Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-20 @ 9:07 AM
Study NCT ID:
NCT05455567
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2022-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OCTA Study of Choroidal Vasculature in Open Angle Glaucoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The measurements of choroidal thickness and choriocapillary vessel density in patients with open angle glaucoma.', 'timeFrame': 'up to 5 months', 'description': 'correlation of measurement of choroidal thickness and choriocapillary vessel density in three different patients groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma Open-Angle Primary']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to examine and measure SFCT and CCVD using respectively EDI-OCT and OCTA in preperimetric and advanced glaucomatous eyes, in order to shed light on the vascular pathogenesis of glaucoma disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participans were older than 40 years with diagnosis of open angle glaucoma. They did not present any other ophthalmological disease, diabetes, heart diseases and hypertension.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:• age older than 40 years\n\n* diagnosis of glaucoma\n* absence of diabetes, heart diseases, hypertension\n* absence of drug intake\n* absence of vitreoretinal, vascular retinal diseases\n* absence of previous ocular surgery and congenital eye diseases.\n* absence of errors of refraction\n* absence of lens opacities\n* absence of low-quality OCT and OCTA images\n\nExclusion Criteria:\n\n* age younger than 40 years\n* presence of diabetes, heart diseases, hypertension\n* vitreoretinal and vascular retinal diseases\n* previous ocular surgery and congenital eye diseases\n* errors of refraction\n* lens opacities\n* low-quality OCT and OCTA images'}, 'identificationModule': {'nctId': 'NCT05455567', 'briefTitle': 'OCTA Study of Choroidal Vasculature in Open Angle Glaucoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'OCTA as a New Biomarker in the Pathogenesis of Primary Open Angle Glaucoma', 'orgStudyIdInfo': {'id': '0102/22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with pre perimetric open angle glaucoma', 'interventionNames': ['Diagnostic Test: OCTA']}, {'label': 'patients with perimetric open angle glaucoma', 'interventionNames': ['Diagnostic Test: OCTA']}, {'label': 'healthy patients', 'interventionNames': ['Diagnostic Test: OCTA']}], 'interventions': [{'name': 'OCTA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Choriocapillary vessel density calculated with OCTA', 'armGroupLabels': ['healthy patients', 'patients with perimetric open angle glaucoma', 'patients with pre perimetric open angle glaucoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80100', 'city': 'Naples', 'country': 'Italy', 'facility': 'University of Naples "Federico II"', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Gilda Cennamo', 'investigatorAffiliation': 'Federico II University'}}}}