Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-08 @ 4:03 AM
Study NCT ID:
NCT02915133
Status:
SUSPENDED
Last Update Posted:
2019-09-19
First Post:
2016-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Structure and Visual Function in Myopia Foveoschisis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'study changed waiting renew', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2021-09-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2016-09-04', 'studyFirstSubmitQcDate': '2016-09-23', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline OCT at 6 months', 'timeFrame': '6 month postoperatively'}, {'measure': 'change from multifocal ERG at 6 months', 'timeFrame': '6 month postoperatively'}], 'secondaryOutcomes': [{'measure': 'change from Best-corrected visual acuity (BCVA) at 6 months', 'timeFrame': '6 month postoperatively'}]}, 'conditionsModule': {'keywords': ['high myopia', 'myopia foveoschisis', 'macular buckling'], 'conditions': ['High Myopia']}, 'descriptionModule': {'briefSummary': 'Macular foveoschisis (MF) is a common complication of pathological myopia, which is characterized by choroid-retinal degeneration and vision impairment. Although pars plana vitrectomy (PPV) is the primary method for MF treatment, there is still a large proportion of recurrent MF due to the extremely long global axial length and posterior staphyloma. Macular buckling (MB) surgery aims at counteracting the traction exerted by the posterior staphyloma, and has been proven an effective method for treating MF. Optical Coherence Tomography (OCT) is widely used for the structural analysis of MF. Multifocol electroretinogram (mfERG) is an objective examination for visual evaluation. To our knowledge, there is a lack of data on the comprehensive visual function evaluations of MF patients associated with OCT findings. Our clinical trial aims to provide the structural and functional relationship in MF patients undergoing MB surgery, and find out potential factors to determine the visual prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive participants with high myopia associated macular foveoschsis, who scheduled for surgery at Zhongshan Ophthalmic Center, Sun Yat-sen University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter;\n2. macular foveoschisis that requires surgical intervention.\n\nExclusion Criteria:\n\n1. ocular trauma or surgery history;\n2. glaucoma, diabetic retinopathy;\n3. intraocular active hemorrhage or inflammation;\n4. unable to coordinate the OCT, mfERG, or other ophthalmological examinations.'}, 'identificationModule': {'nctId': 'NCT02915133', 'briefTitle': 'The Relationship Between Structure and Visual Function in Myopia Foveoschisis', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Correlation of Structural and Visual Function Changes in Myopia Foveoschisis Patients Undergoing Macular Buckle Surgery', 'orgStudyIdInfo': {'id': '2016HM-MF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MF-MB', 'description': 'Consecutive participants with high myopic foveoschisis are scheduled to macular buckling (MB) surgery.', 'interventionNames': ['Procedure: macular buckling surgery']}], 'interventions': [{'name': 'macular buckling surgery', 'type': 'PROCEDURE', 'description': 'Participants with high myopia foveoschisis are scheduled to macular buckling (MB) surgery.', 'armGroupLabels': ['MF-MB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Fundus Disease Center of Zhongshan Ophthalmic Center', 'investigatorFullName': 'Lin Lu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}