Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT00706251
Status:
COMPLETED
Last Update Posted:
2008-06-27
First Post:
2008-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Follow up of Nasolacrimal Intubation in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D003607', 'term': 'Dacryocystitis'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'lastUpdateSubmitDate': '2008-06-26', 'studyFirstSubmitDate': '2008-06-26', 'studyFirstSubmitQcDate': '2008-06-26', 'lastUpdatePostDateStruct': {'date': '2008-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient being completely free of tearing.', 'timeFrame': '1 year.'}], 'secondaryOutcomes': [{'measure': 'Following nasolacrimal intubation, did the patient need a Dacryocystorhinostomy surgery.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lacrimal Apparatus Diseases', 'Dacryocystitis']}, 'referencesModule': {'references': [{'pmid': '8597274', 'type': 'BACKGROUND', 'citation': 'Becker BB, Berry FD, Koller H. Balloon catheter dilatation for treatment of congenital nasolacrimal duct obstruction. Am J Ophthalmol. 1996 Mar;121(3):304-9. doi: 10.1016/s0002-9394(14)70279-x.'}, {'pmid': '3951812', 'type': 'BACKGROUND', 'citation': 'Hurwitz JJ, Rutherford S. Computerized survey of lacrimal surgery patients. Ophthalmology. 1986 Jan;93(1):14-9. doi: 10.1016/s0161-6420(86)33779-5.'}, {'pmid': '5635571', 'type': 'BACKGROUND', 'citation': 'Keith CG. Intubation of the lacrimal passages. Am J Ophthalmol. 1968 Jan;65(1):70-4. doi: 10.1016/0002-9394(68)91031-3. No abstract available.'}, {'pmid': '5445947', 'type': 'BACKGROUND', 'citation': 'Quickert MH, Dryden RM. Probes for intubation in lacrimal drainage. Trans Am Acad Ophthalmol Otolaryngol. 1970 Mar-Apr;74(2):431-3. No abstract available.'}, {'pmid': '922571', 'type': 'BACKGROUND', 'citation': 'Crawford JS. Intubation of obstructions in the lacrimal system. Can J Ophthalmol. 1977 Oct;12(4):289-92.'}, {'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': '16547322', 'type': 'BACKGROUND', 'citation': "Connell PP, Fulcher TP, Chacko E, O' Connor MJ, Moriarty P. Long term follow up of nasolacrimal intubation in adults. Br J Ophthalmol. 2006 Apr;90(4):435-6. doi: 10.1136/bjo.2005.084590."}]}, 'descriptionModule': {'briefSummary': "For patients with chronic epiphora, Dacryocystorhinostomy is currently the gold standard treatment, with a success rate of 80-90% according to literature. Another available treatment, which is far less used, in nasolacrimal intubation, using a silicone tube.\n\nIn our study, we would like to find the efficacy of nasolacrimal duct intubation, which was performed in our medical center on a few hundred patients with mild epiphora.\n\nStudy hypothesis: nasolacrimal intubation in adults, with a clinically mild epiphora, is close in it's efficacy to the Dacryocystorhinostomy procedure.", 'detailedDescription': "Under normal conditions, the amount of tears excreted from lacrimal glands to the eye is equal to the amount drained through the tear duct. Epiphora in adults usually involves a blockage of the lacrimal sac or the nasolacrimal duct. Epiphora causes tearing in patients, which can be treated sympthomatically in a conservative way (antibiotic treatment, probing of the tear duct, pressure irrigation of the tear duct) or therapeutic in an invasive way. The invasive treatment includes one of the following:\n\n1. Dacryocystorhinostomy - surgery for reconstructing an alternative path for tear drainage.\n2. Nasolacrimal intubation - inserting a silicone tube through the tear duct. The tube is usually removed after 3-6 months.\n\nCurrently, there are only a few reports regarding the efficacy of nasolacrimal intubation, all with a small number of research subjects. Also, these reports have stratified the patients according to the location of the tear duct blockage, and didn't take into account the severity of the blockage (ie the severity of symptoms) prior to performing the intubation.\n\nIn our research, we would like to find the efficacy of nasolacrimal intubation which was performed in our medical center on a few hundred patients with mild epiphora, and to compare in with the efficacy of the Dacryocystorhinostomy - which is 80-90% according to literature."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who underwent nasolacrimal intubation in Maccabi Healthcare, due to mild epiphora, during the years 2000-2007.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of mild epiphora.\n* Underwent nasolacrimal intubation during 01/2000 - 12/2007.\n\nExclusion Criteria:\n\n* Purulent excretions from nasolacrimal duct on day of admission or intubation.\n* Nasolacrimal intubation in the past.\n* Dacryocystorhinostomy in the past.'}, 'identificationModule': {'nctId': 'NCT00706251', 'briefTitle': 'Follow up of Nasolacrimal Intubation in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Long Term Follow up of Nasolacrimal Intubation in Adults With Mild Epiphora', 'orgStudyIdInfo': {'id': 'LTFNIAME'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary', 'description': 'All the patients in our medical center who underwent nasolacrimal intubation, due to mild epiphora, during the years 2000-2007.', 'interventionNames': ['Device: Silicone tube']}], 'interventions': [{'name': 'Silicone tube', 'type': 'DEVICE', 'description': 'Silicone tube which is inserted into the tear duct through the punctum in the eyelid, then passed through the tear duct till it enters the nose and secured in place using a surgical knot. The tube remains in place for 3-6 months, than take out by the surgeon.', 'armGroupLabels': ['Primary']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Maccabi Healthcare Eye Clinic', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Arie Nemet, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shaare Zedek Medical Center, Maccabi Healthcare'}, {'name': 'Arie Nemet, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shaare Zedek Medical Center, Maccabi Healthcare'}, {'name': 'Arie Nemet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaare Zedek Medical Center, Maccabi Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Arie Nemet, MD', 'oldOrganization': 'Shaare Zedek Medical center, Maccabi Healthcare Services'}}}}