Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT00435058
Status:
COMPLETED
Last Update Posted:
2007-02-19
First Post:
2007-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Function Changes After Intraocular Pressure Reduction
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2006-04'}, 'lastUpdateSubmitDate': '2007-02-16', 'studyFirstSubmitDate': '2007-02-12', 'studyFirstSubmitQcDate': '2007-02-12', 'lastUpdatePostDateStruct': {'date': '2007-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraocular pressure'}, {'measure': 'contrast sensitivity'}, {'measure': 'visual quality perception'}], 'secondaryOutcomes': [{'measure': 'Mean deviation of the visual field (MD)'}, {'measure': 'Pattern Standard Deviation of the visual field (PSD)'}, {'measure': 'visual acuity'}]}, 'conditionsModule': {'keywords': ['intraocular pressure', 'contrast sensitivity', 'visual function'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'During the glaucomatous disease process, subpopulations of cells may be dead, damaged or healthy. Visual function changes could be observed due to a recovering of the suffering ganglion cells after the intraocular pressure reduction. This study aims at evaluating the correlation between intraocular pressure reduction and visual function changes in glaucoma patients after using antiglaucoma medications.', 'detailedDescription': 'Primary open angle glaucoma patients without use of antiglaucoma medications will be enrolled in this study. After inclusion, the patients will randomly receive one of three antiglaucoma medications (timolol maleate 0,5%, brimonidine tartrate 0,2% or travoprost 0,004%) in one randomly selected eye.\n\nThe patients will be evaluated with Goldmann applanation tonometry, visual acuity test, contrast sensitivity test, visual quality perception test (visual analogue scale) and standard automated perimetry before and after 4 weeks of glaucoma treatment onset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary open angle glaucoma\n* Intraocular pressure greater than 21 mmHg\n\nExclusion Criteria:\n\n* Best corrected visual acuity (BCVA) worse than 20/80\n* Significant media opacity\n* History of steroid use'}, 'identificationModule': {'nctId': 'NCT00435058', 'briefTitle': 'Visual Function Changes After Intraocular Pressure Reduction', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Visual Function Changes After Intraocular Pressure Reduction Using Antiglaucoma Medications: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CEP 1021/05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'timolol maleate 0,5%', 'type': 'DRUG'}, {'name': 'brimonidine tartrate 0,2%', 'type': 'DRUG'}, {'name': 'travoprost 0,004%', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Tiago Prata, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Luiz A Melo Jr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}}}}