Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-01 @ 5:48 AM
Study NCT ID:
NCT01686906
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2012-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2012-09-13', 'studyFirstSubmitQcDate': '2012-09-13', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal power', 'timeFrame': '2011-2020', 'description': 'Reduction and stabilizing of the corneal power after Bowman layer graft implantation'}], 'secondaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': '2011-2020'}]}, 'conditionsModule': {'keywords': ['Keratoconus', 'Bowman layer'], 'conditions': ['Advanced Keratoconus']}, 'referencesModule': {'references': [{'pmid': '25596620', 'type': 'BACKGROUND', 'citation': 'van Dijk K, Liarakos VS, Parker J, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Bowman layer transplantation to reduce and stabilize progressive, advanced keratoconus. Ophthalmology. 2015 May;122(5):909-17. doi: 10.1016/j.ophtha.2014.12.005. Epub 2015 Jan 14.'}, {'pmid': '24557359', 'type': 'BACKGROUND', 'citation': 'van Dijk K, Parker J, Tong CM, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Midstromal isolated Bowman layer graft for reduction of advanced keratoconus: a technique to postpone penetrating or deep anterior lamellar keratoplasty. JAMA Ophthalmol. 2014 Apr 1;132(4):495-501. doi: 10.1001/jamaophthalmol.2013.5841.'}, {'pmid': '27362885', 'type': 'BACKGROUND', 'citation': 'Groeneveld-van Beek EA, Parker J, Lie JT, Bourgonje V, Ham L, van Dijk K, van der Wees J, Melles GR. Donor Tissue Preparation for Bowman Layer Transplantation. Cornea. 2016 Dec;35(12):1499-1502. doi: 10.1097/ICO.0000000000000905.'}, {'pmid': '26077628', 'type': 'BACKGROUND', 'citation': 'Parker JS, van Dijk K, Melles GR. Treatment options for advanced keratoconus: A review. Surv Ophthalmol. 2015 Sep-Oct;60(5):459-80. doi: 10.1016/j.survophthal.2015.02.004. Epub 2015 Mar 5.'}, {'pmid': '34620767', 'type': 'BACKGROUND', 'citation': 'van der Star L, van Dijk K, Vasiliauskaite I, Dapena I, Oellerich S, Melles GRJ. Long-Term Outcomes of Bowman Layer Inlay Transplantation for the Treatment of Progressive Keratoconus. Cornea. 2022 Sep 1;41(9):1150-1157. doi: 10.1097/ICO.0000000000002871. Epub 2021 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to reduce and stabilize ectasia in eyes with advanced keratoconus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n•Advanced keratoconus\n\nExclusion Criteria:\n\n* Further ophthalmic diseases\n* History of ocular surgery\n* Pregnancy, brest feeding'}, 'identificationModule': {'nctId': 'NCT01686906', 'briefTitle': 'Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus', 'organization': {'class': 'OTHER', 'fullName': 'Netherlands Institute for Innovative Ocular Surgery'}, 'officialTitle': 'Mid-stromal Isolated Bowman Layer Graft Implantation to Reduce and Stabilize Advanced Keratoconus', 'orgStudyIdInfo': {'id': 'NIIOS-BL-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bowman layer graft implantation', 'interventionNames': ['Procedure: Bowman layer graft implantation']}], 'interventions': [{'name': 'Bowman layer graft implantation', 'type': 'PROCEDURE', 'description': 'For patients with progressive advanced keratoconus, a mid-stromal manual dissection is made and a donor isolated Bowman layer is positioned into the stromal pocket.', 'armGroupLabels': ['Bowman layer graft implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3071 AA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Netherlands Institute for Innovative Ocular Surgery', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Gerrit RJ Melles, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Netherlands Institute for Innovative Ocular Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Netherlands Institute for Innovative Ocular Surgery', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amnitrans Eyebank Rotterdam', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}