Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT05999058
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2023-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Lacrimal Drainage Obstruction Diseases Using Dacryoendoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007767', 'term': 'Lacrimal Duct Obstruction'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 522}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-25', 'studyFirstSubmitDate': '2023-08-13', 'studyFirstSubmitQcDate': '2023-08-13', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative success rate', 'timeFrame': '2 years', 'description': 'The main outcome measure was the cumulative success rate of DLDI within 2 years follow-up of obtained using the Kaplan-Meier estimator.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lacrimal Duct Obstruction', 'Dacryoendoscopy', 'Dacryoplasty'], 'conditions': ['Lacrimal Duct Obstruction']}, 'referencesModule': {'references': [{'pmid': '39486803', 'type': 'DERIVED', 'citation': 'Li H, Li J, Zhang L, Yang L, Zhao Y, Zhao H, Pan Y. Clinical outcomes and prognostic factors in patients with nasolacrimal duct obstruction or stenosis using dacryoendoscopy. BMJ Open Ophthalmol. 2024 Oct 31;9(1):e001743. doi: 10.1136/bmjophth-2024-001743.'}]}, 'descriptionModule': {'briefSummary': 'Nasolacrimal duct obstruction (NLDO) can manifest as epiphora or recurrent infections with mucopurulent discharge and may even cause social embarrassment. Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation (DLDI) offers direct therapy to the obstructed site, leading to minimal collateral damage external to the target zone. Although the silicone intubation using dacryoendoscopy has increased the success rates, the success rates vary from a low of 51% to a high of 90%. The difference in success rates seems to depend on the site of obstruction, differences in the surgical technique, stringency of definitions of success, and duration of follow-up. The aim of our study was to report the results of DLDI for the management of NLDO, and to identify factors associated with DLDI failure.', 'detailedDescription': 'Lacrimal drainage obstruction can manifest as epiphora or recurrent infections with mucopurulent discharge and may even cause social embarrassment. Obstruction can occur at any level along the lacrimal drainage system: punctum, canaliculus, nasolacrimal duct, or nasal ostium. It is seen more often in females, especially in postmenopausal women. The etiopathogenesis of lacrimal passage obstruction appears to be multifactorial. Chronic inflammation has been suggested to be the most causal. Dacryocystorhinostomy (DCR) is a standard surgical procedure used to treat nasolacrimal duct obstruction (NLDO), with a reported success rate of more than 90%.\n\nKnowledge concerning the morphological characteristics of lacrimal passage obstruction using traditional diagnostic methods (e.g., lacrimal irrigation, probing, dacryocystography) is limited. Dacryoendoscopy was originally described in 1979 and has recently matured for use in lacrimal drainage system imaging. It has been proved to be a useful instrument not only for understanding differences in the etiology of obstructions but also for treating LD obstructions. On the other hand, semiconductor diode laser can achieve more effective tissue dissection than direct probing technique with minimal hemorrhage and improved intraoperative view. Hence, dacryoendoscopic-assisted laser dacryoplasty with silicone intubation (DLDI) offers direct therapy to the obstructed site, leading to minimal collateral damage external to the target zone. In addition, this procedure can be performed under local anesthesia as an outpatient procedure in the office, and it has advantages such as short surgery time and less risk of bleeding during surgery, resulting in its increasingly widespread use in China. Although the silicone intubation using dacryoendoscopy has increased the success rates, the success rates vary from a low of 51% to a high of 90%. The difference in success rates seems to depend on the site of obstruction, differences in the surgical technique, stringency of definitions of success, and duration of follow-up.\n\nA greater understanding of factors associated with treatment failure may allow us to glean insights regarding patient selection and ultimately improve treatment outcome. The aim of our study was to report the results of DLDI for the management of NLDO, and to identify factors associated with DLDI failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1) confirmed diagnosis of nasolacrimal duct obstruction or stenosis, based on dacryoendoscopic examination with or without radiologic confirmation on dacryocystogram; (2) recurrent or persistent and symptomatic epiphora; (3) follow-up of longer than 6 months after removal of the silicone stent.\n\nExclusion Criteria:\n\n(1) congenital or traumatic lacrimal duct obstruction; (2) previous acute dacryocystitis; (3) facial nerve palsy; (4) lower eyelid or punctal malposition or laxity of sufficient severity to contribute to epiphora; (5) previous dacryocystorhinostomy; (6) incomplete medical records.'}, 'identificationModule': {'nctId': 'NCT05999058', 'briefTitle': 'Clinical Study of Lacrimal Drainage Obstruction Diseases Using Dacryoendoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Eye Hospital'}, 'officialTitle': 'Clinical Characteristics and Treatment Outcomes of Nasolacrimal Duct Obstruction Using Dacryoendoscopy', 'orgStudyIdInfo': {'id': 'KY-2023038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'group A higher nasolacrimal duct obstruction', 'interventionNames': ['Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation']}, {'type': 'EXPERIMENTAL', 'label': 'group B', 'description': 'group B: lower nasolacrimal duct obstruction', 'interventionNames': ['Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation']}, {'type': 'EXPERIMENTAL', 'label': 'group C', 'description': 'group C: nasolacrimal duct stenosis', 'interventionNames': ['Procedure: Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation']}], 'interventions': [{'name': 'Dacryoendoscopic-assisted laser dacryoplasty with silicone intubation', 'type': 'PROCEDURE', 'description': 'The dacryoendoscopy was inserted into the lacrimal duct through the upper or lower lacrimal punctum. When the dacryoendoscopy reached the postsaccal obstruction, laser dacryoplasty (FOX diode laser, A.R.C. Laser, Nürnberg, Germany) was performed by widening the stenotic or obstructed section. After removing the dacryoendoscopy, a silicone tube inserted into lacrimal passage. Double bicanalicular silicone intubation was performed as previously described.', 'armGroupLabels': ['group A', 'group B', 'group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Eye Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}