Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 10:16 PM
Study NCT ID:
NCT01658761
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2012-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-01', 'studyFirstSubmitDate': '2012-07-28', 'studyFirstSubmitQcDate': '2012-08-01', 'lastUpdatePostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'One year', 'description': 'Preoperative and postoperative visual acuity'}], 'secondaryOutcomes': [{'measure': 'Optical coherence tomography', 'timeFrame': 'One year', 'description': 'Anatomical retinal images by optical cohernce tomography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myopic traction maculopathy', 'vitrectomy', 'internal limiting membrane', 'Retrospective, case control study'], 'conditions': ['Maculopathy', 'High Myopia', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.', 'detailedDescription': 'Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage of macular retinischisis, foveal detachment, or macular hole. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eyes with myopic traction maculopathy in highly myopic eyes with refractive errors ≤ -8.0 diopters and axial length ≥ 26.0 mm who underwent vitrectomy\n\nExclusion Criteria:\n\n* Eyes with follow-up less than a year'}, 'identificationModule': {'nctId': 'NCT01658761', 'briefTitle': 'Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes', 'organization': {'class': 'OTHER', 'fullName': 'Kyorin University'}, 'officialTitle': 'Surgical Outcome of Vitrectomy for Myopic Traction Maculopathy in Highly Myopic Eyes', 'orgStudyIdInfo': {'id': 'KyorinEye008'}, 'secondaryIdInfos': [{'id': 'Myopic maculopathy'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myopic traction maculopathy', 'description': 'The 71 eyes of 64 patients (14 men and 50 women) with myopic traction maculopathy in highly myopic eyes (refractive errors ≤-8.0 diopters and axial length ≥26.0 mm) who underwent vitrectomy were retrospectively reviewed.', 'interventionNames': ['Procedure: vitrectomy']}], 'interventions': [{'name': 'vitrectomy', 'type': 'PROCEDURE', 'otherNames': ['Myopic traction maculopathy in highly myopic eyes'], 'description': 'Surgery', 'armGroupLabels': ['Myopic traction maculopathy']}]}, '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyorin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assosiate professor of Ophthalmology', 'investigatorFullName': 'Makoto Inoue', 'investigatorAffiliation': 'Kyorin University'}}}}