Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT05400759
Status:
COMPLETED
Last Update Posted:
2022-06-02
First Post:
2022-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of the Implementation of Diurnal IOP Curve to 1500 Patients - A Cohort Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-27', 'studyFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2022-05-27', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diurnal IOP monitoring', 'timeFrame': '12 years', 'description': 'This analysis provides a "real life\' account of IOP in a large number of glaucoma suspects and patients. Our results demonstrate the potential for significant additional information, being obtained from diurnal IOP monitoring, in clinical practice.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tonometric curve, diurnal IOP, IOP phasing, IOP monitoring, glaucoma, glaucoma suspects, IOP peaks, hypertension, compliance, adherence,'], 'conditions': ['To Present the Clinical Outcomes of Diurnal IOP Monitoring and Determine Its Value in Our Clinical Practice']}, 'descriptionModule': {'briefSummary': 'To present the clinical outcomes of diurnal IOP monitoring and determine its value in our clinical practice.We reviewed the records of 1500 patients (glaucoma suspects or glaucoma patients), who were admitted for diurnal curve during almost 12 years.', 'detailedDescription': 'We reviewed the records of 1500 patients, who were admitted for diurnal curve during almost 12 years. All patients were hospitalized because their within office-hours exams were considered inadequate and inconclusive for decision-making\n\n744 patients needed change of treatment. 121 patients were programmed for interventional therapy (laser or surgery). 68 patients were declassified, as overdiagnosed and overtreated. In 250 patients hidden adherence problem revealed. In 720 patients peak IOP occurred out of office hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients were retrieved from the eye clinic database. The records of all 1500 patients were retrospectively reviewed. We included the last 1500 patients who had undergone diurnal IOP monitoring in the clinic until the conduct of the study. All of them were hospitalized between November 2007 and December 2019, at the Eye Clinic of General Hospital "George Papanikolaou" in Thessaloniki, Greece.', 'eligibilityCriteria': 'Inclusion Criteria: IOP diurnal curve consisted of glaucoma patients with intraocular pressure higher than target pressure despite referred previously sufficient therapy and also patients with equal or lower than target pressure, but with disease progression. There were also included patients with advanced glaucoma with visual field defects on the visual field testing, as well as patients with normal tension glaucoma and labile secondary glaucomas (exfoliative, pigmentary and chronic angle closure glaucoma), for whom close monitoring and therapy reconsidering was judged appropriate.Glaucoma suspects, demonstrating findings consistent with increased risk for glaucoma development, were included.\n\n\\-\n\nExclusion Criteria: Patients with missing data values for IOP\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05400759', 'briefTitle': 'Clinical Outcomes of the Implementation of Diurnal IOP Curve to 1500 Patients - A Cohort Study.', 'organization': {'class': 'OTHER', 'fullName': 'George Papanicolaou Hospital'}, 'officialTitle': 'Clinical Outcomes of the Implementation of Diurnal IOP Curve to 1500 Patients - A Cohort Study.', 'orgStudyIdInfo': {'id': 'GeorgePH 1500 IOP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'IOP monitoring data', 'type': 'OTHER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Papanicolaou Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Sevasti Tsironi', 'investigatorFullName': 'Diamantis Almaliotis', 'investigatorAffiliation': 'George Papanicolaou Hospital'}}}}