Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT02356094
Status:
UNKNOWN
Last Update Posted:
2015-02-05
First Post:
2015-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posterior Cornea in Primary Open Angle Glaucoma
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': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-01', 'studyFirstSubmitDate': '2015-02-01', 'studyFirstSubmitQcDate': '2015-02-01', 'lastUpdatePostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean posterior corneal elevation', 'timeFrame': 'Single point in time, at baseline at the moment of study enrollment', 'description': 'Mean posterior corneal elevation based on the relative elevation of the cornea related with the best-fit sphere'}], 'secondaryOutcomes': [{'measure': 'Mean anterior corneal elevation', 'timeFrame': 'Single point in time, at baseline at the moment of study enrollment', 'description': 'Mean anterior corneal elevation based on the relative elevation of the cornea related with the best-fit sphere'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glaucoma', 'primary open angle glaucoma', 'cornea'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '23939294', 'type': 'RESULT', 'citation': 'Arranz-Marquez E, Bolivar G, Pinero DP, Konstas AG, Mikropoulos DG, Teus MA. Orbscan topography in primary open-angle glaucoma. Optom Vis Sci. 2013 Oct;90(10):1098-103. doi: 10.1097/OPX.0000000000000019.'}]}, 'descriptionModule': {'briefSummary': 'Characterization of posterior corneal changes in primary open angle glaucoma patients, using Scheimpflug examination.', 'detailedDescription': 'A cohort of primary open angle glaucoma (POAG) patients is submitted to Scheimpflug Pentacam examination. The results are compared with a control group of age and central corneal thickness matched healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cases from the Glaucoma Outpatient Clinic and controls from the General Ophthalmology Outpatient Clinic from a single ophthalmological center.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary open angle glaucoma, with the diagnosis supported on structural and functional complementary exams according to the current European Glaucoma Society guidelines\n* Healthy subjects from the General Ophthalmology Outpatient Clinic\n\nExclusion Criteria:\n\n* age inferior to 18 years old\n* primary closed angle glaucoma\n* secondary open angle glaucoma\n* previous intra-ocular surgery\n* known or suspected corneal disease\n* previous intra-ocular inflammation\n* previous ocular trauma'}, 'identificationModule': {'nctId': 'NCT02356094', 'briefTitle': 'Posterior Cornea in Primary Open Angle Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar do Baixo Vouga'}, 'officialTitle': 'Posterior Cornea in Primary Open Angle Glaucoma', 'orgStudyIdInfo': {'id': 'CHBaixoVouga2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients with primary open angle glaucoma, randomly selected from the Glaucoma Outpatient Clinic to be submitted to Pentacam examination', 'interventionNames': ['Procedure: Pentacam']}, {'label': 'Controls', 'description': 'Control group of age and central corneal thickness matched healthy subjects, randomly selected from the General Ophthalmology Outpatient Clinic to be submitted to Pentacam examination', 'interventionNames': ['Procedure: Pentacam']}], 'interventions': [{'name': 'Pentacam', 'type': 'PROCEDURE', 'description': 'Corneal topography using Scheimpflug Pentacam examination', 'armGroupLabels': ['Cases', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3814-501', 'city': 'Aveiro', 'state': 'Aveiro District', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Pedro Gil, MSc, MD', 'role': 'CONTACT', 'email': 'sec-geral@hdaveiro.min-saude.pt', 'phone': '00351234378300'}, {'name': 'Rita Matos, MSc, MD', 'role': 'CONTACT', 'email': 'rita9matos@hotmail.com', 'phone': '00351914452190'}, {'name': 'Pedro Gil, MSc, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Hospitalar Baixo Vouga', 'geoPoint': {'lat': 40.64575, 'lon': -8.64643}}], 'centralContacts': [{'name': 'Pedro Gil, MSc, MD', 'role': 'CONTACT', 'email': 'pedroqgil@gmail.com', 'phone': '00351915687941'}, {'name': 'João Gil, MSc, MD', 'role': 'CONTACT', 'email': 'joaomqgil@hotmail.com', 'phone': '00351915821918'}], 'overallOfficials': [{'name': 'Pedro Gil, MSc, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Hospitalar Baixo Vouga'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar do Baixo Vouga', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pedro Gil, MSc, MD', 'investigatorFullName': 'Pedro Gil', 'investigatorAffiliation': 'Centro Hospitalar do Baixo Vouga'}}}}