Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
Study NCT ID:
NCT04976608
Status:
UNKNOWN
Last Update Posted:
2021-07-26
First Post:
2021-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000550', 'term': 'Amblyopia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-15', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macular thickness', 'timeFrame': '2021.12.30', 'description': 'Scan the 3.0mm diameter ETDRS ring area in the macular area with SD-OCT.'}, {'measure': 'Subfoveal choroidal thickness', 'timeFrame': '2021.12.30', 'description': 'Scan the Subfoveal choroid in enhanced scan mode with SD-OCT.'}, {'measure': 'Retinal nerve fiber layer thickness', 'timeFrame': '2021.12.30', 'description': 'Scan concentric circles with a length of 3.4mm and a diameter ranging from 2.5mm to 4.0mm in 12 directions centered on the optic disc with SD-OCT.'}, {'measure': 'The volume of the lateral geniculate body', 'timeFrame': '2021.12.30', 'description': 'Measure the volume of the lateral geniculate body by T1 phase scan of MRI'}, {'measure': 'The volume of the brodmann 17,18,19 area', 'timeFrame': '2021.12.30', 'description': 'Masure the volume of the brodmann 17,18,19 area by T1 phase scan of MRI'}, {'measure': 'The FA of the white matter fiber bundle', 'timeFrame': '2021.12.30', 'description': 'Measure the Fraction Anisotropy of the white matter fiber bundle related to visual signal transduction by DWI scan of MRI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['amblyopia', 'MRI', 'SD-OCT', 'visual acuity', 'retinal structure', 'visual cortex structure'], 'conditions': ['Congenital Cataract']}, 'referencesModule': {'references': [{'pmid': '30854758', 'type': 'BACKGROUND', 'citation': 'Lu L, Li Q, Zhang L, Tang S, Yang X, Liu L, Sweeney JA, Gong Q, Huang X. Altered cortical morphology of visual cortex in adults with monocular amblyopia. J Magn Reson Imaging. 2019 Nov;50(5):1405-1412. doi: 10.1002/jmri.26708. Epub 2019 Mar 10.'}, {'pmid': '29450539', 'type': 'BACKGROUND', 'citation': 'Allen B, Schmitt MA, Kushner BJ, Rokers B. Retinothalamic White Matter Abnormalities in Amblyopia. Invest Ophthalmol Vis Sci. 2018 Feb 1;59(2):921-929. doi: 10.1167/iovs.17-22930.'}, {'pmid': '28539328', 'type': 'BACKGROUND', 'citation': 'Long E, Zhang X, Liu Z, Wu X, Tan X, Lin D, Cao Q, Chen J, Lin Z, Wang D, Li X, Li J, Wang J, Li W, Lin H, Chen W, Liu Y. Dynamic response to initial stage blindness in visual system development. Clin Sci (Lond). 2017 Jun 28;131(13):1515-1527. doi: 10.1042/CS20170234. Print 2017 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the influence of the visual acuity after congenital surgery on the retinal and visual cortex structure.', 'detailedDescription': 'According to the visual acuity after congenital cataract surgery, 30 patients are divided into 3 groups.SD-OCT and MRI were used to measure the parameters of the retina and the visual cortex, to compare the differences between different groups, and to analyze the relationship between the structure of the retina and the visual cortex and visual acuity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '4 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with congenital cataract and were informed about their inclusion in the study and provided written consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of 4-60 years\n* Congenital cataract surgery is planned\n* The operation was successful without any complications\n* Can cooperate well with OCT and MRI examinations\n\nExclusion Criteria:\n\n* Intraoperative and postoperative complications include glaucoma, retinal, corneal, or refractive medium diseases\n* Behavioral, cognitive impairment\n* Developmental delay'}, 'identificationModule': {'nctId': 'NCT04976608', 'briefTitle': 'Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery', 'orgStudyIdInfo': {'id': 'amblyopia-LZL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'The BCVA of eyes is greater than 0.6'}, {'label': 'Group 2', 'description': 'The BCVA of eyes is from 0.1 to 0.6'}, {'label': 'Group 3', 'description': 'The BCVA of eyes is less than 0.6'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhangliang Li', 'role': 'CONTACT', 'email': 'lizhangliang0328@126.com', 'phone': '13968832833'}], 'facility': 'Eye Hospital of Wenzhou Medical College', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Yune Zhao', 'role': 'CONTACT', 'email': 'zyehzeye@126.com', 'phone': '8613819707056'}, {'name': 'Jiayan Fang', 'role': 'CONTACT', 'email': '1132093186@qq.com', 'phone': '8615957793328'}], 'overallOfficials': [{'name': 'Yune Zhao', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ophthalmology and Optometry Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Eye Hospital of Wenzhou Medical University', 'investigatorFullName': 'Yune Zhao', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}