[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02157025":3,"trial-entities:NCT02157025":98,"trial-summary:NCT02157025":105},{"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":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":43,"secondary_outcomes":48,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":67,"locations":69,"central_contacts":83,"overall_officials":91,"references":96,"see_also_links":97},"NCT02157025","KID_VF","A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics","RECRUITING","2027-12","2025-09","2025-09-10","2015-02","Nova Southeastern University","OTHER",false,"The majority of young children do not think that visual field (VF) testing of peripheral vision is similar to a game; therefore, it is not surprising that they have difficulty maintaining attention during VF testing and thus the test reliability suffers as a consequence. Poor VF reliability has been a longstanding, major issue since it leads to an increased number of tests and\u002For longer duration of time needed to determine when there are true vision losses. Providers are less likely to obtain VF tests in children since the results are of doubtful value and challenging to interpret when they are inconsistent. Effectively this means that children with untreated, slowly progressive eye diseases may go undiagnosed and incur greater visual losses. The investigators aim to create a prototype device that the investigators hypothesize will make VF testing more engaging for young children, thus increasing their attention and consistency of their responses to the test stimuli, which in turn should improve VF reliability. The components include a microdisplay video screen (1.5\" diameter) as the fixation target (instead of the standard LED light) displaying video clips of popular cartoon characters, and audio clips of impersonated cartoon character voices presented by the test operator to provide instructional feedback based on the child's performance during testing. Improved VF reliability from the investigators intervention would translate to improved diagnosis and care for young childrens' peripheral vision loss through widespread implementation of the investigators innovative, affordable and readily adoptable system at eye care providers' offices.",null,[18,19,20,21],"Glaucoma, Suspect","Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System","Congenital Coloboma of the Optic Nerve","Optic Nerve Head Pits, Bilateral Congenital",[23,24,25],"Humphrey visual fields","perimetry","pediatrics","INTERVENTIONAL","DIAGNOSTIC",[29],"NA",{"count":31,"type":32},20,"ESTIMATED",[34,39],{"type":35,"name":36,"armGroupLabels":37},"DEVICE","Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry",[38],"Cartoon Intervention",{"type":13,"name":40,"armGroupLabels":41},"Usual Care procedures during Humphrey perimetry for children",[42],"Usual Care",[44],{"measure":45,"description":46,"timeFrame":47},"Humphrey Visual Field Test-Retest Variability of Mean Deviation scores (dB)","Within subject, the investigators will determine the coefficient of variation in the mean deviation scores obtained at the two sessions a week apart (dB). The investigators will test for significant differences between subjects who receive the intervention versus the usual care control group for the test-retest variability.","1 week",[49],{"measure":50,"description":51,"timeFrame":47},"Humphrey Visual Field Reliability Indices and Ratings","The investigators will test for significant differences between subjects who receive the intervention versus the usual care control group for the visual field reliability criteria (false negatives, false positives and fixation losses; expressed as %), and operator ratings (subjects' fixation, cooperation and fatigue; scale 1 to 5).","ALL","5 Years","8 Years",true,{"inclusion":57,"exclusion":62,"raw_text":66},[58,59,60,61],"Ages 5-8","Seen previously in the clinics at Nova Southeastern University's The Eye Care Institute with a diagnosis for glaucoma suspect or optic nerve abnormalities","Able and willing to complete VF testing at 2 study visits about a week apart","Provide informed consent",[63,64,65],"History of having previously completed a VF test using Humphrey static perimetry","Inability to understand study or communicate responses (cognitive impairment)","Unable to understand, read and speak English fluently","Inclusion Criteria:\n\n* Ages 5-8\n* Seen previously in the clinics at Nova Southeastern University's The Eye Care Institute with a diagnosis for glaucoma suspect or optic nerve abnormalities\n* Able and willing to complete VF testing at 2 study visits about a week apart\n* Provide informed consent\n\nExclusion Criteria:\n\n* History of having previously completed a VF test using Humphrey static perimetry\n* Inability to understand study or communicate responses (cognitive impairment)\n* Unable to understand, read and speak English fluently",[68],"CHILD",[70],{"facility":71,"status":7,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":80},"The Eye Care Institute","Fort Lauderdale","Florida","33328","United States",[77],{"name":78,"role":79},"So Yeon Lee, OD","PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},26.12231,-80.14338,[84,88],{"name":78,"role":85,"phone":86,"email":87},"CONTACT","954-262-1478","slee@nova.edu",{"name":89,"role":85,"email":90},"Ava Bittner, OD, PhD","abittne1@jhmi.edu",[92],{"name":93,"affiliation":94,"role":95},"Ava Bittner","University of California, Los Angeles","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":99,"biomarkers":104},[100,101,102,103],"Congenital coloboma of optic disc","Glaucoma","Optic nerve head pit","Optic Nerve Hypoplasia",[],{"nct_id":4,"found":55,"summary":106,"prompt_version":116},{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This study is an interventional study with an unclear status, planning to enroll 20 participants aged 5-8 years old.","completed","Visual Field Test for Children with Glaucoma or Optic Nerve Abnormalities","This study is testing a new way to make visual field (VF) tests more engaging for children aged 5 to 8 years old who have glaucoma or optic nerve problems. VF tests check your peripheral (side) vision. Currently, these tests can be hard for children to focus on, making the results less reliable. This study compares the usual VF test to one that uses cartoon videos and character voices to help children pay attention. The goal is to see if these changes make the test results more consistent, which would help doctors better understand and treat vision loss in children. The study is looking to enroll 20 participants.","The primary endpoint, Humphrey Visual Field Test-Retest Variability, is measured at 1 week.",108,"You would need to complete VF testing at two study visits, about one week apart.","Not stated in the trial record.",[],"v2"]