Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-29 @ 12:13 AM
Study NCT ID:
NCT01083056
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2010-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study - ILM Peeling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012167', 'term': 'Retinal Perforations'}, {'id': 'D005911', 'term': 'Gliosis'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-30', 'studyFirstSubmitDate': '2010-03-08', 'studyFirstSubmitQcDate': '2010-03-08', 'lastUpdatePostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BCVA', 'timeFrame': '6 months after ILM peeling'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['retina', 'gliosis', 'macula', 'membrane', 'ILM'], 'conditions': ['Epimacular Gliosis', 'Macular Hole']}, 'descriptionModule': {'briefSummary': 'This observational study investigates the effects of epimacular membrane peeling on the structure and function of the retina.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients at the University Eye Hospital Tuebingen', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Epimacular Gliosis\n* Must be scheduled for ILM-peeling independently of study\n* Must be older then 18 years of age\n\nExclusion Criteria:\n\n* Visual acuity \\> 0,4 logMAR (\\< 20/50 EDTRS)\n* Other ophthalmological disorder affecting visual acuity and/or visual field and/or retinal structure'}, 'identificationModule': {'nctId': 'NCT01083056', 'briefTitle': 'Observational Study - ILM Peeling', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Observational Study On Retinal Structure And Function Before And After Epimacular Membrane Peeling', 'orgStudyIdInfo': {'id': 'ILM Peeling'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epimacular Gliosis Without Macular Hole'}, {'label': 'Epimacular Gliosis With Macular Hole'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Centre for Ophthalmology, University Hospital Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Florian Gekeler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Ophthalmology, University Hospital Tuebingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. M. Dominik Fischer', 'investigatorFullName': 'M. Dominik Fischer', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}