Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2026-01-01 @ 5:41 PM
Study NCT ID:
NCT00120432
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2005-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015878', 'term': 'Mydriasis'}], 'ancestors': [{'id': 'D011681', 'term': 'Pupil Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014331', 'term': 'Tropicamide'}, {'id': 'D010656', 'term': 'Phenylephrine'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-07', 'studyFirstSubmitDate': '2005-07-11', 'studyFirstSubmitQcDate': '2005-07-15', 'lastUpdatePostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'horizontal pupil diameter', 'timeFrame': '30 min'}], 'secondaryOutcomes': [{'measure': 'systolic blood pressure', 'timeFrame': '30 min'}, {'measure': 'diastolic blood pressure', 'timeFrame': '30 min'}, {'measure': 'heart rate', 'timeFrame': '30 min'}, {'measure': 'adverse drug reaction', 'timeFrame': '30 min'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['single dose', 'mydriatic drug', 'pupillary dilation'], 'conditions': ['Eye Diseases']}, 'referencesModule': {'references': [{'pmid': '17205877', 'type': 'RESULT', 'citation': 'Ratanapakorn T, Yospaiboon Y, Chaisrisawadsuk N. Single dose of 1% tropicamide and 10% phenylephrine for pupil dilation. J Med Assoc Thai. 2006 Nov;89(11):1934-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.', 'detailedDescription': "To the best of the authors' knowledge, there have been no clinical trials using an appropriate regimen for pupillary dilation up until now. Therefore, the authors were interested to find out the most appropriate regimen for complete ocular examination, based on the finding that a pupil diameter of 6 mm or greater is adequate for indirect ophthalmoscopy. The authors hypothesize that a single dose of 1% tropicamide and 10% phenylephrine is adequate to complete the job and are conducting this prospective randomized clinical controlled trial to prove the hypothesis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* aged between 20 and 80 years old\n* dark iris\n* require binocular indirect ophthalmoscopy for complete ocular examination\n* signed written consent forms\n\nExclusion Criteria:\n\n* history of ocular trauma\n* history of intraocular surgery\n* history of laser treatment\n* previous eye drop instillation that may affect pupillary dilation\n* ocular diseases that may affect pupil size such as Horner's syndrome, Adies' pupil, glaucoma and uveitis\n* history of diabetes mellitus, severe hypertension and cardiovascular diseases"}, 'identificationModule': {'nctId': 'NCT00120432', 'briefTitle': 'Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation', 'orgStudyIdInfo': {'id': 'HE461104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'single dose vs three doses of 1%tropicamide and 10%phenylephrine', 'interventionNames': ['Drug: 1% tropicamide and 10% phenylephrine']}], 'interventions': [{'name': '1% tropicamide and 10% phenylephrine', 'type': 'DRUG', 'description': 'single dose vs three doses of 1%tropicamide and 10%phenylephrine', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'state': 'Changwat Khon Kaen', 'country': 'Thailand', 'facility': 'Srinagarind Hospital', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Yosanan Yospaiboon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Khon Kaen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yosanan Yospaiboon', 'investigatorAffiliation': 'Khon Kaen University'}}}}