Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT04255667
Status:
UNKNOWN
Last Update Posted:
2021-01-27
First Post:
2020-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Eyelid Crush for Marginal Eyelid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005141', 'term': 'Eyelid Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2020-02-03', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of intraoperative bleeding', 'timeFrame': 'intraoperative', 'description': 'bleeding is recorded by photography'}], 'secondaryOutcomes': [{'measure': 'time of operation', 'timeFrame': 'intraoperative', 'description': 'time of surgery is recorded by stopwatch'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eyelid margin', 'hemostasis'], 'conditions': ['Eyelid Diseases']}, 'descriptionModule': {'briefSummary': 'Surgery involves eyelid margin asscocited with intraoperative bleeding. Proper intra-operative homeostasis is essential for good intraoperative procedure and postoperative results.', 'detailedDescription': 'baseline and postoperative full ophthalmic examination was done.Procedure include all surgeries involving eyelid margin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '60 patient with marginal eyelid diseases surgeries will undergo surgeries', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All surgeries involving eyelid margin\n\nExclusion Criteria:\n\n* bleeding tendency'}, 'identificationModule': {'nctId': 'NCT04255667', 'briefTitle': 'Eyelid Crush for Marginal Eyelid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Outcome of Eyelid Crush for Intraoperative Hemostasis of Eyelid Margin Surgery', 'orgStudyIdInfo': {'id': 'hamaky4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Eyelid surgery involving eyelid margin is done after eyelid margin crushing with hemostat at start of surgery', 'interventionNames': ['Procedure: Eyelid margin crush']}, {'label': 'Control group', 'description': 'Eyelid surgery involving eyelid margin is done after eyelid margin crushing without hemostat', 'interventionNames': ['Procedure: Eyelid margin crush']}], 'interventions': [{'name': 'Eyelid margin crush', 'type': 'PROCEDURE', 'description': 'after marking eyelid , hemostat is used for eyelid margin incision crush . Then eyelid surgery is done', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46266', 'city': 'Abu Dhabi', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'TAREK ELHAMAKY, MD', 'role': 'CONTACT'}], 'facility': 'INMC', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'TAREK R ELHAMAKY, MD', 'role': 'CONTACT', 'email': 'dr_thamakyy@yahoo.com', 'phone': '+971503207889'}, {'name': 'TAREK R ELHAMAKY', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'TAREK R ELHAMAKY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha university faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer ophthalmology', 'investigatorFullName': 'Tarek Roshdy mohamed Mahgoub ELhamaky', 'investigatorAffiliation': 'Benha University'}}}}