[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658053":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":27,"studyPopulation":11,"armGroups":28,"interventions":45,"overallOfficials":56,"centralContacts":60,"locations":66,"responsibleParty":79,"collaborators":82,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":11,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":11,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":105,"whyStopped":11,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Tianjin Medical University Eye Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"The final spherical equivalent refractive error (SER) measured by cycloplegic refraction combined with both automated and subjective refraction after 12 months of wearing glasses, compared with the baseline value.",null,"From enrollment to the end of treatment at 12 months",[14],{"measure":15,"description":11,"timeFrame":12},"The change in AL (axial length) from the baseline after wearing the glasses for 12 months",{"allocation":17,"interventionModel":18,"interventionModelDescription":11,"primaryPurpose":19,"observationalModel":11,"timePerspective":11,"maskingInfo":20},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":21,"maskingDescription":11,"whoMasked":22},"QUADRUPLE",[23,24,25,26],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This study focused on 6-9-year-old young children as the research subjects, aiming to investigate 1. The effectiveness of using H.O.P.E. lenses alone and in combination with 0.02% atropine eye drops, in order to provide data support and clinical guidance for the clinical effectiveness and safety of the high-order phase unit (H.O.P.E.) array microstructure lenses in young children with myopia.",[29,35,40],{"label":30,"type":31,"description":32,"interventionNames":33},"Group A (H.O.P.E. Lens Group)","ACTIVE_COMPARATOR","Wearing H.O.P.E. lens frame glasses (provided by Shenyang Kangnd Medical Technology Co., Ltd.)",[34],"Device: High-order Phase Element Array Microstructure Design Lens (H.O.P.E.)",{"label":36,"type":31,"description":37,"interventionNames":38},"Group B (0.02% Atropine group)","Use 0.02% atropine sulfate eye drops (provided by Shenyang Xingqi Eye Pharmaceuticals Co., Ltd.)",[39],"Drug: 0.02% Atropine Sulfate Eye Drops",{"label":41,"type":42,"description":43,"interventionNames":44},"Group C (H.O.P.E. lenses + 0.02% atropine group)","EXPERIMENTAL","Wearing H.O.P.E. lens frame glasses (provided by Shenyang Kangnd Medical Technology Co., Ltd.); Use 0.02% atropine sulfate eye drops (provided by Shenyang Xingqi Eye Pharmaceuticals Co., Ltd.)",[34,39],[46,51],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":11},"DEVICE","High-order Phase Element Array Microstructure Design Lens (H.O.P.E.)","Wear the H.O.P.E. lens frame glasses and use the placebo. Use it once per night for both eyes.",[30,41],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":11},"DRUG","0.02% Atropine Sulfate Eye Drops","Wear single-vision frame glasses and use 0.02% atropine sulfate eye drops twice a day, once at night for both eyes.",[36,41],[57],{"name":58,"affiliation":5,"role":59},"Ruihua Wei","PRINCIPAL_INVESTIGATOR",[61],{"name":62,"role":63,"phone":64,"phoneExt":11,"email":65},"Meinan He","CONTACT","13672135765","hmn509@tmu.edu.cn",[67],{"facility":5,"status":11,"city":68,"state":11,"zip":11,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Tianjin","China","CN",{"type":72,"coordinates":73},"Point",[74,75],117.17667,39.14222,{"lat":75,"lon":74},[78],{"name":62,"role":63,"phone":64,"phoneExt":11,"email":65},{"type":80,"investigatorFullName":58,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Professor",[83],{"name":5,"class":6},"100658053","control-of-myopia-in-young-children-using-hope-lenses-combined-with-002-atropine-eye-drops-100658053",false,"NCT07846787","Control of Myopia in Young Children Using H.O.P.E. Lenses Combined With 0.02% Atropine Eye Drops","A Multicenter, Prospective, Intervention Study on the Control of Myopia in Young Children Using High-order Phase Element Array Microstructure Lenses (H.O.P.E.) in Combination With Low-concentration Atropine Eye Drops (0.02%)","Inclusion Criteria:\n\n1. Age: 6-9 years old (6 years old but under 10 years old), gender not restricted;\n2. Clinically diagnosed with bilateral myopia (after cycloplegia), refractive error within -6.00D \\\u003C SER ≤ -0.50D, astigmatism ≤ 1.50D, refractive anisometropia ≤ 1.50D (based on subjective refraction values);\n3. Corrected visual acuity LogMAR ≤ 0.1;\n4. Able to understand the research purpose, voluntarily participate, and the subject and his\u002Fher legal guardian sign the informed consent form.\n\nExclusion Criteria:\n\nIf a subject meets any of the following exclusion criteria, they will not be included in this study:\n\n1. Those who have discontinued the use of atropine eye drops (due to glaucoma or a tendency towards glaucoma, or are allergic to scopolamine or the components of this product);\n2. Those currently suffering from any of the following diseases that may affect vision or refractive errors, or ocular organic diseases: such as diseases causing damage to the lens like cataracts, glaucoma, macular degeneration, corneal diseases, uveitis, retinal detachment, severe vitreous opacity, acute\u002Fchronic keratitis, conjunctivitis, irregular cornea, keratoconus, manifest strabismus, fundus diseases, etc.; systemic diseases that may affect the eyes, such as immune system diseases, central nervous system diseases, Down syndrome, asthma, epilepsy, severe heart or lung function disorders, severe liver or kidney function impairments, etc.;\n3. Those who have participated in other clinical trials or studies related to myopia control within 90 days before signing the informed consent form;\n4. Those who have used myopia control products within 90 days before signing the informed consent form (such as near-axial lenses, low-concentration atropine eye drops, corneal reshaping lenses, red light, etc.);\n5. Those who cannot wear glasses regularly or use the medication as required (such as having a significant difference in compliance);\n6. During the screening period, the intraocular pressure of either eye is greater than 21 mmHg or less than 10 mmHg, or the intraocular pressure difference between both eyes is ≥ 5 mmHg;\n7. There is a severe abnormality in the accommodative function (accommodative amplitude \\\u003C 8D);\n8. Only one eye meets the inclusion criteria;\n9. Other situations that the researcher deems unsuitable for participating in this study.","ALL","6 Years","9 Years",{"count":95,"type":96},264,"ESTIMATED","INTERVENTIONAL",[99],"NA","A multicenter, prospective, intervention study on the control of myopia in young children using high-order phase element array microstructure lenses (H.O.P.E.) in combination with low-concentration atropine eye drops (0.02%)",[102],"Myopia",[104],"myopia","NOT_YET_RECRUITING","2026-09-22",{"date":108,"type":109},"2026-09-29","ACTUAL",{"date":111,"type":96},"2026-09-30",{"date":113,"type":96},"2028-09-20",{"name":58,"class":6},1]