Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 4:43 PM
Study NCT ID:
NCT01021657
Status:
COMPLETED
Last Update Posted:
2009-11-30
First Post:
2009-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lipid Profile of Tenon's Capsule
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014130', 'term': 'Trabeculectomy'}], 'ancestors': [{'id': 'D018463', 'term': 'Filtering Surgery'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Eye Tenon's Capsule"}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-27', 'studyFirstSubmitDate': '2009-11-27', 'studyFirstSubmitQcDate': '2009-11-27', 'lastUpdatePostDateStruct': {'date': '2009-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To provide data on the lipid profile of the Tenon's capsule in Human glaucomatous eyes and to establish possible relationships with the short term outcome of filtration surgery.", 'timeFrame': '6 month later'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', "Tenon's Capsule", 'Lipid profile', "Assessment of lipid profile in Tenon's capsule in patients with Glaucoma"], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to provide data on the lipid profile of the Tenon's capsule in Human glaucomatous eyes and to establish possible relationships with the short term outcome of filtration surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient suffering from Glaucoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Glaucoma\n* Eligibility for surgery\n\nExclusion Criteria:\n\n* Patients without Glaucoma'}, 'identificationModule': {'nctId': 'NCT01021657', 'briefTitle': "Lipid Profile of Tenon's Capsule", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': "Lipid Profile of Tenon's Capsule in Glaucoma Patients", 'orgStudyIdInfo': {'id': 'Alain01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glaucoma', 'interventionNames': ['Procedure: trabeculectomies, non penetrating deep sclerectomies']}], 'interventions': [{'name': 'trabeculectomies, non penetrating deep sclerectomies', 'type': 'PROCEDURE', 'armGroupLabels': ['Glaucoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Ophthalmology Unit CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'overallOfficials': [{'name': 'Catherine Creuzot-Gracher, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmology unit CHU Dijon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Catherine Creuzot-Garcher', 'oldOrganization': 'Ophthalmology Department'}}}}