Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:16 PM
Study NCT ID:
NCT02456961
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
2015-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-01-19', 'releaseDate': '2016-11-23'}], 'estimatedResultsFirstSubmitDate': '2016-11-23'}}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2015-05-20', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kmax, D', 'timeFrame': '2 years', 'description': 'Using topography measurements, clinical stabilisation is defined as an increase of no more than 1 diopter of the maximum keratometry value over the preoperative maximum keratometry value'}], 'secondaryOutcomes': [{'measure': 'Corneal thickness, μm, as measured by OCT tomography', 'timeFrame': '2 years', 'description': 'Using optical coherence tomography to estimate the pachymetry changes'}, {'measure': 'Visual acuity as assessed by Decimal system', 'timeFrame': '2 years', 'description': 'Decimal visual acuity assessed on a study later was converted to the logarithm of minimal angle of resolution (logMAR).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Collagen crosslinking (CXL)', 'Standard corneal crosslinking (CXL)', 'Transepithelial CXL', 'Iontophoresis', 'Riboflavin'], 'conditions': ['Keratoconus']}, 'descriptionModule': {'briefSummary': "The standard CXL technique involves removal of the epithelium to enable riboflavin to penetrate into stromal tissue, to avoid epithelial debridement and increasing the patient's comfort and safety transepithelial corneal crosslinking (CXL) was suggested. Iontophoresis of riboflavin is one of approach for riboflavin impregnation.\n\nIn this study, the investigators compared the results of standard corneal crosslinking (CXL) and transepithelial CXL via iontophoresis of riboflavin after 24 months follow up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented progressive KC (by Pentacam and/or corneal topography imaging).\n* A clear central cornea.\n* A minimal corneal thickness of ≥ 400 µm at the thinnest corneal location (Pentacam imaging).\n* Minimal Snellen corrected distance visual acuity of ≥ 0.4.\n* Patient age of ≥ 18 years.\n\nExclusion Criteria:\n\n* Corneal scarring.\n* History of epithelial healing problems.\n* History or presence of ocular infection (such as herpes keratitis)\n* Pregnancy and/or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT02456961', 'briefTitle': 'Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin', 'organization': {'class': 'OTHER', 'fullName': 'Ufa Eye Research Institute'}, 'officialTitle': 'Comparative Study of Results of Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin: a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'TCXL-ionto'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard epithelium-off CXL', 'description': 'Removing the central 8-10mm of the epithelium and applying a riboflavin solution (0.1% riboflavin-5-phosphate and 20% dextran T-500) to the corneal surface 30 minutes before irradiation and at 5 minutes intervals during the course of a 30 minute exposure to 370 nm UVA with an irradiance of 3 mWcm-2 (UFalink, Russian Federation)', 'interventionNames': ['Procedure: epithelium-off', 'Procedure: Corneal collagen crosslinking', 'Drug: Dextralink', 'Device: UFalink']}, {'type': 'EXPERIMENTAL', 'label': 'Transepithelial CXL via iontophoresis of riboflavin', 'description': 'impregnation of the cornea with a riboflavin 0.1% hypotonic solution is performed by using an iontophoresis device (galvanizator; Potok-1, Russian Federation). The passive electrode (anode) was applied to the inferior part of the cervical vertebrae. The active electrode (cathode), a bath tube (glass or plastic - 10-12 ml) is applied to the open eye,then r the tube is taped to the skin of the orbital margins and filled with riboflavin 0.1%. The current intensity is initially 0.2 mA and then gradually increased to 1.0 mA at 0.2 mA for 1 minute at 10-second intervals increments to determine individual tolerance. The total time that the riboflavin administration is 10 minutes.\n\nStandard surface UVA irradiation (370 nm, 3 mW/cm2) using UFalink device, (Russian Federation) is then applied at a 5-cm distance for 30 minutes with continuing hypotonic riboflavin drops every 2 minutes', 'interventionNames': ['Procedure: iontophoresis of riboflavin', 'Procedure: Corneal collagen crosslinking', 'Device: galvanizator, Potok-1', 'Drug: Riboflavin 0,1%', 'Device: UFalink']}], 'interventions': [{'name': 'iontophoresis of riboflavin', 'type': 'PROCEDURE', 'armGroupLabels': ['Transepithelial CXL via iontophoresis of riboflavin']}, {'name': 'epithelium-off', 'type': 'PROCEDURE', 'armGroupLabels': ['Standard epithelium-off CXL']}, {'name': 'Corneal collagen crosslinking', 'type': 'PROCEDURE', 'description': 'Standard surface UVA irradiation (370 nm, 3 mW/cm2; UFalink, Russian Federation) was then applied at a 5-cm distance for 30 minutes. During UVA exposure, hypotonic riboflavin drops were continued every 2 minutes.', 'armGroupLabels': ['Standard epithelium-off CXL', 'Transepithelial CXL via iontophoresis of riboflavin']}, {'name': 'galvanizator, Potok-1', 'type': 'DEVICE', 'description': 'Device for providing iontophoresis procedure', 'armGroupLabels': ['Transepithelial CXL via iontophoresis of riboflavin']}, {'name': 'Dextralink', 'type': 'DRUG', 'description': 'Riboflavin 0,1% + Dextran T-500', 'armGroupLabels': ['Standard epithelium-off CXL']}, {'name': 'Riboflavin 0,1%', 'type': 'DRUG', 'armGroupLabels': ['Transepithelial CXL via iontophoresis of riboflavin']}, {'name': 'UFalink', 'type': 'DEVICE', 'description': 'device for UVA irradiation - providing UVA light - 370 nm, 3 mW/cm2', 'armGroupLabels': ['Standard epithelium-off CXL', 'Transepithelial CXL via iontophoresis of riboflavin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mukharram Bikbov, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Ufa Eye Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ufa Eye Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-11-23', 'type': 'RELEASE'}, {'date': '2017-01-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ufa Eye Research Institute'}}}}