[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Salus University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100614676","validation-of-clinical-outcome-measures-specific-to-mtbi-related-oculomotor-disorders-100614676",false,"NCT07282691","Validation of Clinical Outcome Measures Specific to mTBI-Related Oculomotor Disorders","Inclusion Criteria:\n\n* Diagnosis of mTBI within previous 1 to 6 months\n* Distance visual acuity better than or equal to 20\u002F25 in each eye\n* Score \\>21 on Convergence Insufficiency Symptom Survey\n\nExclusion Criteria:\n\n* Diagnosis of moderate or severe TBI; \\> 30-min loss of consciousness\n* Not wearing required refractive error)\n* Disease(s) known to affect oculomotor system (multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease)-Manifest strabismus or intraocular injury (evaluated at vision examination)\n* Cognitive delays that may impact testing",true,"ALL","18 Years","35 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","The specific aim of this project is to validate clinical tests to be used as outcome measures in studies of mTBI-related vision problems.",[25],"MTBI - Mild Traumatic Brain Injury",[27,28,29,30,31,32],"mTBI","convergence insufficiency","concussion","concussion-related vision disorders","vision rehabilitation","vision therapy","RECRUITING","2025-12-01",{"date":36,"type":37},"2025-12-15","ACTUAL",{"date":39,"type":37},"2025-04-01",{"date":41,"type":21},"2028-09-29",{"name":43,"class":44},"Salus University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100581312","phase-2-natural-history-of-mtbi-related-convergence-insufficiency--effectiveness-of-vision-therapy-for-mtbi-related-ci-100581312","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",{"count":55,"type":21},100,"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",[61,63,27,64,65],"Vision Therapy","Concussion","Office-based vergence\u002Faccommodative therapy","NOT_YET_RECRUITING","2025-02-21",{"date":69,"type":37},"2025-02-27",{"date":71,"type":21},"2026-11-01",{"date":73,"type":21},"2028-09-30",{"name":43,"class":44},""]