Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT05367193
Status:
COMPLETED
Last Update Posted:
2024-06-17
First Post:
2022-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-13', 'studyFirstSubmitDate': '2022-04-26', 'studyFirstSubmitQcDate': '2022-05-04', 'lastUpdatePostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of injections of ICG', 'timeFrame': 'operation day', 'description': 'Fixed and minimal concentration: ICG (25mg/vial) is diluted to 0.05% Fixed time: Each injection is 15 sec Interval time for washout: consistent as 10 sec'}], 'secondaryOutcomes': [{'measure': 'Total surgical time', 'timeFrame': 'Intraoperative', 'description': 'Total surgical time'}, {'measure': 'ILM peeling time', 'timeFrame': 'operation day', 'description': 'ILM peeling time'}, {'measure': 'ICG exposure time', 'timeFrame': 'operation day', 'description': 'ICG exposure time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitreoretinal surgery', 'high myopia', 'Pars plana vitrectomy', '3D visualization system'], 'conditions': ['Patients With Highly Myopic Eyes']}, 'descriptionModule': {'briefSummary': 'To investigate the surgical outcomes and intraoperative parameters evaluation of 3D visualization system for vitreoretinal diseases in highly myopic eyes', 'detailedDescription': 'The investigators aimed to compare the safety and efficacy of NGENUITY® 3D Visualization System (Alcon, TX, USA) in vitreoretinal surgery of highly myopic patients with standard binocular microscope pars plana vitrectomy of highly myopic patients. This is a randomized controlled study and will enroll highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery. The enrolled patients will be randomized into "NGENUITY® 3D Visualization System (Alcon, TX, USA) group"(trial group) and "standard binocular microscope pars plana vitrectomy group"(controlled group). The investigators will compare the number of injections of dye (indocyanine green (ICG) or brilliant blue G (BBG)), total surgical time, total peeling time, exposure time of dye, power of endoilluminator, the rate of probe bending, surgical time, postoperative intraocular pressure (IOP), the rate of wound leakage, hypotony, subconjunctival hemorrhage, vitreous hemorrhage, retinal hemorrhage, and endophthalmitis, best-corrected visual acuity (BCVA), structural changes shown on OCT and so on between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Highly myopic patients (axial length ≥ 26mm, no upper limit)\n2. Patient with vitreoretinal pathology that require vitrectomy who had not received previous ICG or BBG-assisted membrane peeling\n3. Patient aged ≥ 20 years\n\nExclusion criteria:\n\n1. Patient who had previous ICG or BBG-assisted membrane peeling\n2. Patient who received combined vitrectomy and trabeculectomy\n3. Patient with endophthalmitis or intraocular foreign body'}, 'identificationModule': {'nctId': 'NCT05367193', 'briefTitle': '3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Surgical Outcomes and Intraoperative Parameters Evaluation of 3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes', 'orgStudyIdInfo': {'id': '202110065DINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA)', 'description': 'NGENUITY® 3D Visualization System (Alcon, TX, USA)', 'interventionNames': ['Procedure: pars plana vitrectomy', 'Device: NGENUITY® 3D Visualization System (Alcon, TX, USA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard binocular microscope pars plana vitrectomy', 'description': 'standard binocular microscope pars plana vitrectomy', 'interventionNames': ['Procedure: pars plana vitrectomy']}], 'interventions': [{'name': 'pars plana vitrectomy', 'type': 'PROCEDURE', 'description': 'pars plana vitrectomy for vitreoretinal disease in highly myopic eyes', 'armGroupLabels': ['pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA)', 'standard binocular microscope pars plana vitrectomy']}, {'name': 'NGENUITY® 3D Visualization System (Alcon, TX, USA)', 'type': 'DEVICE', 'description': 'Injection of ICG to stain internal limiting membrane', 'armGroupLabels': ['pars plana vitrectomy performed using NGENUITY® 3D Visualization System (Alcon, TX, USA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ho Tzyy-Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data may be provided under reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}