Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-25 @ 11:02 PM
Study NCT ID:
NCT02528058
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2015-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014821', 'term': 'Vitrectomy'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Excised internal limiting membrane during the surgical treatment for myopic traction maculopathy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-17', 'studyFirstSubmitDate': '2015-08-16', 'studyFirstSubmitQcDate': '2015-08-17', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity before and after surgery', 'timeFrame': '6 months', 'description': 'Comparison in logarithm of Minimum Angle of Resolution (logMAR) vision'}], 'secondaryOutcomes': [{'measure': 'Retinal reattachment', 'timeFrame': '6 months', 'description': 'Resolution of macular retinoschisis and foveal detachment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myopic traction maculopathy'], 'conditions': ['Myopic Traction Maculopathy']}, 'descriptionModule': {'briefSummary': 'The excised ILM from 7 eyes of 7 patients with MTM including 7 eyes with macular retinoschisis and 4 eyes with foveal detachment but without any retinal break underwent vitrectomy with induction of posterior vitreous detachment and ILM peeling was examined to evaluate ultrastructure with electron microscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who underwent vitrectomy with internal limiting membrane peeling for myopic traction maculopathy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane peeling for myopic traction maculopathy and had a follow-up for more than 6 months.\n\nExclusion Criteria:\n\n* The patients with follow-up less than 6 months'}, 'identificationModule': {'nctId': 'NCT02528058', 'briefTitle': 'Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy', 'organization': {'class': 'OTHER', 'fullName': 'Kyorin University'}, 'officialTitle': 'Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy', 'orgStudyIdInfo': {'id': 'Kyorineye018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Myopic traction maculopathy', 'interventionNames': ['Procedure: Vitrectomy with internal limiting membrane peeling']}], 'interventions': [{'name': 'Vitrectomy with internal limiting membrane peeling', 'type': 'PROCEDURE', 'armGroupLabels': ['Myopic traction maculopathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '181-8611', 'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Makoto Inoue', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}], 'overallOfficials': [{'name': 'Akito Hirakata, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyorin Eye Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyorin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kyorin Eye Center', 'investigatorFullName': 'Makoto Inoue', 'investigatorAffiliation': 'Kyorin University'}}}}