[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652627":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":50,"locations":30,"responsibleParty":59,"collaborators":30,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":30,"enrollmentInfo":72,"targetDuration":30,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":89,"whyStopped":30,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":30},{"fullName":5,"class":6},"Minia University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Subciliary Approach","ACTIVE_COMPARATOR","Participants will undergo orbital fracture repair using the subciliary approach.",[13],"Procedure: Subciliary Approach",{"label":15,"type":16,"description":17,"interventionNames":18},"Subciliary Approach with Lateral Canthopexy","EXPERIMENTAL","Participants will undergo orbital fracture repair using the subciliary approach combined with lateral canthopexy. The effect of lateral canthopexy on postoperative lower eyelid position and the incidence of ectropion will be evaluated.",[13,19],"Procedure: Lateral Canthopexy",{"label":21,"type":16,"description":22,"interventionNames":23},"Subciliary Approach with Orbicularis Oculi Suspension","Participants will undergo orbital fracture repair using the subciliary approach combined with orbicularis oculi suspension. The effect of orbicularis oculi suspension on postoperative lower eyelid position and the incidence of ectropion will be evaluated.",[13,24],"Procedure: Orbicularis Oculi Suspension",[26,31,35],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Standardized subciliary approach for orbital fracture repair. The skin incision will be placed approximately 2 mm below the lower eyelid margin within a natural skin crease, extending from approximately 1 mm temporal to the inferior punctum toward the lateral canthal region. A stepped skin-muscle approach will be used, with the skin incision followed by inferior subcutaneous dissection and subsequent incision of the preseptal orbicularis oculi muscle approximately 7 mm inferior to the subciliary margin. Dissection will proceed to the infraorbital rim while maintaining the integrity of the orbital septum. The periosteum will be incised approximately 3-4 mm below the inferior orbital rim on its facial aspect to obtain surgical exposure.",[9,15,21],null,{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Lateral Canthopexy","Lateral Canthopexy Technique: A 4-0 polydioxanone (PDS) suture on a P2 needle will be placed through the periosteum of the inner aspect of the lateral orbital rim over Whitnall's tubercle at the desired height. The suture will then engage the medial end of the lateral canthal tendon and the lateral border of the lower eyelid tarsus in a vertical direction. The suture will be tied with the lower eyelid positioned at the desired height. Periosteal fixation will be used.",[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Orbicularis Oculi Suspension","A standardized orbicularis oculi suspension procedure performed in conjunction with the subciliary approach. Following the subciliary incision, the orbicularis oculi muscle is split 7 mm inferior to the subciliary margin while preserving pretarsal muscle function. The lateral edge of the preseptal orbicularis oculi muscle is bluntly dissected to the lateral orbital rim and suspended to the periosteum at the anchoring point using a Vicryl 5-0 or 6-0 horizontal mattress suture with appropriate tension.",[21],[40,44,48],{"name":41,"affiliation":42,"role":43},"Hamed Gad, PhD","Faculty of Dentistry, Minia University","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":46,"role":47},"Alaa Othman, PhD","Samalout Specialized Hospital","STUDY_DIRECTOR",{"name":49,"affiliation":42,"role":47},"Mohamed S. Elkhouly, PhD",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":30,"email":55},"Yasmin Abdelfattah, BDS","CONTACT","+20 1116104101","yasmin.a7med16@yahoo.com",{"name":49,"role":53,"phone":57,"phoneExt":30,"email":58},"+20 1002318399","mohammed.s.elkhouly@minia.edu.eg",{"type":43,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Yasmin Ahmed Moustafa Kamal Abdelfattah","Teaching Assistant, Oral and Maxillofacial Surgery, Faculty of Dentistry, Deraya University","100652627","a-trial-to-evaluate-two-ectropion-preventive-measures-using-the-subciliary-approach-in-orbital-fracture-surgery-100652627",false,"NCT07775417","A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery.","A Comparative Clinical Trial Evaluating Preventive Techniques for Postoperative Ectropion Following the Subciliary Approach in Orbital Trauma.","PREVENTECT","Inclusion Criteria:\n\n* Systemically healthy patients aged 18 years or older, with no history of chronic or uncontrolled systemic diseases.\n* Patients with primary orbital trauma requiring surgical treatment through a standardized subciliary approach, presenting with orbital floor fractures with or without associated lateral orbital rim fractures involving the lateral canthal tendon region, and without associated zygomaticomaxillary complex (ZMC) fractures.\n\nExclusion Criteria:\n\n* Secondary orbital trauma (revision cases or patients with previous orbital trauma).\n* Previous lower eyelid surgery.\n* Pre-existing eyelid malposition (ectropion or entropion) or other pre-existing lower eyelid or lateral canthal abnormalities.\n* Uncontrolled systemic conditions that may affect wound healing, eyelid integrity, or lower eyelid laxity, including uncontrolled diabetes mellitus, immunocompromised status, chronic corticosteroid therapy, or collagen vascular diseases.\n* Previous radiotherapy to the orbital or facial region.","ALL","18 Years",{"count":73,"type":74},30,"ESTIMATED","INTERVENTIONAL",[77],"NA","The goal of this clinical trial is to investigate whether preventive surgical techniques can reduce the incidence of lower eyelid ectropion after the subciliary approach in adult patients undergoing surgery for orbital fractures.\n\nThe main questions it aims to answer are:\n\nDo lateral canthopexy or orbicularis oculi suspension reduce the incidence of postoperative ectropion? Which preventive technique provides better postoperative lower eyelid outcomes?\n\nResearchers will compare three groups: subciliary approach alone, subciliary approach with lateral canthopexy, and subciliary approach with orbicularis oculi suspension to investigate which approach is most effective in preventing postoperative ectropion.\n\nParticipants will undergo surgical treatment according to their assigned group and will attend scheduled postoperative follow-up visits for clinical evaluation of lower eyelid position and surgical outcomes.",[80,81],"Orbital Fractures","Orbital Floor Fractures",[80,83,9,84,32,36,85,86,87,88],"Orbital Floor Fracture","Ectropion","Lower Eyelid Malposition","Orbital Reconstruction","Oral and Maxillofacial Surgery","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-08-16",{"date":92,"type":93},"2026-08-20","ACTUAL",{"date":95,"type":74},"2026-09-01",{"date":97,"type":74},"2027-11-30",{"name":5,"class":6}]