Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-31 @ 2:48 AM
Study NCT ID:
NCT05019768
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2021-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS
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': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2021-08-10', 'studyFirstSubmitQcDate': '2021-08-19', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Topographical parameters', 'timeFrame': '2 years', 'description': 'Maximum keratometry: diopters Mean keratometry: diopters Minimum corneal tickness: diopters'}], 'secondaryOutcomes': [{'measure': 'Refractive parameters', 'timeFrame': '2 years', 'description': 'Corrected distance acuity (BCVA): Logarithm of the Minimum Angle of Resolution (logMAR)'}, {'measure': 'Refractive parameters', 'timeFrame': '2 years', 'description': 'Spherical equi-valent: diopters Refractive cylinder magnitude: diopters'}, {'measure': 'Biomechanical parameters', 'timeFrame': '2 years', 'description': 'Corneal hysteresis: mmHg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Keratoconus']}, 'referencesModule': {'references': [{'pmid': '26606293', 'type': 'BACKGROUND', 'citation': 'Caruso C, Ostacolo C, Epstein RL, Barbaro G, Troisi S, Capobianco D. Transepithelial Corneal Cross-Linking With Vitamin E-Enhanced Riboflavin Solution and Abbreviated, Low-Dose UV-A: 24-Month Clinical Outcomes. Cornea. 2016 Feb;35(2):145-50. doi: 10.1097/ICO.0000000000000699.'}, {'pmid': '28257382', 'type': 'BACKGROUND', 'citation': 'Caruso C, Epstein RL, Ostacolo C, Pacente L, Troisi S, Barbaro G. Customized Corneal Cross-Linking-A Mathematical Model. Cornea. 2017 May;36(5):600-604. doi: 10.1097/ICO.0000000000001160.'}]}, 'descriptionModule': {'briefSummary': 'In the present study the investigators compare the clinical outcome corneal cross linking with either the stand-ard Dresden (sCXL) or the accelerated custom-fast (aCFXL) ultraviolet A irradiation protocol using riboflavin-D-α-Tocopheryl polyethyleneglycol1000 succinate for progressive keratoconus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* documented progressive keratoconus\n* changes in uncorrected distance visual acuity (UDVA) above 1.00 D\n* Corrected distance visual acuity (BCVA) above 1.00 D\n* spherical equivalent greater than 0.50 D\n\nExclusion Criteria:\n\n* Corneal pachymetry of less than 400 µm\n* less than 2000 cells/cm2,\n* corneal scarring,\n* nystagmus or any motility disorder that prevented a fixed gaze during the examination\n* Current contact lens use'}, 'identificationModule': {'nctId': 'NCT05019768', 'briefTitle': 'Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS', 'organization': {'class': 'OTHER', 'fullName': 'Corneal Transplant Center, Pellegrini Hospital'}, 'officialTitle': 'Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS: Results of a 2-year Randomized Study', 'orgStudyIdInfo': {'id': '127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sCXL', 'description': 'Standard protocol of Dresden Riboflavin-VEPTGS solution applied every 2 mins during UV UVA fluence of 3mW/cm2 UVA Irradiation time 30 minutes', 'interventionNames': ['Other: Standard CXL']}, {'type': 'EXPERIMENTAL', 'label': 'aCFXL', 'description': 'Accelerated custom fast CXL protocol. The protocol has been developed on a published mathematical model that takes into consideration objective variables such as the equation governing the UVA-induced riboflavin con-sumption rate and the corneal thickness at its thinnest point.\n\nRiboflavin-VEPTGS solution: Epithelial lavage before UV UVA fluence of 1.8 ±0.9 mW/cm2 UVA Irradiation time 10 ± 1.5 minutes', 'interventionNames': ['Other: accelerated custom-fast CXL']}], 'interventions': [{'name': 'accelerated custom-fast CXL', 'type': 'OTHER', 'description': 'The accelerated custom fast CXL (aCFXL) has been developed on a published mathematical model that takes into consideration objective variables such as the equation governing the UVA-induced riboflavin consumption rate and the corneal thickness at its thinnest point. By knowing both values, the mathematical model allows to objectively calculate both the exact UVA irradiation value (intensity), expressed in mW/cm2, and the irradiation time', 'armGroupLabels': ['aCFXL']}, {'name': 'Standard CXL', 'type': 'OTHER', 'description': 'The standard CXL procedure has been carried on following the Dresden protocol', 'armGroupLabels': ['sCXL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Napoli', 'country': 'Italy', 'facility': 'Pellegrini Hospital', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ciro Caruso', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, Head of Corneal Transplant Center', 'investigatorFullName': 'Ciro Caruso', 'investigatorAffiliation': 'Corneal Transplant Center, Pellegrini Hospital'}}}}