Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 3:21 PM
Study NCT ID:
NCT00818233
Status:
WITHDRAWN
Last Update Posted:
2016-05-13
First Post:
2008-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Difficulty recruiting patients. PI left research facility.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2008-11-18', 'studyFirstSubmitQcDate': '2009-01-06', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The variability of intraocular pressure measurements using dynamic contour tonometry', 'timeFrame': 'Same day'}], 'secondaryOutcomes': [{'measure': 'Observe how pulse amplitude, as measured by dynamic contour tonometry, correlates with the difference in systolic and diastolic blood pressures', 'timeFrame': 'Same day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dynamic contour tonometry', 'variability', 'pulse amplitude', 'Ocular pulse amplitude'], 'conditions': ['Intraocular Pressure']}, 'descriptionModule': {'briefSummary': 'The aim of the protocol is to document intra-observer and inter-observer variability with dynamic contour tonometry, and will also test the theory that pulse amplitude, as measured by dynamic contour tonometry, is correlated with the difference in systolic and diastolic blood pressures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy, competent adults with normal, healthy eyes.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal, healthy eyes\n* Minimal to moderate refractive error\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Diagnosis of any type of glaucoma\n* Any prior ocular surgery\n* Any prior ocular trauma\n* Any known anterior segment pathology'}, 'identificationModule': {'nctId': 'NCT00818233', 'briefTitle': 'Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.', 'orgStudyIdInfo': {'id': '0601001047'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation', 'description': 'Variability will be assessed between each examiner.', 'interventionNames': ['Device: Dynamic contour tonometry']}], 'interventions': [{'name': 'Dynamic contour tonometry', 'type': 'DEVICE', 'otherNames': ['PASCAL tonometry', 'DCT'], 'description': 'Observe variability of measurements by dynamic contour tonometry', 'armGroupLabels': ['Observation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Eye Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Hylton R Mayer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hylton R. Mayer', 'oldOrganization': 'Yale University'}}}}