Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-30 @ 9:36 PM
Study NCT ID:
NCT05691335
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2023-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2023-01-07', 'studyFirstSubmitQcDate': '2023-01-17', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected distance visual acuity', 'timeFrame': '36 months', 'description': 'measured in logarithm of minimal angle of resolution (logMAR)'}, {'measure': 'Corrected distance visual acuity', 'timeFrame': '36 months', 'description': 'measured in logarithm of minimal angle of resolution (logMAR)'}, {'measure': 'Sphere', 'timeFrame': '36 months', 'description': 'measured in diopters (D)'}, {'measure': 'Cylinder', 'timeFrame': '36 months', 'description': 'measured in diopters (D)'}, {'measure': 'Keratometry (Kmax)', 'timeFrame': '36 months', 'description': 'measured in diopters (D)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Corneal Ectasia']}, 'descriptionModule': {'briefSummary': 'comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking', 'detailedDescription': 'comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking for treatment of documented pediatric keratoconus progression. The study patients are divided into 3 groups. Group A patient treated with standard cross-linking. Group B patients treated with accelerated cross-linking. Group C patients treated with transepithelial cross-linking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patient less than 18 years old\n* keratoconus stage I-III ABCD keratoconus grading system\n\nExclusion Criteria:\n\n* age more than 18 years\n* previous eye surgery\n* current eye infection or pathology'}, 'identificationModule': {'nctId': 'NCT05691335', 'briefTitle': 'Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Analysis of the Outcomes of Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus', 'orgStudyIdInfo': {'id': '10-4/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard CXL', 'description': 'Patients treated according to Dresden Protocol with epithelium-off CXL.', 'interventionNames': ['Procedure: Standard CXL']}, {'type': 'EXPERIMENTAL', 'label': 'Accelerated CXL', 'description': 'Patients treated according to accelerated Protocol with epithelium-off CXL.', 'interventionNames': ['Procedure: Accelerated CXL']}, {'type': 'EXPERIMENTAL', 'label': 'Transepithelial CXL', 'description': 'Patients treated according to transepithelial Protocol with epithelium-on CXL.', 'interventionNames': ['Procedure: Transepithelial CXL']}], 'interventions': [{'name': 'Standard CXL', 'type': 'PROCEDURE', 'description': 'Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 30 minutes.', 'armGroupLabels': ['Standard CXL']}, {'name': 'Accelerated CXL', 'type': 'PROCEDURE', 'description': 'Epithelium-off CXL performed by removal of corneal epithelium, instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.', 'armGroupLabels': ['Accelerated CXL']}, {'name': 'Transepithelial CXL', 'type': 'PROCEDURE', 'description': 'Epithelium-on CXL performed by instillation of riboflavin onto the cornea followed by UVA corneal irradiation for 5 minutes.', 'armGroupLabels': ['Transepithelial CXL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82425', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Mohammed Iqbal, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Mohammed Iqbal', 'investigatorAffiliation': 'Sohag University'}}}}