Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2026-01-03 @ 10:52 AM
Study NCT ID:
NCT06357559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OCTA Changes in Choroidal Neovascularization in High Myopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describing the Choroidal Neovascularization in High Myopic Patients diagnosed by OCTA', 'timeFrame': '1 year', 'description': 'Describing the Choroidal Neovascularization in High Myopic Patients diagnosed by OCTA Regarding its Activity ..'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopic Choroidal Neovascularisation']}, 'referencesModule': {'references': [{'pmid': '29111299', 'type': 'BACKGROUND', 'citation': 'Ohno-Matsui K, Ikuno Y, Lai TYY, Gemmy Cheung CM. Diagnosis and treatment guideline for myopic choroidal neovascularization due to pathologic myopia. Prog Retin Eye Res. 2018 Mar;63:92-106. doi: 10.1016/j.preteyeres.2017.10.005. Epub 2017 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'To Analyze the Ability of Optical Coherence Tomography Angiography ( OCT-A ) to detect the presence of myopic Choroidal Neovascularization and to describe the structural features of Myopic CNV..', 'detailedDescription': 'To Analyze the Ability of Optical Coherence Tomography Angiography ( OCT-A ) to detect the presence of myopic Choroidal Neovascularization and to describe the structural features of Myopic CNV.. regarding the size , shape , core , margin , Appearance , and activity of CNV..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with High Myopia ( Refractive Error \\> -6D or Axial Length \\> 26,5 mm ) with Fundoscopic Changes Consistent with CNVM.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Patients with High Myopia ( \\> -6 D or Axial Length \\> 26.5 mm ) with Fundoscopic Changes Consistent with CNVM , with Clear Media are Subjected to OCTA\n\nExclusion Criteria:\n\n* Patients with Treated CNVs , or with other Causes of CNVs including :\n\nNeovascular AMD , Idiopathic CNV , Traumatic , Inflammatory , Neoplastic , Degenerative ..'}, 'identificationModule': {'nctId': 'NCT06357559', 'briefTitle': 'OCTA Changes in Choroidal Neovascularization in High Myopia', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Optical Coherence Tomography Angiography Changes in Choroidal Neovascularization in High Myopia', 'orgStudyIdInfo': {'id': 'OCTA in Myopic CNV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OCTA', 'type': 'DEVICE', 'description': 'Optical Coherence Tomography Angiography'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Hamdy', 'role': 'CONTACT', 'email': 'fcb9976@Gmail.com', 'phone': '01287307536'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Ahmed Hamdy Abdelrahman', 'investigatorAffiliation': 'Sohag University'}}}}