Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT04888156
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2021-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Self-tonometry on Glaucoma Treatment Decision.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D017889', 'term': 'Exfoliation Syndrome'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-01', 'studyFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Clinician's choice of glaucoma treatment", 'timeFrame': 'One month', 'description': 'Type of treatment received by patient after performance of self-tonometry with iCare Home'}], 'secondaryOutcomes': [{'measure': 'Occurence of IOP peaks', 'timeFrame': 'Three days of self-tonometry', 'description': 'Occurence of IOP peaks measured by self-tonometry'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glaucoma', 'self-tonometry', 'treatment', 'IOP peaks'], 'conditions': ['Glaucoma', 'Glaucoma, Open-Angle', 'OHT - Ocular Hypertension', 'Glaucoma Capsulare']}, 'descriptionModule': {'briefSummary': "Self-tonometry with iCare Home is performed by one hundred patients annually at Sankt Erik's Eye Hospital. The investigators want to evaluate the impact that self-tonometry results have on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours.", 'detailedDescription': "Since a few years back, self-tonometry has been available in glaucoma care. Self-tonometry allows patients to measure their eye pressure themselves using a portable tonometer. Sankt Erik's Eye Hospital was the first healthcare provider in Sweden to use this new technology. The investigators have previously conducted studies that have shown good agreement between the measurements made by patients and the gold standard method, e.g. Goldman applanation tonometry (GAT) (Chen, Querat et al. 2016, Querat and Chen 2017). About one hundred patients perform pressure curves with self-tonometry annually.\n\nAs the method is used regularly, the investigators want to evaluate the impact of self-tonometry results on the clinician's choice of glaucoma treatment. The investigators also want to evaluate how often pressure peaks occur outside the clinic's opening hours and how much they differ from GAT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All glaucoma patients who obtained an IOP curve using an iCare Home® self-tonometer between January 2018 and December 2020 and who fulfill all the inclusion criteria and none of the exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosed with POAG (primary open-angle glaucoma), PEX (pseudo-exfoliation glaucoma) or OHT (ocular hypertension)\n* Difference between patients' and staff's iCare Home® measurements less than 5 mmHg at Baseline\n* Difference between Goldman Applanation tonometry (GAT) and patient's highest iCare Home® measurements less than 7 mmHg at baseline\n* Monitoring over at least two days\n\nExclusion Criteria:\n\n* More than one measurement with iCare Home® tonometer below 5 mmHg\n* Missing more than one daily measurement with iCare Home® tonometer"}, 'identificationModule': {'nctId': 'NCT04888156', 'briefTitle': 'Impact of Self-tonometry on Glaucoma Treatment Decision.', 'organization': {'class': 'OTHER', 'fullName': 'St. Erik Eye Hospital'}, 'officialTitle': 'Impact of Self-tonometry With iCare Home ® on Glaucoma Treatment Decision.', 'orgStudyIdInfo': {'id': 'iCare Home'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GAT IOP below 15 mmHg', 'description': 'Glaucoma patients with an IOP measured with GAT below 15 mmHg prior performance of self-tonometry with iCare Home', 'interventionNames': ['Other: Unchanged treatment', 'Other: Changed treatment']}, {'label': 'GAT IOP equal or above 15 mmHg', 'description': 'Glaucoma patients with an IOP measured with GAT equal or above 15 mmHg prior performance of self-tonometry with iCare Home', 'interventionNames': ['Other: Unchanged treatment', 'Other: Changed treatment']}], 'interventions': [{'name': 'Unchanged treatment', 'type': 'OTHER', 'description': 'Treatment is the same pre- and post self-tonometry', 'armGroupLabels': ['GAT IOP below 15 mmHg', 'GAT IOP equal or above 15 mmHg']}, {'name': 'Changed treatment', 'type': 'OTHER', 'description': 'Treatment is changed post self-tonometry', 'armGroupLabels': ['GAT IOP below 15 mmHg', 'GAT IOP equal or above 15 mmHg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11282', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'St Erik Eye Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Enping Chen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Erik Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Erik Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Ph D', 'investigatorFullName': 'Enping Chen', 'investigatorAffiliation': 'St. Erik Eye Hospital'}}}}