Ignite Creation Date:
2025-12-24 @ 3:19 PM
Ignite Modification Date:
2026-01-01 @ 3:24 PM
Study NCT ID:
NCT06748092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2024-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validation of iCare IC1000 Tonometer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Investigator cannot see the measurement results.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on the reference tonometer measurements. The iCare IC1000 Tonometer measurements shall be within +/-5.0 mmHg of the reference tonometer measurements in all groups.'}], 'secondaryOutcomes': [{'measure': 'Retrospective analysis of "Quick Measure" mode', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'The secondary objective of this study is to do a retrospective analysis of "Quick Measure" mode. Instead of 6 shots that are taken in Default Measure, Quick Measure takes only 2 shots (or 3 shots if the difference between the first two shots is greater than 2 mmHg). The Quick Measure results are calculated retrospectively from the raw data of the Default Measure results. Quick Measure comparison to reference measurements is done similarly as with Default Measure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraocular Pressure']}, 'descriptionModule': {'briefSummary': 'Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Subjects with only one functional eye\n* Subjects having poor or eccentric fixation in the study eye\n* High corneal astigmatism \\>3D in the study eye\n* Central corneal scarring\n* History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye\n* Microphthalmos\n* Buphthalmos\n* Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally\n* Dry eyes (clinically significant)\n* Lid squeezers - blepharospasm\n* Nystagmus\n* Keratoconus\n* Any other corneal or conjunctival pathology or infection relevant to this study\n* Central corneal thickness greater than 600 µm or less than 500 µm in the study eye\n* Cataract Extraction within last 2 months in the study eye'}, 'identificationModule': {'nctId': 'NCT06748092', 'briefTitle': 'Clinical Validation of iCare IC1000 Tonometer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Icare Finland Oy'}, 'officialTitle': 'Clinical Validation of iCare IC1000 Tonometer', 'orgStudyIdInfo': {'id': 'TA032-135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iCare IC1000 vs GAT, iCare IC200 and Perkins', 'interventionNames': ['Device: iCare IC1000', 'Device: iCare IC200', 'Device: GAT', 'Device: Perkins']}], 'interventions': [{'name': 'iCare IC1000', 'type': 'DEVICE', 'description': 'Measurement of Intraocular Pressure (IOP) in sitting and supine position', 'armGroupLabels': ['iCare IC1000 vs GAT, iCare IC200 and Perkins']}, {'name': 'iCare IC200', 'type': 'DEVICE', 'description': 'Measurement of Intraocular Pressure (IOP) in sitting and supine position', 'armGroupLabels': ['iCare IC1000 vs GAT, iCare IC200 and Perkins']}, {'name': 'GAT', 'type': 'DEVICE', 'description': 'Measurement of Intraocular Pressure (IOP) in sitting position', 'armGroupLabels': ['iCare IC1000 vs GAT, iCare IC200 and Perkins']}, {'name': 'Perkins', 'type': 'DEVICE', 'description': 'Measurement of Intraocular Pressure (IOP) in supine position', 'armGroupLabels': ['iCare IC1000 vs GAT, iCare IC200 and Perkins']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'contacts': [{'name': 'Balwantray Chauhan, Prof.', 'role': 'CONTACT', 'email': 'bal@dal.ca', 'phone': '902-473-3202'}], 'facility': 'Nova Scotia Health/Dalhousie University', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'centralContacts': [{'name': 'Balwantray Chauhan, Prof.', 'role': 'CONTACT', 'email': 'bal@dal.ca', 'phone': '902-473-3202'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icare Finland Oy', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}