[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584941":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":36,"responsibleParty":77,"collaborators":20,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":20,"enrollmentInfo":89,"targetDuration":20,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":58,"whyStopped":20,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Alberta","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Placement of suture lid spring","EXPERIMENTAL","Instead of tying tissue with the surgical suture (polypropylene) that is normally used in lid surgery we will make a loop out of the suture and place it underneath the eyelid skin to see if it will help with eyelid closure in patients with facial nerve palsy.\n\nThere is no placebo or comparison group",[13],"Device: Polypropylene Suture Eyelid Spring for Paralytic Lagophthalmos",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Polypropylene Suture Eyelid Spring for Paralytic Lagophthalmos","The polypropylene loop eyelid suture spring will be centrally placed without fixation to the bone unlike a metal lid spring.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Edsel Ing, MD PhD FRCSC","PRINCIPAL_INVESTIGATOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Edsel B Ing, MD PhD FRCSC MPH MIAD MEd MBA","CONTACT","6472930155","780) 735-8784","ed.ing@ualberta.ca",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Erin Childs, MOA","7807358784","erin.childs@ahs.ca",[37,57],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Eye Institute of Alberta, Royal Alexandra Hospital","NOT_YET_RECRUITING","Edmonton","Alberta","T5H 3V9","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-113.46871,53.55014,{"lat":49,"lon":48},[52,55],{"name":53,"role":28,"phone":54,"phoneExt":20,"email":31},"Edsel B Ing, MD PhD","780) 735 8784",{"name":56,"role":28,"phone":54,"phoneExt":20,"email":35},"Erin MM&E Childs",{"facility":38,"status":58,"city":40,"state":41,"zip":59,"country":43,"countryCode":44,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"RECRUITING","T5J 0N3",{"type":46,"coordinates":61},[48,49],{"lat":49,"lon":48},[64,67,70,72,75],{"name":65,"role":28,"phone":66,"phoneExt":20,"email":31},"Edsel Ing, MD PhD FRCSC MPH MEd MIAD MBA","16472930155",{"name":68,"role":28,"phone":20,"phoneExt":20,"email":69},"Rita Whitford","whitford@ualberta.ca",{"name":71,"role":24,"phone":20,"phoneExt":20,"email":20},"Edsel Ing, MD PhD",{"name":73,"role":74,"phone":20,"phoneExt":20,"email":20},"Imran Jivraj, MD","SUB_INVESTIGATOR",{"name":76,"role":74,"phone":20,"phoneExt":20,"email":20},"Galvez Ruiz Alberto, MD",{"type":78,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100584941","early-phase-1-suture-lid-spring-for-lid-closure-in-patients-with-facial-nerve-palsy-100584941",false,"NCT06895902","Suture Lid Spring for Lid Closure in Patients With Facial Nerve Palsy","Suture Eyelid Spring for Eyelid Closure in Patients With Facial Nerve Palsy","SESPL","Inclusion Criteria:\n\n* Adults 18 years of age or older with facial nerve transection or paralytic lagophthalmos that has not improved after 6 weeks.\n\nExclusion Criteria:\n\n* Patients unable to tolerate awake eyelid surgery under local anesthetic.","ALL","18 Years",{"count":90,"type":91},10,"ESTIMATED","INTERVENTIONAL",[94],"EARLY_PHASE1","The eyelids protect the cornea and eyelid closure is essential to ocular health and clear vision.\n\nPatients with permanent Bells palsy or facial nerve palsy from other reasons such as tumours or trauma may be unable to blink and protect their cornea.\n\nIrreversible visual loss can occur if the cornea is not kept lubricated.\n\nCurrent treatment options for patients whose eyelid blink does not recover include lubricating the eye every hour or two with drops and lubricating ointment at night, patching the eye closed, sewing parts of the eyelid together (tarsorrpahy), upper lid gold weight or a dental wire spring.\n\nIt is inconvenient to lubricate the cornea constantly, and the lubricating drops and ointment usually cost more than $80.00 per month. Lubrication often blurs vision, because the patient must look through a film.\n\nPatching the eye closed and tarsorraphy deprives the patient of peripheral vision, can impede social interaction, and is objectionable cosmetically.\n\nUpper-lid gold weights can be placed underneath the eyelid skin and work by gravity. A gold weight will only work when the patient initiates a forced blink. Gold weights may not work when the patient is lying down because there is no gravity to assist lid closure. The eyelid skin is the thinnest skin in the body and can extrude through the skin over time.\n\nEyelid springs made of metal dental wire exist but are not frequently used because they often extrude through the thin eyelid skin. Also, dental wire springs require attachment to the bone near the side of the eye. It is not uncommon that dental wire springs have to be removed or replaced.\n\nThe investigators propose a new spring to close the eyelid made out of the surgical stitches (sutures) commonly used in medicine and eyelid surgery. The stitch will be made into a custom shape and attached underneath the skin near the centre of the lid, without attachment to the bone.\n\nUpper lid gold weights, dental wire springs, and our proposed suture spring are all foreign bodies and can all become infected or extrude through the skin. Because the suture spring is thinner than a gold weight and because it does not have sharp edges like a metal spring, there should be less risk of extrusion. The suture spring will lose its elasticity over time and will require replacement.",[97,98,99],"Facial Nerve Palsy","Corneal Exposure","Paralytic Lagophthalmos",[101],"Paralytic lagophthalmos","2026-05-29",{"date":104,"type":105},"2026-06-02","ACTUAL",{"date":107,"type":105},"2025-04-28",{"date":109,"type":91},"2028-07-31",{"name":5,"class":6},2]