Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT00864656
Status:
COMPLETED
Last Update Posted:
2009-03-19
First Post:
2009-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 10% Phenylephrine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001763', 'term': 'Blepharoptosis'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-18', 'studyFirstSubmitDate': '2009-03-17', 'studyFirstSubmitQcDate': '2009-03-18', 'lastUpdatePostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper lid height before and after phenylephrine test lower lid height before and after phenylephrine test', 'timeFrame': '3, 10, 15 and 30 minutes'}], 'secondaryOutcomes': [{'measure': 'Scobee test to detect eye dominance', 'timeFrame': '15 minutes before 10% phenylephrine instillation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adrenergic alpha-agonists', 'phenylephrine', 'drug effects', 'diagnostic use'], 'conditions': ['Blepharoptosis']}, 'referencesModule': {'references': [{'pmid': '19039456', 'type': 'BACKGROUND', 'citation': 'Nunes TP, Matayoshi S. [Phenylephrine 10% eye drop action in the eyelid position in healthy subjects]. Arq Bras Oftalmol. 2008 Sep-Oct;71(5):639-43. doi: 10.1590/s0004-27492008000500006. Portuguese.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to quantify eyelid position changes in tested and opposite eyes in ptosis patients submitted to 1, 2 or 4 drops of 10% phenylephrine in one eye. The secondary objective is to correlate the eye dominance, severity and laterality of ptosis with eyelid position changes in these 3 groups.', 'detailedDescription': 'This is a prospective observational study conducted in involutional ptosis patients, which will be submitted to instillation of a single drop of 10% phenylephrine in one eye(Group 1), 2 drops (G2) or 4 drops ( G3).\n\nVideo camera will record the images of both eyes before and after drug application at 3, 10, 15 and 30 minutes. The images will be edited to analyze upper and lower lid height.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Involutional blepharoptosis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Involutional blepharoptosis\n* Upper Margin-reflex distance less or equal 2.0mm\n* Good fixation and collaboration\n\nExclusion Criteria:\n\n* Previous eyelid surgeries\n* Use of adrenergic or sympathicomimetics drugs\n* Myopathies\n* Thyroid orbitopathy\n* Non-controlled cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT00864656', 'briefTitle': 'Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 10% Phenylephrine', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Comparative Study of Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 1, 2 or 4 Drops of 10% Phenylephrine', 'orgStudyIdInfo': {'id': 'phenylephrine test'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients submitted to application of 1 drop of 10% phenylephrine'}, {'label': '2', 'description': 'Patients submitted to application of 2 drops of 10% phenylephrine'}, {'label': '3', 'description': 'Patients submitted to application of 4 drops of 10% phenylephrine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Ophthalmology Dept. University of Sao Paulo General Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Suzana Matayoshi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Opthalmology Dept.Sao Paulo University General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Suzana Matayoshi', 'oldOrganization': 'Clinica Oftalmologica HCFMUSP'}}}}