Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-02-02 @ 2:44 AM
Study NCT ID:
NCT00679666
Status:
WITHDRAWN
Last Update Posted:
2017-04-20
First Post:
2008-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corneal Crosslinking in Keratoconus and Corneal Ectasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}, {'id': 'D004108', 'term': 'Dilatation, Pathologic'}, {'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012256', 'term': 'Riboflavin'}], 'ancestors': [{'id': 'D005415', 'term': 'Flavins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Investigator no longer at university', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-18', 'studyFirstSubmitDate': '2008-04-02', 'studyFirstSubmitQcDate': '2008-05-16', 'lastUpdatePostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in keratometry', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'best spectacle-corrected visual acuity', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['keratoconus', 'ectasia', 'cross-linking', 'riboflavin', 'UVA light', 'cornea'], 'conditions': ['Progressive Keratoconus', 'Corneal Ectasia']}, 'descriptionModule': {'briefSummary': 'Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.', 'detailedDescription': 'After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of keratoconus with documented progression over the previous 12 months.\n* Diagnosis of corneal ectasia\n* Must be able to complete all study visits.\n\nExclusion Criteria:\n\n* Prior corneal surgery in keratoconus group\n* Corneal scarring\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00679666', 'acronym': 'CXL', 'briefTitle': 'Corneal Crosslinking in Keratoconus and Corneal Ectasia', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia', 'orgStudyIdInfo': {'id': '2008H0050,2008H0049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham treatment', 'description': 'Subjects are randomized to control (sham) group or a treatment group with the control group crossed over to the treatment group at the 3 month visit.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Arm', 'description': 'After randomization, the active arm will have the collagen crosslinking intervention.', 'interventionNames': ['Drug: Riboflavin']}], 'interventions': [{'name': 'Riboflavin', 'type': 'DRUG', 'otherNames': ['Vitamin B2'], 'description': '01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes', 'armGroupLabels': ['Treatment Arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.', 'armGroupLabels': ['Sham treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'OSU Havener Eye Institute', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}], 'overallOfficials': [{'name': 'Richard Keates, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ohio State Univesity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}