Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT03586193
Status:
UNKNOWN
Last Update Posted:
2018-07-13
First Post:
2018-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pars Plana Vitrectomy Alone in the Treatment of Macular Schisis in High Myopic Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-02', 'studyFirstSubmitDate': '2018-06-15', 'studyFirstSubmitQcDate': '2018-07-02', 'lastUpdatePostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The morphologic change of macular area', 'timeFrame': 'OCT will be done one day before surgery and one week, one month, three months and six months after surgery', 'description': 'The thickness of the macular fovea in optical coherence tomography (OCT)'}], 'secondaryOutcomes': [{'measure': 'The best corrected visual acuity (BCVA) change', 'timeFrame': 'One day before surgery and one week, one month, three months and six months after surgery', 'description': 'The BCVA of all involved patients'}, {'measure': 'The best corrected near visual acuity (BCNVA) change', 'timeFrame': 'One day before surgery and one week, one month, three months and six months after surgery', 'description': 'The BCNVA of all involved patients'}, {'measure': 'The visual function change', 'timeFrame': 'One day before surgery and one week, one month, three months and six months after surgery', 'description': 'The contrast sensitivity of all involved patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retinal Disease', 'Macular Retinoschisis']}, 'referencesModule': {'references': [{'pmid': '24414402', 'type': 'BACKGROUND', 'citation': 'Chang JS, Flynn HW Jr, Engelbert M, Shane AR, Smiddy WE, Chang S. Pars plana vitrectomy in patients with myopic macular retinoschisis. Br J Ophthalmol. 2014 Apr;98(4):534-7. doi: 10.1136/bjophthalmol-2013-304578. Epub 2014 Jan 10.'}, {'pmid': '27429390', 'type': 'RESULT', 'citation': 'Zhang Z, Wei Y, Jiang X, Zhang S. PARS PLANA VITRECTOMY AND WIDE INTERNAL LIMITING MEMBRANE PEELING WITH PERFLUOROPROPANE TAMPONADE FOR HIGHLY MYOPIC FOVEOSCHISIS-ASSOCIATED MACULAR HOLE. Retina. 2017 Feb;37(2):274-282. doi: 10.1097/IAE.0000000000001146.'}, {'pmid': '24246446', 'type': 'RESULT', 'citation': 'Rey A, Jurgens I, Maseras X, Carbajal M. Natural course and surgical management of high myopic foveoschisis. Ophthalmologica. 2014;231(1):45-50. doi: 10.1159/000355324. Epub 2013 Nov 12.'}]}, 'descriptionModule': {'briefSummary': 'High myopic schisis (HMF) has the clinical feature of separation between retinal layers. It is sometimes accompanied with foveal retinal detachment, macular lamellar hole, epiretinal membrane and vitreous retraction. HMF may develop to macular hole, macular detachment and will damage the visual function. Pars plana vitrectomy (PPV) is a commonly used surgery in the treatment of HMF. PPV together with internal limiting membrane (ILM) peeling and long-term gas tamponade was reported to be safe and effective. But nowadays there was no available long-term gas in our country. Also, whether ILM peeling is necessary remains controversial, Indole cyanine green (ICG)was proved to have potential toxicity to the retina and the ILM peeling has the risk of causing secondary macular hole. We propose to make a prospective nonrandomized controlled study to evaluate the safety and efficiency of using PPV alone in the treatment of HMF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be selected from the in-patients in Shanghai Aier Eye Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed as high myopic macular retinoschisis, with axial length more than 26.5mm.\n2. Morphologic manifestation in OCT shows split between retinal layers in macular area.\n3. Patients without severe systemic disease and can tolerate surgery.\n\nExclusion Criteria:\n\n1. Patients also have other ocular disease, including glaucoma, keratitis,uveitis, retinal detachment,etc.\n2. Patients with nystagmus or have difficult to open the eye.\n3. Patients with severe systemic disease and cannot tolerate surgery.'}, 'identificationModule': {'nctId': 'NCT03586193', 'briefTitle': 'Pars Plana Vitrectomy Alone in the Treatment of Macular Schisis in High Myopic Eyes', 'organization': {'class': 'OTHER', 'fullName': 'Aier School of Ophthalmology, Central South University'}, 'officialTitle': 'Application of Pars Plana Vitrectomy in the Treatment of Macular Schisis in High Myopic Eyes', 'orgStudyIdInfo': {'id': 'SHIRB2018014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with HMF', 'description': 'Patients who are diagnosed as high myopic macular schisis and agree to receive pars plana vitrectomy as the treatment are planned to allocated in this group', 'interventionNames': ['Procedure: Pars plana vitrectomy']}], 'interventions': [{'name': 'Pars plana vitrectomy', 'type': 'PROCEDURE', 'description': 'pars plana vitrectomy without ICG staining and ILM peeling', 'armGroupLabels': ['patients with HMF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhuyun Qian, Doctor', 'role': 'CONTACT', 'email': 'qianzhuyun552@126.com', 'phone': '+8613817109809', 'phoneExt': '+8618650424985'}, {'name': 'Wensheng Li, Doctor', 'role': 'CONTACT', 'email': 'drlws@qq.com', 'phone': '+8618650424985', 'phoneExt': '+8618650424985'}], 'facility': 'Shanghai Aier Eye hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhuyun Qian, Doctor', 'role': 'CONTACT', 'email': 'qianzhuyun552@126.com', 'phone': '+8613817109809', 'phoneExt': '+8618650424985'}, {'name': 'Wensheng Li, Doctor', 'role': 'CONTACT', 'email': 'drlws@qq.com', 'phone': '+8618650424985', 'phoneExt': '+8618650424985'}], 'overallOfficials': [{'name': 'Wensheng Li, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Aier Eye Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After this study is finished the data will become available for 1year.', 'ipdSharing': 'YES', 'description': 'all individual participant data (IPD) that underlie results', 'accessCriteria': 'The analytical data will be accessed in published articles.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aier School of Ophthalmology, Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}