Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-30 @ 4:42 AM
Study NCT ID:
NCT01340703
Status:
COMPLETED
Last Update Posted:
2011-04-22
First Post:
2011-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitrectomy for Optic Disc Pit Maculopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012163', 'term': 'Retinal Detachment'}, {'id': 'D041441', 'term': 'Retinoschisis'}, {'id': 'D020255', 'term': 'Vitreous Detachment'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014821', 'term': 'Vitrectomy'}, {'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-21', 'studyFirstSubmitDate': '2011-04-21', 'studyFirstSubmitQcDate': '2011-04-21', 'lastUpdatePostDateStruct': {'date': '2011-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anatomical result', 'timeFrame': 'one year', 'description': 'resolution of retinal detachment or retinoschisis'}], 'secondaryOutcomes': [{'measure': 'visual acuity', 'timeFrame': 'one year', 'description': 'preoperative and postoperative visual acuity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['optic disc pit', 'retinal detachment', 'retinoschisis', 'vitrectomy', 'posterior vitreous detachment'], 'conditions': ['Optic Disc Pit Maculopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of vitrectomy, without gas tamponade or laser photocoagulation to the margin of the optic nerve, for the treatment of macular detachment associated with optic disc pits and to characterize retinal manifestations during treatment of optic pit maculopathy using optical coherence tomography (OCT). Vitrectomy with induction of a PVD at the optic disc without gas tamponade or laser photocoagulation appears to be an effective method of managing macular detachment due to optic disc pits. OCT scanning pre- and postoperatively suggests that peripapillary vitreous traction with the passage of fluid into the retina through the pit is the cause of the schisis-like separation seen in optic disc pit maculopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* eyes with optic disc pit maculopathy\n\nExclusion Criteria:\n\n* eyes without macular elevation associated with optic disc pit'}, 'identificationModule': {'nctId': 'NCT01340703', 'briefTitle': 'Vitrectomy for Optic Disc Pit Maculopathy', 'organization': {'class': 'OTHER', 'fullName': 'Kyorin University'}, 'officialTitle': 'Vitrectomy Without Laser or Gas Tamponade for Optic Disc Pit Maculopathy', 'orgStudyIdInfo': {'id': 'KyorinEye005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'optic disc pit maculopathy', 'interventionNames': ['Procedure: vitrectomy without laser or gas tamponade']}], 'interventions': [{'name': 'vitrectomy without laser or gas tamponade', 'type': 'PROCEDURE', 'description': 'vitrectomy without laser or gas tamponade', 'armGroupLabels': ['optic disc pit maculopathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '181-8611', 'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kyroin University Eye Center', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}], 'overallOfficials': [{'name': 'Akito Hirakata, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyroin University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyorin University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Akito Hirakata', 'oldOrganization': 'Kyorin University'}}}}