis\u003c/p\u003e\n\u003cp\u003eFor comparing the time to myopia onset (time-to-event outcome) among 3 treatment groups, we'll create a number-at-risk table and use the Kaplan-Meier method to estimate survival curves, followed by the log-rank test to assess differences statistically.\u003c/p\u003e\n\u003cp\u003e2. Myopia Onset Associations\u003c/p\u003e\n\u003cp\u003eA logistic regression model will be built with myopia onset as the dependent variable and near-work duration, device usage duration, and confounding factors as independent variables. Odds ratio (OR) and its 95% confidence interval will be estimated to determine associations while controlling for confounding.\u003c/p\u003e\n\u003cp\u003e3. Dose-Response Relationship Analysis\u003c/p\u003e\n\u003cp\u003eWe will group near-work and device usage durations (e.g., by quartiles). Use the Cochrance - Armitage trend test to analyze if there's a dose-response relationship. Curve fitting (such as polynomial regression) can also be used to further explore the non-linear relationship between them.\u003c/p\u003e\n\u003cp\u003e4. Choroidal Thickness Changes\u003c/p\u003e\n\u003cp\u003eFor exploring changes in choroidal thickness during different follow-up periods among three groups, repeated measures analysis of variance (ANOVA) will be used. If significant effects are found, post hoc tests (like Bonferroni or Tukey's) will determine specific differences.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003ch3\u003eInterim analyses {21b}\u003c/h3\u003e\n\u003cp\u003eN/A\u003c/p\u003e\n\u003ch3\u003eMethods for additional analyses (e.g. subgroup analyses) {20b}\u003c/h3\u003e\n\u003cp\u003eSubgroup analysis will be conducted based on the total duration of near-work and the usage duration of devices in this study. The aim is to explore the impacts of these two factors on the AL growth and the incidence rate of myopia among the subjects.\u003c/p\u003e\n\u003cp\u003eFirstly, we will divide the subjects into different subgroups according to specific criteria regarding the durations of near-work and device usage.\u003c/p\u003e\n\u003cp\u003eThen, appropriate statistical methods will be employed for the analysis. To analyze the impact on the AL growth, which is a continuous variable, we will consider using analysis of variance (ANOVA) or regression analysis to compare the differences in AL changes among different subgroups and to determine whether there are significant associations between the durations of near-work/device usage and the AL growth. In this process, relevant covariates such as age, gender, baseline refractive status, and outdoor activity time will be adjusted to control for potential confounding effects.\u003c/p\u003e\n\u003cp\u003eFor the analysis of the impact on the incidence rate of myopia, which is a binary variable, logistic regression will be utilized. The myopia incidence will be set as the dependent variable, while the durations of near-work and device usage will be the main independent variables. Additionally, the same set of covariates as mentioned above will be included in the model to account for confounding factors and to obtain more accurate estimates of the odds ratios and their corresponding confidence intervals, which can reflect the strength and significance of the associations between these factors and the myopia incidence.\u003c/p\u003e\n\u003cp\u003eFurthermore, interaction terms between the durations of near-work and device usage might be considered in the models to explore whether there are combined effects of these two factors on the outcomes of interest. Through this comprehensive subgroup analysis, we expect to gain a more detailed and in-depth understanding of how the durations of near-work and device usage influence the AL growth and the myopia incidence among the subjects.\u003c/p\u003e\n\u003ch3\u003eSubgroup Analysis of Secondary Outcomes\u003c/h3\u003e\n\u003cp\u003eSubgroup analyses will be conducted to investigate two primary factors among pre-myopic children: (1) the total duration of device usage, and (2) the duration of near-work. The objective is to determine how these factors affect key myopia prevention indicators\u0026mdash;including the primary endpoint (proportion of myopia onset) and secondary outcomes (proportion of fast progressors, change in spherical equivalent progression, and change in axial length).\u003c/p\u003e\n\u003ch3\u003eStratification and Definition:\u003c/h3\u003e\n\u003cp\u003eParticipants will be stratified into subgroups based on predetermined thresholds for both device usage and near-work duration. For the purposes of this study, we will operationally define \u003cstrong\u003ehigh-intensity near-work behavior\u003c/strong\u003e as a daily at-home near-work duration of two hours or more, while near-work behavior lasting less than two hours per day will be classified as \u003cstrong\u003elow-intensity\u003c/strong\u003e. Similarly, daily device usage of 30 minutes or longer will be considered indicative of \u003cstrong\u003ehigh adherence\u003c/strong\u003e, whereas usage of less than 30 minutes per day will be classified as \u003cstrong\u003elow adherence\u003c/strong\u003e. These thresholds may be refined based on the statistical distribution of the relevant data at the end of the study.\u003c/p\u003e\n\u003ch3\u003eStatistical Procedures:\u003c/h3\u003e\n\u003cp\u003eContinuous Outcomes (Axial Length, Spherical Equivalent Change):\u003c/p\u003e\n\u003cp\u003eFor outcomes measured on a continuous scale (i.e., axial length growth and change in spherical equivalent), we will use analysis of variance (ANOVA) or linear regression models. In these models, the subgroup classifications (based on device usage and near-work duration) will be the main independent variables. Adjustments will be made for covariates such as age, gender, baseline refractive error, and outdoor activity time to control for potential confounding. Model selection will follow a strategy to achieve parsimony\u0026mdash;incorporating only those covariates that are theoretically justified and empirically significant.\u003c/p\u003e\n\u003cp\u003eBinary Outcomes (Myopia Incidence and Proportion of Fast Progressors):\u003c/p\u003e\n\u003cp\u003eFor binary outcomes, logistic regression will be utilized. Here, the dependent variable will be the incidence of myopia (or classification as a fast progressor), and the primary predictors will be the categorized durations of device usage and near-work. The same set of covariates (age, gender, baseline refractive error, outdoor activity time) will be included to adjust for confounding. Odds ratios with corresponding 95% confidence intervals will be calculated to quantify the associations.\u003c/p\u003e\n\u003cp\u003eInteraction Analysis:\u003c/p\u003e\n\u003cp\u003eInteraction terms between device usage duration and near-work duration will be incorporated into the regression models to explore potential synergistic effects on myopia prevention outcomes.\u003c/p\u003e\n\u003cp\u003eRationale and Interpretation:\u003c/p\u003e\n\u003cp\u003eThe independent analysis of these subgroups is designed to provide a deeper understanding of how both device usage and near-work independently and jointly influence myopia progression indicators. This analysis is not dependent on the primary endpoint results; rather, it is intended to complement the overall findings and help refine targeted intervention strategies for high-risk pre-myopic children.\u003c/p\u003e\n\u003cp\u003eThe results will be presented as adjusted means (for continuous outcomes) and adjusted odds ratios (for binary outcomes) along with their standard errors or 95% confidence intervals. This comprehensive subgroup analysis will yield insights that may inform future recommendations for reducing near-work-related visual stress and optimizing the use of the DIST device in myopia prevention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo comprehensively assess the impact of the devices on delaying myopia onset, we will conduct data analyses using both the Intention-to-Treat (ITT) analysis as the primary result and the Per-Protocol (PP) analysis as the secondary result, along with appropriate handling of missing data in both processes.\u003c/p\u003e\n\u003cp\u003eITT Analysis (Primary Result)\u003c/p\u003e\n\u003cp\u003eThe ITT analysis will be carried out to reflect the real-world application effect of the devices in preventing myopia onset. In case a participant drops out or has missing data during the follow-up period, we will use the Last Observation Carried Forward (LOCF) method. This ensures that all randomly assigned participants are retained in the analysis, maintaining the integrity of the randomization and providing a comprehensive view of the overall effect of the devices in a real-life scenario.\u003c/p\u003e\n\u003cp\u003ePP Analysis (Secondary Result)\u003c/p\u003e\n\u003cp\u003eThe PP analysis will be employed as a secondary result to focus on the effect among those participants who strictly adhered to the use of the devices and followed the study protocol precisely. Only those subjects who completed all the required procedures, used the devices as instructed (e.g., for the specified duration and frequency), and attended all the follow-up visits without any major deviations from the protocol will be included in this analysis. To maintain the purity of the analysis, we will use direct exclusion to hand the missing data.\u003c/p\u003e\n\u003cp\u003eIn conclusion, by utilizing both ITT and PP analyses with appropriate handling of missing data, we expect to obtain a comprehensive and in-depth understanding of the effect of the DIST on delaying myopia onset in pre-myopia children from different perspectives, which will contribute to a more robust and reliable evaluation of the efficacy of these devices in this context.\u003c/p\u003e\n\u003ch3\u003ePlans to give access to the full protocol, participant level-data and statistical code {31c}\u003c/h3\u003e\n\u003cp\u003eIn our clinical research, we have well-defined plans for sharing important study materials to ensure transparency and reproducibility.\u003c/p\u003e\n\u003cp\u003eFirstly, the full protocol of our study will be published in the \u003cem\u003eTrials\u003c/em\u003e. Additionally, when the research is concluded and the corresponding article is published, the full protocol will also be attached as Supplementary materials at the end of the main text.\u003c/p\u003e\n\u003cp\u003eSecondly, regarding the raw data, we will make it available on the data platform of our hospital's clinical research center. However, this will take place after the official publication of the research article. To access the raw data, interested parties are required to fill out a corresponding application form. They can then submit the application to the corresponding author for review. During this process, strict ethical and privacy safeguards are in place. The raw data will be anonymized to protect the identities of the participants by removing or encrypting personal identifiers such as names, addresses, and social security numbers. This ensures that while enabling the sharing of valuable data for further research and verification purposes, the privacy rights of the participants are duly respected.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOversight and monitoring\u003c/strong\u003e\u003c/p\u003e\n\u003ch3\u003eComposition of the coordinating centre and trial steering committee {5d}\u003c/h3\u003e\n\u003cp\u003eIn this single-center clinical trial, the coordinating center is the hospital's Clinical Research Center. The trial steering committee plays a key role, composed of 2 hospital senior ophthalmology experts, 3 statistics experts (1 external), the project leader, and the sponsor's leader. It's responsible for determining the full trial protocol, reviewing progress, and setting endpoints.\u003c/p\u003e\n\u003cp\u003eThe Ethics Committee safeguards ethical aspects. The Endpoint Adjudication Committee with 2 experts ensures endpoint accuracy. And the Data Management Team, having 2 admins and 2 quality control staff, maintains data quality.\u003c/p\u003e\n\u003cp\u003eThe project research team consists of clinical ophthalmologists, laboratory researchers, and research assistants from the sponsor. They jointly handle tasks like participant recruitment, intervention implementation, outcome evaluation, data management, and analysis. Each task has an experienced leader. The steering committee oversees the whole study, while the research team holds monthly meetings to discuss progress and solve trial-related issues. Together, these components work in harmony to support the trial's success and ensure its scientific integrity and high quality.\u003c/p\u003e\n\u003ch3\u003eComposition of the data monitoring committee, its role and reporting structure {21a}\u003c/h3\u003e\n\u003cp\u003eThe Data Monitoring Committee (DMC) of the Clinical Trial Center at the Eye Hospital, Wenzhou Medical University, will be responsible for data monitoring and overseeing the entire study. The committee members are independent and do not include any personnel involved in this study, ensuring no conflicts of interest. All raw data will be stored with the Data Monitoring Committee and will not be made publicly available before the results are published.\u003c/p\u003e\n\u003ch3\u003eAdverse event reporting and harms {22}\u003c/h3\u003e\n\u003cp\u003eIn our study, a meticulous approach is adopted for adverse event reporting and addressing potential harms.\u003c/p\u003e\n\u003cp\u003eWe utilize paper-based CRFs to record relevant information. During each follow-up visit, investigators will actively inquire about participants' ocular discomfort manifestations, such as visual fatigue, dry eyes, and foreign body sensation. Meanwhile, we also collect information on other unexpected reactions like having a cold or a fever, including details about the duration of these symptoms as well as the methods used for relief and cure.\u003c/p\u003e\n\u003cp\u003eBased on the participants' reported reactions, investigators will carefully assess the correlation between these events and the trial. Appropriate handling plans will then be formulated accordingly.\u003c/p\u003e\n\u003cp\u003eMoreover, participants are encouraged to contact our investigators immediately if they experience any ocular discomfort symptoms or unexpected reactions during the use of relevant items in the study. Our investigators will provide timely and correct handling solutions to ensure the well-being of the participants and minimize potential harms. Through such a comprehensive process, we strive to closely monitor and effectively manage adverse events and safeguard the health and safety of all participants involved in our study.\u003c/p\u003e\n\u003ch3\u003eFrequency and plans for auditing trial conduct {23}\u003c/h3\u003e\n\u003cp\u003eThe trial steering committee regularly reviews the progress of the study (such as progress monitoring, decision modification, et al.) at intervals of every three months. It plays a crucial and pivotal role in our project It is independent from both the searchers and the sponsors.\u003c/p\u003e\n\u003ch3\u003ePlans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}\u003c/h3\u003e\n\u003cp\u003eBefore the commencement of the study, specifically during the design stage, the research protocol needs to undergo multiple rounds of demonstration and modification before it can be implemented. During the implementation process, if there are contents that truly require adjustments, for example, regarding the age in the inclusion criteria of this study, which was originally set as 6\u0026ndash;12 years old and has been changed to 6\u0026ndash;10 years old, the hospital's Clinical Research Center has a clear process in place to determine whether such modifications will affect the scientific integrity, ethical considerations, and practical implementation of the study. This involves relevant parties such as the investigators, CRC, who participate in the trial and the trial registration institutions.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDissemination plans {31a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe researchers and sponsors have developed a comprehensive plan for disseminating the trial results to various audiences, including trial participants, healthcare practitioners, the general public, and other relevant groups.\u003c/p\u003e\n\u003cp\u003eFirstly, the trial results may be shared at academic conferences and events. After we complete the whole trial and data analysis, the complete results of the trial will be published in scientific journals. Secondly, after publication, all raw data and statistical results will be made publicly available on the Chinese Clinical Trial Registry website. However, this data sharing will be carried out in compliance with ethical and legal requirements, ensuring that participant privacy is protected. Lastly, it should be noted that there may be certain publication restrictions. For example, if the study involves intellectual property rights or confidential agreements with collaborating partners, the dissemination of specific details may be limited until the relevant permissions are obtained. In such cases, we will ensure transparency by clearly communicating the reasons for these restrictions to the interested parties.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe rising global prevalence of myopia has made its prevention and control a critical public health challenge, particularly among children and adolescents [\u003cspan additionalcitationids=\"CR28 CR29\" citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. While managing myopia progression is important, preventing its onset is an even more valuable strategy. The International Myopia Institute (IMI) highlights the concept of \"pre-myopia,\" which refers to a refractive state of \u0026le;\u0026thinsp;+\u0026thinsp;0.75 D and \u0026gt;-0.50 D [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. In this state, combined with baseline refractive error, age, and other quantifiable risk factors, the likelihood of developing myopia in the future is significantly high, warranting preventive intervention. Although some preventive measures are available, including optical interventions, time spent outdoors, and behavioural influences [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e], the limitations of these methods underscore the need for innovative myopia prevention strategies. This study focuses on addressing the issue of near work in children, aiming to evaluate the effectiveness of DIST as a supplementary approach for pre-myopia interventions.\u003c/p\u003e\u003cp\u003eGiven that the participants are still pre-myopic children, we rationally include a control group that performed conventional near work to investigate whether DIST alone was effective in delaying the onset of myopia on the one hand and whether it would be better when combined with optical defocusing techniques on the other. The questionnaire is designed to capture critical factors influencing insufficient hyperopic reserve at this stage, such as parental myopia, the participants\u0026rsquo; eye habits, and time spent in outdoor activities. We also introduced a near-work log card to record additional near-work duration at home, as near-work at school is currently unavoidable. This allows us to evaluate the potential impact of DIST during discretionary near-work periods. In addition, due to the lack of previous studies using similar equipment as a reference, the sample size calculation in our study may result in insufficient statistical power, potentially affecting the reliability of the results. However, our results could provide a foundation for future research.\u003c/p\u003e\u003cp\u003eIn the current educational situation, increasing academic pressure on children and adolescents has made it challenging to ensure sufficient outdoor activities and exposure to natural light. Compared to other devices that can reduce near-work, such as projectors or large-screen televisions, DIST requires only a small space and offers a more seamless integration with children\u0026rsquo;s near-task activities, allowing their eyes to relax by focusing on distant objects without interfering with their learning tasks, thereby reducing visual strain. If the effectiveness of DIST is demonstrated, it could serve as a promising supplementary strategy for myopia prevention. Moreover, if DIST proves to be more effective when combined with widely recognized optical defocusing techniques, it will open up opportunities for further individualization of optical defocus parameters to cater to patient-specific needs, unlocking greater clinical potential. Although we measured changes in choroidal thickness in an attempt to explore the underlying mechanisms, this study primarily discusses the clinical applicability of DIST intervention, further investigation and refinement are needed to fully elucidate the mechanisms.\u003c/p\u003e\u003cp\u003e\u003cb\u003eTrial status\u003c/b\u003e\u003c/p\u003e\u003cp\u003eVersion and date of this protocol: version 1, April 21, 2025\u003c/p\u003e\u003cp\u003eRecruitment schedule: started in March 2024 and complete in September 2025\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eDIST \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Distant-Image Screen Technology\u003c/p\u003e\n\u003cp\u003eSE \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Spherical Equivalent\u003c/p\u003e\n\u003cp\u003eRLRL \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Repeated low-level red light\u003c/p\u003e\n\u003cp\u003eCRFs \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Case report forms\u003c/p\u003e\n\u003cp\u003eAL \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Axis length\u003c/p\u003e\n\u003cp\u003eChT \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Choroidal thickness\u003c/p\u003e\n\u003cp\u003eOCT \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Optical coherence tomography\u003c/p\u003e\n\u003cp\u003eITT \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Intent-to-Treat\u003c/p\u003e\n\u003cp\u003ePP \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Per-protocol\u003c/p\u003e\n\u003cp\u003eVIF \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Variance inflation factors\u003c/p\u003e\n\u003cp\u003eMAR \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Missing at random\u003c/p\u003e\n\u003cp\u003eAIC \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Akaike Information Criterion\u003c/p\u003e\n\u003cp\u003eANCOVA \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Analysis of covariance\u003c/p\u003e\n\u003cp\u003eLSMEANS \u0026nbsp; \u0026nbsp; \u0026nbsp;Least-squares means\u003c/p\u003e\n\u003cp\u003eOR\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Odds ratio\u003c/p\u003e\n\u003cp\u003eANOVA \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Analysis of variance\u003c/p\u003e\n\u003cp\u003eLOCF \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Last Observation Carried Forward\u003c/p\u003e\n\u003cp\u003eDMC \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Data Monitoring Committee\u003c/p\u003e\n\u003cp\u003eIMI \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;International Myopia Institute\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe sincerely appreciate the contributions of all the staff and participants involved in this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors’ contributions {31b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMP and JZ designed the study. LZ drafted the manuscript and XL helped to plot the figures and tables. XL will collect the data and perform the statistical analysis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding {4}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis investigator-initiated trial is sponsored by the Eye Hospital of Wenzhou Medical University, Zhejiang, China, which will provide all necessary medical instruments, examinations, and evaluation services free of charge. No external funding is involved, ensuring the study’s independence and impartiality.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials {29}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDue to ethical restrictions, we cannot share the full dataset collected. However, the datasets used and analyzed in this study are available upon request from the corresponding author.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate {24}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe protocol and all study procedures are approved by the Medical Ethics Committee of the Affiliated Eye Hospital of Wenzhou Medical University (2024-016-K-015-05) and conducted following the ethical standards of the Declaration of Helsinki. Subjects are required to sign an ethical informed consent form before participating in the experiment.\u0026nbsp;For children under the age of 8, consent may be signed by their guardians on their behalf.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication {32}\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;All authors have read and agreed to the final version of the manuscript\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests {28}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u003c/strong\u003e\u003cstrong\u003e’\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003einformation (optional)\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e1\u003c/sup\u003e School of Ophthalmology \u0026amp; Optometry and Eye Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, China\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e2\u003c/sup\u003e National Clinical Research Center for Ocular Disease, Wenzhou, Zhejiang, China\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eHolden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016;123(5):1036\u0026ndash;42.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eModjtahedi BS, Abbott RL, Fong DS, Lum F, Tan D, Ang M, et al. Reducing the Global Burden of Myopia by Delaying the Onset of Myopia and Reducing Myopic Progression in Children. Ophthalmology. 2021;128(6):816\u0026ndash;26.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eYou QS, Wu LJ, Duan JL, Luo YX, Liu LJ, Li X, et al. Factors associated with myopia in school children in China: the Beijing childhood eye study. PLoS ONE. 2012;7(12):e52668.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRisk factors for idiopathic rhegmatogenous retinal detachment. The Eye Disease Case-Control Study Group. Am J Epidemiol. 1993;137(7):749\u0026ndash;57.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLiang YB, Friedman DS, Wong TY, Zhan SY, Sun LP, Wang JJ, et al. Prevalence and causes of low vision and blindness in a rural chinese adult population: the Handan Eye Study. Ophthalmology. 2008;115(11):1965\u0026ndash;72.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKanthan GL, Mitchell P, Rochtchina E, Cumming RG, Wang JJ. Myopia and the long-term incidence of cataract and cataract surgery: the Blue Mountains Eye Study. Clin Exp Ophthalmol. 2014;42(4):347\u0026ndash;53.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMitchell P, Hourihan F, Sandbach J, Wang JJ. The relationship between glaucoma and myopia: the Blue Mountains Eye Study. Ophthalmology. 1999;106(10):2010\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHoly C, Kulkarni K, Brennan NA. Predicting Costs and Disability from the Myopia Epidemic\u0026ndash;A Worldwide Economic and Social Model. Investig Ophthalmol Vis Sci. 2019;60(9):5466\u0026ndash;5466.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSankaridurg P, Tahhan N, Kandel H, Naduvilath T, Zou H, Frick KD, et al. IMI Impact of Myopia. Invest Ophthalmol Vis Sci. 2021;62(5):2.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eZhang W, Chang S, Jiang J, Yu M, Chen S, Hu Y, et al. Association between vision-related quality of life and mental health status in myopia children using various optical correction aids. Cont Lens Anterior Eye. 2024;47(5):102287.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGoldstand S, Koslowe KC, Parush S. Vision, visual-information processing, and academic performance among seventh-grade schoolchildren: a more significant relationship than we thought? Am J Occup Ther. 2005;59(4):377\u0026ndash;89.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDudovitz RN, Izadpanah N, Chung PJ, Slusser W. Parent, Teacher, and Student Perspectives on How Corrective Lenses Improve Child Wellbeing and School Function. Matern Child Health J. 2016;20(5):974\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eEnthoven CA, Tideman JWL, Polling JR, Yang-Huang J, Raat H, Klaver CCW. The impact of computer use on myopia development in childhood: The Generation R study. Prev Med. 2020;132:105988.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBiswas S, El Kareh A, Qureshi M, Lee DMX, Sun CH, Lam JSH, et al. The influence of the environment and lifestyle on myopia. J Physiol Anthropol. 2024;43(1):7.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSivaraman V, Rizwana JH, Ramani K, Price H, Calver R, Pardhan S, et al. Near work-induced transient myopia in Indian subjects. Clin Exp Optom. 2015;98(6):541\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHuang HM, Chang DST, Wu PC. The Association between Near Work Activities and Myopia in Children-A Systematic Review and Meta-Analysis. PLoS ONE. 2015;10(10):e0140419.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eEppenberger LS, Grzybowski A, Schmetterer L, Ang M. Myopia Control: Are We Ready for an Evidence Based Approach? Ophthalmol Ther. 2024;13(6):1453\u0026ndash;77.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLiang X, Wei S, Zhao S, Li SM, An W, Sun Y, et al. Investigation of Choroidal Blood Flow and Thickness Changes Induced by Near Work in Young Adults. Curr Eye Res. 2023;48(10):939\u0026ndash;48.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eChhabra S, Rathi M, Sachdeva S, Rustagi IM, Soni D, Dhania S. Association of near work and dim light with myopia among 1400 school children in a district in North India. Indian J Ophthalmol. 2022;70(9):3369\u0026ndash;72.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eZhen Y, Zhang W, Shen J, Cheng D, Shen W, Wang NL. The clinical value of using a distant-image screen for reading and learning. Chin J Ophthalmol. 2022;58(12):1045\u0026ndash;50.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAnstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011;118(6):1152\u0026ndash;61.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBerntsen DA, Barr CD, Mutti DO, Zadnik K. Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses. Invest Ophthalmol Vis Sci. 2013;54(8):5761\u0026ndash;70.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWildsoet CF, Chia A, Cho P, Guggenheim JA, Polling JR, Read S, et al. IMI - Interventions Myopia Institute: Interventions for Controlling Myopia Onset and Progression Report. Invest Ophthalmol Vis Sci. 2019;60(3):M106\u0026ndash;31.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCho P, Cheung SW. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial. Invest Ophthalmol Vis Sci. 2012;53(11):7077\u0026ndash;85.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eChan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346(jan08 15):e7586\u0026ndash;7586.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eFang PC, Chung MY, Yu HJ, Wu PC. Prevention of myopia onset with 0.025% atropine in premyopic children. J Ocul Pharmacol Ther. 2010;26(4):341\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDong L, Kang YK, Li Y, Wei WB, Jonas JB, PREVALENCE AND TIME TRENDS OF MYOPIA IN CHILDREN AND ADOLESCENTS IN CHINA. A Systemic Review and Meta-Analysis. Retina. 2020;40(3):399\u0026ndash;411.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDing BY, Shih YF, Lin LLK, Hsiao CK, Wang IJ. Myopia among schoolchildren in East Asia and Singapore. Surv Ophthalmol. 2017;62(5):677\u0026ndash;97.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eYotsukura E, Torii H, Inokuchi M, Tokumura M, Uchino M, Nakamura K, et al. Current Prevalence of Myopia and Association of Myopia With Environmental Factors Among Schoolchildren in Japan. JAMA Ophthalmol. 2019;137(11):1233\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eXiang F, He M, Zeng Y, Mai J, Rose KA, Morgan IG. Increases in the prevalence of reduced visual acuity and myopia in Chinese children in Guangzhou over the past 20 years. Eye (Lond). 2013;27(12):1353\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eFlitcroft DI, He M, Jonas JB, Jong M, Naidoo K, Ohno-Matsui K, et al. IMI - Defining and Classifying Myopia: A Proposed Set of Standards for Clinical and Epidemiologic Studies. Invest Ophthalmol Vis Sci. 2019;60(3):M20\u0026ndash;30.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eJonas JB, Ang M, Cho P, Guggenheim JA, He MG, Jong M, et al. IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci. 2021;62(5):6.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Myopia prevention, Pre-myopia, Distant-image screen technology, Progression, Axial length","lastPublishedDoi":"10.21203/rs.3.rs-6496580/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6496580/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e• \u003cstrong\u003eBackground\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eMyopia is an escalating global health issue, particularly among adolescents, and its increasing prevalence is associated with a rising burden of ocular complications that adversely affect quality of life and strain healthcare resources. Extensive evidence links prolonged near work to myopia progression, prompting the development of innovative control strategies. One promising approach is the distant-image screen (DIST), which transforms a nearby real image into a virtual one that appears much farther away, thereby reducing the accommodative stress typically induced by prolonged near work. This study is designed to evaluate the efficacy of DIST in delaying the onset of myopia among pre-myopic children.\u003c/p\u003e\n\u003cp\u003e• \u003cstrong\u003eMethods\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eThis is a one-year, multi-arm randomized controlled trial involving 192 children, who will be randomly assigned in a 1:1:1 ratio to one of three groups: (1) a DIST group; (2) a Combined Intervention group, which will receive both DIST and an optical defocusing intervention and (3) a control group, engaging in regular near work without the use of DIST. The primary objective is to assess whether the use of DIST—alone or in combination with optical defocusing—can effectively delay the onset of myopia in pre-myopic children. The primary outcome is the proportion of myopia onset, and the secondary outcomes are the proportion of fast myopia progressors, change in spherical equivalent progression, and change in axial length at each follow-up point.\u003c/p\u003e\n\u003cp\u003e• \u003cstrong\u003eDiscussion\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eThe study aims to determine the independent efficacy of DIST as well as its potential synergistic benefits when combined with optical defocusing techniques. In the context of increasing academic demands and near-work exposure, DIST offers a space-efficient, practical solution that could alleviate visual strain without interfering with learning. By providing robust data on both refractive and ocular structural changes, the findings may inform personalized myopia prevention strategies. If successful, DIST could serve as a valuable adjunct to current myopia control methods, ultimately reducing the public health burden of myopia.\u003c/p\u003e\n\u003cp\u003e• \u003cstrong\u003eTrial registration\u003c/strong\u003e: Chinese Clinical Trial Registry (ChiCTR), ChiCTR2400082078. Registered on 20 March 2024. https://www.chictr.org.cn/showproj.html?proj=221835\u003c/p\u003e","manuscriptTitle":"Effect of distant-image screen technology (DIST) on delaying myopia onset in pre-myopia children: study protocol for a 1-year randomized controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-01 08:49:10","doi":"10.21203/rs.3.rs-6496580/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-08-19T09:13:48+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-08-19T07:26:14+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-06-17T05:58:41+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-06-17T01:57:02+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"bf45e6ad-15b5-492a-826f-3ae95f1a51fd","owner":[],"postedDate":"September 1st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-04-13T16:03:53+00:00","versionOfRecord":{"articleIdentity":"rs-6496580","link":"https://doi.org/10.1186/s13063-026-09696-2","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2026-04-11 15:58:01","publishedOnDateReadable":"April 11th, 2026"},"versionCreatedAt":"2025-09-01 08:49:10","video":"","vorDoi":"10.1186/s13063-026-09696-2","vorDoiUrl":"https://doi.org/10.1186/s13063-026-09696-2","workflowStages":[]},"version":"v1","identity":"rs-6496580","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6496580","identity":"rs-6496580","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}