[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06049459":3,"trial-entities:NCT06049459":109,"trial-summary:NCT06049459":112},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":45,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":15,"eligibility_criteria":67,"std_ages":86,"locations":88,"central_contacts":104,"overall_officials":106,"references":107,"see_also_links":108},"NCT06049459","2023H0013","Novel Amblyopia Treatment With Virtual Reality Games","Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games","RECRUITING","2026-12-31","2025-07","2025-07-22","2024-03-14","Marjean Kulp","OTHER",false,"The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is:\n\nIs a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min\u002Fday, 6 days\u002Fweek more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone?\n\nParticipants will each serve as their own control and complete:\n\nTreatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min\u002Fday, 6 days\u002Fweek) plus continued optical correction",null,[19],"Amblyopia",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},8,"ESTIMATED",[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Optical Correction","Optical correction (if needed)",[34,35],"Optical Correction alone","Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Therapeutic Dichoptic Virtual Reality Games","Virtual Reality Game play for amblyopia treatment",[35],[41],{"measure":42,"description":43,"timeFrame":44},"Difference in Mean Change in Amblyopic Eye Visual Acuity","Optical correction worn for testing using Amblyopia Treatment Study (ATS) protocol; HOTV for ages 5-6 years; E-ETDRS for ages 7 years and older","Baseline to 16 weeks versus 16 weeks to 32 weeks",[46,49,52,55,58,61],{"measure":47,"description":48,"timeFrame":44},"Difference in Change in Stereoacuity\u002FBinocularity","Optical correction worn for testing. Stereoacuity scores (seconds of arc) calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) tests. Lower scores indicate better stereoacuity. Nil (4000) defined as an incorrect response (or lack of an attempt) on the butterfly without a correct response on 800 seconds of arc level of Randot Preschool stereoacuity test. Stereoacuity scores will be ordered and assigned a rank score. Change in stereoacuity will be calculated as the difference in change in ranked score.",{"measure":50,"description":51,"timeFrame":44},"Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity","Optical correction worn for testing. Spot Checks;Contrast sensitivity scores range from unable (\\\u003C0.90), and then from 0.90 to 2.05 (by 0.05 log contrast sensitivity units).",{"measure":53,"description":54,"timeFrame":44},"Difference in Mean Change in Attention","Optical correction worn for testing. The Children's Color Trails Test (CCTT) is a neuropsychological standardized test that measures attention, divided attention, and speed of mental processing.",{"measure":56,"description":57,"timeFrame":44},"Difference in Mean Change in reading eye movements","Optical correction worn for testing with Readalyzer eye tracker.",{"measure":59,"description":60,"timeFrame":44},"Difference in Mean Change in visual-motor integration","Optical correction worn for testing. Beery Visual-Motor Integration; standard scores with mean of 100, standard deviation of 15",{"measure":62,"description":63,"timeFrame":44},"Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)","Pediatric Eye Questionnaire (PedEyeQ) domain score; scores for questionnaire items will be obtained from published look-up tables available at www.pedig.net; scaled to score from 0 to 100 (worst to best)","ALL","5 Years","17 Years",{"inclusion":68,"exclusion":75,"raw_text":85},[69,70,71,72,73,74],"Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and\u002For strabismus of ≤5pd","Age normal VA in the nonamblyopic eye","Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (\\\u003C0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)","Interocular difference of ≥ 3 lines","No amblyopia treatment in the past 2 weeks","An interpupillary distance of 52-72 mm (inclusive)",[76,77,78,79,80,81,82,83,84],"Myopia greater than -6.00 diopters (D) spherical equivalent in either eye.","Previous intraocular or refractive surgery.","Previous dichoptic treatment \\> 2 weeks in duration","Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met).","Diplopia more than once per week over the last week prior to enrollment by parental report.","Down syndrome or cerebral palsy.","Light-induced seizures","Known simulator sickness","Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and\u002For learning disabilities are not excluded.","Inclusion Criteria:\n\nPatients ages 5 to 17 years of age\n\n* Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and\u002For strabismus of ≤5pd\n* Age normal VA in the nonamblyopic eye\n* Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (\\\u003C0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)\n* Interocular difference of ≥ 3 lines\n* No amblyopia treatment in the past 2 weeks\n* An interpupillary distance of 52-72 mm (inclusive)\n\nExclusion Criteria:\n\n* Myopia greater than -6.00 diopters (D) spherical equivalent in either eye.\n* Previous intraocular or refractive surgery.\n* Previous dichoptic treatment \\> 2 weeks in duration\n* Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met).\n* Diplopia more than once per week over the last week prior to enrollment by parental report.\n* Down syndrome or cerebral palsy.\n* Light-induced seizures\n* Known simulator sickness\n* Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and\u002For learning disabilities are not excluded.",[87],"CHILD",[89],{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":101},"The Ohio State University College of Optometry","Columbus","Ohio","43210","United States",[96],{"name":97,"role":98,"phone":99,"email":100},"Marjean T Kulp, OD, MS","CONTACT","614-688-3336","kulp.6@osu.edu",{"lat":102,"lon":103},39.96118,-82.99879,[105],{"name":97,"role":98,"phone":99,"email":100},[],[],[],{"nct_id":4,"conditions":110,"biomarkers":111},[19],[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This interventional study plans to enroll 8 participants. It compares two treatment periods to see which is more effective.","completed","Virtual Reality Games for Amblyopia Treatment","This study is testing if using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games can improve vision in children with amblyopia (sometimes called \"lazy eye\"). Participants, aged 5 to 17, will use these virtual reality games for about 25 minutes a day, 6 days a week, for 16 weeks. Researchers want to see if this treatment is more effective at improving vision in the amblyopic eye, as well as other visual skills and quality of life, compared to just wearing glasses for 16 weeks. The main goal is to measure the change in vision in the amblyopic eye over time. The study is currently unclear on its recruitment status.","Vision in the amblyopic eye will be measured at baseline, 16 weeks, and 32 weeks.",108,"Participants will use Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approximately 25 minutes a day, 6 days a week, for 16 weeks. Optical correction (glasses) may also be used if needed.","Not stated in the trial record.",[],"v2"]