Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2025-12-26 @ 11:45 AM
Study NCT ID:
NCT06040216
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2023-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evolution of EIFL Following PPV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye 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': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-10', 'studyFirstSubmitDate': '2023-09-10', 'studyFirstSubmitQcDate': '2023-09-10', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': '1-month', 'description': 'Best corrected visual acuity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epiretinal Membrane']}, 'descriptionModule': {'briefSummary': 'Various classification systems have been described for epiretinal membrane (ERM). One of them is a new OCT-based staging scheme based on displacement and reorganization of inner retinal layers called ectopic inner retinal layers (EIFL). We evaluated pre-and perioperative factors related to time for evolution of EIFL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective study included 81 consecutive eyes with idiopathic epiretinal membrane that underwent vitrectomy surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing idiopathic epiretinal membrane surgery\n\nExclusion Criteria:\n\n* Patients undergoing seconder epiretinal membrane surgery'}, 'identificationModule': {'nctId': 'NCT06040216', 'briefTitle': 'Evolution of EIFL Following PPV', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Long-term Follow-up Results of Ectopic Inner Foveal Retinal Layers Evolution Following Pars Plana Vitrectomy', 'orgStudyIdInfo': {'id': 'KocaeliUniversity'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stage 2 ERM', 'interventionNames': ['Other: optical coherence tomography']}, {'label': 'Stage 3 ERM', 'interventionNames': ['Other: optical coherence tomography']}, {'label': 'Stage 4 ERM', 'interventionNames': ['Other: optical coherence tomography']}], 'interventions': [{'name': 'optical coherence tomography', 'type': 'OTHER', 'description': 'We observed the postoperative improvement in EIFL severity with optical coherence tomography', 'armGroupLabels': ['Stage 2 ERM', 'Stage 3 ERM', 'Stage 4 ERM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41001', 'city': 'Kocaeli', 'state': 'None Selected', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University School of Medicine', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Levent Karabas', 'investigatorAffiliation': 'Kocaeli University'}}}}