[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05606237":3,"trial-entities:NCT05606237":95,"trial-summary:NCT05606237":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":60,"locations":62,"central_contacts":83,"overall_officials":87,"references":89,"see_also_links":94},"NCT05606237","21-35793","Efficacy of Repeated Low-level Red-light Therapy in Myopia Control","Efficacy of Repeated Low-level Red-light Therapy in Myopia Control: a Single Arm Controlled Trial","RECRUITING","2027-01-14","2026-01","2026-01-28","2023-07-14","University of California, San Francisco","OTHER",true,"Low-level red-light technology provides a new and innovative myopia control approach. This strategy enables relatively high energies of light to be delivered at much shorter durations of exposure to induce the myopia control effect. The efficacy of the low-level red-light technology has been proven in a Chinese population. This trial demonstrated that 3-minutes per session twice a day repeated low-level red-light treatment controlled 87.7% of refraction progression and 76.8% of axial length elongation when the time of compliance to the treatment was 75%. Repeating this RCT in culturally diverse groups will confirm and translate this technology into a solution for myopia control globally.","The purpose of this study is to assess the safety and efficacy of low level red light therapy in myopia control in African, Hispanic, and Caucasian children. This is a prospective, multi-ethnic, parallel-controlled randomized trial that will enroll myopic children aged 8-13 years old as subjects. On top of wearing single vision spectacles, subjects in the intervention group will receive treatment twice a day from Monday to Friday, with each treatment lasting for 3 minutes at a minimal interval of 4 hours. Subjects in the control group will wear single vision spectacles. The study will evaluate axial elongation, cycloplegic spherical equivalent change, changes in other biological parameters (except axial length), and uncorrected and best corrected visual acuity of the two groups of subjects at 1 month, 3 months, 6 months, and 12 months after enrollment. The study plans to conduct an interim analysis at a three-month follow-up. The enrollment target is 90 participants: 30 Hispanic Children (15 control and 15 treatment) , 30 African Children (15 control and 15 treatment), and 30 Caucasian Children (15 control and 15 treatment).",[19],"Myopia",[21],"myopia","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},90,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Low-level Red Light Therapy Device","The treatment device used in this study is a semi-conductor laser product (Eyerising International Pty Ltd, Melbourne, Australia), emitting low-level red-light with a wavelength of 650 ± 10 nm. Based on calculations done by the manufacturer, the device provides light at a power of 2.00 ± 0.50 mW.",[35],"Low Level Red Light Treatment Arm",[37,41,43,46,49],{"measure":38,"description":39,"timeFrame":40},"Axial Length (AL) (mm) at Baseline","Axial Length (AL) is characterized as the combination of anterior chamber depth, lens thickness and vitreous chamber depth and measured by results from the IOLMaster. AL will be taken at the 1-, 3-, 6-, and 12-month follow-up visits.","1 month",{"measure":42,"description":39,"timeFrame":40},"Axial Length (AL) (mm) at Month 1",{"measure":44,"description":39,"timeFrame":45},"Axial Length (AL) (mm) at Month 3","3 months",{"measure":47,"description":39,"timeFrame":48},"Axial Length (AL) (mm) at Month 6","6 months",{"measure":50,"description":39,"timeFrame":51},"Axial Length (AL) (mm) at Year 1","1 Year",[],"ALL","8 Years","13 Years",{"inclusion":57,"exclusion":58,"raw_text":59},[],[],"Inclusion Criteria:\n\n1. Provision of consent\n2. Non-Chinese Ethnicity\n3. Age: ≥8 and ≤13 years at enrollment\n4. Myopia: Spherical equivalent refractions (SERs) under cycloplegia: -1.00 to -5.00 diopters (D)\n\n4\\) Astigmatism of 2.50 D or less 5) Anisometropia of 1.50 D or less 6) Corrected monocular logMAR visual acuity (VA): 1.0 or better 7) Consent to participate in random allocation of grouping 8) Fluent in English 9) Willing and able to participate in all required activities of the study6) Corrected monocular logMAR visual acuity (VA): 1.0 or better\n\nExclusion Criteria:\n\n1. Strabismus and binocular vision abnormalities in either eye\n2. Ocular abnormalities in either eye or other systemic abnormalities that affect participate in all required activities of the study.\n3. Other reasons, including but not limited to severe physical and cognitive disability, that the physician may consider inappropriate for enrollment\n4. Noncompliance with treatment\n5. Children whose parents do not sign informed consent",[61],"CHILD",[63],{"facility":13,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":80},"San Francisco","California","94143","United States",[69,74,77],{"name":70,"role":71,"phone":72,"email":73},"Jenny Lu","CONTACT","415-476-5321","jenny.lu@ucsf.edu",{"name":75,"role":76},"Tiffany Chen, MD","PRINCIPAL_INVESTIGATOR",{"name":78,"role":79},"Ying Han, MD\u002FPhD","SUB_INVESTIGATOR",{"lat":81,"lon":82},37.77493,-122.41942,[84],{"name":75,"role":71,"phone":85,"email":86},"4155143503","Tiffany.A.Chen@ucsf.edu",[88],{"name":75,"affiliation":13,"role":76},[90],{"pmid":91,"type":92,"citation":93},"26875007","BACKGROUND","Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016\u002Fj.ophtha.2016.01.006. Epub 2016 Feb 11.",[],{"nct_id":4,"conditions":96,"biomarkers":97},[19],[],{"nct_id":4,"found":15,"summary":99,"prompt_version":109},{"design":100,"status":101,"heading":102,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is a randomized study comparing Low-level Red Light Therapy Device to wearing single vision spectacles. It plans to enroll 90 participants: 30 Hispanic, 30 African, and 30 Caucasian children.","completed","Low-level Red-light Therapy for Myopia Control in Children","This study is testing a device called Low-level Red Light Therapy Device to see how well it controls myopia (nearsightedness) in children. We are looking for children aged 8 to 13 who have myopia. The study aims to measure changes in axial length (AL), which is the length of the eyeball, at 1 month and 3 months. This device has shown promising results in a Chinese population, and this trial will help confirm its effectiveness in African, Hispanic, and Caucasian children. The study plans to enroll 90 participants.","Participants will be followed for 12 months after enrollment to assess changes in their vision and eye measurements.",88,"If you join, you will either receive the Low-level Red Light Therapy Device treatment twice a day, Monday to Friday, for 3 minutes each time, or wear single vision spectacles. You will have follow-up visits at 1, 3, 6, and 12 months.","Not stated in the trial record.",[32],"v2"]