Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-02 @ 1:09 AM
Study NCT ID:
NCT01544192
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
2011-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Oral Versatile Antioxidants on Glaucoma Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000096983', 'term': 'Ginkgo Extract'}, {'id': 'D024502', 'term': 'alpha-Tocopherol'}], 'ancestors': [{'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D024505', 'term': 'Tocopherols'}, {'id': 'D014810', 'term': 'Vitamin E'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-02', 'studyFirstSubmitDate': '2011-10-19', 'studyFirstSubmitQcDate': '2012-03-02', 'lastUpdatePostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal nerve fiber layer thickness', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antioxidant', 'α-tocopherol', 'Vitamin E', 'Gingko Biloba', 'Glaucoma', 'Neuroprotection', 'Retina'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Background: The significance of retinal ganglion cell protection in the glaucoma led the view that, glaucomatous optical neuropathy can also be considered as a pathology of central nervous system. It is known that α-tocopherol and Gingko Biloba have specific neuroprotective and vasoregulatory activities, in addition to antioxidant effects. In this study, the investigators compared early neuroprotective effects of α-tocopherol and GB with each other as well as control and a strong antioxidant formulation in patients with glaucoma.\n\nMethods: In this non-randomized control trial, 120 eyes of 60 patients with glaucoma were enrolled into the study and divided into 4 groups, each consisting of 30 eyes. Unlike the controls, patients in the 3 antioxidant groups received α-tocopherol, Gingko Biloba and a strong antioxidant formula for 3 months. Central vision field and MD, PSD and OCT as well as thickness of retinal nerve fiber layer, ganglion cell counts and c/d ratios were recorded. The data were compared statistically.', 'detailedDescription': 'A significant difference was observed between MD, PSD, s-RNFL and m-RNFL levels of groups (p\\<0.05) (Table 3), but when compared with Groups of Vit E and AOF, MD and s-RNFL levels of the Group GB were significantly low and PSD level was significantly high in the same group. m-RNFL level of the Vit E group was significantly higher than m-RNFL levels of GB, AOF and Control groups (p\\<0.05, p\\<0.01). In the comparison of Vitamin E with GB, MD values were found significantly higher and PSD values were significantly low (p\\<0.05). No statistically significant difference was present between I-RNFL levels of groups (p\\>0.05). While the difference between c/d levels of groups were highly significant (p\\<0.01) (Table 3), c/d levels of Vit E and GB groups were found significantly lower than c/d levels of AOF and Control groups (p\\<0.01). c/d level of the Vit E group is significantly lower than c/d levels of AOF and Control groups (p\\<0.01). No statistically significant difference was found between c/d levels of other groups (p\\>0.05).\n\nNo statistically significant difference was present between s-GCC and i-GCC levels of groups (p\\>0.05). A high statistically significant difference was found between m-GCC levels of groups (p\\<0.01). While highly 201 significant and significant difference were present between m-GCC level of the Vit E Group and m-GCC levels of AOF and Control Groups, respectively, (p\\<0.01, p\\<0.05), m-GCC level of the Group GB was significantly higher than that of Group AOF (p\\<0.05). No statistically significant difference was observed between m-GCC levels of other groups (p\\>0.05).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who received follow-up in our glaucoma polyclinics\n\nExclusion Criteria:\n\n* Known ocular or systemic concomitant disorders\n* Previous glaucoma surgeries\n* Antioxidant usage'}, 'identificationModule': {'nctId': 'NCT01544192', 'briefTitle': 'Impact of Oral Versatile Antioxidants on Glaucoma Progression', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bagcilar Training and Research Hospital'}, 'officialTitle': 'Impact of Oral Versatile Antioxidants on Glaucoma Progression:Comparative Early Results', 'orgStudyIdInfo': {'id': 'BEAH-Ophthalmol-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'retinal nerve fiber thickness', 'interventionNames': ['Drug: Gingko Biloba', 'Drug: α-tocopherol', 'Drug: Placebo', 'Drug: Antioxidant formula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mean Deviation', 'interventionNames': ['Drug: Gingko Biloba', 'Drug: α-tocopherol', 'Drug: Placebo', 'Drug: Antioxidant formula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pattern Standard Deviation', 'interventionNames': ['Drug: Gingko Biloba', 'Drug: α-tocopherol', 'Drug: Placebo', 'Drug: Antioxidant formula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ganglion cell count', 'interventionNames': ['Drug: Gingko Biloba', 'Drug: α-tocopherol', 'Drug: Placebo', 'Drug: Antioxidant formula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'c/d ratios', 'interventionNames': ['Drug: Gingko Biloba', 'Drug: α-tocopherol', 'Drug: Placebo', 'Drug: Antioxidant formula']}], 'interventions': [{'name': 'Gingko Biloba', 'type': 'DRUG', 'otherNames': ['Gingko Biloba (Vega Natural, Konya, Turkey)'], 'description': '2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)', 'armGroupLabels': ['Mean Deviation', 'Pattern Standard Deviation', 'c/d ratios', 'ganglion cell count', 'retinal nerve fiber thickness']}, {'name': 'α-tocopherol', 'type': 'DRUG', 'otherNames': ['α-tocopherol (Roche Pharma, Istanbul, Turkey)'], 'description': '2x300 mg α-tocopherol', 'armGroupLabels': ['Mean Deviation', 'Pattern Standard Deviation', 'c/d ratios', 'ganglion cell count', 'retinal nerve fiber thickness']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'control group did not receive oral neuroprotective agent', 'armGroupLabels': ['Mean Deviation', 'Pattern Standard Deviation', 'c/d ratios', 'ganglion cell count', 'retinal nerve fiber thickness']}, {'name': 'Antioxidant formula', 'type': 'DRUG', 'otherNames': ['AOF (Vega Natural, Konya, Turkey)'], 'description': '2x1 tablet AOF', 'armGroupLabels': ['Mean Deviation', 'Pattern Standard Deviation', 'c/d ratios', 'ganglion cell count', 'retinal nerve fiber thickness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34147', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bakırköy Şadi Konuk Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Kaya N Engin, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bagcilar TRH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bagcilar Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}