[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613267":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":53,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Zhongshan Ophthalmic Center, Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","D.D.C dual-control technology spectacle lenses",[13],"Device: D.D.C dual-control technology spcetacle lenses",{"label":15,"type":10,"description":16,"interventionNames":17},"Control","Aspheric single-vision spectacle lenes",[18],"Device: Aspheric single-vision lenses",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","D.D.C dual-control technology spcetacle lenses","The children in the intervention group will wear D.D.C dual-control technology spcetacle lenses type A for one year, with follow-up visits at baseline, 1 month, 6 months, and 12 months. And then they will be randomized in a 1:1 ratio to either continue with type A lenses or switch to type B lenses, which differ only in the defocus zone. Follow-up visits will be conducted at 13, 18, and 24 months.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Aspheric single-vision lenses","The children in control group will wear aspheric single-vision lenses for one year, with follow-up visits at baseline, 1 month, 6 months, and 12 months. And then they will be randomized in a 1:1 ratio to either D.D.C dual-control technology spcetacle lenses type A lenses or alternate quarterly (every 3 months) between D.D.C dual-control technology spcetacle lenses type A and type B lenses. Follow-up visits will be conducted at 13, 18, and 24 months.",[15],[31],{"name":32,"affiliation":5,"role":33},"Jian Ge","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Yangfa Zeng","CONTACT","+86-020-6686986","zengyangfa@qq.com",[41],{"facility":5,"status":25,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":25},"Guangzhou","Guangdong","510060","China","CN",{"type":48,"coordinates":49},"Point",[50,51],113.25,23.11667,{"lat":51,"lon":50},{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[56],{"name":57,"class":58},"Guangzhou Youyan Vision Technology Co., Ltd.","UNKNOWN","100613267","evaluation-of-the-safety-and-efficacy-of-the-ddc-dual-control-technology-spectacle-lenses-in-delaying-the-progression-of-myopia-a-randomized-controlled-trial-100613267",false,"NCT07264361","Evaluation of the Safety and Efficacy of the D.D.C Dual-control Technology Spectacle Lenses in Delaying the Progression of Myopia: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 6 and 14 years;\n* Cycloplegic spherical equivalent refraction between -1.50 D and -5.00 D with astigmatism ≥ -1.50 D in both eyes;\n* Absolute interocular difference in spherical equivalent refraction ≤ 1.50 D;\n* Binocular best-corrected visual acuity ≥ 1.0;\n* Intraocular pressure between 10 and 21 mmHg in both eyes;\n* Volunteer to participate in this clinical trial with signature of the informed consent form.\n\nExclusion Criteria:\n\n* History of eye injury or intraocular surgery or ocular trauma;\n* Clinically abnormal slit-lamp findings;\n* Abnormal fundus examination;\n* Presence of ocular diseases such as cataract, glaucoma, fundus pathology, ocular trauma, manifest strabismus, or any other condition affecting visual function;\n* Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);\n* Participation in a drug clinical trial within 3 months or a device clinical trial within 1 month prior to enrollment;\n* Participation in any myopia control clinical trial within the past 3 months and a history of myopia control interventions (e.g., orthokeratology, atropine);\n* Only one eye meeting the inclusion criteria;\n* Inability to attend regular ophthalmic examinations.","ALL","8 Years","12 Years",{"count":69,"type":70},316,"ESTIMATED","INTERVENTIONAL",[73],"NA","The burden of myopia among Chinese children and adolescents is severe and trending toward younger ages, making control of myopia progression a public health priority. Current mainstream strategies include optical interventions, pharmacologic therapy, and environmental measures. Among these strategies, spectacle designs based on optical defocus-such as defocus-incorporated multiple-segment (DIMS) lenses-have demonstrated efficacy; however, the effect of such designs may attenuate over time because of \"defocus adaptation.\" To address this limitation, D.D.C dual-control spectacles employ a densely staggered microlens layout, a gradient-defocus architecture, and an added peripheral \"fogging zone\" to disrupt the spatial distribution of defocus cues and reduce contrast, thereby delaying adaptation and enhancing myopia-control efficacy.\n\nThe present study therefore proposes a 24-month prospective randomized controlled trial in Guangzhou, enrolling eligible myopic adolescents. The trial will first compare 12-month outcomes between D.D.C-A lenses and single-vision lenses, followed by a crossover and alternating-wear phase, to systematically evaluate the safety and efficacy of the D.D.C technology in slowing myopia progression.",[76],"Myopia, Progressive",[78,79],"Defocus diffusion composite technology","Myopia control","NOT_YET_RECRUITING","2026-03-11",{"date":83,"type":84},"2026-03-12","ACTUAL",{"date":86,"type":70},"2026-03-30",{"date":88,"type":70},"2027-12-20",{"name":5,"class":6},1]