Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-28 @ 9:44 PM
Study NCT ID:
NCT06428266
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closed Dacryointubation vs Bicanalicular Intubation for Proximal Tear Duct Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007767', 'term': 'Lacrimal Duct Obstruction'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients from the consultation of the Oculoplastics Department of the Institute of Ophthalmology "Conde de Valenciana I.A.P", between July 2021 and July 2022 who met the inclusion and exclusion criteria were enrolled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-05-20', 'studyFirstSubmitQcDate': '2024-05-20', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Irrigation of tha lacrimal duct', 'timeFrame': 'three and four months after the procedure', 'description': 'Irrigation of the lacrimal duct with saline solution to seek for permeability'}, {'measure': 'Epiphora', 'timeFrame': 'one, three and four months after surgery', 'description': 'evidence of epiphora as told by the subject'}], 'secondaryOutcomes': [{'measure': 'Occurrence of epistaxis', 'timeFrame': 'one, three and four months after surgery', 'description': 'postoperative bleeding throug the nose'}, {'measure': 'Presence of extrusion of bicanalicular intubation tubes', 'timeFrame': 'one, three and four months after surgery', 'description': 'extruded or non-extruded'}, {'measure': 'How well is the positioning of the silicone tubes', 'timeFrame': 'one, three and four months after surgery', 'description': 'how well positioned or poorly positioned the tubes are'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['upper lacrimal duct obstruction', 'bicanalicular intubation', 'closed dacriointubation'], 'conditions': ['Lacrimal Duct Obstruction', 'Lacrimal Apparatus Diseases', 'Lacrimal Stenosis', 'Lacrimal Elimination']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '1. Schaefer DP. Acquired Etiologies of Lacrimal System Obstructions. In: Cohen AJ, Mercandetti M, Brazzo BG, editors. The Lacrimal System [Internet]. Springer New York; 2006 [cited 2020 Jan 15]. p. 43-65.'}, {'pmid': '9893595', 'type': 'BACKGROUND', 'citation': "Fulcher T, O'Connor M, Moriarty P. Nasolacrimal intubation in adults. Br J Ophthalmol. 1998 Sep;82(9):1039-41. doi: 10.1136/bjo.82.9.1039."}, {'pmid': '454271', 'type': 'BACKGROUND', 'citation': 'Pashby RC, Rathbun JE. Silicone tube intubation of the lacrimal drainage system. Arch Ophthalmol. 1979 Jul;97(7):1318-22. doi: 10.1001/archopht.1979.01020020060014.'}, {'pmid': '22259230', 'type': 'BACKGROUND', 'citation': 'Tabatabaie SZ, Rajabi MT, Rajabi MB, Eshraghi B. Randomized study comparing the efficacy of a self-retaining bicanaliculus intubation stent with Crawford intubation in patients with canalicular obstruction. Clin Ophthalmol. 2012;6:5-8. doi: 10.2147/OPTH.S25172. Epub 2011 Dec 20.'}], 'seeAlsoLinks': [{'url': 'http://www.accessdata.fda.gov/cdrh_docs/pdf13/K130375.pdf', 'label': 'characteristics of the Self-Stable Intubation Set II FCI'}]}, 'descriptionModule': {'briefSummary': 'In Mexico, upper lacrimal duct obstruction (ULDO) is a common pathology, and the standard surgical treatment is closed dracryointubation. Based on statistics from our headquarters, in 30% of cases there is a failure of the technique and recurrence of symptoms due to associated complications. Because of this, the application of a self-stable bicananlicular intubation set is proposed. The aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II (FCI) and closed dacryointubation in patients with ULDO .', 'detailedDescription': 'Upper lacrimal duct obstruction (ULDO) or proximal lacrimal tract obstruction occurs when an occlusion is located in the lacrimal point, in superior and inferior canaliculi, or in the common canaliculus. When the ULDO is at the level of the canaliculi (superior, inferior or common), the alternatives available for its management are closed dacryointubation with Crowford catheter, conjunctivadacryocystorhinostomy, and bicanalicular intubation.\n\nClosed dacryointubation with Crowford tube is a technique effective in approximately 90% of children diagnosed with congenital occlusion of the lacrimal duct, however, in adults the reported surgical success rate is lower, approximately 70% according to different authors.\n\nThe conjunctivadacryocystorhinostomy is the procedure proposed by many authors when there is point and canaliculi obstruction in which canalicular intubation cannot be performed due to atresia or total obstruction.\n\nThe bicanaliculalr intubation with the Self-Stable Canalicular Intubation Set (FCI R), an FDA-approved silicone bicanalicular retention device, is especially indicated for the treatment of lacrimal point stenosis and horizontal canalicular obstruction.\n\nThe aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II (ICF) and closed dacryointubation in patients with ULDO'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age\n* Patients with stenosis and incomplete obstruction of the upper lacrimal duct with epiphora \\> 2 on the Munk scale who have not previously undergone surgery on the affected tear duct\n* Patients who may undergo general anesthesia and sedation\n* Patients who are able to present and continue follow-up for the duration of the study\n* Acceptance to participate in the study by signing an informed consent\n\nExclusion Criteria:\n\n* Patients with ocular surface involvement affecting the upper lacrimal duct, such as blepharitis with tear point epithelialization\n* Patients with lacrimal point malposition and/or eyelid malposition due to entropion or ectropion\n* Patients with congenital or acquired obstruction of the lower lacrimal duct\n* Patients with a history of facial paralysis\n* Patients with systemic inflammatory disease such as scarring pemphigoid or Steven Johnson\n* Patients in whom tumour involvement of the lacrimal duct is suspected\n* Patients with reflex tear hypersecretion due to ocular surface involvement or other causes.\n* Pregnancy and breastfeeding\n* Active infection, eye trauma, history of facial trauma with broken bones of the nose, or history of sinus surgery.'}, 'identificationModule': {'nctId': 'NCT06428266', 'acronym': 'DICvsBIcanal', 'briefTitle': 'Closed Dacryointubation vs Bicanalicular Intubation for Proximal Tear Duct Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Oftalmología Fundación Conde de Valenciana'}, 'officialTitle': 'Comparative Study of Safety and Efficacy of Closed Dacryointubation vs Bicanalicular Intubation in the Treatment of Proximal Tear Duct Obstruction in Adult Patients', 'orgStudyIdInfo': {'id': 'CI 09 015 008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Closed dacryointubation', 'description': "Patients undergoing conventional closed dacryointubation with Crawford's tube", 'interventionNames': ['Procedure: Closed dacryointubation']}, {'type': 'EXPERIMENTAL', 'label': 'Bicanalicular Intubation', 'description': 'Patients undergoing bicanalicular intubation with Self-Stable Intubation Set II FCI', 'interventionNames': ['Device: Bicanalicular intubation']}], 'interventions': [{'name': 'Bicanalicular intubation', 'type': 'DEVICE', 'description': 'Placement of the bicanalicular intubation set at each lacrimal point and fixed by means of its flaps at the level of the opening of the lacrimal sac.', 'armGroupLabels': ['Bicanalicular Intubation']}, {'name': 'Closed dacryointubation', 'type': 'PROCEDURE', 'description': 'Placement of dacryointubation tube through the canaliculus until it reaches the medial wall of the lacrimal sac and then passed the nasolacrimal duct until it empties out at the level of the inferior meatus.', 'armGroupLabels': ['Closed dacryointubation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Institiuto de Oftalmología Fundación Conde de Valenciana', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Oftalmología Fundación Conde de Valenciana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}