Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT02628158
Status:
COMPLETED
Last Update Posted:
2015-12-11
First Post:
2015-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fundus Autofluorescence After Vitrectomy for Epiretinal Membrane
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': 'D014821', 'term': 'Vitrectomy'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2015-12-06', 'studyFirstSubmitQcDate': '2015-12-08', 'lastUpdatePostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity before and after surgery', 'timeFrame': 'Changes from baseline to 1, 3, 6 months', 'description': 'Vision'}], 'secondaryOutcomes': [{'measure': 'Presence of fluids autofluorescence at the macular area', 'timeFrame': 'Changes from baseline up to 6 months', 'description': 'Fundus autofluorescence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epiretinal membrane'], 'conditions': ['Epiretinal Membrane']}, 'descriptionModule': {'briefSummary': 'Fundus autofluorescence (FAF) at the macula originates from hyperfluorescence from retinal pigment epithelium (RPE) and blockage of hyperfluorescence by macular pigment. Investigators evaluate whether presence of FAF may correlate to the postoperative visual outcome for epiretinal membrane.', 'detailedDescription': '92 eyes with epiretinal membrane were performed vitreous surgery, epiretinal membrane removal and internal limiting membrane (ILM) peeling. Presence of hyperfluorescence in FAF at the macular area and best-corrected visual acuity (BCVA) was evaluated preoperatively and at postoperative 1, 3, and 6 months with ultra-wide angle imaging.'}, 'eligibilityModule': {'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients with epiretinal membrane who underwent vitrectomy with epiretinal membrane and internal limiting membrane removal', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal for epiretinal membrane and had followed for more than 6 months.\n\nExclusion Criteria:\n\n* The patients with follow-up less than 6 months.'}, 'identificationModule': {'nctId': 'NCT02628158', 'briefTitle': 'Fundus Autofluorescence After Vitrectomy for Epiretinal Membrane', 'organization': {'class': 'OTHER', 'fullName': 'Kyorin University'}, 'officialTitle': 'Correlation of Postoperative Vision and Fundus Autofluorescence After Vitrectomy for Epiretinal Membrane', 'orgStudyIdInfo': {'id': 'Kyorineye019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vitrectomy with internal limiting membrane removal', 'type': 'PROCEDURE', 'description': 'Vitrectomy with removal of epiretinal membrane and internal limiting membrane'}]}, 'contactsLocationsModule': {'locations': [{'zip': '181-8611', 'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kyorin Eye Center', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}], 'overallOfficials': [{'name': 'Makoto Inoue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyorin Eye Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyorin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology', 'investigatorFullName': 'Makoto Inoue', 'investigatorAffiliation': 'Kyorin University'}}}}