Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT06133660
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2023-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-10', 'studyFirstSubmitDate': '2023-11-10', 'studyFirstSubmitQcDate': '2023-11-10', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'degree of lens opacity', 'timeFrame': '1 year'}, {'measure': 'lens thickness', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'anterior chamber depth', 'timeFrame': '1 year'}, {'measure': 'axial length', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aqueous tamponade', 'cataract', 'lens thickness', 'axial length', 'pars plana vitrectomy'], 'conditions': ['Aqueous Tamponade', 'Cataract']}, 'descriptionModule': {'briefSummary': 'To observe the effects of vitreous cavity Balanced salt solution (BSS) tamponade on the state of the lens and related parameters of the eye, and whether the changes of the above parameters are correlated with age, gender, diabetes or not, etc., so as to provide references for the diagnosis and treatment of related diseases and scientific research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who undergoing vitrectomy for diabetic retinopathy, epiretinal membranes, macular hole, retinal detachment, and other diseases, or underwent vitreous silicone oil tamponade and vitreous silicone oil removal due to various causes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ① Patients undergoing vitrectomy for diabetic retinopathy, epiretinal membranes, macular hole, retinal detachment, and other diseases;\n\n * Patients who underwent vitreous silicone oil tamponade and vitreous silicone oil removal due to various causes; ③ Intraoperative BSS was used for fill the vitreous cavity; ④ Before treatment, inform the patient that the clinical data may be used in clinical research, and the patient and his family are informed and sign the informed consent.\n\nExclusion Criteria:\n\n* ① The operation eye was intraocular lens or cataract extraction during operation; ② Suspensory ligament relaxation or rupture, ciliary body detachment or transaction, lens dislocation, endophthalmitis, traumatic cataract;\n\n * intraoperative lens injury; ④ patients who refused to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06133660', 'briefTitle': 'Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular', 'organization': {'class': 'OTHER', 'fullName': 'Second Hospital of Jilin University'}, 'officialTitle': 'Influence of Intravitreal Aqueous Tamponade on Lens Status and Ocular', 'orgStudyIdInfo': {'id': 'second hospital of JilinU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PPV（pars plana vitrectomy） group', 'interventionNames': ['Procedure: pars plana vitrectomy']}, {'label': 'Silicone oil removal group', 'interventionNames': ['Procedure: pars plana vitrectomy']}], 'interventions': [{'name': 'pars plana vitrectomy', 'type': 'PROCEDURE', 'otherNames': ['Silicone oil removal'], 'description': 'pars plana vitrectomy and Silicone oil removal to distinguish subjects', 'armGroupLabels': ['PPV（pars plana vitrectomy） group', 'Silicone oil removal group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changchun', 'country': 'China', 'facility': 'The Second Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bo Jia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Bo Jia', 'investigatorAffiliation': 'Second Hospital of Jilin University'}}}}