Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-28 @ 5:16 PM
Study NCT ID:
NCT01768260
Status:
UNKNOWN
Last Update Posted:
2017-03-31
First Post:
2013-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of EECP on Anterior Ischemic Optic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018917', 'term': 'Optic Neuropathy, Ischemic'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}], 'ancestors': [{'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2013-01-08', 'studyFirstSubmitQcDate': '2013-01-11', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Central retinal artery flow velocity', 'timeFrame': '7 weeks'}], 'primaryOutcomes': [{'measure': 'visual acuity', 'timeFrame': '7 weeks'}], 'secondaryOutcomes': [{'measure': 'Ophthalmic artery blood flow velocity', 'timeFrame': '7 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['visual acuity', 'artery flow velocity', 'Enhanced External Counterpulsation', 'Ischemic', 'Optic Neuropathy'], 'conditions': ['Anterior Ischemic Optic Neuropathy']}, 'referencesModule': {'references': [{'pmid': '15300074', 'type': 'BACKGROUND', 'citation': 'Werner D, Michalk F, Harazny J, Hugo C, Daniel WG, Michelson G. Accelerated reperfusion of poorly perfused retinal areas in central retinal artery occlusion and branch retinal artery occlusion after a short treatment with enhanced external counterpulsation. Retina. 2004 Aug;24(4):541-7. doi: 10.1097/00006982-200408000-00006.'}]}, 'descriptionModule': {'briefSummary': 'Enhanced External Counterpulsation(EECP) therapy may promote the recovery of visual function by improving the blood perfusion of eyes. The present study aims to investigate the effect of EECP on Anterior Ischemic Optic Neuropathy.', 'detailedDescription': 'Patients with Anterior Ischemic Optic Neuropathy are randomized into two groups: one group receive standard medical treatment for ischemic optic neuropathy, the other group plus EECP therapy besides standard medical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ischemic optic neuropathy\n* within 1 month\n\nExclusion Criteria:\n\n* Hemorrhagic disease\n* thrombophlebitis or infection lesions\n* severe hypertensive patients\n* Atrial fibrillation\n* Aortic regurgitation'}, 'identificationModule': {'nctId': 'NCT01768260', 'acronym': 'AION', 'briefTitle': 'Effect of EECP on Anterior Ischemic Optic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Study of the Effect of EECP on Anterior Ischemic Optic Neuropathy', 'orgStudyIdInfo': {'id': 'Eye EECP-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced External conterpulsation', 'description': 'Enhanced external counterpulsation (EECP) is a noninvasive modality for the treatment of ischemic cardiovascular disease. EECP therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole.', 'interventionNames': ['Device: Enhanced external counterpulsation', 'Drug: Aspirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'aspirin', 'description': 'The subjects with Anterior ischemic Optic Neuropathy received aspirin therapy.', 'interventionNames': ['Drug: Aspirin']}], 'interventions': [{'name': 'Enhanced external counterpulsation', 'type': 'DEVICE', 'otherNames': ['EECP'], 'description': 'EECP is performed for 1 hours every day, for a total of 36 hours.', 'armGroupLabels': ['Enhanced External conterpulsation']}, {'name': 'Aspirin', 'type': 'DRUG', 'description': 'Standard drug therapy', 'armGroupLabels': ['Enhanced External conterpulsation', 'aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ling Zhang, MA', 'role': 'CONTACT', 'email': 'Zhanglingaben@126.com', 'phone': '862087755766', 'phoneExt': '8035'}], 'facility': 'The First Affiliated Hospital of Sun Yat- sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yan Zhang, MD', 'role': 'CONTACT', 'email': 'Zhyan3@mail.sysu.edu.cn', 'phone': '862087755766', 'phoneExt': '8141'}], 'overallOfficials': [{'name': 'Yan Zhang, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Oculist-in-charge', 'investigatorFullName': 'WenHui Zhu', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}