Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT00874835
Status:
UNKNOWN
Last Update Posted:
2010-05-07
First Post:
2009-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corneal Endothelium Delivery Instrument
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-06', 'studyFirstSubmitDate': '2009-04-01', 'studyFirstSubmitQcDate': '2009-04-02', 'lastUpdatePostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-month post-operative endothelial cell density', 'timeFrame': '6-months post-operatively'}], 'secondaryOutcomes': [{'measure': '12-month post-operative endothelial cell density', 'timeFrame': '12-months post-operatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endothelial Keratoplasty', 'EK', 'Descemet Stripping Endothelial Keratoplasty', 'Corneal Transplantation', 'Keratoplasty', 'DSEK', 'DSAEK'], 'conditions': ['Corneal Transplantation']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether the surgical outcomes in patients undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of an insertion device over the traditional forceps insertion method.", 'detailedDescription': 'Laboratory studies and clinical functionality tests have shown that the study device safely forms the tissue without creasing or folding. It allows the allograft tissue to safely pass into the anterior chamber without compression, crushing, or squeezing the endothelial cells.\n\nThe device provides continuous irrigation into the eye to prevent collapse of the anterior chamber during insertion. Our study will focus on the safety and efficacy of the novel instrument over the current method of insertion (forceps).\n\nFDA has classified the device as Class I, Reserved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Fuchs endothelial dystrophy or bullous keratopathy determined to need a corneal transplant for visual restoration.'}, 'identificationModule': {'nctId': 'NCT00874835', 'briefTitle': 'Corneal Endothelium Delivery Instrument', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ocular Systems, Inc.'}, 'officialTitle': "Endothelial Graft Injector Versus Folding Forceps Insertion During Descemet's Stripping Endothelial Keratoplasty (DSEK)", 'orgStudyIdInfo': {'id': 'Endo33171'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EndoSaver™ Corneal Endothelium Delivery Instrument', 'type': 'DEVICE', 'description': 'Efficacy of device to maintain function and integrity of corneal endothelial cells during insertion into the eye during keratoplasty.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Eye Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Keith A Walter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Eye Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ocular Systems, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Wake Forest University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Kurt R. Weber', 'oldOrganization': 'Ocular Systems, Inc.'}}}}