Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-01-01 @ 12:30 AM
Study NCT ID:
NCT00887900
Status:
COMPLETED
Last Update Posted:
2009-04-24
First Post:
2009-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Anterior Lamellar Keratoplasty (DALK)
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-23', 'studyFirstSubmitDate': '2009-04-23', 'studyFirstSubmitQcDate': '2009-04-23', 'lastUpdatePostDateStruct': {'date': '2009-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lamellar keratoplasty', 'keratoconus', 'penetrated keratoplasty', 'Visual acuity'], 'conditions': ['Keratoconus']}, 'referencesModule': {'references': [{'pmid': '17721317', 'type': 'RESULT', 'citation': 'Tan DT, Parthasarathy A. Deep anterior lamellar keratoplasty for keratoconus. Cornea. 2007 Sep;26(8):1025; author reply 1025-6. doi: 10.1097/ICO.0b013e31805771e3. No abstract available.'}, {'pmid': '17434435', 'type': 'RESULT', 'citation': 'Vajpayee RB, Tyagi J, Sharma N, Kumar N, Jhanji V, Titiyal JS. Deep anterior lamellar keratoplasty by big-bubble technique for treatment corneal stromal opacities. Am J Ophthalmol. 2007 Jun;143(6):954-957. doi: 10.1016/j.ajo.2007.02.036. Epub 2007 Apr 16.'}, {'pmid': '17258522', 'type': 'RESULT', 'citation': 'Ardjomand N, Hau S, McAlister JC, Bunce C, Galaretta D, Tuft SJ, Larkin DF. Quality of vision and graft thickness in deep anterior lamellar and penetrating corneal allografts. Am J Ophthalmol. 2007 Feb;143(2):228-235. doi: 10.1016/j.ajo.2006.10.043. Epub 2006 Nov 30.'}, {'pmid': '22331118', 'type': 'DERIVED', 'citation': 'Tzelikis PF, Santos JD, Garcez RC, Akaishi L. [Deep anterior lamellar keratoplasty by big-bubble technique]. Arq Bras Oftalmol. 2011 Nov-Dec;74(6):435-40. doi: 10.1590/s0004-27492011000600011. Portuguese.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'label': 'PUBMED'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.', 'detailedDescription': 'Purpose: To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.\n\nMethods: Thirty four unselected consecutive patients were submitted to DALK big-bubble technique. Intraoperative and postoperative complications, postoperative uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), spherical equivalent (SE), corneal topography, and endothelial cell density were evaluated. All patients were followed for at least 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* keratoconus\n\nExclusion Criteria:\n\n* central endothelial cell count less than 2000 cells/mm2\n* glaucoma or intraocular pressure greater than 21 mmHg\n* amblyopia\n* retinal abnormalities\n* diabetes mellitus\n* steroid or immunosuppressive treatment\n* connective tissue diseases'}, 'identificationModule': {'nctId': 'NCT00887900', 'acronym': 'DALK', 'briefTitle': 'Deep Anterior Lamellar Keratoplasty (DALK)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Oftalmologico de Brasilia'}, 'officialTitle': 'Deep Anterior Lamellar Keratoplasty by Big-Bubble Technique: Results and Complications', 'orgStudyIdInfo': {'id': 'DALK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Submitted to deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.', 'interventionNames': ['Procedure: Deep anterior lamellar keratoplasty (DALK)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Submitted to regular penetrating keratoplasty', 'interventionNames': ['Procedure: Penetrated keratoplasty']}], 'interventions': [{'name': 'Deep anterior lamellar keratoplasty (DALK)', 'type': 'PROCEDURE', 'otherNames': ['GROUP 1: DALK'], 'description': 'Deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.', 'armGroupLabels': ['1']}, {'name': 'Penetrated keratoplasty', 'type': 'PROCEDURE', 'otherNames': ['GROUP 2: PK'], 'description': 'Regular corneal transplant using the penetrated keratoplasty technique', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70200670', 'city': 'BrasÃlia', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital Oftalmologico de BrasÃlia', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}], 'overallOfficials': [{'name': 'PATRICK F TZELIKIS, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Minas Gerais'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Oftalmologico de Brasilia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'PATRICK TZELIKIS', 'oldOrganization': 'HOB'}}}}