Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-03 @ 12:41 AM
Study NCT ID:
NCT00566605
Status:
UNKNOWN
Last Update Posted:
2007-12-03
First Post:
2007-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015948', 'term': 'Keratoplasty, Penetrating'}], 'ancestors': [{'id': 'D016039', 'term': 'Corneal Transplantation'}, {'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-11-30', 'studyFirstSubmitDate': '2007-11-29', 'studyFirstSubmitQcDate': '2007-11-30', 'lastUpdatePostDateStruct': {'date': '2007-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Pachimetry, Microscopy, Corneal topography', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Keratoconus']}, 'descriptionModule': {'briefSummary': 'To compare the early visual results and postoperative recovery between two groups of keratoconic patients - one group having undergone a traditional, mechanical vacuum trephine procedure while the second group underwent femtosecond-enabled penetrating keratoplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years old, with keratoconus and corneal transplant indication\n\nExclusion Criteria:\n\n* Exclusion criteria included different ocular pathology and a potential visual acuity of less than 20/40'}, 'identificationModule': {'nctId': 'NCT00566605', 'briefTitle': 'Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Oftalmologico de Sorocaba'}, 'officialTitle': 'Visual Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty', 'orgStudyIdInfo': {'id': '466.07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'interventionNames': ['Procedure: Penetrating keratoplasty with IntraLase']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'interventionNames': ['Procedure: Penetrating keratoplasty with vacuum trephine']}], 'interventions': [{'name': 'Penetrating keratoplasty with IntraLase', 'type': 'PROCEDURE', 'description': 'penetrating keratoplasty with femtosecond laser shaped incisions- IntraLase TM (IntraLase Enabled Keratoplasty \\[IEK\\])', 'armGroupLabels': ['Group 1']}, {'name': 'Penetrating keratoplasty with vacuum trephine', 'type': 'PROCEDURE', 'description': 'Group 2 - penetrating keratoplasty with vacuum trephine', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sorocaba', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Sorocaba Eye Bank - HOSBOS', 'geoPoint': {'lat': -23.50167, 'lon': -47.45806}}], 'overallOfficials': [{'name': 'Elissandro M Silva, Lindoso', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Oftalmologico de Sorocaba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Oftalmologico de Sorocaba', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Luciene Barbosa de Sousa', 'oldOrganization': 'HOSBOS'}}}}