Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 4:14 AM
Study NCT ID:
NCT06536569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2024-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Efficacy Between ILM Forceps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012167', 'term': 'Retinal Perforations'}, {'id': 'D019773', 'term': 'Epiretinal Membrane'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-07-22', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Corrected Distance Visual Acuity', 'timeFrame': '1 Month Postoperatively'}], 'primaryOutcomes': [{'measure': 'Number of attempts to initiate peeling', 'timeFrame': 'Surgery (Operative Visit)', 'description': 'Evaluated by recorded video'}], 'secondaryOutcomes': [{'measure': 'Number of handle-ReSite/widefield viewing system lens touches', 'timeFrame': 'Surgery (Operative Visit)', 'description': 'Evaluated by recorded video'}, {'measure': 'Duration of Peel', 'timeFrame': 'Surgery (Operative Visit)', 'description': 'Start to completion of peel'}, {'measure': 'Number of deep retinal grasps', 'timeFrame': 'Surgery (Operative Visit)', 'description': 'Evaluated by recorded video'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Macular Holes', 'Epiretinal Membrane']}, 'descriptionModule': {'briefSummary': 'This study is a Single center, prospective, observational, multi surgeon randomized controlled trial. Subjects will be assessed pre-operatively, operatively and at 1 month postoperatively. Clinical evaluations will include measurement of visual acuity and optical coherence tomography (OCT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• 19y and older patients with symptomatic ERM (grade 2-3) or Macular hole (non flap-requiring) for elective ILM peeling surgery.\n\nExclusion Criteria:\n\n* Co-morbid diabetic retinopathy of any grade.\n* Neovascular AMD.\n* Previous vitrectomy.\n* Previous retinal detachment treated with scleral buckle or pneumatic retinopexy.\n* Uncontrolled glaucoma or previous glaucoma surgery.\n* Combined phacovitrectomy.\n* Macula holes with severity requiring flap.'}, 'identificationModule': {'nctId': 'NCT06536569', 'briefTitle': 'Comparison of Efficacy Between ILM Forceps', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'A Comparison of the Efficacy of 25g Grieshaber Sharkskin ILM Forceps With Reflex Handle vs Standard 25g Grieshaber ILM Forceps for Internal Limiting Membrane Peeling', 'orgStudyIdInfo': {'id': 'H23-03318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sharkskin Group', 'description': '25g Grieshaber Sharkskin ILM Forceps with Reflex Handle', 'interventionNames': ['Device: Internal limiting membrane (ILM) Peeling with Sharkskin Forceps']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Group', 'description': '25g Grieshaber standard ILM', 'interventionNames': ['Device: Internal limiting membrane (ILM) Peeling with Standard Forceps']}], 'interventions': [{'name': 'Internal limiting membrane (ILM) Peeling with Sharkskin Forceps', 'type': 'DEVICE', 'description': '25g Grieshaber Sharkskin ILM Forceps with Reflex Handle', 'armGroupLabels': ['Sharkskin Group']}, {'name': 'Internal limiting membrane (ILM) Peeling with Standard Forceps', 'type': 'DEVICE', 'description': '25g Grieshaber Standard ILM Forceps', 'armGroupLabels': ['Standard Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'contacts': [{'name': 'Bryon McKay, MD, PhD', 'role': 'CONTACT', 'email': 'mckaybr.phd@gmail.com', 'phone': '604 806 9090'}, {'name': 'Bryon McKay, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Department of Ophthalmology & Visual Sciences, St Paul's Hospital, Ophthalmology", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Bryon McKay, MD, PhD', 'role': 'CONTACT', 'email': 'mckaybr.phd@gmail.com', 'phone': '604 806 9090'}], 'overallOfficials': [{'name': 'Bryon McKay, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UBC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sengi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bryon McKay', 'investigatorAffiliation': 'University of British Columbia'}}}}