Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT00734695
Status:
WITHDRAWN
Last Update Posted:
2010-03-02
First Post:
2008-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Use of Vitamin c (Ascorbic Acid) in Eye Burn in Subconjunctival Injection to Topical or Oral Treatment.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D014785', 'term': 'Vision, Ocular'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D055537', 'term': 'Light Signal Transduction'}, {'id': 'D015398', 'term': 'Signal Transduction'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009799', 'term': 'Ocular Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'whyStopped': "couldn't recruit patients", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-28', 'studyFirstSubmitDate': '2008-08-13', 'studyFirstSubmitQcDate': '2008-08-13', 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EXTENSION OF FLORSCEIN PAINT ON THE CORNEA AND CONJUNCTIVA', 'timeFrame': 'BID'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BURN', 'EYE', 'VITAMIN C', 'ASCORBIC ACID'], 'conditions': ['Burn']}, 'descriptionModule': {'briefSummary': 'Eye burns may cause a severe permanent damage. One kind of treatment is the use of vitamin C (Ascorbic acid). This study will compare between subconjunctival topical and/or systemic route of administration and topical and/or systemic administration.', 'detailedDescription': 'In order to prevent permanent and severe damage to the eye after eye burn early treatment is mandatory. It is well known and published that the use of Vitamin c may contribute to the healing process of such burns, including burns from chemicals or heat. We believe that the route pf administration of the medicine is as important as the kind of medicine and that subconjunctival injection will have better effect and will influence in a favorable manner on the the end result as well as on the time of the healing.\n\nIn order to be able to compare between cases we made a new definition of the severity of the burn according to the extension of the damage on the cornea, conjunctiva and limbus, and according to the severity and depth of the ischemia.\n\nIn 3 medical centers 3 protocols of treatment and followup will be compared while only in Baruch Pade Medical Center the main route of administration will be subconjunctival on top of the topical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eyes clinic patients presented with acute chemical or thermal burn.\n\nExclusion Criteria:other disease'}, 'identificationModule': {'nctId': 'NCT00734695', 'briefTitle': 'Comparing the Use of Vitamin c (Ascorbic Acid) in Eye Burn in Subconjunctival Injection to Topical or Oral Treatment.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The Baruch Padeh Medical Center, Poriya'}, 'officialTitle': 'The Effect of Subconjunctival Vitamin c on Recovery Rate and End Result From Eye Burn.', 'orgStudyIdInfo': {'id': 'vitcbrn.CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Baruch Pade Medical Center', 'interventionNames': ['Dietary Supplement: vitamin c']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Rambam Medical Center', 'interventionNames': ['Dietary Supplement: vitamin c']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Soroka Medical Center', 'interventionNames': ['Dietary Supplement: vitamin c']}], 'interventions': [{'name': 'vitamin c', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['subconjunctival', 'ascorbic acid'], 'description': 'Subconjunctival daily or bid', 'armGroupLabels': ['1']}, {'name': 'vitamin c', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Burn', 'eye', 'ascorbic acid'], 'description': 'topical and systemic', 'armGroupLabels': ['2']}, {'name': 'vitamin c', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['burn'], 'description': 'topical systemic', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'facility': 'Movshovitz Ina', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'city': 'Tiberias', 'country': 'Israel', 'facility': 'Naftali Modi', 'geoPoint': {'lat': 32.79221, 'lon': 35.53124}}], 'overallOfficials': [{'name': 'naftali modi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baruch Pade medical center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Baruch Padeh Medical Center, Poriya', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, {'name': 'Soroka University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Modi Naftali', 'oldOrganization': 'Baruch Pade Medical Center'}}}}