Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-07 @ 6:52 AM
Study NCT ID:
NCT03381794
Status:
RECRUITING
Last Update Posted:
2024-12-02
First Post:
2017-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The German Keratoplasty Registry of the German Ophthalmological Society (DOG)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016039', 'term': 'Corneal Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}, 'targetDuration': '16 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2001-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2032-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2017-12-11', 'studyFirstSubmitQcDate': '2017-12-18', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'An overview about absolute numbers of corneal transplantation in Germany.', 'timeFrame': '01/01/2001 to 31/12/2031', 'description': 'A questionnaire about absolute numbers of corneal transplantation per year was sent to the 111 ophthalmological departments in Germany performing corneal transplantation. Data has been and is collected annually since 2001.'}, {'measure': 'An overview about trends in the various types of corneal transplantation in Germany.', 'timeFrame': '01/01/2001 to 31/12/2031', 'description': "The questionnaire also records the types of corneal transplantation (i.e. penetrating keratoplasty, deep anterior lamellar keratoplasty, Descemet membrane endothelial keratoplasty (DMEK) and Descemet's stripping automated endothelial keratoplasty DSAEK) allowing a discussion of trends in corneal transplantation. Data has been and is collected annually since 2001."}, {'measure': 'An overview about indications for corneal transplantation in Germany.', 'timeFrame': '01/01/2001 to 31/12/2031', 'description': "The questionnaire also records the indications for corneal transplantation (e.g. Fuchs' endothelial corneal dystrophy, pseudophakic corneal decompensation, repeated keratoplasty after graft failure, keratoconus and corneal scarring). Data has been and is collected annually since 2001."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Keratoplasty Registry, PKP, DSAEK, DMEK, DALK'], 'conditions': ['Corneal Transplantation']}, 'referencesModule': {'references': [{'pmid': '37586835', 'type': 'BACKGROUND', 'citation': "Flockerzi E, Turner C, Seitz B, Collaborators GSG; GeKeR Study Group. Descemet's membrane endothelial keratoplasty is the predominant keratoplasty procedure in Germany since 2016: a report of the DOG-section cornea and its keratoplasty registry. Br J Ophthalmol. 2024 May 21;108(5):646-653. doi: 10.1136/bjo-2022-323162."}, {'pmid': '29410297', 'type': 'BACKGROUND', 'citation': 'Flockerzi E, Maier P, Bohringer D, Reinshagen H, Kruse F, Cursiefen C, Reinhard T, Geerling G, Torun N, Seitz B; all German Keratoplasty Registry Contributors. Trends in Corneal Transplantation from 2001 to 2016 in Germany: A Report of the DOG-Section Cornea and its Keratoplasty Registry. Am J Ophthalmol. 2018 Apr;188:91-98. doi: 10.1016/j.ajo.2018.01.018. Epub 2018 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'Aim of this study is to reflect on the changing trends in absolute numbers, surgical techniques and indications of corneal transplantations being performed in Germany.\n\nThe Section Cornea of the German Ophthalmological Society provides interim-assessments on a regular basis about the most up-to-date results of this long-term study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients in Germany treated with the different types of corneal transplantation since 2001.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients in Germany treated with the different types of corneal transplantation since 2001.\n\nExclusion Criteria:\n\nPatients without corneal transplantation.'}, 'identificationModule': {'nctId': 'NCT03381794', 'briefTitle': 'The German Keratoplasty Registry of the German Ophthalmological Society (DOG)', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Trends in Corneal Transplantation from 2001 in Germany: Reports of the DOG-Section Cornea and Its Keratoplasty Registry', 'orgStudyIdInfo': {'id': 'GeKeR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with corneal transplantation', 'description': 'Aim is to include all patients in Germany treated with the different types of corneal transplantation.', 'interventionNames': ['Procedure: Corneal transplantation']}], 'interventions': [{'name': 'Corneal transplantation', 'type': 'PROCEDURE', 'otherNames': ['PKP, DALK, DMEK, DSAEK'], 'description': "PKP: Penetrating Keratoplasty DALK: Deep Anterior Lamellar Keratoplasty DMEK: Descemet Membrane Endothelial Keratoplasty DSAEK: Descemet's Stripping Automated Endothelial Keratoplasty", 'armGroupLabels': ['Patients with corneal transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Elias Flockerzi, PD Dr.med.', 'role': 'CONTACT', 'email': 'elias.flockerzi@uks.eu', 'phone': '0049-6841-16-22302'}, {'name': 'Berthold Seitz, Prof.Dr.med.', 'role': 'CONTACT', 'email': 'berthold.seitz@uks.eu', 'phone': '0049-6841-16-22387'}], 'facility': 'Department of Ophthalmology', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}], 'centralContacts': [{'name': 'Elias Flockerzi, PD Dr.med.', 'role': 'CONTACT', 'email': 'elias.flockerzi@uks.eu', 'phone': '0049-6841-16-22302'}, {'name': 'Berthold Seitz, Prof.Dr.med.', 'role': 'CONTACT', 'email': 'berthold.seitz@uks.eu', 'phone': '0049-6841-16-22387'}], 'overallOfficials': [{'name': 'Berthold Seitz, Prof.Dr.med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universität des Saarlandes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität des Saarlandes', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Eye Hospital, Freiburg', 'class': 'OTHER'}, {'name': 'University of Erlangen-Nürnberg', 'class': 'OTHER'}, {'name': 'University of Cologne', 'class': 'OTHER'}, {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Resident of Ophthalmology', 'investigatorFullName': 'Elias Flockerzi', 'investigatorAffiliation': 'University Hospital, Saarland'}}}}