Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-04-04 @ 9:25 AM
Study NCT ID:
NCT02133495
Status:
COMPLETED
Last Update Posted:
2014-05-08
First Post:
2014-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Outcomes Assessment of the Utility of Belladerm Acellular Dermal Allograft in Ocular Lower Lid Retraction Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-07', 'studyFirstSubmitDate': '2014-05-06', 'studyFirstSubmitQcDate': '2014-05-07', 'lastUpdatePostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inferior scleral show', 'timeFrame': '1 year', 'description': 'Pre and post operative margin reflex distance 2 (MRD2) and inferior scleral show (ISS) where measured for each eyelid elevation and decrease in inferior scleral show.'}], 'primaryOutcomes': [{'measure': 'Pre and Post operative margin reflex distance 2 MRD 2', 'timeFrame': '1 year', 'description': 'Pre and postoperative margin reflex distance 2 (MRD2) and inferior scleral show (ISS) was measured of each eyelid, and success was defined as a positive eyelid elevation and decrease in inferior scleral show. Long- term stability beyond 12 months was evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lower eyelid', 'retraction'], 'conditions': ['Lower Eyelid Retraction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to Evaluate the efficacy and longevity of a Human-derived, non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the correction of lower eyelid retraction, taking into consideration issues associated with the use of acelular dermis such as contraction and potential regression of repairs.', 'detailedDescription': 'To Evaluate the efficacy and longevity of a Human-derived, non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the correction of lower eyelid retraction, taking into consideration issues associated with the use of acelular dermis such as contraction and potential regression of repairs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lower eyelid retraction, defined as inferior displacement of the lower eyelid margin with inferior scleral show, may be asymptomatic\n* May have ocular irritation including foreign body sensation, burning, photophobia and tearing.\n* May have aesthetically unsatisfactory eyelid appearance.\n\nExclusion Criteria:\n\n* Have a condition that would be contraindicated to surgery'}, 'identificationModule': {'nctId': 'NCT02133495', 'briefTitle': 'An Outcomes Assessment of the Utility of Belladerm Acellular Dermal Allograft in Ocular Lower Lid Retraction Repair', 'organization': {'class': 'NETWORK', 'fullName': 'SGM Physician Research Consortium'}, 'officialTitle': 'Use of Non-Cadaveric Human Acellular Dermal Tissue (BellaDerm®) in Lower Eyelid Retraction Repair', 'orgStudyIdInfo': {'id': 'KMBella1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'open label', 'description': 'Non Cadaveric human BellaDerm Acellular dermal tissue', 'interventionNames': ['Procedure: Non Cadaveric Human Acellular Dermal Tissue']}], 'interventions': [{'name': 'Non Cadaveric Human Acellular Dermal Tissue', 'type': 'PROCEDURE', 'otherNames': ['Bella Derm'], 'armGroupLabels': ['open label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19087', 'city': 'Wayne', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Morgenstern Center for Orbital and Facial Plastic Surgery', 'geoPoint': {'lat': 40.044, 'lon': -75.38769}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SGM Physician Research Consortium', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Musculoskeletal Transplant Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kenneth Morgenstern, MD', 'investigatorFullName': 'Kenneth Morgenstern, MD', 'investigatorAffiliation': 'SGM Physician Research Consortium'}}}}