Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT00560651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-10
First Post:
2007-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
German Corneal Cross Linking Register
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}, {'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002433', 'term': 'Cefaclor'}, {'id': 'D000094504', 'term': 'Corneal Cross-Linking'}], 'ancestors': [{'id': 'D002506', 'term': 'Cephalexin'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010778', 'term': 'Photochemotherapy'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7500}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2007-11-19', 'studyFirstSubmitQcDate': '2007-11-19', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Keratometry', 'timeFrame': 'yearly'}], 'secondaryOutcomes': [{'measure': 'Slit-lamp biomicroscopical findings', 'timeFrame': 'yearly'}, {'measure': 'Best corrected Visual Acuity', 'timeFrame': 'Yearly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['keratoconus', 'cornea', 'cross linking', 'UV-light', 'riboflavin'], 'conditions': ['Keratoconus']}, 'referencesModule': {'references': [{'pmid': '17846959', 'type': 'BACKGROUND', 'citation': 'Koller T, Seiler T. [Therapeutic cross-linking of the cornea using riboflavin/UVA]. Klin Monbl Augenheilkd. 2007 Sep;224(9):700-6. doi: 10.1055/s-2007-963492. German.'}, {'pmid': '17457183', 'type': 'BACKGROUND', 'citation': 'Spoerl E, Mrochen M, Sliney D, Trokel S, Seiler T. Safety of UVA-riboflavin cross-linking of the cornea. Cornea. 2007 May;26(4):385-9. doi: 10.1097/ICO.0b013e3180334f78.'}, {'pmid': '17133053', 'type': 'BACKGROUND', 'citation': 'Seiler T, Hafezi F. Corneal cross-linking-induced stromal demarcation line. Cornea. 2006 Oct;25(9):1057-9. doi: 10.1097/01.ico.0000225720.38748.58.'}, {'pmid': '17321404', 'type': 'BACKGROUND', 'citation': 'Wollensak G, Aurich H, Pham DT, Wirbelauer C. Hydration behavior of porcine cornea crosslinked with riboflavin and ultraviolet A. J Cataract Refract Surg. 2007 Mar;33(3):516-21. doi: 10.1016/j.jcrs.2006.11.015.'}], 'seeAlsoLinks': [{'url': 'http://www.freiheit-ohne-brille.de', 'label': 'Click here for more information about this study: German Register of Corneal Cross Linking'}]}, 'descriptionModule': {'briefSummary': "Corneal Cross Linking is new treatment modality for patients with keratoconus. A keratoconus is characterized by progressive bulging and thinning of the eye's cornea. Keratoconus is a potentially severely sight impairing condition that may necessitate corneal transplantation in the progressive state.\n\nCorneal Cross Linking is designed to\n\n* increase the cornea's mechanical stability\n* to stop progression of bulging and thinning of the cornea\n* to prevent the need for corneal transplantation\n\nCorneal Cross Linking is performed by\n\n1. Applying Riboflavin (Vitamin B2) eye drops every 2 minutes for 30 minutes to the cornea\n2. Illuminating the cornea with UV-light\n\nThis register of Corneal Cross Linking procedures performed in Germany serves to\n\n* gather long-term results\n* detect rare complications and side-effects\n* evaluate the efficacy in a large number of patients"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with Corneal Cross Linking in Germany', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with keratokonus and treated with corneal cross Linking in Germany\n\nExclusion Criteria:\n\n* Non-ectatic conditions'}, 'identificationModule': {'nctId': 'NCT00560651', 'briefTitle': 'German Corneal Cross Linking Register', 'organization': {'class': 'OTHER', 'fullName': 'St. Franziskus Hospital'}, 'officialTitle': 'German Corneal Cross Linking Register', 'orgStudyIdInfo': {'id': 'CCL'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Cross linked eyes', 'interventionNames': ['Procedure: CCL (Corneal Cross Linking)']}], 'interventions': [{'name': 'CCL (Corneal Cross Linking)', 'type': 'PROCEDURE', 'otherNames': ['Collagen cross linking', 'Corneal collagen cross linking', 'CCL', '3C-L'], 'description': 'Apply Riboflavin 0.1% in Dextran 500 20% in NaCl solution Illuminate with UV-light of 365 nm wave-length and 3.0 mW/cm² intensity at 5 cm distance', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg', 'country': 'Germany', 'facility': 'University of Saar', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '48145', 'city': 'Münster', 'country': 'Germany', 'facility': 'Augenklinik am St. Franziskus Hospital', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Suphi Taneri, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Augenklinik am St. Franziskus Hospital'}, {'name': 'Berthold Seitz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Homburg, Saar, Germany'}, {'name': 'Philip Maier, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Univer. Freiburg, Germany'}, {'name': 'Claus Cursiefen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Univer. Erlangen, Germany'}, {'name': 'Thomas Reinhard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univers. Freiburg'}, {'name': 'Arnd Heiligenhaus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augenklinik am St.Franzsikus Hospital, Münster'}, {'name': 'Walter Sekundo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univers. Mainz'}, {'name': 'Theo Seiler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IROC, Zürich'}, {'name': 'Atilla Osvald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univers Homurg, Saar'}, {'name': 'Jan M Vetter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univers. Mainz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suphi Taneri', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Suphi Taneri', 'investigatorAffiliation': 'St. Franziskus Hospital'}}}}