[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06429280":3,"trial-entities:NCT06429280":207,"trial-summary:NCT06429280":16},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":16,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":30,"secondary_outcomes":42,"sex":57,"minimum_age":16,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":58,"std_ages":65,"locations":69,"central_contacts":203,"overall_officials":204,"references":205,"see_also_links":206},"NCT06429280","R-AM-1","Clinical Data Registry of Amblyopia Patients on Luminopia Treatment","RECRUITING","2026-12-31","2025-09","2025-09-12","2023-09-01","Luminopia","INDUSTRY",false,"Amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%. The most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a combination of these. In addition to reduced visual acuity, amblyopic patients may also have measurable dysfunction of accommodation, fixation, binocularity, vergence, reading fluency, depth perception, and contrast sensitivity.\n\nFor the first time since the incorporation of atropine penalization into amblyopia management, physicians can now offer Luminopia, an FDA-approved dual action dichoptic treatment, to patients with amblyopia. Since the product became commercially available in November 2022, the number of patients on Luminopia therapy continues to grow. This presents a unique opportunity to gather real world evidence from a large number of patients, representative of how ophthalmologists and optometrists are applying this novel treatment in the real world. A registry of the clinical data associated with Luminopia treatment, with IRB oversight, will provide answers to key scientific questions using a large dataset.",null,[18],"Amblyopia",[],"OBSERVATIONAL",[],{"count":23,"type":24},500,"ESTIMATED",[26],{"type":27,"name":28,"description":29},"DEVICE","N\u002FA this is an observational study of Standard of Care","Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision",[31,34,36,38,40],{"measure":32,"description":32,"timeFrame":33},"Change in Visual Acuity from baseline to consecutive visits","3, 6,12, 24 months",{"measure":35,"description":35,"timeFrame":33},"Duration of Visual Acuity treatment and number of follow-up visits",{"measure":37,"description":37,"timeFrame":33},"Durability of Visual Acuity results post-treatment cessation",{"measure":39,"description":39,"timeFrame":33},"Adherence with Luminopia treatment",{"measure":41,"description":41,"timeFrame":33},"Change in Stereoacuity from 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undergoing Luminopia treatment for a minimum of 12 weeks",[63],"Have participated in prior Luminopia clinical trials","Inclusion Criteria:\n\n* Have a diagnosis of amblyopia\n* Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks\n\nExclusion Criteria:\n\n-Have participated in prior Luminopia clinical trials",[66,67,68],"CHILD","ADULT","OLDER_ADULT",[70,85,95,105,111,123,133,143,153,163,173,183,193],{"facility":71,"status":7,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":82},"UCSF Benioff Children's Physicians","San Ramon","California","94583","United States",[77],{"name":78,"role":79,"phone":80,"email":81},"Endri Angjeli","CONTACT","9788067080","endria@luminopia.com",{"lat":83,"lon":84},37.77993,-121.97802,{"facility":86,"status":7,"city":87,"state":73,"zip":88,"country":75,"contacts":89,"geoPoint":92},"Sansum Clinic","Santa 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Philadelphia","Philadelphia","Pennsylvania","19104",[189],{"name":78,"role":79,"phone":80,"email":91},{"lat":191,"lon":192},39.95238,-75.16362,{"facility":194,"status":7,"city":195,"state":196,"zip":197,"country":75,"contacts":198,"geoPoint":200},"Pediatric Eye Specialist","Fort Worth","Texas","76104",[199],{"name":78,"role":79,"phone":80,"email":91},{"lat":201,"lon":202},32.72541,-97.32085,[],[],[],[],{"nct_id":4,"conditions":208,"biomarkers":209},[18],[]]