Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2026-05-17 @ 5:31 PM
Study NCT ID:
NCT04067258
Status:
COMPLETED
Last Update Posted:
2020-06-26
First Post:
2019-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Choroidal Thickness in Beta-thalassemia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017086', 'term': 'beta-Thalassemia'}], 'ancestors': [{'id': 'D013789', 'term': 'Thalassemia'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-24', 'studyFirstSubmitDate': '2019-08-21', 'studyFirstSubmitQcDate': '2019-08-21', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subfoveal choroidal thickness', 'timeFrame': '8-10 am', 'description': 'Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted subfoveally'}], 'secondaryOutcomes': [{'measure': 'Choroidal thickness nasally to the fovea', 'timeFrame': '8-10 am', 'description': 'Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted at anatomic locations nasally to the subfoveal point'}, {'measure': 'Choroidal thickness inferiorly to the fovea', 'timeFrame': '8-10 am', 'description': 'Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted at anatomic locations inferiorly to the subfoveal point'}, {'measure': 'Choroidal thickness temporally to the fovea', 'timeFrame': '8-10 am', 'description': 'Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted at anatomic locations temporally to the subfoveal point'}, {'measure': 'Choroidal thickness superiorly to the fovea', 'timeFrame': '8-10 am', 'description': 'Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted at anatomic locations superiorly to the subfoveal point'}, {'measure': 'Peripapillary choroidal thickness (inferior, superior, nasal and temporal fields)', 'timeFrame': '8-10 am', 'description': 'Manual measurements of the choroid starting from the end of the retinal pigment epithelium throughout the outline of the sclera, will be conducted at the inferior, superior, nasal and temporal quadrants in the peripapillary area.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['beta-thalassemia', 'choroidal thickness', 'enhanced depth imaging', 'optical coherence tomography'], 'conditions': ['Beta-Thalassemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine choroidal thickness in beta-thalassemia patients and compare it to the one of healthy controls.\n\nAn equal number of transfusion dependent beta-thalassemic patients and age and sex matched healthy volunteers will undergo spectral-domain optical coherence tomography utilizing the enhanced depth imaging application to visualize and measure the choroid.', 'detailedDescription': "Beta thalassemia is an inherited hemoglobinopathy, associated with defective production of beta-chain globin resulting in problematic HbA production. It is classified according to the severity as minor, intermedia and major. Patients suffering from beta-thalassemia intermedia and beta-thalassemia major require regular blood transfusions. Transfusion related hemosiderosis in these patients necessitates the use of chelating agents to prevent iron overload in vital organs such as the liver and heart.\n\nA number of ocular abnormalities can present in beta-thalassemia patients. Those are categorized as pseudoxanthoma elasticum (PXE)-like changes that include angioid streaks, peau d'orange like fundus and optic nerve head drusen and non-PXE-like changes such as increased venous tortuosity.\n\nFurthermore, it is well established that prolonged treatment with some of the chelating agents such as deferoxamine are associated with ocular toxicity, namely nyctalopia, colour perception anomalies, visual field disturbances, cataract formation, optic neuropathy and pigmentary retinopathy.\n\nThe pathophysiology of those ocular manifestations has not been fully clarified. The role of the choroid has not been determined since this particular tissue was previously unaccessible to imaging. Enhanced depth imaging optical coherence tomography is able to image the choroid providing reasonable clarity compared to spectral domain optical coherence tomography.\n\nThe aim of this study is to evaluate possible alterations of choroidal thickness in beta thalassemia as compared to healthy controls."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with beta-thalassemia major or intermedia undergoing blood transfusions will be examined utilizing EDI-OCT.\n\nA group of equal healthy volunteers will also be included to serve as controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Beta thalassemia patients undergoing blood transfusions\n\nExclusion Criteria:\n\n* History of glaucoma, keratoconus, retinal disease, ocular trauma, ocular surgery, uveitis, amblyopia, strabismus, ocular vascular abnormalities\n* Spherical refractive error greater than 4 diopters or cylindrical refractive error greater than 2 diopters\n* History of other systemic disease such as uncontrolled hypertension, diabetes mellitus, or connective tissue disease.'}, 'identificationModule': {'nctId': 'NCT04067258', 'briefTitle': 'Choroidal Thickness in Beta-thalassemia Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Patras'}, 'officialTitle': 'Evaluation of Choroidal Thickness in Patients Suffering From Beta-thalassemia', 'orgStudyIdInfo': {'id': '9894 / 20 -5 -2016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Beta-Thalassemia group', 'description': 'Patients suffering from beta thalassemia major or intermedia will be included in this group', 'interventionNames': ['Diagnostic Test: EDI-OCT']}, {'label': 'Control group', 'description': 'Healthy age and sex matched volunteers will be included in this group', 'interventionNames': ['Diagnostic Test: EDI-OCT']}], 'interventions': [{'name': 'EDI-OCT', 'type': 'DIAGNOSTIC_TEST', 'description': 'EDI-OCT (enhanced depth imaging spectral domain optical coherence tomography) wiil be performed in all study participants.\n\nThree sets of measurements in the macular (horizontal and vertical) and peripapillary area will be averaged.', 'armGroupLabels': ['Beta-Thalassemia group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GR26504', 'city': 'Pátrai', 'state': 'Achaea', 'country': 'Greece', 'facility': 'Department of Ophthalmology, General University Hospital of Patras', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Patras', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in Ophthalmology', 'investigatorFullName': 'Constantinos D. Georgakopoulos, MD, PhD', 'investigatorAffiliation': 'University Hospital of Patras'}}}}