Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT01174420
Status:
UNKNOWN
Last Update Posted:
2011-05-09
First Post:
2010-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014130', 'term': 'Trabeculectomy'}], 'ancestors': [{'id': 'D018463', 'term': 'Filtering Surgery'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-05', 'studyFirstSubmitDate': '2010-08-02', 'studyFirstSubmitQcDate': '2010-08-02', 'lastUpdatePostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure (IOP) reduction', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of complications', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ologen', 'Mitomycin-C', 'Collagen Matrix', 'trabeculectomy', 'glaucoma', 'filtering surgery'], 'conditions': ['Open-angle Glaucoma']}, 'referencesModule': {'references': [{'pmid': '36912740', 'type': 'DERIVED', 'citation': 'Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.', 'detailedDescription': 'ologen® Collagen Matrix (CM) is an artificial extracellular matrix (ECM) specifically configured to support repair in connective and epithelial ocular tissue. The device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. ologen® CM is a biodegradable scaffold matrix, inducing a regenerative non-scarring wound healing process without using anti-fibrotic agents. For application in glaucoma filtration surgery, ologen® CM is designed to prevent scar formation (subconjunctival and scleral flap scarring is the major risk factor for failure of trabeculectomy). After implanting the ologen® CM on top of the scleral flap in the subconjunctival space, a functional bleb can be created.\n\nThe aim of the present study is to determine the effectiveness of the ologen® CM and reduce wound scarring, thereby increasing success of trabeculectomy without side effects of MMC. A means of producing better success rate and reduced complications is the purpose of ologen® Collagen Matrix for the aid of glaucoma surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or over\n* Uncontrolled open-angle glaucoma\n* Subject is willing to sign informed consent\n* Subject is able and willing to complete post-operative follow-up requirements\n\nExclusion Criteria:\n\n* Inflammatory eye diseases\n* Angle-closure glaucoma\n* Secondary glaucoma with anatomical malformations of the eye\n* Subjects having single functional eye\n* Previous conjunctival surgery\n* Known allergic reactions to ingredients of ologen Collagen Matrix\n* Excessive myopia (axial length (AL)\\> 27 mm or more than -10 diopters)\n* Previous vitrectomy eye surgery\n* Subjects do not consent to participate'}, 'identificationModule': {'nctId': 'NCT01174420', 'briefTitle': 'Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy: A Study in Germany', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aeon Astron Europe B.V.'}, 'officialTitle': 'A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy', 'orgStudyIdInfo': {'id': 'AAE-CT-DEU-2009-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ologen Collagen Matrix', 'interventionNames': ['Device: Use of ologen Collagen Matrix in trabeculectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mitomycin-C (MMC)', 'interventionNames': ['Drug: Use of Mitomycin-C in trabeculectomy']}], 'interventions': [{'name': 'Use of ologen Collagen Matrix in trabeculectomy', 'type': 'DEVICE', 'description': 'After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing', 'armGroupLabels': ['ologen Collagen Matrix']}, {'name': 'Use of Mitomycin-C in trabeculectomy', 'type': 'DRUG', 'description': 'After creating a scleral flap, a sponge with Mitomycin-C (0.02%) is applied on the scleral surface for 3 minutes. Afterwards, Mitomycin-C was rinsed out with balanced salt solution.', 'armGroupLabels': ['Mitomycin-C (MMC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Dietlein, MD', 'role': 'CONTACT', 'email': 'thomas.dietlein@uk-koeln.de', 'phone': '+49-221-478-5862', 'phoneExt': '4300'}, {'name': 'Thomas Dietlein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Thomas Dietlein, MD', 'role': 'CONTACT', 'email': 'thomas.dietlein@uk-koeln.de', 'phone': '+49-221-478-5862', 'phoneExt': '4300'}], 'overallOfficials': [{'name': 'Thomas Dietlein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology, University of Cologne, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aeon Astron Europe B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Thomas Dietlein', 'oldOrganization': 'Department of Ophthalmology, University of Cologne, Germany'}}}}