Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT04120818
Status:
COMPLETED
Last Update Posted:
2019-10-09
First Post:
2019-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Cytokines in Congenital Cataract After Lensectomy and Anterior Vitrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-06', 'studyFirstSubmitDate': '2019-06-19', 'studyFirstSubmitQcDate': '2019-10-06', 'lastUpdatePostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inflammatory cytokines', 'timeFrame': 'before the surgery of secondary IOL implantation', 'description': 'investigate inflammatory microenvironment changes in the aqueous of children after surgery.aqueous humor levels of cytokines, chemokines and growth factors including TGFβ2, TNF-α, IL-6, IP10, IL-10, MCP-1, VEGF, IL-1, IFN-γ, IL-1r,IL-4,IL-17, IL-2,IL-5,G-CSF,IL-12, IL-15.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inflammatory cytokines'], 'conditions': ['Congenital Cataract']}, 'descriptionModule': {'briefSummary': 'In this prospective study , a cohort of 58 eyes with congenital cataract from Wenzhou medical university was erolled.33 eyes with congenital cataract was after lensectomy and anterior vitrectomy as post-surger group, 26 eyes without cataract surgery as control group. The cytokines of MCP-1, VEGF, IL-1, IFN-γ, IL-1r,IL-4,IL-17, IL-2,IL-5,G-CSF,IL-12, IL-15 was evaluated', 'detailedDescription': 'Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and primary IOL implantation in children with congenital cataract were both performed by the same surgeon(Z.Y.E) and videos were collected to review the capsular reconstruction condition and lens implantation position.\n\nAqueous humor (100-200 μl) was aspirated from each patient before the surgery. The research was to evaluate the relationship between the cytokine profile in aqueous humor and the state of capsule after Lensectomy and Anterior Vitrectomy.Aqueous humor was obtained , Human Magnetic Luminex Screening Assay was used to determine the aqueous humor levels of cytokines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '72 Months', 'minimumAge': '10 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'congenital cataract age from 10 months to 72 months who underwent cataract surgery or aphakic children age from 15 months to 72 months who underwent secondary IOL implantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: aphakic children diagnosed with congenital cataract who underwent secondary IOL implantation and children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation\n\nExclusion Criteria:patients with mild cataracts do not require surgery\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04120818', 'briefTitle': 'Inflammatory Cytokines in Congenital Cataract After Lensectomy and Anterior Vitrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Expression Profile of Inflammatory Cytokines in Congenital Cataract After Lensectomy and Anterior Vitrectomy', 'orgStudyIdInfo': {'id': 'yyzhao'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SIOL group', 'description': 'aphakic children diagnosed with congenital cataract who underwent secondary IOL implantation', 'interventionNames': ['Procedure: secondary IOL implantation']}, {'label': 'PIOL group', 'description': 'children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation', 'interventionNames': ['Procedure: primary IOL implantation']}], 'interventions': [{'name': 'secondary IOL implantation', 'type': 'PROCEDURE', 'description': 'reopened the fibrotic, closed capsular bag and achieve IOL placement', 'armGroupLabels': ['SIOL group']}, {'name': 'primary IOL implantation', 'type': 'PROCEDURE', 'description': 'lensectomy and anterior vitrectomy and primary IOL implantation', 'armGroupLabels': ['PIOL group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Eye Hosptial of Wenzhou Medical College', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Ophthalmology and Optometry Hospital', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'yin ying zhao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'yin ying zhao', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}