Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-26 @ 1:44 PM
Study NCT ID:
NCT06886893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Coherence Tomography in Retinal Vein Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-15', 'studyFirstSubmitDate': '2025-03-15', 'studyFirstSubmitQcDate': '2025-03-15', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in OCT biomarkers and visual acuity post-treatment.', 'timeFrame': '6 months', 'description': 'Correlation between baseline OCT biomarkers and visual acuity at presentation after 1, 3, and 6 months post-treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OCT', 'retinal vein occlusion'], 'conditions': ['Optical Coherence Tomography (OCT)']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate how optical coherence tomography (OCT) can help predict outcomes in patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. The study will use OCT scans to assess changes in the retina and how these changes relate to vision improvement over time.', 'detailedDescription': 'Objectives Evaluate how OCT data can predict visual outcomes by analyzing retinal changes and macular edema characteristics.\n\nAssess the correlation between baseline OCT biomarkers and visual acuity improvements over time.\n\nStudy Design Type: Cross-sectional study.\n\nSetting: Conducted at several eye care centers in Egypt.\n\nParticipants Inclusion Criteria: Adults with branch or central RVO, macular edema confirmed by OCT, and no prior RVO in the affected eye.\n\nExclusion Criteria: Other retinal diseases, recent intraocular surgery, or significant media opacities.\n\nProcedures Informed Consent and History Taking.\n\nOphthalmologic Examination: Includes BCVA, IOP, slit-lamp biomicroscopy, and fundus examination.\n\nOCT Imaging: Using NIDEK RS-330 Retina scan duo 2 (SD-OCT) to assess macular changes.\n\nOCT Image Evaluation: Classification of macular edema types and assessment of biomarkers like subretinal fluid and cystoid changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. Adults aged 18 or older with branch or central retinal vein occlusion. Patients must have macular edema confirmed by OCT and no previous RVO in the affected eye.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older.\n\nPatients diagnosed with branch or central retinal vein occlusion.\n\nPatients with macular edema confirmed by OCT due to vein occlusion.\n\nPatients with no prior history of RVO in the affected eye.\n\nExclusion Criteria:\n\n* Presence of other retinal diseases that could affect OCT interpretation (e.g., diabetic retinopathy, age-related macular degeneration).\n\nHistory of intraocular surgery within the last three months.\n\nPresence of significant media opacities (e.g., dense cataract, vitreous hemorrhage) that interfere with OCT imaging.'}, 'identificationModule': {'nctId': 'NCT06886893', 'briefTitle': 'Optical Coherence Tomography in Retinal Vein Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Optical Coherence Tomography Data As a Prognostic Indicator in Retinal Vein Occlusion', 'orgStudyIdInfo': {'id': 'OCT in retinal vein occlusion'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with branch or central RVO, macular edema confirmed by OCT, and no prior RVO in the affected', 'description': 'Adults aged 18 years or older.\n\nPatients diagnosed with branch or central retinal vein occlusion.\n\nPatients with macular edema confirmed by OCT due to vein occlusion.\n\nPatients with no prior history of RVO in the affected eye.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at the ophtalmology department', 'investigatorFullName': 'Mayar Adel Francis', 'investigatorAffiliation': 'Assiut University'}}}}