Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
Study NCT ID:
NCT04146350
Status:
UNKNOWN
Last Update Posted:
2019-10-31
First Post:
2019-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Multicenter Study of Different Surgical Methods in the Treatment of High Myopic Macular Schisis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005740', 'term': 'Gases'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2022-06-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-29', 'studyFirstSubmitDate': '2019-10-24', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'foveal thickness', 'timeFrame': 'change from baseline foveal thickness at 3, 6, 9, 12 months', 'description': 'measured by OCT'}, {'measure': 'retinal thickness of the most significant schisis', 'timeFrame': 'change from baseline at 3, 6, 9, 12 months', 'description': 'measured by OCT'}], 'secondaryOutcomes': [{'measure': 'best corrected visual acuity', 'timeFrame': 'change from baseline at 3, 6, 9, 12 months', 'description': 'BCVA'}, {'measure': 'mf-ERG', 'timeFrame': 'change from baseline at 3, 6, 9, 12 months', 'description': 'multifocal-ERG'}, {'measure': 'Visual quality questionnaire', 'timeFrame': 'change from baseline at 3, 6, 9, 12 months', 'description': 'Visual quality questionnaire'}, {'measure': 'axial length', 'timeFrame': 'change from baseline at 3, 6, 9, 12 months', 'description': 'axial length measured by IOL Master'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Macular Schisis']}, 'referencesModule': {'references': [{'pmid': '31060414', 'type': 'BACKGROUND', 'citation': 'Dolar-Szczasny J, Swiech-Zubilewicz A, Mackiewicz J. A Review of Current Myopic Foveoschisis Management Strategies. Semin Ophthalmol. 2019;34(3):146-156. doi: 10.1080/08820538.2019.1610180. Epub 2019 May 6.'}]}, 'descriptionModule': {'briefSummary': 'In view of the current problem of treating high myopic macular schisis, the main purpose of our study is to find out the most appropriate time of surgical intervention, to compare the effectiveness and safety of various surgical methods in the treatment of high myopic macular schisis, and to find out the advantages and disadvantages of each surgical method in the treatment of MF. As well as the outcomes and complications of long-term follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. diopter ≤-6.00D or axial length ≥ 26.00mm;\n2. OCT showed macular schisis with or without macular retinal detachment;\n3. agreed to participate in this project and signed informed consent form.\n\nExclusion Criteria:\n\n1. OCT confirmed full-thickness macular hole with or without macular retinal detachment；\n2. submacular active or inactive CNV;\n3. previous vitreoretinal surgery and anti-glaucoma surgery；\n4. with rhegmatogenous retinal detachment, ocular trauma, glaucoma, corneal opacity and other ophthalmic diseases;\n5. complicated with severe systemic disease can not tolerate surgery or follow-up;\n6. do not agree to participate the project or disagree with the follow-up.'}, 'identificationModule': {'nctId': 'NCT04146350', 'acronym': 'Recovery', 'briefTitle': 'A Prospective Multicenter Study of Different Surgical Methods in the Treatment of High Myopic Macular Schisis', 'organization': {'class': 'OTHER', 'fullName': 'Aier School of Ophthalmology, Central South University'}, 'officialTitle': 'A Prospective Multicenter Study of Different Surgical Methods for the Treatment of Macular Schisis in High Myopia Based on the Real World', 'orgStudyIdInfo': {'id': 'AM1901D3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PPV+/-Cat', 'interventionNames': ['Procedure: PPV+/-Cat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PPV+/-Cat+Gas', 'interventionNames': ['Procedure: PPV+/-Cat+Gas']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PPV+ILM+/-Cat+/-Gas', 'interventionNames': ['Procedure: PPV+ILM+/-Cat+/-Gas']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PPV+ILM+/-Cat+/-Oil', 'interventionNames': ['Procedure: PPV+ILM+/-Cat+/-Oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PSR', 'interventionNames': ['Procedure: PSR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）', 'interventionNames': ['Procedure: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gas', 'interventionNames': ['Procedure: Gas']}], 'interventions': [{'name': 'PPV+/-Cat', 'type': 'PROCEDURE', 'description': 'pars plana vitrectomy+/-cataract', 'armGroupLabels': ['PPV+/-Cat']}, {'name': 'PPV+/-Cat+Gas', 'type': 'PROCEDURE', 'description': 'pars plana vitrectomy+/-cataract+gas tamponade', 'armGroupLabels': ['PPV+/-Cat+Gas']}, {'name': 'PPV+ILM+/-Cat+/-Gas', 'type': 'PROCEDURE', 'description': 'pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-gas tamponade', 'armGroupLabels': ['PPV+ILM+/-Cat+/-Gas']}, {'name': 'PPV+ILM+/-Cat+/-Oil', 'type': 'PROCEDURE', 'description': 'pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade', 'armGroupLabels': ['PPV+ILM+/-Cat+/-Oil']}, {'name': 'PSR', 'type': 'PROCEDURE', 'description': 'posterior scleral reinforcement', 'armGroupLabels': ['PSR']}, {'name': 'PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）', 'type': 'PROCEDURE', 'description': 'posterior scleral reinforcement+pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade (or gas)', 'armGroupLabels': ['PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）']}, {'name': 'Gas', 'type': 'PROCEDURE', 'description': 'gas tamponade alone', 'armGroupLabels': ['Gas']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiasong Yang', 'role': 'CONTACT', 'email': 'cammel@qq.com', 'phone': '+8618113024536'}, {'name': 'Wensheng Li', 'role': 'CONTACT', 'email': 'drlws@qq.com', 'phone': '+8618650424985'}], 'facility': 'Shanghai Aier Eye Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jiasong Yang', 'role': 'CONTACT', 'email': 'cammel@qq.com', 'phone': '+8618113024536'}, {'name': 'Wensheng Li', 'role': 'CONTACT', 'email': 'drlws@qq.com', 'phone': '+8618650424985'}], 'overallOfficials': [{'name': 'Weisheng Li', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Aier Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aier School of Ophthalmology, Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}