Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-27 @ 8:59 AM
Study NCT ID:
NCT02439866
Status:
UNKNOWN
Last Update Posted:
2015-05-12
First Post:
2015-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Steroid and Oxygen Therapy Versus Placebo Therapy in Non-arteritic Anterior Ischemic Optic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008397', 'term': 'Masks'}], 'ancestors': [{'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2015-05-08', 'studyFirstSubmitDate': '2015-05-07', 'studyFirstSubmitQcDate': '2015-05-08', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity using Snellen chart', 'timeFrame': 'until 6 months', 'description': 'Snellen chart'}], 'secondaryOutcomes': [{'measure': 'Visual field mean deviation index using the Humphrey Visual Field Analyzer', 'timeFrame': 'until 6 months', 'description': 'the Humphrey Visual Field Analyzer (HFA; model 750; Carl Zeiss Meditec, Inc., Dublin, California, USA)'}]}, 'conditionsModule': {'conditions': ['NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)']}, 'descriptionModule': {'briefSummary': 'Patients diagnosed with NAION within 14 days of onset were included. Patients were randomized into 3 groups. Group 1 or control consisted of 30 patients who received gelatinous capsules filled with sugar as placebo. Group 2 or steroid consisted of 30 patients received methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day. Thirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks Functional and structural outcomes were assessed at 1 and 6 months following treatment. Best corrected visual acuity was the main outcome measure, and mean deviation index of visual field test and peripapillary retinal nerve fiber layer thickness were secondary outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with recent onset ( within 2 weeks) of non-arteritic ischemic optic neuropathy\n\nExclusion Criteria:\n\n* the presence of glaucoma, or any other ocular, neurologic, or systemic disease that may influence visual acuity and visual field; abnormal results in laboratory assessments, including an abnormally elevated erythrocyte sedimentation rate and positive serum C-reactive protein;\n* a history of previous ocular surgery;\n* a history of prior treatment of any type for NAION;\n* systemic condition such as diabetes mellitus and poorly controlled hypertension'}, 'identificationModule': {'nctId': 'NCT02439866', 'acronym': 'NAION', 'briefTitle': 'Outcomes of Steroid and Oxygen Therapy Versus Placebo Therapy in Non-arteritic Anterior Ischemic Optic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'The Effect of High Dose Steroid and Normobaric Oxygen Therapy on Recent Onset Non-arteritic Anterior Ischemic Optic Neuropathy(NAION); a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '93222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'prescription placebo', 'description': 'control Group consisted of 30 patients who received gelatinous capsules filled with sugar as placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'prescription Intravenous methylprednisolone', 'description': 'Group 2 or steroid consisted of 30 patients received methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day', 'interventionNames': ['Drug: Intravenous methylprednisolone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'prescription normobaric oxygen with face mask', 'description': 'Thirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks', 'interventionNames': ['Drug: normobaric oxygen with face mask']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'gelatinous capsules filled with sugar as placebo', 'armGroupLabels': ['prescription placebo']}, {'name': 'Intravenous methylprednisolone', 'type': 'DRUG', 'description': 'Intravenous methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day (Prednisolone Fort; Sina Daroo, Iran', 'armGroupLabels': ['prescription Intravenous methylprednisolone']}, {'name': 'normobaric oxygen with face mask', 'type': 'DRUG', 'description': 'normobaric oxygen100% with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks', 'armGroupLabels': ['prescription normobaric oxygen with face mask']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'mohammad pakravan', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '009822591616'}], 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'mohammad pakravan', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '009822591616'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Shahid Beheshti Medical University', 'investigatorFullName': 'Zahra Rabbani Khah', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}