Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-01 @ 1:45 PM
Study NCT ID:
NCT00543660
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2007-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057111', 'term': 'Descemet Stripping Endothelial Keratoplasty'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016039', 'term': 'Corneal Transplantation'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2007-10-11', 'studyFirstSubmitQcDate': '2007-10-11', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best spectacle corrected visual acuity', 'timeFrame': '1998 - 2018'}], 'secondaryOutcomes': [{'measure': 'Corneal endothelial cell density', 'timeFrame': '1998-2018'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Corneal transplantation, Descemet membrane, endothelium'], 'conditions': ['Corneal Dystrophies, Hereditary']}, 'referencesModule': {'references': [{'pmid': '17102659', 'type': 'RESULT', 'citation': 'Melles GR. Posterior lamellar keratoplasty: DLEK to DSEK to DMEK. Cornea. 2006 Sep;25(8):879-81. doi: 10.1097/01.ico.0000243962.60392.4f. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the transplantation of a posterior corneal disc for the management of corneal endothelial disorders in Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet Stripping Automated Endothelial Keratoplasty (DSAEK).', 'detailedDescription': 'Please see above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Corneal endothelial disorders\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT00543660', 'acronym': 'DSAEK', 'briefTitle': 'Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)', 'organization': {'class': 'OTHER', 'fullName': 'Netherlands Institute for Innovative Ocular Surgery'}, 'officialTitle': 'Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)', 'orgStudyIdInfo': {'id': 'NIIOS.1998.04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm DSEK', 'description': 'Intervention: DSEK', 'interventionNames': ['Procedure: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)']}], 'interventions': [{'name': 'Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)', 'type': 'PROCEDURE', 'otherNames': ['Descemet Stripping Endothelial Keratoplasty (DSEK)', 'Please see www.niios.com'], 'armGroupLabels': ['Intervention arm DSEK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3071 AA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Netherlands Institute for Innovative Ocular Surgery', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Gerrit RJ Melles, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Netherlands Institute for Innovative Ocular Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Netherlands Institute for Innovative Ocular Surgery', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amnitrans Eyebank Rotterdam', 'class': 'OTHER'}, {'name': 'Melles CorneaClinic Rotterdam', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'GRJ Melles, MD, PhD', 'investigatorAffiliation': 'Netherlands Institute for Innovative Ocular Surgery'}}}}