Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-02-20 @ 6:04 PM
Study NCT ID:
NCT00524758
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2007-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oculusgen (Ologen) Glaucoma MMC Control in Estonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D015812', 'term': 'Glaucoma, Angle-Closure'}, {'id': 'D015355', 'term': 'Glaucoma, Neovascular'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2007-09-04', 'studyFirstSubmitQcDate': '2007-09-04', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP <21mmHg without anti glaucoma medication', 'timeFrame': '180 days'}], 'secondaryOutcomes': [{'measure': 'IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication', 'timeFrame': '180-day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ologen', 'oculusgen', 'collagen matrix', 'trabeculectomy', 'filtering surgery', 'mitomycin-C', 'MMC', 'Aeon Astron'], 'conditions': ['Open Angle Glaucoma', 'Angle Closure Glaucoma', 'Uveitis Glaucoma', 'Young Age Glaucoma', 'Neovascular Glaucoma', 'High Risk Patient']}, '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.'}], 'seeAlsoLinks': [{'url': 'http://www.oculusgen.com', 'label': 'oculusgen (ologen) collagen matrix is to facilitate the wound healing after surgery.'}]}, 'descriptionModule': {'briefSummary': 'To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery.\n\nThe ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. The MMC application is as the standard.', 'detailedDescription': 'Ologen collagen matrix is implanted on the top of sclera flap after the loose stich sclera flap is done for the filtering surgery. The concept of ologen collagen matrix is to creat the subconjunctiva bleb and modulate the wound healing for the surgery. By implanting ologen collagen matrix in the place, subconjuctival and trabdoor scars might be prevented. This is because the ologen collagen matrix is a 3-D scaffold porous structure that can guide fibroblast to grow randomly, instead of linear alignment. This can reduce the scar formation.\n\nDoctors apply MMC for the glaucoma surgery is also trying to inhibite the scar formation. But MMC has been long time used and glaucoma specialists have not found anything to replace it.\n\nOlogen collagen matrix concept is not INHIBITION, it is guiding and creating a physiological tissue. The successful of ologen collagen matrix may be on par with MMC but the safety and side effects will be much less.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Max anti glaucoma medication failed,\n\nExclusion Criteria:\n\n* Age less than 18, woman in pregnant, hemodialysis patient'}, 'identificationModule': {'nctId': 'NCT00524758', 'briefTitle': 'Oculusgen (Ologen) Glaucoma MMC Control in Estonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pro Top & Mediking Company Limited'}, 'officialTitle': 'Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery', 'orgStudyIdInfo': {'id': 'oculusgen 2006-02-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ologen in Trabeculectomy', 'description': 'Ologen in Trabeculectomy', 'interventionNames': ['Device: ologen (oculusgen) collagen matrix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MMC in Trabeculectomy', 'description': 'MMC in Trabeculectomy', 'interventionNames': ['Drug: MMC in Trabeculectomy']}], 'interventions': [{'name': 'ologen (oculusgen) collagen matrix', 'type': 'DEVICE', 'otherNames': ['ologen collagen matrix', 'oculusgen collagen matrix'], 'description': 'Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.', 'armGroupLabels': ['Ologen in Trabeculectomy']}, {'name': 'MMC in Trabeculectomy', 'type': 'DRUG', 'description': 'MMC in Trabeculectomy', 'armGroupLabels': ['MMC in Trabeculectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Clinics', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}], 'overallOfficials': [{'name': 'Kuldar Kaljurand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tartu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pro Top & Mediking Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}