[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659546":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":38,"studyPopulation":27,"armGroups":39,"interventions":51,"overallOfficials":59,"centralContacts":67,"locations":27,"responsibleParty":73,"collaborators":27,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":27,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":27,"enrollmentInfo":86,"targetDuration":27,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":102,"whyStopped":27,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":27},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Margin Reflex Distance 1","Mean change in Margin Reflex Distance 1 (MRD1) in millimeters from baseline to 3 months after the first injection.","At 3 months",[14,17,21,24],{"measure":15,"description":16,"timeFrame":12},"Proportion of eyes with effective response","Proportion of eyes achieving MRD1 ≤ 4.5 mm at 3 months.",{"measure":18,"description":19,"timeFrame":20},"Mean number of injections required","Mean number of betamethasone injections required to reach target MRD1.","At 12 months",{"measure":22,"description":23,"timeFrame":20},"Proportion of eyes with intraocular pressure elevation","Proportion of eyes with intraocular pressure ≥ 21 mmHg or increase ≥ 5 mmHg from baseline.",{"measure":25,"description":26,"timeFrame":12},"Change in Graefe sign","Mean change in lid lag on downgaze (Graefe sign) in millimeters from baseline to 3 months.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":33,"maskingDescription":34,"whoMasked":35},"DOUBLE","Participants and outcomes assessors will be masked to the injection approach.",[36,37],"PARTICIPANT","OUTCOMES_ASSESSOR","Thyroid eye disease is an autoimmune orbital disorder that frequently causes upper eyelid retraction. Local corticosteroid injection around the levator-Müller complex is a minimally invasive treatment option.\n\nThis prospective randomized double-blind parallel-group trial will compare two injection approaches (transconjunctival versus transcutaneous) of betamethasone in adult patients with thyroid eye disease-related upper eyelid retraction. The primary outcome is the change in Margin Reflex Distance 1 (MRD1) at 3 months after the first injection.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Transconjunctival Perilevator Injection","EXPERIMENTAL","Perilevator betamethasone injection delivered via the transconjunctival (subconjunctival\u002Fretro-septal) approach.",[45],"Drug: Betamethasone",{"label":47,"type":48,"description":49,"interventionNames":50},"Transcutaneous Perilevator Injection","ACTIVE_COMPARATOR","Perilevator betamethasone injection delivered via the transcutaneous (percutaneous para-levator) approach.",[45],[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"DRUG","Betamethasone","Betamethasone suspension 1 mL injected into the perilevator space.",[41,47],[58],"Celestone",[60,64],{"name":61,"affiliation":62,"role":63},"Abdelnasser m Awad, prof","Ophthalmology Department, Assiut University Hospitals","STUDY_CHAIR",{"name":65,"affiliation":66,"role":63},"Sarah H Alataar, Prof","Ophthalmology Department,Assiut University Hospitals",[68],{"name":69,"role":70,"phone":71,"phoneExt":27,"email":72},"Heba A Nashat, Resident","CONTACT","+20 10 27021038","Heba.nashaat6@gmail.com",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Heba Nashaat","Resident Physician, Department of ophthalmology","100659546","transconjunctival-versus-transcutaneous-betamethasone-for-upper-eyelid-retraction-in-ted-100659546",false,"NCT07866261","Transconjunctival Versus Transcutaneous Betamethasone for Upper Eyelid Retraction in TED","Transconjunctival Versus Transcutaneous Perilevator Betamethasone Injection for the Management of Thyroid Eye Disease-Related Upper Eyelid Retraction","Inclusion Criteria:\n\n* \\- Age 18 years or older\n* Clinical diagnosis of thyroid eye disease with stable thyroid function for at least 3 months\n* Unilateral or bilateral upper eyelid retraction with Margin Reflex Distance 1 greater than 4.5 mm in at least one eye\n* Thyroid eye disease duration less than 24 months\n* Written informed consent\n\nExclusion Criteria:\n\n* \\- Active sight-threatening thyroid eye disease requiring urgent decompression or systemic immunosuppression\n* Current or recent (within 3 months) systemic corticosteroids or other immunosuppressives for thyroid eye disease\n* Previous levator or Müller muscle surgery, botulinum toxin, or filler injection to the upper eyelid within 6 months\n* Contraindications to local steroid injection (active ocular infection, uncontrolled glaucoma, pregnancy or lactation)\n* Significant corneal exposure keratopathy requiring immediate surgical intervention","ALL","18 Years",{"count":87,"type":88},54,"ESTIMATED","INTERVENTIONAL",[91],"NA","This randomized controlled trial aims to compare the efficacy and safety of transconjunctival versus transcutaneous perilevator betamethasone injection in reducing upper eyelid retraction in patients with thyroid eye disease.",[94],"Thyroid Eye Disease",[96,97,54,98,99,100,101],"Transconjunctival","Thyroid eye disease","Upper eyelid retraction","Transcutaneous","Perilevator injection","Assiut","NOT_YET_RECRUITING","2026-10-04",{"date":105,"type":106},"2026-10-08","ACTUAL",{"date":108,"type":88},"2026-10-10",{"date":110,"type":88},"2028-03-01",{"name":5,"class":6}]