[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05150197":3,"trial-entities:NCT05150197":118,"trial-summary:NCT05150197":122},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":54,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":82,"locations":85,"central_contacts":101,"overall_officials":106,"references":109,"see_also_links":117},"NCT05150197","Pro00109426","Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease","Virtual Reality Visual Field Testing as an Alternative to Standard Automated Perimetry in Childhood Eye Disease","RECRUITING","2028-07-01","2026-05","2026-05-26","2022-01-19","Duke University","OTHER",true,"The purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at. This new visual field test (called VisuALL) is an FDA-approved virtual reality system which has been used in adults and children. This study will compare the performance of the VisuALL to the standard testing for peripheral vision, which is called the Humphrey Visual Field (HVF) test.\n\nThe study will recruit both healthy children, as well children and young adults who have eye conditions which require visual field testing as part of their standard care. The test will be performed on a day when the child or young adult already has a scheduled eye appointment as standard care. The test does not touch the eyes or require any eye drops to be given, and there is no known risk associated with the test itself. There may be a risk of loss of confidentiality. Participating in this study will require approximately 30 minutes, has no extra cost associated with it, and will be compensated by a parking pass for the day of the visit. There are no direct benefits for participants.\n\nSelected participants will be also be given training and then loaned a home VisuALL system to allow home visual field testing. If your child is selected, additional information would be provided.",null,[19],"Visual Field Defect, Peripheral",[21,22,23],"Virtual Reality Visual Field","Glaucoma","Neuro-ophthalmology","INTERVENTIONAL","DIAGNOSTIC",[27],"NA",{"count":29,"type":30},1000,"ESTIMATED",[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","VisuALL","Virtual Reality Visual Field Device",[37,38],"Control group","Patient (pathology) group",{"type":33,"name":40,"description":41,"armGroupLabels":42},"Humphrey Visual Field","Standard of care Visual Field test",[38],[44,48,51],{"measure":45,"description":46,"timeFrame":47},"Mean deviation results of visual field parameters","Mean deviation of the visual field is one score measured in decibels calculated from device reading","During office visit, approximately 30 minutes",{"measure":49,"description":50,"timeFrame":47},"Pattern standard deviation results of visual field parameters","Pattern standard deviation of the visual field is one score calculated from device reading",{"measure":52,"description":53,"timeFrame":47},"Sensitivity results of visual field parameters","Sensitivities are the results of each space in the visual field measured in decibels",[55,57,61,63],{"measure":56,"timeFrame":47},"Percent of times that scotomas were visualized as measured by visual field tests",{"measure":58,"description":59,"timeFrame":60},"Percent of participants stating satisfaction as measured by questionnaire","12 questions with strongly disagree to strongly agree","During office visit, approximately 5 minutes",{"measure":62,"timeFrame":47},"Percent of patients able to use VisuALL in-office testing as measured by patient observation",{"measure":64,"description":65,"timeFrame":66},"Percent of patients able to use VisuALL home testing as measured by device reading","Home testing will be done in a few patients that demonstrate facility with the device","During office visit, 30 minutes","ALL","4 Years","21 Years",{"inclusion":71,"exclusion":77,"raw_text":81},[72,73,74,75,76],"Patients must be at least four (4) years old","Cognitively normal (no developmental delay or syndrome)","Be able to tolerate wearing the virtual reality goggles for at least 10 minutes","Be able to provide informed consent of a parent\u002Fguardian (and assent if 12 years or older)","Do not have any ocular diseases that could interfere with the visual field testing",[78,79,80],"Developmental delay","Inability to obtain consent","Inability to understand English","Inclusion Criteria:\n\n* Patients must be at least four (4) years old\n* Cognitively normal (no developmental delay or syndrome)\n* Be able to tolerate wearing the virtual reality goggles for at least 10 minutes\n* Be able to provide informed consent of a parent\u002Fguardian (and assent if 12 years or older)\n* Do not have any ocular diseases that could interfere with the visual field testing\n\nExclusion Criteria:\n\n* Developmental delay\n* Inability to obtain consent\n* Inability to understand English",[83,84],"CHILD","ADULT",[86],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":98},"Duke University Medical Center","Durham","North Carolina","27705","United States",[93],{"name":94,"role":95,"phone":96,"email":97},"Nikita Piryani, MD","CONTACT","2624081232","nikita.piryani@duke.edu",{"lat":99,"lon":100},35.99403,-78.89862,[102],{"name":103,"role":95,"phone":104,"email":105},"Sharon F Freedman, MD","(919) 681-3937","sharon.freedman@duke.edu",[107],{"name":103,"affiliation":13,"role":108},"PRINCIPAL_INVESTIGATOR",[110,114],{"pmid":111,"type":112,"citation":113},"32941320","BACKGROUND","Razeghinejad R, Gonzalez-Garcia A, Myers JS, Katz LJ. Preliminary Report on a Novel Virtual Reality Perimeter Compared With Standard Automated Perimetry. J Glaucoma. 2021 Jan 1;30(1):17-23. doi: 10.1097\u002FIJG.0000000000001670.",{"pmid":115,"type":112,"citation":116},"34003954","Montelongo M, Gonzalez A, Morgenstern F, Donahue SP, Groth SL. A Virtual Reality-Based Automated Perimeter, Device, and Pilot Study. Transl Vis Sci Technol. 2021 Mar 1;10(3):20. doi: 10.1167\u002Ftvst.10.3.20.",[],{"nct_id":4,"conditions":119,"biomarkers":121},[22,120],"Visual Field Defect",[],{"nct_id":4,"found":15,"summary":123,"prompt_version":133},{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This study is an interventional study planning to enroll 1000 participants. It compares a new virtual reality device (VisuALL) to the standard visual field test (Humphrey Visual Field).","completed","Virtual Reality Visual Field Testing in Children","This study is testing a new way to check your peripheral vision (side vision), which is called a visual field test. Instead of a large machine, this new test uses a virtual reality headset called VisuALL. It's already approved by the FDA and has been used in adults and children. We want to see how well VisuALL works compared to the standard test, called the Humphrey Visual Field (HVF) test. We are looking for children and young adults aged 4 to 21 who are generally healthy, or who have eye conditions that require visual field testing. You must be able to wear the VR goggles for at least 10 minutes and not have other eye diseases that would interfere with the test. The study will measure how accurately VisuALL detects changes in your vision. We are currently recruiting participants.","The primary measurements are taken during a single office visit, approximately 30 minutes long. No further follow-up is specified.",139,"You would wear virtual reality goggles for at least 10 minutes during an office visit, which takes about 30 minutes. This testing will be done on a day you already have a scheduled eye appointment.","Not stated in the trial record.",[34,40],"v2"]