Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT06272851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measuring Choroidal Thickness Using Optical Coherence Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2029-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison between choroidal thickness', 'timeFrame': '2 years', 'description': 'To compare choroidal thickness using optical coherence tomography between eyes of healthy individuals and diabetic patients without retinopathy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Choroid Disease', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '33940045', 'type': 'BACKGROUND', 'citation': 'Teo ZL, Tham YC, Yu M, Chee ML, Rim TH, Cheung N, Bikbov MM, Wang YX, Tang Y, Lu Y, Wong IY, Ting DSW, Tan GSW, Jonas JB, Sabanayagam C, Wong TY, Cheng CY. Global Prevalence of Diabetic Retinopathy and Projection of Burden through 2045: Systematic Review and Meta-analysis. Ophthalmology. 2021 Nov;128(11):1580-1591. doi: 10.1016/j.ophtha.2021.04.027. Epub 2021 May 1.'}, {'pmid': '36699020', 'type': 'BACKGROUND', 'citation': 'Tan TE, Wong TY. Diabetic retinopathy: Looking forward to 2030. Front Endocrinol (Lausanne). 2023 Jan 9;13:1077669. doi: 10.3389/fendo.2022.1077669. eCollection 2022.'}, {'pmid': '35035435', 'type': 'BACKGROUND', 'citation': 'Hassan H, Cheema A, Tahir MA, Nawaz HN. Comparison of choroidal thickness in eyes of diabetic patients with eyes of healthy individuals using optical coherence tomography in a tertiary care hospital. Pak J Med Sci. 2022 Jan-Feb;38(1):254-260. doi: 10.12669/pjms.38.1.4443.'}, {'pmid': '32574782', 'type': 'BACKGROUND', 'citation': 'Endo H, Kase S, Saito M, Yokoi M, Takahashi M, Ishida S, Kase M. Choroidal Thickness in Diabetic Patients Without Diabetic Retinopathy: A Meta-analysis. Am J Ophthalmol. 2020 Oct;218:68-77. doi: 10.1016/j.ajo.2020.05.036. Epub 2020 Jun 20.'}, {'pmid': '22374157', 'type': 'BACKGROUND', 'citation': 'Regatieri CV, Branchini L, Carmody J, Fujimoto JG, Duker JS. Choroidal thickness in patients with diabetic retinopathy analyzed by spectral-domain optical coherence tomography. Retina. 2012 Mar;32(3):563-8. doi: 10.1097/IAE.0b013e31822f5678.'}, {'pmid': '28267113', 'type': 'BACKGROUND', 'citation': 'Tavares Ferreira J, Vicente A, Proenca R, Santos BO, Cunha JP, Alves M, Papoila AL, Abegao Pinto L. CHOROIDAL THICKNESS IN DIABETIC PATIENTS WITHOUT DIABETIC RETINOPATHY. Retina. 2018 Apr;38(4):795-804. doi: 10.1097/IAE.0000000000001582.'}]}, 'descriptionModule': {'briefSummary': 'To compare the choroidal thickness in eyes of diabetic patients with eyes of age matched controls using optical coherence tomography.', 'detailedDescription': 'Diabetic retinopathy (DR) is the most common and specific complication of DM. It is one of the leading causes of preventable blindness in the adult working population. (1) DR was the fifth leading cause of blindness and of moderate and severe vision impairment.\n\nGlobal prevalence of diabetic retinopathy was 22.27% and prevalence was highest in Africa (35.90%). (1)\n\nFortunately, much of the visual loss from DR is preventable, and the rates of vision loss from diabetes and DR have declined over the past few decades due to advances in ocular disease assessment, screening, imaging and treatment in recent years. (2)\n\nThe outer third of the retina gets oxygen and nutrients from choroid. The three vascular layers of choroid are chorio capillaries layer, Sattler layer and Haller layer. (3)\n\nA healthy choroid is essential for retinal function by continuous perfusion into the outer retina, which plays critical roles in thermoregulation of the retina, maintenance of the anatomic position of the retina, removal of residues, and secretion of growth factors. (4-5)\n\nThe vascular choroid changes of the diabetic patients are quite similar to those seen in DR, such as increased vascular tortuosity, vascular outpouchings, microaneurysms, nonperfusion areas, vascular dilations and narrowing, and choroidal neovascularization. (6)\n\nUntil recently, the choroid could only be evaluated by indocyanine green angiography, laser Doppler flowmetry, and ultrasonography. (6) Optical coherence tomography (OCT) is a non-invasive imaging modality, which is used in acquiring high-resolution sections of retina. (5)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'known Type 2 DM patients aged 30 to 95 years either gender with no history of ocular treatment and non-diabetic healthy individuals who come to the hosoital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All known Type 2 DM patients aged 30 to 95 years either gender who presented to ophthalmology clinics in Assuit ophthalmology hospital with no history of ocular treatment (ocular treatment naïve) and visual acuity of 0.1 (6/60) or more that are able to complete an eye examination, and non-diabetic healthy individuals (HbA1c \\<7) will be included in the study.\n\nExclusion Criteria:\n\n* Known diagnosis of any other retinal disease, glaucoma, neurodegenerative disease, and any significant media opacities that precluded fundus imaging and not giving consent will be excluded.'}, 'identificationModule': {'nctId': 'NCT06272851', 'briefTitle': 'Measuring Choroidal Thickness Using Optical Coherence Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparing the Choroidal Thickness Using Optical Coherence Tomography Between the Eyes of Healthy Individuals and Diabetic Patients Without Retinopathy', 'orgStudyIdInfo': {'id': 'Choroidal thickness by OCT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diabetics', 'description': 'Type 2 DM patients aged 30 to 80 years', 'interventionNames': ['Device: optical coherence tomography']}, {'label': 'non diabetics', 'description': 'non-diabetic healthy individuals', 'interventionNames': ['Device: optical coherence tomography']}], 'interventions': [{'name': 'optical coherence tomography', 'type': 'DEVICE', 'description': 'measuring choroidal thickness using optical coherence tomography', 'armGroupLabels': ['diabetics', 'non diabetics']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nancy Basem Monir', 'role': 'CONTACT', 'email': 'nancy.basem2010@gmail.com', 'phone': '+201229159038'}, {'name': 'Islam Mohamed Gouda', 'role': 'CONTACT', 'email': 'Islamgoda@med.aun.edu.eg', 'phone': '+201061882554'}], 'overallOfficials': [{'name': 'Mohammed Shehata Hussein', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Dalia Mohamed El-Sebaity', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'NBMonier', 'investigatorFullName': 'Nancy Basem Monier', 'investigatorAffiliation': 'Assiut University'}}}}