[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516099":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":64,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":26,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"St. Joseph's Healthcare Hamilton","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Face-Down Positioning for 3-Days and Nights","EXPERIMENTAL","Patients allocated to this study arm will maintain face-down positioning for 3-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours.",[13],"Behavioral: 3 Days of face-down positioning",{"label":15,"type":16,"description":17,"interventionNames":18},"Face-Down Positioning for 7-Days and Nights","ACTIVE_COMPARATOR","Patients allocated to this study arm will maintain face-down positioning for 7-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours.",[19],"Behavioral: 7 Days of face-down positioning",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","3 Days of face-down positioning","Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"7 Days of face-down positioning","Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.",[15],[32],{"name":33,"affiliation":34,"role":35},"Varun Chaudhary, MD, FRCSC","McMaster University, St. Joseph's Hospital","PRINCIPAL_INVESTIGATOR",[37,42],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","905-573-7777","38058","vchaudh@mcmaster.ca",{"name":43,"role":38,"phone":44,"phoneExt":26,"email":45},"Keean Nanji, MD","905-573-4848","Keean.Nanji@medportal.ca",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"St. Joseph's Hospital King Campus","RECRUITING","Stoney Creek","Ontario","L8G 5E4","Canada","CA",{"type":56,"coordinates":57},"Point",[58,59],-79.76633,43.21681,{"lat":59,"lon":58},[62],{"name":43,"role":38,"phone":63,"phoneExt":26,"email":45},"6474575454",{"type":35,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Varun Chaudhary","Professor, Department of Surgery, Chief of Ophthalmology, Hamilton Regional Eye Institute","100516099","duration-of-face-down-positioning-for-full-thickness-macular-hole-repair-100516099",false,"NCT06000111","Duration of Face Down Positioning for Full-Thickness Macular Hole Repair","Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study","Inclusion Criteria:\n\n* Consecutive patients with an idiopathic full-thickness macular hole\n* Symptom duration of less than 6 months\n* Patient must agree to participate in this investigation\n\nExclusion Criteria:\n\n* Macular hole minimum diameter \\>1000 μm\n* A history of high myopia (\\> -6)\n* Traumatic macular hole\n* Amblyopia\n* Retinal vein occlusion\n* Inflammatory eye diseases\n* Patients found to have a retinal tear during either the pre-operative assessment or intraoperatively","ALL","18 Years",{"count":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[81],"NA","A full-thickness macular hole is when there is a small gap that opens in the center part of the retina (the light-sensitive layer of tissue in the back of the eye). Following surgical repair of these holes, patients have to lie face down for a number of days and nights. The exact amount of time necessary to position is however unknown. The goal of this randomized feasibility clinical trial is to compare 3 days and nights of face-down positioning to 7 days and nights of face-down positioning following pars plana vitrectomy surgery for full-thickness macular holes on key patient outcomes. This study will be a feasibility study to better inform a future larger clinical trial. Additionally, this investigation will be examining the rates of macular hole closure, patient visual acuity following surgery, patient quality of life, patient compliance, and complication rates.",[84],"Macular Holes","2024-11-26",{"date":87,"type":88},"2024-11-29","ACTUAL",{"date":90,"type":88},"2023-11-21",{"date":92,"type":78},"2025-12-31",{"name":5,"class":6},1]