[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659398":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":50,"overallOfficials":59,"centralContacts":64,"locations":26,"responsibleParty":72,"collaborators":26,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":26,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":99,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":26},{"fullName":5,"class":6},"National Yang Ming Chiao Tung University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Myopic shift of spherical equivalent refraction","The change of mean cycloplegic spherical equivalent refraction over 7 years","7 years",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Axial length elongation","The change of mean axial length over 7 years",{"measure":18,"description":19,"timeFrame":12},"Incidence of myopia","the cumulative percentage of incident myopia",{"measure":21,"description":22,"timeFrame":12},"Fast myopic shift of spherical equivalent refraction","the cumulative percentage of fast myopic shift of spherical equivalent refraction",{"measure":24,"description":25,"timeFrame":12},"Subfoveal choroidal thickness","the vertical distance from the outer edge of the retinal pigment epithelium (or Bruch's membrane) to the inner surface of the sclera (the chorioscleral border) directly beneath the fovea",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE","With the increasing popularity of screen-based digital devices in the post-pandemic era, childhood myopia prevention and control has become a growing global challenge. Although the protective effect of increased outdoor time has been well established, the optimal strategy for preventing or delaying the onset of childhood myopia remains to be determined, particularly among pre-myopic children around the age of school entry. A substantial increase in myopia prevalence has been reported before and after entry into elementary school, and children with early-onset myopia are at increased risk of rapid progression and subsequent development of high myopia later in life.\n\nRecent evidence suggests that low-concentration atropine eye drops may reduce the incidence of childhood myopia. However, photophobia and other dose-related adverse effects associated with higher concentrations of atropine may interfere with daytime visual activities and potentially reduce children's willingness to engage in outdoor activities. In addition, evidence regarding optical interventions for the prevention of myopia onset remains limited.\n\nThese unmet clinical needs motivate us to propose a randomized controlled trial evaluating optical and pharmacological approaches for myopia prevention using Defocus Incorporated Multiple Segments Triple Enhanced Design (DIMS TED) spectacle lenses and 0.025% atropine eye drops, respectively, in pre-myopic preschool children aged 5-6 years.\n\nIn this proposed study, we plan to recruit a total of 240 eligible participants identified as pre-myopic and asymptomatic through a population-based eye care program in Yilan County. Eligible participants will be randomly assigned to three groups: the DIMS TED spectacle lens group (n=80), the 0.025% atropine group (n=80), and the usual-care group (n=80).\n\nBecause environmental and near-work demands are generally lower during preschool than after entry into elementary school, children assigned to the DIMS TED group will be instructed to wear the spectacles using a stepwise strategy: primarily at home and during near-work activities during the preschool stage, followed by full-time wear after entering elementary school.\n\nCycloplegic spherical equivalent (SE) refraction and axial length will be measured every 6 months during the 7-year follow-up period. The primary outcome will be the change in mean cycloplegic SE over the study period among the three groups. Secondary outcomes will include the cumulative incidence of myopia, the cumulative proportion of participants exhibiting a fast myopic shift in SE, and changes in mean axial length over the study period.\n\nThis proposed project may provide further evidence regarding early optical and pharmacological intervention strategies for myopia prevention and may support the development of an eye-care model emphasizing early identification and intervention for pre-myopic preschool children before or around the time of elementary school entry.",[35,41,46],{"label":36,"type":37,"description":38,"interventionNames":39},"DIMS TED","ACTIVE_COMPARATOR","Stepwise wearing of DIMS TED",[40],"Device: DIMS TED",{"label":42,"type":37,"description":43,"interventionNames":44},"0.025% Atropine","Daily administration of 0.025% Atropine",[45],"Drug: 0.025% atropine eye drops",{"label":47,"type":48,"description":49,"interventionNames":26},"Normal activities","NO_INTERVENTION","Normal promotion of outdoor activities",[51,56],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":26},"DRUG","0.025% atropine eye drops","Daily instillation of 0.025% atropine",[42],{"type":57,"name":36,"description":38,"armGroupLabels":58,"otherNames":26},"DEVICE",[36],[60],{"name":61,"affiliation":62,"role":63},"Hsin-Yu Yang","National Yang Ming Chiao Tung University Hospital, Yilan, Taiw","PRINCIPAL_INVESTIGATOR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":26,"email":69},"Hsin-Yu Yang MD, MD","CONTACT","+886 3 9325192","lisa771102@yahoo.com.tw",{"name":71,"role":67,"phone":26,"phoneExt":26,"email":69},"DR.",{"type":63,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Der-Chong Tsai, MD PhD","Principal Investigator","100659398","phase-2-early-intervention-for-high-risk-premyopic-children-100659398",false,"NCT07863713","Early Intervention for High Risk Premyopic Children","Early Intervention for High Risk Premyopic Children: A Comparison Study of Defocus Integrated Multiple Segments Triple Enhanced Design Spectacle Lenses, 0.025% Atropine and Usual Care for Myopia Prevention","Inclusion Criteria:\n\n* Age at enrollment: 5-6 years old (the senior grade of kindergarten)\n* Cycloplegic SE of the eye with less SE (less positive or more negative refractive error): \\\u003C +1.00 D and \\> -0.50 D\n* Astigmatism: 1.5 D or less in both eyes\n* Anisometropia: 1.50 D or less\n* Monocular uncorrected visual acuity: 6\u002F7.5 or better in both eyes\n* Either of the parents with moderate myopia\n* Acceptance of random group allocation\n* Submission of complete informed consent.\n\nExclusion Criteria:\n\n* Strabismus or any ocular motility disorder\n* Any ophthalmic and systemic disorders that might affect visual functions or refractive development\n* Previous treatment of atropine or other myopia control intervention",true,"ALL","5 Years","6 Years",{"count":87,"type":88},240,"ESTIMATED","INTERVENTIONAL",[91],"PHASE2","The purpose of this research project is to add evidence of pharmacological (0.025% atropine) and optical (Defocus Integrated Multiple Segments Triple Enhanced Design spectacle lenses ) approaches for myopia prevention among premyopic preschoolers, which may contribute to a better understanding of the intervention strategy for myopia control in premyopic children.",[94],"Myopia",[96,36,97,98],"myopia","Atropine","Outdoor activities","NOT_YET_RECRUITING","2026-10-02",{"date":102,"type":103},"2026-10-07","ACTUAL",{"date":105,"type":88},"2026-10-24",{"date":107,"type":88},"2033-10-24",{"name":5,"class":6}]