Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2026-03-01 @ 12:31 PM
Study NCT ID:
NCT03445806
Status:
TERMINATED
Last Update Posted:
2021-05-13
First Post:
2018-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IOP Monitoring After Trabeculectomy Using iCare Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D017889', 'term': 'Exfoliation Syndrome'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Difficulty recruiting patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2018-02-15', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lowering of IOP levels after trabeculectomy', 'timeFrame': '2-3 months', 'description': 'Mean (SD) IOP pre- and post trabeculectomy'}], 'secondaryOutcomes': [{'measure': 'Lowering of IOP fluctuations after trabeculectomy', 'timeFrame': '2-3 months', 'description': 'Mean (SD) IOP range pre- and post trabeculectomy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IOP fluctuations', 'iCare Home', 'Trabeculectomy', 'self-tonometry'], 'conditions': ['Glaucoma, Open-Angle', 'Pseudo Exfoliation Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate how much trabeculectomy influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).', 'detailedDescription': "Fifty glaucoma patients (POAG and PEX) planned for trabeculectomy will be recruited.\n\nAt baseline, patients will be trained to use the iCare Home tonometer (RTHome), a handheld device based on rebound tonometry and designed for patients to use at home. After the training session and when patients feel confident, a measurement will be recorded. At the same visit, a new measurement will be obtained by the study staff, an optometrist or a nurse, using the same device. No IOP values will be visible for the examiner at that point. A single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will come for a second visit where new measurements will be made in the same way as at baseline.\n\nIn between visits, patients will borrow the iCare Home tonometer to measure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve.\n\nTwo-three months after trabeculectomy, a new IOP curve will be obtained following the same procedure as pre-operatively. There will be no restrictions in patients' daily activities regarding diet, physical activity or slee. If patients use any eyedrops, they will continue to use them as prescribed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Consecutive male and female patients, older than 18 y.o., at St Erik's Eye Hospital in Stockholm, Sweden, diagnosed with POAG or PXG and listed for a trabeculectomy.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* POAG\n* PXG\n\nExclusion Criteria:\n\n* previous trabeculectomy\n* reduced hand and arm mobility (e. due to rheumatism)'}, 'identificationModule': {'nctId': 'NCT03445806', 'briefTitle': 'IOP Monitoring After Trabeculectomy Using iCare Home', 'organization': {'class': 'OTHER', 'fullName': 'St. Erik Eye Hospital'}, 'officialTitle': 'IOP Monitoring After Trabeculectomy Using iCare Home', 'orgStudyIdInfo': {'id': 'Home Trab'}}, 'contactsLocationsModule': {'locations': [{'zip': '11282', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'St Erik Eye Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Erik Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Enping Chen', 'investigatorAffiliation': 'St. Erik Eye Hospital'}}}}