Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2026-01-07 @ 4:15 AM
Study NCT ID:
NCT00674661
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2008-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Corneal Collagen Cross-Linking for Ectasia (CXL)
Sponsor:
Organization:
Raw JSON
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'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'anterior chamber flare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Meibomian gland dyisfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.', 'unitOfMeasure': 'diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Corneal Collagen Cross-linking (CXL) Treatment Group', 'description': 'riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'riboflavin opthalmic solution without UVA irradiation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Corneal Collagen Cross-linking (CXL) Treatment Group', 'description': 'riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'riboflavin opthalmic solution without UVA irradiation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, 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'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'dispFirstSubmitDate': '2012-05-18', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2008-05-06', 'dispFirstSubmitQcDate': '2012-05-18', 'resultsFirstSubmitDate': '2016-08-17', 'studyFirstSubmitQcDate': '2008-05-06', 'dispFirstPostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-02', 'studyFirstPostDateStruct': {'date': '2008-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Maximum Keratometry (Kmax)', 'timeFrame': 'baseline,12 months', 'description': 'The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ectasia', 'cross-linking', 'crosslinking', 'cornea', 'riboflavin', 'UVA'], 'conditions': ['Ectasia']}, 'referencesModule': {'references': [{'pmid': '22692521', 'type': 'DERIVED', 'citation': 'Greenstein SA, Fry KL, Hersh PS. Effect of topographic cone location on outcomes of corneal collagen cross-linking for keratoconus and corneal ectasia. J Refract Surg. 2012 Jun;28(6):397-405. doi: 10.3928/1081597X-20120518-02.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.', 'detailedDescription': 'Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ectasia after refractive surgery\n* Documented ectasia on Pentacam or topography map\n* BSCVA worse than 20/20\n* Must complete all study visits\n\nExclusion Criteria:\n\n* History of delayed wound healing\n* History of corneal melt or corneal dystrophy'}, 'identificationModule': {'nctId': 'NCT00674661', 'acronym': 'CXL', 'briefTitle': 'Corneal Collagen Cross-Linking for Ectasia (CXL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery', 'orgStudyIdInfo': {'id': 'UVX-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Corneal Collagen Cross-linking (CXL) Treatment Group', 'description': 'riboflavin ophthalmic solution and UVA irradiation', 'interventionNames': ['Drug: riboflavin ophthalmic solution', 'Device: UVA Irradiation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'riboflavin opthalmic solution without UVA irradiation', 'interventionNames': ['Drug: riboflavin ophthalmic solution']}], 'interventions': [{'name': 'riboflavin ophthalmic solution', 'type': 'DRUG', 'description': 'riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)', 'armGroupLabels': ['Control Group', 'Corneal Collagen Cross-linking (CXL) Treatment Group']}, {'name': 'UVA Irradiation', 'type': 'DEVICE', 'otherNames': ['UV-X™ Illumination System'], 'description': 'UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes', 'armGroupLabels': ['Corneal Collagen Cross-linking (CXL) Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Shiley Eye Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91222', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Gordon -Weiss Vision Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Excellence in Eye Care', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Price Vision Group', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66211', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Durrie Vision', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Wilmer Eye Institute at Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Eye Consultants', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cornea & Laser Eye Institute; Hersh Vision Group', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Edward Harkness Eye Institute at Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11570', 'city': 'Rockville Centre', 'state': 'New York', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Long Island', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'overallOfficials': [{'name': 'Peter Hersh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cornea and Laser Eye Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}