protocolSection identificationModule nctId: NCT06344429, orgStudyIdInfo id: STL_CT_0001, briefTitle: Stellest Lenses and Low-concentration Atropine Myopia Control Among Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-20, primaryCompletionDateStruct date: 2024-08-20, completionDateStruct date: 2025-08-20, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Essilor-Polylite Taiwan Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The prevalence of myopia is increasing globally, especially in Asian countries. 70-80% of the young population suffers from myopia, and almost 20% have high myopia. High myopia can easily lead to blinding diseases, including retinal detachment, macular degeneration, and glaucoma. In Taiwan, according to a survey by the National Health Administration, the proportion of myopia among Grade 1 students has exceeded 81%.There are many ways to control myopia progression. High concentrations of atropine have been reported highly effective in the control of the myopia progression. However the accompanied side effects such as photophobia and near blurred vision. Recent research shows that low-concentration atropine can achieve similar control effect and more acceptable with much minimal side effect compared to high concentration of atropine.Multiple animal experiments have confirmed that giving retinal myopia defocus signals can effectively decrease the growth of the eye, thereby inhibiting the progression of myopia. Therefore, regarding lens design, myopic defocus does play an important role in myopia control, including orthokeratology lenses, multifocal soft contact lenses, and peripheral defocus lenses.Stellest, a myopia control lens based on the myopia defocus theory, is equipped with highly aspheric lenslet technology. In a recent study, compared with single vision lenses, Stellest significantly slowed down the myopia progression reaching 67% and retard axial elongation reaching 64% The purpose of this study is to explore the effectiveness of Stellest Lenses in controlling myopia in Taiwanese children and whether Stellest Lenses combined with low-concentration atropine eye drops can increase the effect of myopia control., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Stellest Lenses, interventions name: Stellest Lenses+0.05% atropine, interventions name: Single vision Lenses+0.05% atropine, outcomesModule primaryOutcomes measure: Spherical equivalent refraction power, primaryOutcomes measure: Axial length, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Kaohsiung Chang Gung Memorial Hospital, status: RECRUITING, city: Kaohsiung, zip: 833401, country: Taiwan, contacts name: Pei-Chang Wu, role: CONTACT, contacts name: Pei-Chang Wu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False