[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04310241":3,"trial-entities:NCT04310241":107,"trial-summary:NCT04310241":110},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":15,"eligibility_criteria":58,"std_ages":64,"locations":68,"central_contacts":87,"overall_officials":91,"references":94,"see_also_links":106},"NCT04310241","12-915","Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy","Oculomotor Disorders: Experimental and Clinical Study","RECRUITING","2027-03-12","2026-03","2026-03-04","2020-02-21","The Cleveland Clinic","OTHER",false,"Amblyopia and strabismus are characterized by a reduction in visual acuity, contrast sensitivity, grating acuity, vernier acuity, reading difficulties and binocular visual function deficits. Treated patients have residual visual function deficits. The purpose of the current study is to quantify various visual functions in amblyopic and strabismic participants at baseline, during and at the completion of treatment.","To examine the response of therapy on visual functions in amblyopic and strabismic participants.\n\nThe following visual functions will be measured prior to treatment. Eye movements, contrast sensitivity, grating acuity, visual acuity, vernier acuity, binocular visual functions, reading and visual scanning will be measured. The testing will comprise of one or more of the above paradigms depending on participant's cooperation and understanding as majority of the study participants will be children. The above measurements will be repeated during amblyopia therapy ( which comprises of glasses, patching and\u002For atropine eye drops) and at the completion of treatment. For participants with strabismus requiring strabismus surgery the measurements will be repeated after strabismus surgery.",[19,20],"Amblyopia","Strabismus",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},150,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BEHAVIORAL","Patching therapy, Glasses","Patching, glasses and strabismus surgery are commonly employed measures in treatment of amblyopia and strabismus.",[19],[35],"Strabismus surgery",[37,41,43,46,48,50,52],{"measure":38,"description":39,"timeFrame":40},"Visual Functions","contrast sensitivity","0-3 years depending on duration of treatment",{"measure":38,"description":42,"timeFrame":40},"visual acuity",{"measure":44,"description":45,"timeFrame":40},"Visual functions","vernier acuity",{"measure":44,"description":47,"timeFrame":40},"grating acuity",{"measure":44,"description":49,"timeFrame":40},"binocular functions- stereopsis, inter-ocular functions",{"measure":44,"description":51,"timeFrame":40},"eye movement measurements",{"measure":44,"description":53,"timeFrame":40},"reading- reading speeds, eye movement measurements",[],"ALL","6 Months","90 Years",{"inclusion":59,"exclusion":61,"raw_text":63},[60],"History of amblyopia or presence of amblyogenic risk factors.",[62],"History of neurologic disorders","Inclusion Criteria:\n\n* History of amblyopia or presence of amblyogenic risk factors.\n\nExclusion Criteria:\n\n* History of neurologic disorders",[65,66,67],"CHILD","ADULT","OLDER_ADULT",[69],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":84},"Cleveland Clinic","Cleveland","Ohio","44195","United States",[76,80],{"name":77,"role":78,"phone":79},"Fatema Ghasia, MD","CONTACT","216 318 7809",{"name":81,"role":78,"phone":82,"email":83},"Kimberly Baynes","2164442566","baynesk@ccf.org",{"lat":85,"lon":86},41.4995,-81.69541,[88],{"name":89,"role":78,"phone":90,"email":83},"Kimberly Baynes, MSN","216-444-2566",[92],{"name":77,"affiliation":13,"role":93},"PRINCIPAL_INVESTIGATOR",[95,99,103],{"pmid":96,"type":97,"citation":98},"16213398","BACKGROUND","Chatzistefanou KI, Theodossiadis GP, Damanakis AG, Ladas ID, Moschos MN, Chimonidou E. Contrast sensitivity in amblyopia: the fellow eye of untreated and successfully treated amblyopes. J AAPOS. 2005 Oct;9(5):468-74. doi: 10.1016\u002Fj.jaapos.2005.05.002.",{"pmid":100,"type":101,"citation":102},"26930079","RESULT","Shaikh AG, Otero-Millan J, Kumar P, Ghasia FF. Abnormal Fixational Eye Movements in Amblyopia. PLoS One. 2016 Mar 1;11(3):e0149953. doi: 10.1371\u002Fjournal.pone.0149953. eCollection 2016.",{"pmid":104,"type":101,"citation":105},"28698242","Ghasia FF, Otero-Millan J, Shaikh AG. Abnormal fixational eye movements in strabismus. Br J Ophthalmol. 2018 Feb;102(2):253-259. doi: 10.1136\u002Fbjophthalmol-2017-310346. Epub 2017 Jul 11.",[],{"nct_id":4,"conditions":108,"biomarkers":109},[19,20],[],{"nct_id":4,"found":111,"summary":112,"prompt_version":122},true,{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an observational study, meaning researchers will watch how treatments like patching, glasses, and surgery affect visual functions over time. It is not a clinical trial testing a new treatment.","completed","Observational Study of Visual Function in Amblyopia and Strabismus","This study is looking at how different visual abilities are affected by amblyopia (often called \"lazy eye\") and strabismus (crossed eyes), and how these abilities change with treatment. Researchers will measure various visual functions, like how well you see details or colors, in people with these conditions. The treatments being observed include patching therapy, glasses, and strabismus surgery. The goal is to understand if current treatments fully correct these visual problems. You may be able to join if you are between 6 months and 90 years old and have a history of amblyopia or risk factors for it. The study is currently unclear on its recruitment status and plans to enroll 150 participants.","Visual functions will be measured for up to 3 years, depending on the duration of your treatment.",113,"You would have various visual functions measured before, during, and after treatment for amblyopia or strabismus. These measurements may include eye movements, contrast sensitivity, and visual acuity.","Not stated in the trial record.",[31],"v2"]