[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631370":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":44,"studyPopulation":37,"armGroups":45,"interventions":58,"overallOfficials":75,"centralContacts":79,"locations":85,"responsibleParty":101,"collaborators":37,"id":103,"slug":37,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":37,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":37,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":122,"whyStopped":37,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Beijing Tongren Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":37},[9,13],{"measure":10,"description":11,"timeFrame":12},"Total Clinical Effectiveness Rate at 3 Months","Based on symptom resolution and lacrimal irrigation:\n\nCured: complete symptom resolution and patent irrigation\n\nEffective: mild tearing, patent or pressurized irrigation\n\nIneffective: persistent tearing or obstruction Total effectiveness = (cured + effective cases) \u002F total × 100%.","3 months postoperatively",{"measure":14,"description":15,"timeFrame":16},"Lacrimal Ostium Formation Rate at 3 Months","Assessment: endoscopic confirmation of epithelialized, patent ostium.","3 months",[18,22,25,29,33],{"measure":19,"description":20,"timeFrame":21},"Operation Time","Duration of surgery measured from incision to closure, reported in minutes.","During surgery",{"measure":23,"description":24,"timeFrame":21},"Intraoperative Blood Loss","Volume of blood loss during surgery, reported in milliliters (mL).",{"measure":26,"description":27,"timeFrame":28},"Length of Hospital Stay","Number of days from surgery to hospital discharge.","Postoperative hospitalization (within 1 week)",{"measure":30,"description":31,"timeFrame":32},"Recurrence Rate","Definition: recurrence of tearing with obstruction confirmed by irrigation.","3 months, 6 months, and 12 months",{"measure":34,"description":35,"timeFrame":36},"Patient Satisfaction Score","Scale: 0-100 (very satisfied 80-100, satisfied 60-79, dissatisfied \\\u003C60).","12 months",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE","This is a prospective, multicenter, randomized, parallel-controlled clinical trial conducted to assess the safety and effectiveness of an absorbable lacrimal sac drug-eluting stent in patients with recurrent chronic dacryocystitis undergoing endoscopic endonasal dacryocystorhinostomy (E-DCR).\n\nEligible patients diagnosed with recurrent chronic dacryocystitis and meeting the inclusion criteria will be enrolled and randomly assigned in a 1:1 ratio to either the intervention group or the control group. Patients in the intervention group will receive implantation of an absorbable polymer mesh stent coated with mometasone furoate at the osteotomy site during E-DCR. Patients in the control group will undergo E-DCR with conventional packing, followed by routine postoperative intranasal budesonide therapy.\n\nThe absorbable drug-eluting stent is designed to locally release mometasone furoate to reduce postoperative inflammation and adhesion formation, thereby maintaining ostium patency and promoting mucosal healing. Patients will be followed postoperatively according to the study protocol, with scheduled assessments of clinical effectiveness, ostium formation, surgical indicators, recurrence, and patient satisfaction at predefined time points. Safety outcomes will include the incidence of procedure- or device-related adverse events throughout the follow-up period.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Absorbable Lacrimal Sac Drug-Eluting Stent","EXPERIMENTAL","Participants undergo endoscopic dacryocystorhinostomy (E-DCR) with implantation of an absorbable lacrimal sac drug-eluting stent (LN1509, LN1209, or LN0907; PuYi Biotech, Shanghai). The stent provides mechanical separation and sustained local release of mometasone furoate. Postoperatively, all participants receive systemic antibiotics for 1-3 days and topical low-dose corticosteroid and antibiotic eye drops for approximately 2 weeks. Nasal endoscopy and lacrimal irrigation are performed at 1 week, 2 weeks, 1 month, 2 months, and 3 months post-surgery. Granulation tissue is removed as necessary to maintain ostium patency.",[51],"Device: Absorbable Lacrimal Sac Drug-Eluting Stent",{"label":53,"type":54,"description":55,"interventionNames":56},"Standard E-DCR with Conventional Packing","PLACEBO_COMPARATOR","Participants undergo standard endoscopic dacryocystorhinostomy (E-DCR) without a stent. The ostium is packed with conventional materials. Postoperatively, participants receive the same systemic antibiotics and topical eye drops as the experimental group. Additionally, they use budesonide nasal spray (2 sprays\u002Fday) for 3 months. Nasal endoscopy and lacrimal irrigation follow the same schedule as the experimental group, with granulation tissue removed as needed.",[57],"Drug: Conventional Ostium Packing with Budesonide Nasal Spray",[59,68],{"type":60,"name":47,"description":61,"armGroupLabels":62,"otherNames":63},"DEVICE","During E-DCR, the stent is implanted at the osteotomy site to provide mechanical separation and local release of mometasone furoate. The polymer scaffold is fully absorbable. Available models: LN1509 (15×9 mm), LN1209 (12×9 mm), LN0907 (9×7 mm).",[47],[64,65,66,67],"Absorbable Lacrimal Sac Steroid-Eluting Stent","LN1509","LN1209","LN0907",{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"DRUG","Conventional Ostium Packing with Budesonide Nasal Spray","After standard E-DCR, the ostium is packed with conventional materials. Postoperatively, participants use budesonide nasal spray (2 sprays\u002Fday) for 3 months. All other postoperative care is the same as in the experimental group.",[53],[74],"Budesonide Nasal Spray",[76],{"name":77,"affiliation":5,"role":78},"Chengshuo Wang","STUDY_CHAIR",[80],{"name":81,"role":82,"phone":83,"phoneExt":37,"email":84},"Chengshuo wang","CONTACT","86-13911623569","wangcs830@126.com",[86],{"facility":87,"status":37,"city":88,"state":37,"zip":37,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing 100000","Beijing","China","CN",{"type":92,"coordinates":93},"Point",[94,95],116.39723,39.9075,{"lat":95,"lon":94},[98],{"name":99,"role":82,"phone":100,"phoneExt":37,"email":84},"chengshuo wang","+86-13911623569",{"type":102,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100631370",false,"NCT07499791","Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis","A Prospective, Multicenter, Randomized Controlled Trial of an Absorbable Drug-Eluting Lacrimal Sac Stent in Recurrent Chronic Dacryocystitis Undergoing Endoscopic Endonasal Dacryocystorhinostomy","Inclusion Criteria:\n\n* Diagnosed chronic dacryocystitis\n\nHistory of failed E-DCR or lacrimal intubation\n\nPreoperative dacryocystography showing lacrimal sac diameter ≥4 mm\n\nAge ≥18 years\n\nAble to consent and comply with procedures\n\nExclusion Criteria:\n\n* Nasal cavity structural disease: severe septal deviation, tumor, severe sinusitis\n\nLacrimal sac non-visualization on imaging\n\nLacrimal sac rupture, traumatic duct\u002Fbone injuries\n\nAllergy to mometasone furoate or PLA\u002FPGA polymers\n\nPoor general health, unable to tolerate surgery\n\nPsychiatric disorders or antipsychotic drug use\n\nUncontrolled hypertension, diabetes, or severe systemic diseases\n\nKeloid tendency\n\nCoagulation disorders\n\nPregnancy","ALL","18 Years","65 Years",{"count":113,"type":114},40,"ESTIMATED","INTERVENTIONAL",[117],"PHASE2","This study aims to evaluate the safety and effectiveness of an absorbable lacrimal sac drug-eluting stent placed at the osteotomy site during endoscopic endonasal dacryocystorhinostomy (E-DCR) in patients with recurrent chronic dacryocystitis. The stent is composed of absorbable polymer mesh coated with mometasone furoate to reduce postoperative inflammation and adhesion, maintain ostium patency, and improve surgical outcomes. A total of 40 patients will be randomized 1:1 to receive either the absorbable stent or conventional packing with routine postoperative intranasal budesonide therapy.",[120],"Chronic Dacryocystitis",[120],"NOT_YET_RECRUITING","2026-03-25",{"date":125,"type":126},"2026-03-30","ACTUAL",{"date":128,"type":114},"2026-05-01",{"date":130,"type":114},"2027-12-01",{"name":5,"class":6},1]