Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-25 @ 10:44 AM
Study NCT ID:
NCT03780868
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2018-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
External DCR Versus Canalicular SI With MMC in NLDO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'compare external dacryocystorhinostomy versus canalicular silicone intubation with the use of Mitomycin C (MMC) in primary acquired nasolacrimal duct obstruction (NLDO).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2014-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-17', 'studyFirstSubmitDate': '2018-12-09', 'studyFirstSubmitQcDate': '2018-12-17', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'canalicular silicone intubation with MMC', 'timeFrame': '2 years', 'description': 'patency of lacrimal passage was tested by height of tear meniscus and lacrimal syringing. On the basis of subjective and objective evaluation, patients were categorized into three groups: successful surgery (asymptomatic, normal tear meniscus and patent lacrimal system with syringing procedure), improvement (watery eye and/or discharge, moderate tear meniscus and partially patent lacrimal system with syringing procedure with mild regurgitation from the puncta) and failed surgery (watery eye and/or discharge, high tear meniscus and non-patent lacrimal system).'}], 'primaryOutcomes': [{'measure': 'external DCR', 'timeFrame': '2 years', 'description': 'patency of lacrimal passage was tested by height of tear meniscus and lacrimal syringing. On the basis of subjective and objective evaluation, patients were categorized into three groups: successful surgery (asymptomatic, normal tear meniscus and patent lacrimal system with syringing procedure), improvement (watery eye and/or discharge, moderate tear meniscus and partially patent lacrimal system with syringing procedure with mild regurgitation from the puncta) and failed surgery (watery eye and/or discharge, high tear meniscus and non-patent lacrimal system).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['External DCR, canalicular silicone intubation, Mitomycin C'], 'conditions': ['Primary Acquired Nasolacrimal Duct Obstruction']}, 'descriptionModule': {'briefSummary': 'While external DCR is the gold standard procedure for primary NLDO as well as complicated cases, SI with MMC could achieve comparable success rates in primary acquired NLDO, hence should be considered as an alternative as a safe and minimally invasive procedure.', 'detailedDescription': 'Purpose: To compare external dacryocystorhinostomy versus canalicular silicone intubation with the use of Mitomycin C (MMC) in primary acquired nasolacrimal duct obstruction (NLDO).\n\nMethods: the study was carried out at the department of Ophthalmology, Menoufia university Hospital, Egypt, between June 2012 to July 2014. Fifty-six patients who were diagnosed with primary acquired NLDO. Patients were randomly allocated into two groups: thirty cases underwent external DCR and twenty-six cases underwent silicone intubation with MMC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary acquired NLDO\n\nExclusion Criteria:\n\n* All other secondary causes of NLDO'}, 'identificationModule': {'nctId': 'NCT03780868', 'briefTitle': 'External DCR Versus Canalicular SI With MMC in NLDO', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'External Dacryocystorhinostomy Versus Canalicular Silicone Intubation With Mitomycin C in Primary Acquired Nasolacrimal Duct Obstruction', 'orgStudyIdInfo': {'id': 'Ebsar ophthalmic Center'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'external DCR', 'description': "A curvilinear incision of 10-15 mm length was made along the anterior lacrimal crest .\n\nThe smaller end of the blunt dissector was used to fracture Lamina papyracea, the parchment like bone of the posterior half of the lacrimal fossa. the nasal mucosa was stripped from lacrimal bone with the help of Traquair's periosteal elevator, An osteotomy of approximately 12.5 x10mm was created with successive punching of bone by Cittelli's punch. Lacrimal sac and nasal mucosa were opened in a 'H' fashion with the no.11 Bard-Parker blade and Bowman's probe was in place, to form a large anterior and smaller posterior flap.", 'interventionNames': ['Procedure: external dacryocystorhinostomy', 'Procedure: canalicular silicone intubation with MMC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'silicone intubation with MMC', 'description': "Bowman's probe was gently inserted into the inferior canalicular system, until a hard stop was felt in the lacrimal sac, after which it was rotated into the NLD to reach below the inferior concha. The probe was then withdrawn via the inferior punctum and the process was repeated for the upper canaliculus.\n\nAfter irrigation with normal saline to confirm duct patency, irrigation was performed by introducing 1 ml of MMC (0.5 mg/ml) into the duct with a syringe, the ocular surface then irrigatedby normal saline. Intubation was done by a silicone tube connected by each of its end to a malleable steel guide. A grooved director was placed under the inferior turbinate to guide the probe out of the nose, after which the steel guide was cut from the silicone tube", 'interventionNames': ['Procedure: external dacryocystorhinostomy', 'Procedure: canalicular silicone intubation with MMC']}], 'interventions': [{'name': 'external dacryocystorhinostomy', 'type': 'PROCEDURE', 'description': 'external DCR under general anesthesia with standard sterilization procedures.', 'armGroupLabels': ['external DCR', 'silicone intubation with MMC']}, {'name': 'canalicular silicone intubation with MMC', 'type': 'PROCEDURE', 'description': 'canalicular silicone intubation with MMC under general anesthesia with standard sterilization procedures.', 'armGroupLabels': ['external DCR', 'silicone intubation with MMC']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Amin Faisal Ellakwa', 'investigatorAffiliation': 'Menoufia University'}}}}