Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-29 @ 12:45 AM
Study NCT ID:
NCT06250868
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2024-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRK-3 Performance of Pachymetry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cornea thickness', 'timeFrame': '1 day', 'description': 'Thickness of the cornea'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Normal']}, 'descriptionModule': {'briefSummary': 'To evaluate the performance of a new tonometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have healthy cornea', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide voluntary written consent for participation in the study.\n2. Age at least 22 years old at the time of informed consent.\n\nExclusion Criteria:\n\n1. Ocular condition that may affect the ability to perform corneal measurement (e.g., corneal perforation, bullous keratopathy, nystagmus)\n2. Have or is suspected to have an ocular infection in either eye.\n3. Otherwise considered unsuitable for the study by the investigator\n4. Unable to tolerate ophthalmic testing.'}, 'identificationModule': {'nctId': 'NCT06250868', 'briefTitle': 'TRK-3 Performance of Pachymetry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Topcon Corporation'}, 'officialTitle': 'TRK-3 Agreement and Precision of Pachymetry Function', 'orgStudyIdInfo': {'id': 'THQ-THINC-2023-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal cornea', 'interventionNames': ['Device: Kerato-Refracto Tonometer']}], 'interventions': [{'name': 'Kerato-Refracto Tonometer', 'type': 'DEVICE', 'description': 'measures pressure inside the eye and thickness of the cornea.', 'armGroupLabels': ['Normal cornea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Topcon Healthcare Innovation Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Topcon Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}