Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059598) titled 'Repeated Low-level Red Light for Myopia Progression Study: A 1-year, International, Multicenter, Multiethnic Randomized Controlled Trial' on Jan. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - myopia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To assess the efficacy of RLRL therapy to reduce spherical equivalent refractive error (SER) progression in myopic children. To assess the efficacy of RLRL therapy to reduce axial length (AL) elongation in myopic children. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Subjects will be treated with a Myopia Management Devices (Eyerising International, South Yarra VIC, Australia) 5 days a week, three minutes per session, twice a day, with a minimum interval of 4 hours, under the supervision of their parents for a year. Interventions/Control_2 - Subjects will be treated with Sham device 5 days a week, three minutes per session, twice a day, with a minimum interval of 4 hours, under the supervision of their parents for a year.

Eligibility: Age-lower limit - 6 years-old = Gender - Male and Female Key inclusion criteria - 1) Age: 6 to 12 years at enrolment 2) Myopia: Cycloplegic SER -1.0 to -7.0 diopters (D) in each eye 3) Anisometropia : < 1.5 D 4) Astigmatism: < 1.5 D 5) Best corrected visual acuity (BCVA) 20/25 or better. 6) Informed parental consent Key exclusion criteria - 1) Ophthalmic diseases, conditions, or syndromes other than ammetropia and myelinated nerve fiber layer, or prematurity (less than 36 weeks of gestation) 2) Previous use of optical or pharmacologic treatment for myopia control (e.g., defocusing spectacle or contact lenses, orthokeratology, atropine, or pirenzepine) 3) Systemic diseases (e.g., endocrine, cardiac diseases) and developmental anomalies 4) Inability to attend regular follow up visits Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2024 Year 02 Month 06 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067821

Disclaimer: Curated by HT Syndication.