Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00432393
Status:
COMPLETED
Last Update Posted:
2008-10-20
First Post:
2007-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Levodopa-Carbidopa on Visual Function in Patients With Recent-Onset Nonarteritic Anterior Ischemic Optic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018917', 'term': 'Optic Neuropathy, Ischemic'}], 'ancestors': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C009265', 'term': 'carbidopa, levodopa drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2003-04'}, 'lastUpdateSubmitDate': '2008-10-17', 'studyFirstSubmitDate': '2007-02-06', 'studyFirstSubmitQcDate': '2007-02-06', 'lastUpdatePostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-07', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Nonarteritic Anterior Ischemic Optic Neuropathy']}, 'descriptionModule': {'briefSummary': 'Purpose: There are some controversies about the effect of Levodopa-Carbidopa on treatment of non-arteritic anterior ischemic optic neuropathy (NAION). This study was performed to evaluate the effect of Levodopa-Carbidopa on visual acuity, color vision, and visual field in patients with recent onset NAION (less than 6 weeks duration).\n\nPatients and Methods: In this double-blind randomized clinical trial, 13 patients were treated with levodopa-carbidopa and 12 patients took placebo for 3 weeks. Visual acuity, color vision, and visual field were tested before and at 4th, 12th, 16th, and 24th weeks after enrollment, and evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age greater than 50 years old\n* first ophthalmic examination within 6 weeks after onset of disease\n* presence of optic disc swelling followed by optic atrophy within 6 weeks\n* altitudinal, central or generalized visual field defect\n* normal ESR\n\nExclusion Criteria:\n\n* confirmed giant cell arteritis\n* history of any ocular surgeries\n* optic neuropathy due to acute bleeding\n* advanced diabetic retinopathy\n* uncontrolled glaucoma\n* any ocular disorders that cause visual acuity reduction rather than NAION'}, 'identificationModule': {'nctId': 'NCT00432393', 'briefTitle': 'Effect of Levodopa-Carbidopa on Visual Function in Patients With Recent-Onset Nonarteritic Anterior Ischemic Optic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Effect of Levodopa-Carbidopa on Visual Function in Patients With Recent-Onset Nonarteritic Anterior Ischemic Optic Neuropathy', 'orgStudyIdInfo': {'id': '8125'}}, 'armsInterventionsModule': {'interventions': [{'name': 'levodopa-carbidopa', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1666694516', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Ophthalmic research center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Mohammad Pakravan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}}}}