Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-04-16 @ 3:50 PM
Study NCT ID:
NCT01682993
Status:
TERMINATED
Last Update Posted:
2017-04-26
First Post:
2011-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corneal Cross Linking and Topography Guided Excimer Laser Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000094504', 'term': 'Corneal Cross-Linking'}], 'ancestors': [{'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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2011-11-05', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (Pachymetry, K-readings)', 'timeFrame': '1 year'}, {'measure': 'uncorrected visual acuity (UVCA)', 'timeFrame': '1 year'}, {'measure': 'best corrected visual acuity (BCVA)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Progression of ectatic disease (by use of maximum keratometry readings = Kmax)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['corneal cross linking', 'topography guided excimer laser', 'Keratoconus', 'Pellucid marginal degeneration', 'Post Excimer ectasia'], 'conditions': ['Keratoconus', 'Pellucid Marginal Degeneration']}, 'descriptionModule': {'briefSummary': 'Topography guided laser treatment enables the surgeon to correct higher order aberrations in corneas with irregular astigmatism. Several case reports and small uncontrolled trials have been published on the combination of this treatment with corneal cross linking (CCL) in patients with ectatic corneal diseases.\n\nThis randomized study will evaluate the safety and efficacy of a combined treatment of corneal cross linking with a partial topography guided excimer laser treatment in eyes with progressive ectatic corneal diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Patient age 18 - 40 years\n* Documented progressive corneal ectatic disease except post LASIK/LASEK ectasia\n\nExclusion Criteria:\n\n* Allergy to one of the used substances\n* Tendency towards excessive scar formation\n* Pregnancy\n* Rheumatic diseases\n* Central corneal thickness below 450 µm\n* Active infection of the study eye\n* Previous corneal surgery of the study eye'}, 'identificationModule': {'nctId': 'NCT01682993', 'briefTitle': 'Corneal Cross Linking and Topography Guided Excimer Laser Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Topography Guided Excimer Laser Surface Ablation in Combination With Corneal Cross-linking (CCL) in Patients With Progressive Ectatic Corneal Disorders.', 'orgStudyIdInfo': {'id': '367/2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Corneal Cross Linking', 'description': 'Patients will receive a standard corneal cross linking treatment', 'interventionNames': ['Other: Corneal Cross Linking']}, {'type': 'EXPERIMENTAL', 'label': 'Corneal Cross Linking and Topo Laser', 'description': 'Patients will receive a topography guided laser treatment in combination with a standard corneal cross linking treatment in the same session.', 'interventionNames': ['Other: Topography guided Excimer Laser treatment and Corneal Cross Linking']}], 'interventions': [{'name': 'Topography guided Excimer Laser treatment and Corneal Cross Linking', 'type': 'OTHER', 'description': 'A topography guided excimer laser treatment will be performed prior to CCL in one session.', 'armGroupLabels': ['Corneal Cross Linking and Topo Laser']}, {'name': 'Corneal Cross Linking', 'type': 'OTHER', 'description': 'A standard corneal cross linking procedure will be performed in this arm.', 'armGroupLabels': ['Corneal Cross Linking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Department of Ophthalmology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Assistant Professor', 'investigatorFullName': 'Gerald Schmidinger', 'investigatorAffiliation': 'Medical University of Vienna'}}}}