Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT02624427
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2015-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and Corvis ST Tonometer
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-20', 'studyFirstSubmitDate': '2015-11-27', 'studyFirstSubmitQcDate': '2015-12-07', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta IOP', 'timeFrame': 'baseline', 'description': 'IOP difference of Goldmann tonometer and Dynamic Contour tonometer'}], 'secondaryOutcomes': [{'measure': 'Correlation of IOP difference of Goldmann tonometer and Dynamic Contour tonometer with biomechanical corneal properties measured by Corvis ST tonometer', 'timeFrame': 'baseline', 'description': 'Corvis ST has an integrated high-speed Scheimpflug camera which records images on which basis the biomechanical corneal parameter are analyzed (corneal thickness in micrometers, corneal applications in millimeters, peak distance in millimeters, radius in millimeters, and deformation amplitude in millimeters). Those biomechanical parameters of the cornea will be correlated to the difference of the IOP measured by GAT and by DCT (GAT - DCT).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Intraocular Pressure'], 'conditions': ['Glaucoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.usz.ch', 'label': 'Study Center'}]}, 'descriptionModule': {'briefSummary': 'The study is investigating Intra ocular pressure (IOP) by Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and the Corvis ST tonometer.', 'detailedDescription': 'The aim of the study is to approach the "true" Intra ocular pressure (IOP) by correlating the difference between IOP by Goldmann Applanation Tonometry to the IOP by Dynamic Contour Tonometry to the biomechanical parameters of the cornea measured by Corvis ST. Therefore the investigators gain new findings about the influence of the biomechanical corneal parameters on the IOP. In order to do so the investigators want to examine 50 Glaucoma eyes and 50 non-Glaucoma Eyes with Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and Corvis ST.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for the glaucoma group:\n\n* diagnosis of glaucoma\n* 18 years old or older with no upper limit\n\nExclusion Criteria for the glaucoma group:\n\n* IOP lowering surgery within the last 3 weeks\n* any corneal surgery in the past\n* bad fixation\n* insufficient measurement quality with any of the study devices\n\nInclusion Criteria for the healthy control group:\n\n* no diagnosis of glaucoma\n* 18 years old or older with no upper limit\n\nExclusion Criteria for the healthy control group:\n\n* any diagnosis of glaucoma\n* IOP lowering surgery within the last 3 weeks\n* any corneal surgery in the past\n* bad fixation\n* insufficient measurement quality with any of the study devices'}, 'identificationModule': {'nctId': 'NCT02624427', 'briefTitle': 'Goldmann Applanation Tonometry, Dynamic Contour Tonometry, and Corvis ST Tonometer', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Comparison of Intraocular Pressure Measured by Goldmann Applanation Tonometry and Dynamic Contour Tonometry vs. Corvis ST Tonometer', 'orgStudyIdInfo': {'id': 'Corvis and DCT vs. GAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glaucoma Eyes', 'description': 'Measurement of intraocular pressure (IOP)', 'interventionNames': ['Device: Measurement of intraocular pressure (IOP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Eyes', 'description': 'age-matched healthy eyes as controls will undergo Measurement of intraocular pressure (IOP)', 'interventionNames': ['Device: Measurement of intraocular pressure (IOP)']}], 'interventions': [{'name': 'Measurement of intraocular pressure (IOP)', 'type': 'DEVICE', 'description': 'Measurement of IOP with the following devices: (1) Goldmann tonometer, (2) Dynamic Contour tonometer, and (3) Corvis ST tonometer', 'armGroupLabels': ['Glaucoma Eyes', 'Healthy Eyes']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jens Funk, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UniversityHospital of Zurich, Zurich, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}