Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT06266351
Status:
COMPLETED
Last Update Posted:
2024-11-05
First Post:
2024-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D057066', 'term': 'Low Tension Glaucoma'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-03', 'studyFirstSubmitDate': '2024-02-11', 'studyFirstSubmitQcDate': '2024-02-11', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP measurement difference between CATS and GAT in LASIK patients', 'timeFrame': 'single measurement 1 day', 'description': 'IOP measurement'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Glaucoma', 'Ocular Hypertension', 'Normal Tension Glaucoma']}, 'descriptionModule': {'briefSummary': 'The CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral pressure in cadaver eyes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial:\n\n* At least 22 years of age and undergone LASIK treatment\n* Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must meet the following inclusion criteria to be eligible to participate in this clinical trial:\n\n* At least 22 years of age and undergone LASIK treatment\n* Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form\n\nExclusion Criteria:\n\n* Subjects will be excluded from participation if they meet the following criteria:\n\n * Subject has undergone ocular surgery within the last 3 months or LASIK within 6 months\n * Pregnant or nursing women\n * Those who have had previous corneal surgery excluding LASIK\n * Keratoconus\n * Corneal scarring\n * Microphthalmos\n * Buphthalmos\n * Dry eyes with clinical epithelial breakdown upon exam\n * Lid squeezers - blepharospasm\n * Nystagmus\n * Corneal or conjunctival infection.'}, 'identificationModule': {'nctId': 'NCT06266351', 'briefTitle': 'EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intuor Technologies, Inc.'}, 'officialTitle': 'EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS', 'orgStudyIdInfo': {'id': 'LASIKIOP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IOP measurement with CATS', 'interventionNames': ['Device: This is observational IOP measurement']}, {'label': 'IOP measurement with GAT', 'interventionNames': ['Device: This is observational IOP measurement']}], 'interventions': [{'name': 'This is observational IOP measurement', 'type': 'DEVICE', 'description': 'IOP measurement of patients having LASIK with both CATS and GAT', 'armGroupLabels': ['IOP measurement with CATS', 'IOP measurement with GAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Eye Consultants', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Eye Specialty Group', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'likely will provide deindentified data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intuor Technologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}