[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581312":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":24,"responsibleParty":39,"collaborators":24,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":24,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":67,"whyStopped":24,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":24},{"fullName":5,"class":6},"Salus University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate Office-Based Vergence\u002FAccommodative Therapy with Movement (OBVAM)","EXPERIMENTAL","16 sessions, twice per week of office-based vergence\u002Faccommodation therapy (OBVASM)While OBVAM therapy retains the essential elements of OBVAT. The OBVAM therapy protocol has four phases. Phase 1 targets visual\u002Fvestibular issues typical in mTBI-CI by integrating version eye movements, such as saccades and pursuits, with head and body movements. It also includes gross convergence, monocular accommodative (focusing) flexibility, and simple convergence procedures. The subsequent phases concentrate on enhancing ramp vergence amplitudes and improving accommodative facility (Phase 2), focusing on vergence facility and endurance (Phase 3), and integrating vergence and accommodation (Phase 4). Head and body movements are incorporated into some therapy procedures in Phases 3 and 4.",[13],"Other: Office-Based Vergence\u002FAccommodative Therapy with Movement (OBVAM)",{"label":15,"type":16,"description":17,"interventionNames":18},"Delayed Office-Based Vergence\u002FAccommodative Therapy with Movement (OBVAM)","ACTIVE_COMPARATOR","Same as immediate group but delayed 6 weeks",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Office-Based Vergence\u002FAccommodative Therapy with Movement (OBVAM)","Head and body movements are incorporated into some therapy procedures in Phases 3 and 4. Additional details are provided in the Overall Program Narrative. Participants undergoing office-based VAM therapy will be prescribed home therapy procedures including the HTS2 Home Vision Therapy System (https:\u002F\u002Fhtsvision.com\u002F) thrice weekly to support their in-office VAM therapy. This software progressively increases fusional convergence and divergence demands, offers instant user feedback, and will allow us to track participants' usage and progress. Basic procedures like free-space fusion cards and Brock String will also be prescribed for home therapy.",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Mitchell Scheiman, OD, PhD","Drexel University","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"MItchell Scheiman, OD, PhD","CONTACT","215-780-1427","ms5758@drexel.edu",{"name":37,"role":33,"phone":34,"phoneExt":24,"email":38},"Susan Cotter, OD, MS","scotter@ketchum.edu",{"type":40,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100581312","phase-2-natural-history-of-mtbi-related-convergence-insufficiency--effectiveness-of-vision-therapy-for-mtbi-related-ci-100581312",false,"NCT06848673","Natural History of MTBI-related Convergence Insufficiency & Effectiveness of Vision Therapy for MTBI-related CI","PILOT CLINICAL TRIAL (PCT) of the Natural History of the Most Common MTBI-related Oculomotor Disorder Convergence Insufficiency & the Effectiveness of Vergence\u002FAccommodative Therapy for MTBI-related Convergence Insufficiency","TBEye","Inclusion Criteria:\n\n* • Age 18 to 35 years inclusive\n\n  * Medical diagnosis of mTBI or concussion \\> 1 month ago and no longer than 6 months ago\n  * Convergence Insufficiency Symptom (CISS score) ≥ 21\n  * Best-corrected VA of 20\u002F25 or better in both eyes at distance \\& near\n  * Willingness to wear refractive correction, if indicated\n  * Random dot stereopsis of 500 arcsec or better (Randot Stereo Test)\n  * Receded NPC of ≥6 cm\n  * Insufficient PFV (\\\u003C 15∆ or PFV blur point less than twice the near exophoria magnitude)\n  * Wearing refractive correction for cycloplegic refractive errors of:\n  * ≥ +1.25 D SE hyperopia or ≥ -1.00 D SE myopia in either eye\n  * ≥ 1.25 D astigmatism in either eye, ≥ 1.00 D SE anisometropia\n  * Astigmatism axis within ±10 degrees if magnitude is ≤1.00 D and within ±5 degrees if \\>1.00 D\n\nExclusion Criteria:\n\n* • No previous treatment for CI\n\n  * No previous diagnosis of CI from an ophthalmologist or optometrist\n  * No medications known to affect accommodation or vergence\n  * Investigator \\& patient willing to forgo all other CI treatment other than that assigned by randomization",true,"ALL","18 Years","35 Years",{"count":54,"type":55},100,"ESTIMATED","INTERVENTIONAL",[58],"PHASE2","The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of office-based vergence\u002Faccommodative therapy with movement (OBVAM) for mTBI-related convergence insufficiency.",[61],"Convergence Insufficiency",[61,63,64,65,66],"Vision Therapy","mTBI","Concussion","Office-based vergence\u002Faccommodative therapy","NOT_YET_RECRUITING","2025-02-21",{"date":70,"type":71},"2025-02-27","ACTUAL",{"date":73,"type":55},"2026-11-01",{"date":75,"type":55},"2028-09-30",{"name":5,"class":6}]