[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635006":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":32,"studyPopulation":21,"armGroups":33,"interventions":49,"overallOfficials":58,"centralContacts":63,"locations":72,"responsibleParty":93,"collaborators":95,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":21,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":21,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":75,"whyStopped":21,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Choroidal thickness changes","Choroidal thickness will be measured by a swept source optical coherence tomographer. Changes in choroidal thickness from baseline over the first month and every 6 months for 1 year over the study period.","Baseline, every week for 1 month, every 6 months over 1 year",[14,18],{"measure":15,"description":16,"timeFrame":17},"Cycloplegic refraction change in spherical equivalent refraction (SER)","Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline every 6 months for 1 year over the study period.","Baseline, 6 and 12 months",{"measure":19,"description":20,"timeFrame":17},"Axial length changes","Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer. Change in axial length from the baseline every 6 months for 1 year over the study period.",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":28,"whoMasked":29},"DOUBLE","Both participants and their guardians will be masked from the grouping. The outcomes assessors will be also masked from the grouping.",[30,31],"PARTICIPANT","OUTCOMES_ASSESSOR","Optical interventions have been widely used for myopia control in children, however, the effectiveness varied between individuals. The current study spectacle lenses are modified based on DIMS technology.\n\nParticipants will be randomly allocated to single vision (SV) lens group (control), D1 or D2 group (treatment). The weekly choroidal thickness changes will be monitored in the first month of lens wear. Their cycloplegic refraction and axial length will be monitored every 6 months for 1 year.",[34,38,44],{"label":35,"type":36,"description":37,"interventionNames":21},"Single vision lens group","NO_INTERVENTION","Participants in single vision lens group will receive a pair of single vision lenses for 1 year after the short-term monitoring of choroidal thickness.",{"label":39,"type":40,"description":41,"interventionNames":42},"D1 lens group","EXPERIMENTAL","Participants in D1 lens group will receive a pair of D1 lenses over 1 year after the short-term monitoring of choroidal thickness.",[43],"Other: Modified Defocus Incorporated Multiple Segments lens (D1)",{"label":45,"type":40,"description":46,"interventionNames":47},"D2 lens group","Participants in D2 lens group will receive a pair of D2 lenses over 1 year after the short-term monitoring of choroidal thickness.",[48],"Other: Modified Defocus Incorporated Multiple Segments lens (D2)",[50,54],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":21},"Modified Defocus Incorporated Multiple Segments lens (D1)","D1 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously",[39],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":21},"Modified Defocus Incorporated Multiple Segments lens (D2)","D2 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously",[45],[59],{"name":60,"affiliation":61,"role":62},"Rachel Ka Man Chun, PhD","School of Optometry, The Hong Kong Polytechnic University","PRINCIPAL_INVESTIGATOR",[64,68],{"name":60,"role":65,"phone":66,"phoneExt":21,"email":67},"CONTACT","852-27664224","rachel.chun@polyu.edu.hk",{"name":69,"role":65,"phone":70,"phoneExt":21,"email":71},"Dennis Yan Yin Tse, PhD","852-27666096","dennis.tse@polyu.edu.hk",[73],{"facility":74,"status":75,"city":76,"state":77,"zip":21,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Optometry Research Clinic, School of Optometry, The Hong Kong Polytechnic University","RECRUITING","Kowloon","Hong Kong","HK",{"type":80,"coordinates":81},"Point",[82,83],114.18333,22.31667,{"lat":83,"lon":82},[86,88,90],{"name":87,"role":65,"phone":66,"phoneExt":21,"email":67},"Rachel Ka-man Chun, PhD",{"name":89,"role":65,"phone":70,"phoneExt":21,"email":71},"Dennis Yan-yin Tse, PhD",{"name":91,"role":92,"phone":21,"phoneExt":21,"email":21},"Shanica Ying Hon, PhD","SUB_INVESTIGATOR",{"type":94,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[96],{"name":97,"class":98},"HOYA Lens Thailand LTD.","INDUSTRY","100635006","choroidal-response-to-the-modified-defocus-incorporated-multiple-segments-spectacle-lenses-100635006",false,"NCT07547072","Choroidal Response to the Modified Defocus Incorporated Multiple Segments Spectacle Lenses","Choroidal Responses to the Modified Defocus Incorporated Multiple Segments (DIMS) Spectacle Lenses","Inclusion Criteria:\n\n* Hong Kong Chinese\n* Age at enrolment: 6 - 13 years\n* Myopia in spherical power: -1.00D to -5.00D in both eyes\n* Astigmatism: equal or less than 2.00D\n* The sum of spherical power and astigmatism: equal or less than -7.00D\n* Anisometropia (spherical equivalent refraction (SER)): equal or less than 1.50D\n* Previous myopia progression (valid documentation dated within 2 years before screening):\n\n  * -0.50D (SER) per year or more in both eyes OR Axial length elongation: 0.27mm\u002Fyear in both eyes\n  * If myopia is initially detected during screening, eligibility requires myopia (in SER) below the 3rd percentile curve of refraction in both eyes.12\n* Best corrected visual acuity: LogMAR 0.04 or better in both eyes\n* Ocular health: no abnormalities in both internal and external ocular health\n* Binocular vision: no strabismus and other binocular abnormalities\n* Normal colour vision\n* Willing to wear the study spectacles all the time (10 hours per day, for 7 days per week)\n\nExclusion Criteria:\n\n* Previous or current treatment for myopia control (e.g., red-light therapy, atropine, orthokeratology, specialized spectacle lenses and contact lenses and oral supplements for myopic control)\n* Existing or past eye diseases or surgeries (e.g., strabismus surgery, amblyopia, oculomotor nerve palsies, corneal disease, intraocular disease, etc.) that may have an impact on vision or visual development\n* Long-term medication (intake at least 3 days\u002Fweek) or medication\u002Fsupplements that affect eye health\n* Systemic diseases that may have an impact on vision or visual development (e.g., endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.)\n* Allergic to cyclopentolate eye drops\n* Individuals who, in the judgment of the Investigator, are unable to cooperate and follow instructions during eye examination.",true,"ALL","6 Years","13 Years",{"count":111,"type":112},108,"ESTIMATED","INTERVENTIONAL",[115],"NA","The goal of this study is to investigate the short-term changes in choroidal thickness and efficacy of the study spectacle lenses in children. Participants will be prescribed with a pair of study spectacle lenses for daily use and visit the clinic once every week for the first month for checkup and tests. After the first month of follow-up, participants will visit at 1 month, 6- and 12-month for checkup. Choroidal thickness, axial length and refractive errors will be monitored.",[118],"Myopia",[118,120],"Choroidal thickness","2026-09-15",{"date":123,"type":124},"2026-09-17","ACTUAL",{"date":126,"type":124},"2026-04-24",{"date":128,"type":112},"2028-02-29",{"name":5,"class":6},1]