Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-25 @ 4:28 PM
Study NCT ID:
NCT00320957
Status:
COMPLETED
Last Update Posted:
2008-05-26
First Post:
2006-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Zhong-Shan Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D011625', 'term': 'Pterygium'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2008-05-23', 'studyFirstSubmitDate': '2006-05-01', 'studyFirstSubmitQcDate': '2006-05-01', 'lastUpdatePostDateStruct': {'date': '2008-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the effectiveness via the reduction of IOP and the incidence of pterygium recurrence', 'timeFrame': '180 day'}], 'secondaryOutcomes': [{'measure': 'the safety via the incidence of complications and adverse events.', 'timeFrame': '180 day'}]}, 'conditionsModule': {'keywords': ['Glaucoma', 'Pterygium', 'collagen matrix', 'OculusGen', 'trabeculectomy', 'Anti scarring', 'pterygium recurrence', 'tissue engineering', 'Aeon Astron', 'ologen'], 'conditions': ['Glaucomas', 'Pterygium']}, 'referencesModule': {'references': [{'pmid': '10937547', 'type': 'RESULT', 'citation': 'Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.'}], 'seeAlsoLinks': [{'url': 'http://www.oculusgen.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery.', 'detailedDescription': "ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or over\n2. Patient able to cooperate with study procedures and able to perform tests reliably\n3. Patient willing to sign informed consent\n4. Patient able and willing to complete postoperative follow-up requirements\n5. Glaucoma：one/both eyes are affected by glaucoma\n6. Pterygium： patient with pterygium\n\nExclusion Criteria:\n\n* Known allergic reactions to collagen'}, 'identificationModule': {'nctId': 'NCT00320957', 'briefTitle': 'Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Zhong-Shan Hospital', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pro Top & Mediking Company Limited'}, 'officialTitle': 'Study of the Safety and Effectiveness of the Ologen (OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery', 'orgStudyIdInfo': {'id': 'Mediking0503'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OculusGen Biodegradable Collagen Matrix Implant', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Fei Yuan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pro Top & Mediking Company Limited', 'class': 'INDUSTRY'}}}}