Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT07038668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Innovative Appliance of Cohesive Viscoelastic During Pars Plana Vitrectomy in Complicated Ocular Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Corrected Visual Acuity(BCVA)', 'timeFrame': 'From enrollment to the end of follow up in 3 months', 'description': 'Best Corrected Visual Acuity'}, {'measure': 'Reattachment of Retina', 'timeFrame': 'Post operation till the end of follow up in 3 months', 'description': 'Check through ultrasound, optical coherence tomography(OCT) to see if retina is reattached.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ocular Trauma']}, 'descriptionModule': {'briefSummary': 'Viscoelastic is a powerful tool in pars plana vitrectomy(PPV) surgery relative to perfluorocarbon liquid because it has the properties to dilate and engorge the retina and restore the detached retina to its original position. We intend to explore whether the use of viscoelastic to assist PPV surgery can help improve surgical efficiency, reduce tissue damage, and improve the outcomes of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be selected from the outpatient department of Zhongshan Ophthalmic Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe traumatic ocular injury (ocular trauma score, OTS=1 or 2)\n* PVR retinal detachment (Stage D2 or D3)\n\nExclusion Criteria:\n\n* Visual acuity below the base line before injury'}, 'identificationModule': {'nctId': 'NCT07038668', 'briefTitle': 'The Innovative Appliance of Cohesive Viscoelastic During Pars Plana Vitrectomy in Complicated Ocular Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, 'officialTitle': 'The Innovative Appliance of Cohesive Viscoelastic During Pars Plana Vitrectomy in Complicated Ocular Trauma', 'orgStudyIdInfo': {'id': '2025KYPJ043'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed Group', 'interventionNames': ['Procedure: Using of viscoelastic during the operation']}, {'label': 'Non-Exposed Group', 'interventionNames': ['Procedure: No using of viscoelastic during the operation']}], 'interventions': [{'name': 'Using of viscoelastic during the operation', 'type': 'PROCEDURE', 'description': 'Using of viscoelastic during the operation', 'armGroupLabels': ['Exposed Group']}, {'name': 'No using of viscoelastic during the operation', 'type': 'PROCEDURE', 'description': 'No using of viscoelastic during the operation', 'armGroupLabels': ['Non-Exposed Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Liuxueying Zhong, Dr.', 'role': 'CONTACT', 'email': 'zhongliuxueying@gzzoc.com', 'phone': '15099954411'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Xueying Zhongliu', 'investigatorAffiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}}}}