Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-27 @ 5:09 AM
Study NCT ID:
NCT01733550
Status:
UNKNOWN
Last Update Posted:
2012-11-28
First Post:
2012-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-27', 'studyFirstSubmitDate': '2012-10-31', 'studyFirstSubmitQcDate': '2012-11-26', 'lastUpdatePostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer.', 'timeFrame': 'immediate comparison, no time frame required', 'description': 'Patients eye pressure measurement with both devices.\n\n1. Home ICare measurement by study nurse compared to Home ICare by patient compared to Goldmann ATO by study nurse (once for every patient)\n2. 4 times daily: measurement Goldmann ATO (by resident in ophthalmology) and home Icare (by patient)on same moment'}], 'secondaryOutcomes': [{'measure': 'Patient Comfort', 'timeFrame': '1 day hospitalisation', 'description': 'The comfort of the patients will be checked with both methods (home iCare and goldmann applanation tonometry) and look if the patient has a preference for one of them. Pain and discomfort were scaled from 0 to 5 (0 = none,1-2 = slight, 3-4 = moderate, 5 = severe) for both tonometers, and patients were asked which tonometer they preferred.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intraocular Pressure', 'Tonometry, Ocular', 'iCare'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare glaucoma patients' own I Care measurements by the standard Goldmann applanation tonometer intraocular pressure (IOP) measurements.", 'detailedDescription': 'not necessary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Glaucoma patients who are admitted to the hospital for repeated eye pressure measurements learn how to handle the home i care during their stay.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ocular hypertension (OHT):with/without glaucoma drugs\n* Primary open angle glaucoma (POAG)- high pressure: Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) \\>21 mmHg.\n* Primary open angle glaucoma, normal pressure: cfr high pressure but intraocular pressure ≤ 21 mmHg\n* Exfoliative Glaucoma (PEX): Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) \\>21 mmHg, with exfoliation material in the anterior segment.\n* Pigmentary Glaucoma (PDG): Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) \\>21 mmHg, with Krukenberg's spindle and/or pigment dispersed on the trabecular meshwork.\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Other glaucoma types\n* Corneal pathology (edema, dystrophia, corneal transplantation, severe keratoconus, permanent contact lens wear, recurrent corneal erosion)\n* Severe arthritis (unable to handle home i care device)\n* Lack of comprehension\n* Intra ocular surgery and laser treatment during the last 6 months"}, 'identificationModule': {'nctId': 'NCT01733550', 'briefTitle': 'ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer', 'orgStudyIdInfo': {'id': 's54640'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glaucoma patients', 'description': 'Intraocular pressure is measured by Home iCare performed by the study nurse, by the patient it self and by Goldmann applanation tonometry.', 'interventionNames': ['Device: Home iCare (study nurse)', 'Device: goldmann applanation tonometry', 'Device: home iCare (by patient)']}], 'interventions': [{'name': 'Home iCare (study nurse)', 'type': 'DEVICE', 'description': 'the intraocular pressure is measured by iCare performed by the study nurse', 'armGroupLabels': ['Glaucoma patients']}, {'name': 'goldmann applanation tonometry', 'type': 'DEVICE', 'description': 'the intraocular pressure is measured by goldmann applanation tonometry', 'armGroupLabels': ['Glaucoma patients']}, {'name': 'home iCare (by patient)', 'type': 'DEVICE', 'description': 'the intraocular pressure is measured by the iCare performed by the patient him self', 'armGroupLabels': ['Glaucoma patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'contacts': [{'name': 'Sien Boons, Optometrist', 'role': 'CONTACT', 'email': 'sien.boons@uzleuven.be', 'phone': '+3216332361'}, {'name': 'Ingeborg Stalmans', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZLeuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Sien Boons, Optometrist', 'role': 'CONTACT', 'email': 'sien.boons@uzleuven.be', 'phone': '+32-16-33-23-61'}, {'name': 'Evelien Dewilde, Resident', 'role': 'CONTACT', 'email': 'evelien.dewilde@uzleuven.be', 'phone': '+32-16-33-23-61'}], 'overallOfficials': [{'name': 'Ingeborg Stalmans', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}