Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-26 @ 12:55 AM
Study NCT ID:
NCT03598634
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2018-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-14', 'studyFirstSubmitDate': '2018-06-12', 'studyFirstSubmitQcDate': '2018-07-14', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best-corrected visual acuity after treatment', 'timeFrame': 'up to 48 months from the recruitment', 'description': '* Scale name: Early treatment diabetic retinopathy study (ETDRS) charts.\n* Scale range 0-1.\n* highest value of the range (corresponding to 20/20): 0\n* lowest value of the range (corresponding to 20/200): 1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cross-linking'], 'conditions': ['Keratoconus']}, 'descriptionModule': {'briefSummary': 'To evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.', 'detailedDescription': 'The aim of the study is to evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.\n\nForty eyes from 32 patients with progressive keratoconus were prospectively enrolled from June 2014 to June 2015 in this non-blinded, randomized comparative study. Twenty eyes were treated by CXL epi off and 20 by CLX epi on, randomly assigned and followed for 2 years. All patients underwent a complete ophthalmologic testing that included uncorrected and best corrected visual acuity, central and peripheral corneal thickness, corneal astigmatism, simulated maximum, minimum, and average keratometry, corneal confocal microscopy, Schirmer I and break-up time (BUT) tests, and the Ocular Surface Disease Index. Intra-and postoperative complications were recorded. The solution used for CXL epi off comprised riboflavin 0.1% and dextran 20.0% (Ricrolin), whereas the solution for CXL epi on (Ricrolin, TE) comprised riboflavin 0.1%, dextran 15.0%, trometamol (Tris), and ethylene-diamine-tetra-acetic acid. Ultraviolet-A treatment was performed with UV-X System at 3 mW/cm2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with evolving keratoconus\n* aged between 18 and 40 years\n* no evidence of corneal scarring\n\nExclusion Criteria:\n\n* patients with central and paracentral corneal opacities\n* Vogt's striae\n* previous intraocular surgery\n* history of herpetic keratitis\n* history of severe dry eye\n* concomitant autoimmune diseases."}, 'identificationModule': {'nctId': 'NCT03598634', 'briefTitle': 'Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Molise'}, 'officialTitle': 'Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients: a Comparative Study Throught 2 Years Follow-up', 'orgStudyIdInfo': {'id': '0001-05-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Epi-on cross-linking', 'description': 'Intervention: Drug: Riboflavin 0.15 in 20% dextran solution', 'interventionNames': ['Procedure: administration of riboflavin for epi-off cross-linking', 'Procedure: administration of riboflavin for epi-on cross-linking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Epi-off cross-linking', 'description': 'intervention: Drug: Riboflavin 0.15 in 15% dextran solution supplemented with Tris-hydroxymethylaminomethane and sodium ethylenediaminetetraacetic acid', 'interventionNames': ['Procedure: administration of riboflavin for epi-off cross-linking', 'Procedure: administration of riboflavin for epi-on cross-linking']}], 'interventions': [{'name': 'administration of riboflavin for epi-off cross-linking', 'type': 'PROCEDURE', 'description': 'riboflavin 0.1% in 20% dextran solution', 'armGroupLabels': ['Epi-off cross-linking', 'Epi-on cross-linking']}, {'name': 'administration of riboflavin for epi-on cross-linking', 'type': 'PROCEDURE', 'description': 'riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid', 'armGroupLabels': ['Epi-off cross-linking', 'Epi-on cross-linking']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be made available once the studies results will be published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Molise', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor in Ophthalmology', 'investigatorFullName': 'Ciro Costagliola', 'investigatorAffiliation': 'University of Molise'}}}}