Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-10 @ 12:07 AM
Study NCT ID:
NCT05586620
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2022-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3 Snip Punctoplasty With and Without Mitomycine C.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}], 'ancestors': [{'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-15', 'studyFirstSubmitDate': '2022-10-15', 'studyFirstSubmitQcDate': '2022-10-15', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Punctal patency', 'timeFrame': 'Baseline', 'description': 'Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not'}, {'measure': 'Punctal patency', 'timeFrame': '1 week postoperative', 'description': 'Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not'}, {'measure': 'Punctal patency', 'timeFrame': '1 month postoperative', 'description': 'Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not'}, {'measure': 'Punctal patency', 'timeFrame': '3 months postoperative', 'description': 'Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not'}, {'measure': 'Presence of Epiphora', 'timeFrame': 'Baseline', 'description': 'It will be assessed by inspection of the lid by slitlamb examination.'}, {'measure': 'Presence of Epiphora', 'timeFrame': '1 week postoperative', 'description': 'It will be assessed by inspection of the lid by slitlamb examination.'}, {'measure': 'Presence of Epiphora', 'timeFrame': '1 month postoperative', 'description': 'It will be assessed by inspection of the lid by slitlamb examination.'}, {'measure': 'Presence of Epiphora', 'timeFrame': '3 month postoperative', 'description': 'It will be assessed by inspection of the lid by slitlamb examination.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Punctal Stenosis']}, 'descriptionModule': {'briefSummary': 'Punctal stenosis is a progressive constriction of the puncta with resultant epiphora. One of the most effective treatment options is 1- to 4-snip punctoplasty combined with or without Mitomycin-C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '63 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with recurrence of punctal stenosis at the end of 1 month following punctal dilatation.\n\nExclusion Criteria:\n\n* patients with associated lacrimal passage obstruction'}, 'identificationModule': {'nctId': 'NCT05586620', 'briefTitle': '3 Snip Punctoplasty With and Without Mitomycine C.', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Comparative Study on 3 Snip Punctoplasty With and Without Mitomycine C in the Management of Punctual Stenosis or Occlusion', 'orgStudyIdInfo': {'id': '3 Snip Punctoplasty'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '3-snip punctoplasty', 'interventionNames': ['Procedure: 3-snip punctoplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3-snip punctoplasty with mitomycin C', 'interventionNames': ['Procedure: 3-snip punctoplasty and Mitomycin C']}], 'interventions': [{'name': '3-snip punctoplasty', 'type': 'PROCEDURE', 'description': 'punctoplasty, more commonly known as watery eye surgery, is an ophthalmic surgical procedure performed to correct punctal stenosis (a condition that causes tears to overflow from the eyes) by widening the punctal opening to allow the tears to drain with ease.', 'armGroupLabels': ['3-snip punctoplasty']}, {'name': '3-snip punctoplasty and Mitomycin C', 'type': 'PROCEDURE', 'description': 'punctoplasty, more commonly known as watery eye surgery, is an ophthalmic surgical procedure performed to correct punctal stenosis (a condition that causes tears to overflow from the eyes) by widening the punctal opening to allow the tears to drain with ease.\n\nMitomycin C is a chemotherapeutic agent that acts by inhibiting DNA synthesis', 'armGroupLabels': ['3-snip punctoplasty with mitomycin C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34517', 'city': 'Damietta', 'state': 'New Damietta', 'country': 'Egypt', 'facility': 'Ehab tharwat', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ehab tharwat', 'investigatorAffiliation': 'Al-Azhar University'}}}}