Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT05710458
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2023-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}, {'id': 'D012167', 'term': 'Retinal Perforations'}, {'id': 'D014823', 'term': 'Vitreous Hemorrhage'}, {'id': 'D012163', 'term': 'Retinal Detachment'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005130', 'term': 'Eye Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients are randomised and masked from the treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2023-01-25', 'studyFirstSubmitQcDate': '2023-02-01', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Core vitrectomy', 'timeFrame': 'intraoperative (From the moment probe enter into the eye till performing the air/fluid exchange to complete the vitrectomy)', 'description': 'Measurement of core vitrectomy duration by Constellation Vision System'}], 'secondaryOutcomes': [{'measure': 'Non-inferiority of intraoperative and postoperative complication', 'timeFrame': '3 months', 'description': 'Safety and Efficacy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitrectomy', 'Epiretinal Membrane', 'Macular Hole', 'Vitreous Hemorrhage', 'Retinal Detachment']}, 'referencesModule': {'references': [{'pmid': '1147502', 'type': 'BACKGROUND', 'citation': "O'Malley C, Heintz RM Sr. Vitrectomy with an alternative instrument system. Ann Ophthalmol. 1975 Apr;7(4):585-8, 591-4."}, {'pmid': '21685823', 'type': 'BACKGROUND', 'citation': 'Rizzo S, Genovesi-Ebert F, Belting C. Comparative study between a standard 25-gauge vitrectomy system and a new ultrahigh-speed 25-gauge system with duty cycle control in the treatment of various vitreoretinal diseases. Retina. 2011 Nov;31(10):2007-13. doi: 10.1097/IAE.0b013e318213623a.'}]}, 'descriptionModule': {'briefSummary': 'This prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. We plan to target the patients undergoing for vitrectomy for common vitreoretinal pathology. Our plan is to conduct a randomised study with 2 arms, one with the higher cutting rate (20,000 cut/min) versus a second arm using the existing system 10,000 cuts/min.', 'detailedDescription': 'In addition, we will measure the core vitrectomy duration by Constellation Vision System stopwatch. We will count the duration when the vitrectomy probe enter into the eye to the moment the performing the air/fluid exchange by shaving the peripheral vitreous to complete the vitrectomy. For our second outcome measure to prove the no-inferiority of intraoperative and postoperative complications patients will have 3 months follow up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18 years of age who are undergoing vitrectomy for the following conditions:\n\n * Macular hole\n * Epimacular membrane\n * Vitreous hemorrhage\n * Primary retinal detachment\n\nExclusion Criteria:\n\n* Patient who is\n\n * unable to give proper consent\n * previous vitrectomy or scleral buckle surgery\n * cases requiring silicone oil tamponed\n * undergoing repeated retinal detachment surgery\n * undergoing surgery for tractional diabetic retinopathy'}, 'identificationModule': {'nctId': 'NCT05710458', 'briefTitle': 'Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter', 'orgStudyIdInfo': {'id': '20K'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '25 gauge 20,000 cpm Hypervit Dual Blade', 'description': 'New vitrectomy blade with higher cutting rate', 'interventionNames': ['Device: 25 gauge 20,000 cpm Hypervit Dual Blade']}, {'type': 'ACTIVE_COMPARATOR', 'label': '25 gauge 10,000 Ultravit vitrectomy cutter', 'description': 'Existing vitrectomy blade with cutting rate 10,000 cut/min', 'interventionNames': ['Device: 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter']}], 'interventions': [{'name': '25 gauge 20,000 cpm Hypervit Dual Blade', 'type': 'DEVICE', 'otherNames': ['20K'], 'description': 'Vitrectomy blade with increased cutting rate to 20,000 cut/min', 'armGroupLabels': ['25 gauge 20,000 cpm Hypervit Dual Blade']}, {'name': '25 gauge 10,000 cpm Ultravit Vitrectomy Cutter', 'type': 'DEVICE', 'otherNames': ['10K'], 'description': 'Existing Vitrectomy blade with cutting rate 10,000 cut/min', 'armGroupLabels': ['25 gauge 10,000 Ultravit vitrectomy cutter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Grantham Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': '5 Years after the study ends', 'ipdSharing': 'YES', 'description': 'By direct contact to the corresponding author or PI', 'accessCriteria': 'Case by case'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Asst Professor', 'investigatorFullName': 'Dr. Nicholas Fung', 'investigatorAffiliation': 'The University of Hong Kong'}}}}