[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634128":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":41,"centralContacts":58,"locations":64,"responsibleParty":77,"collaborators":41,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":41,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":41,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":41,"overallStatus":98,"whyStopped":41,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Shanghai Eye Disease Prevention and Treatment Center","OTHER",[8,14,19,24,29],{"label":9,"type":10,"description":11,"interventionNames":12},"PPML(multi-point defocus design, non-fading, Nuo Tong)","EXPERIMENTAL","The group wears photolithography plano microstructure lenses （PPML） with a multi-point defocus design, manufactured by Nuo Tong, which feature a non-fading optical property.",[13],"Device: wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property",{"label":15,"type":10,"description":16,"interventionNames":17},"PPML (multi-point defocus design, color, light transmittance 55% after photochromism, Nuo Tong)","PPML (Photolithography Plano Microstructure Lenses) incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 55% post-activation.",[18],"Device: wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activation",{"label":20,"type":10,"description":21,"interventionNames":22},"PPML (multi-point defocus design, color, light transmittance 35% after photochromism, Nuo Tong)","PPML (Photolithography Plano Microstructure Lenses) incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 35% post-activation.",[23],"Device: wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 35% post-activation",{"label":25,"type":10,"description":26,"interventionNames":27},"PPML (designed to reduce contrast, non-fading, Nuo Tong)","PPML (Photolithography Plano Microstructure Lenses), designed by Nuo Tong to reduce contrast sensitivity and featuring a non-fading optical property",[28],"Device: wearing Photolithography Plano Microstructure Lenses designed to reduce contrast sensitivity and featuring a non-fading optical property",{"label":30,"type":31,"description":32,"interventionNames":33},"Plano microstructure lenses (multi-point defocus design，Aspherical Lenslets, Essilor Stellest)","ACTIVE_COMPARATOR","Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest)",[34],"Device: wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest)",[36,42,46,50,54],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DEVICE","wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property","wearing photolithography plano microstructure lenses （PPML） with a multi-point defocus design, manufactured by Nuo Tong, which feature a non-fading optical property for more than 8 hours a day.",[9],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest)","wearing plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) for more than 8 hours.",[30],{"type":37,"name":47,"description":48,"armGroupLabels":49,"otherNames":41},"wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activation","Wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 55% post-activation for more than 8 hours.",[15],{"type":37,"name":51,"description":52,"armGroupLabels":53,"otherNames":41},"wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 35% post-activation","Wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 35% post-activation for more than 8 hours.",[20],{"type":37,"name":55,"description":56,"armGroupLabels":57,"otherNames":41},"wearing Photolithography Plano Microstructure Lenses designed to reduce contrast sensitivity and featuring a non-fading optical property","wearing Photolithography Plano Microstructure Lenses designed by Nuo Tong to reduce contrast sensitivity and featuring a non-fading optical property for more than 8 hours",[25],[59],{"name":60,"role":61,"phone":62,"phoneExt":41,"email":63},"Qiurong Lin","CONTACT","+8615216698330","LQRoph@163.com",[65],{"facility":66,"status":41,"city":67,"state":41,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":41},"Shanghai Eye Disease Prevention and treatment Center","Shanghai","200336","China","CN",{"type":72,"coordinates":73},"Point",[74,75],121.45806,31.22222,{"lat":75,"lon":74},{"type":78,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100634128","efficacy-of-multi-type-photolithography-flat-microstructure-lenses-for-childhood-myopia-control-100634128",false,"NCT07535658","Efficacy of Multi-Type Photolithography Flat Microstructure Lenses for Childhood Myopia Control","Comparative Efficacy and Safety of Multi-Type Photolithography Flat Microstructure Spectacle Lenses Versus Spectacle Lenses With Aspherical Lenslets for Myopia Control in Chinese Children: A 12-Month Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age: 6 years ≤ age ≤ 8 years (calculated based on the informed consent date);\n2. The spherical equivalent (SE) of both eyes is 0D to +1.00D (inclusive of boundary values) after cycloplegia;\n3. Astigmatism: Cylindrical power of both eyes ≤ 1.00D;\n4. Anisometropia: Difference in spherical equivalent between both eyes ≤ 1.00D;\n5. Corrected visual acuity: Best corrected visual acuity (BCVA) of both eyes ≥ 1.0 (decimal notation, 5m);\n6. General health status: No systemic syndromes that affect ocular development; no long-term use of growth hormone, corticosteroids, or antiepileptic drugs;\n7. Previous intervention: No use of any myopia control methods within the past 3 months, including but not limited to: multifocal glasses, atropine eye drops, red light therapy, acupuncture, etc.\n8. Compliance with spectacle wear: Parents ensure that the child wears glasses for ≥8 hours per day;\n9. Follow-up capability: Ability to attend scheduled follow-ups for 12 months (4 visits in total);\n10. Informed consent from guardian: Legal guardian signs the informed consent form; children also sign the assent form.\n\nExclusion Criteria:\n\n1. History or presence of glaucoma, corneal disease, or other ocular organic disease, or acute or chronic ocular inflammation;\n2. Combined with systemic major diseases, mental diseases, or systemic collagen metabolism diseases;\n3. Used any myopia intervention drugs or devices in the past 3 months;\n4. Those who have participated in other similar clinical studies in the past 3 months;\n5. Diagnosis of amblyopia, constant strabismus, and other congenital eye diseases;\n6. Those who are allergic to the lens material or products related to the study;\n7. Allergy to mydriatic agents and related ophthalmic medications;\n8. Allergic to photochromic materials or related dyes; taking photosensitizing drugs; suffering from photo-induced skin or neurological disorders;\n9. Unable to understand the study content or unable to cooperate with the follow-up;\n10. Other reasons why the research doctor believes the patient is not suitable for the study.","ALL","6 Years","8 Years",{"count":90,"type":91},255,"ESTIMATED","INTERVENTIONAL",[94],"NA","The goal of this clinical trial is to learn if photolithographic flat microstructure lenses work to prevent myopia in children. It will also learn about the safety of different designs of photolithographic flat microstructure lenses. The main questions it aims to answer are:\n\nAre photolithography flat microstructure lenses effective and safe in preventing myopia in children? Does the depth of tinted lenses affect visual quality? Researchers will compare photolithography flat microstructure lenses to a spectacle lenses with aspherical lenslets to see if photolithography flat microstructure lenses works to prevent myopia in children.\n\nParticipants will:\n\nWear photolithography flat microstructure lenses or Spectacle Lenses with Aspherical Lenslets more than 8H per day for 1 year.\n\nVisit the clinic once every 3 months for checkups and tests.",[97],"Myopia","NOT_YET_RECRUITING","2026-04-14",{"date":101,"type":102},"2026-04-17","ACTUAL",{"date":104,"type":91},"2026-04-15",{"date":106,"type":91},"2027-12-31",{"name":5,"class":6},1]