Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
Study NCT ID:
NCT04383366
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2020-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Agreement and Accuracy of Different Devices Corneal Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2020-05-07', 'studyFirstSubmitQcDate': '2020-05-11', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum K-value', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Simulated minimum and maximum K-value', 'timeFrame': '1 day'}, {'measure': 'Mean K-values', 'timeFrame': '1 day'}, {'measure': 'Central Corneal thickness', 'timeFrame': '1 day'}, {'measure': 'Thinnest corneal point', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Keratoconus']}, 'descriptionModule': {'briefSummary': 'To compare repeatability, reproducibility and agreement of both, AS- OCT and Scheimpflug imaging, for the measurement of corneal curvature and corneal thickness in patients with keratoconus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 patients with keratoconus will be recruited in the outpatient department of the Department of Ophthalmology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged between 18 and 99 years\n* Presence of keratoconus\n* Signed informed consent\n\nExclusion Criteria:\n\n* Contact lens history within 5 days\n* Pathologic changes of the lid or conjunctiva on slit-lamp examination\n* History of corneal ocular surgery/Previous corneal cross-linking'}, 'identificationModule': {'nctId': 'NCT04383366', 'briefTitle': 'Agreement and Accuracy of Different Devices Corneal Measurements', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Agreement and Accuracy of Different Devices for the Measurement of Corneal Thickness and Corneal Curvature in Patients With Keratoconus', 'orgStudyIdInfo': {'id': 'TOPOC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with keratoconus', 'interventionNames': ['Device: Pentacam® (Oculus, Inc., Wetzlar, Germany)', 'Device: Casia II (Tomey Germany, Nürnberg)', 'Device: Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)']}], 'interventions': [{'name': 'Pentacam® (Oculus, Inc., Wetzlar, Germany)', 'type': 'DEVICE', 'description': 'Scheimpflug imaging', 'armGroupLabels': ['Patients with keratoconus']}, {'name': 'Casia II (Tomey Germany, Nürnberg)', 'type': 'DEVICE', 'description': 'Anterior segment optical coherence tomography', 'armGroupLabels': ['Patients with keratoconus']}, {'name': 'Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)', 'type': 'DEVICE', 'description': 'Anterior segment optical coherence tomography', 'armGroupLabels': ['Patients with keratoconus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Department of Ophthalmology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Gerald Schmidinger, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gerald Schmidinger', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr.', 'investigatorFullName': 'Gerald Schmidinger', 'investigatorAffiliation': 'Medical University of Vienna'}}}}