Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-22 @ 9:26 AM
Study NCT ID:
NCT01862627
Status:
COMPLETED
Last Update Posted:
2014-08-20
First Post:
2013-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057066', 'term': 'Low Tension Glaucoma'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve 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_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-18', 'studyFirstSubmitDate': '2013-05-15', 'studyFirstSubmitQcDate': '2013-05-23', 'lastUpdatePostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optical coherence tomography', 'timeFrame': 'One year', 'description': 'Anatomical improvement detected with optical coherence tomography after surgical intervention.'}], 'secondaryOutcomes': [{'measure': 'Visual recovery', 'timeFrame': 'One year', 'description': 'The number of the patients with visual recovery after surgical intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Macular retinoschisis', 'Macular detachment', 'vitrectomy'], 'conditions': ['Macular Retinoschisis', 'Macular Detachment', 'Normal Tension Glaucoma']}, 'descriptionModule': {'briefSummary': 'Clinical features, optical coherence tomography findings and surgical outcome in eyes with macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit or high myopia were evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients with macular retinoschisis and detachment associated with normal tension glaucoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients with macular retinoschisis and detachment associated with normal tension glaucoma\n\nExclusion Criteria:\n\n* Optic pit maculopathy, high myopia'}, 'identificationModule': {'nctId': 'NCT01862627', 'briefTitle': 'Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Kyorin University'}, 'officialTitle': 'Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy But Without Optic Disc Pit Nor High Myopia', 'orgStudyIdInfo': {'id': 'Kyorineye011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Macular retinoschisis and detachment', 'interventionNames': ['Procedure: Optical coherence tomography']}], 'interventions': [{'name': 'Optical coherence tomography', 'type': 'PROCEDURE', 'armGroupLabels': ['Macular retinoschisis and detachment']}]}, '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': 'Associate professor of ophthalmology', 'investigatorFullName': 'Makoto Inoue', 'investigatorAffiliation': 'Kyorin University'}}}}