Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT01010659
Status:
COMPLETED
Last Update Posted:
2011-07-15
First Post:
2009-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-14', 'studyFirstSubmitDate': '2009-11-05', 'studyFirstSubmitQcDate': '2009-11-09', 'lastUpdatePostDateStruct': {'date': '2011-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of epiphora', 'timeFrame': '15th Day, 1st Month, 6th Month and 12th month'}], 'secondaryOutcomes': [{'measure': 'Post operative complications', 'timeFrame': '15th Day, 1st Month, 6th Month and 12th Month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dacryocystorhinostomy'], 'conditions': ['Epiphora']}, 'descriptionModule': {'briefSummary': 'The purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora.', 'detailedDescription': 'Epiphora is an overflow of tears,usually caused by insufficient drainage of the tear film from the eye.The most common cause is a blockage of the lacrimal ducts located next to the nose, but the condition may also result from the excessive production of tears. Epiphora is a symptom rather than a disease and may be caused by a variety of conditions.\n\n30 subjects will be recruited for this study, informed consent will be taken from the willing subjects. Complete ophthalmic evaluation would be performed including visual acuity. Diagnosis would be made on history of epiphora, regurgitation test, lids examination, nasal examination, probing and syringing. Standard procedure of Dacryocystorhinostomy (DCR) would be adopted in all cases with lacrimal intubation.\n\nSyringing will be done on first follow up visit and skin sutures will also be removed. Tightness and mobility of the silicone tube will be checked. The tube is kept in place for 3-6 months according to need and then finally removed. The patency of lacrimal passage will be investigated by irrigation. A successful outcome will be defined as resolution of symptoms like epiphora and discharge and a patent lacrimal system on irrigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects having epiphora\n* Canalicular blockade ascertained with probing\n* Chronic dacryocystitis\n* Mucocele\n\nExclusion Criteria:\n\n* Absent puncta\n* Acute on chronic dacryocystitis\n* Noticeable lid laxity\n* Previous lacrimal surgery\n* Patients younger than 15 years\n* Suspicion of malignancy\n* Post traumatic lids\n* Bony deformity'}, 'identificationModule': {'nctId': 'NCT01010659', 'briefTitle': 'The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora', 'organization': {'class': 'OTHER', 'fullName': 'Aurolab'}, 'officialTitle': 'Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation', 'orgStudyIdInfo': {'id': '1PN1010940'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lacrimal Tube', 'description': 'Dacryocystorhinostomy with silicone lacrimal intubation', 'interventionNames': ['Device: Lacrimal Tube']}], 'interventions': [{'name': 'Lacrimal Tube', 'type': 'DEVICE', 'otherNames': ['Auro-lac'], 'description': 'Lacrimal Tube', 'armGroupLabels': ['Lacrimal Tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625 020', 'city': 'Madurai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Aravind Eye Hospital', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}], 'overallOfficials': [{'name': 'Dr. Usha Kim, MBBS, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aravind Eye Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aurolab', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Usha Kim', 'oldOrganization': 'Aravind Eye Hospital'}}}}