Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT04723420
Status:
UNKNOWN
Last Update Posted:
2023-04-13
First Post:
2020-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019085', 'term': 'Fluorescent Antibody Technique, Direct'}], 'ancestors': [{'id': 'D005455', 'term': 'Fluorescent Antibody Technique'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2020-12-19', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macular status at Day 1', 'timeFrame': '24hours post intervention', 'description': 'Assessment of macular status by optical coherence tomography at 24 hours after intervention to see which technique is most effective for reattaching the macula'}], 'secondaryOutcomes': [{'measure': 'Anatomical displacement of macula and its changes with time.', 'timeFrame': '1,2, 3 and 6 months post intervention', 'description': 'Measurement of retinal vessel imprinting on fundus autofluorescence'}, {'measure': 'Functional displacement of macula and its changes with time.', 'timeFrame': '1,2, 3 and 6 months post intervention', 'description': 'Measurement of metamorphopsia with M-charts'}, {'measure': 'Macular Status', 'timeFrame': '1hour, 2hours, Day 2, Week 1, Week 2', 'description': 'Looking at macula status via optical coherence tomography after intervention to see which technique is more effective in reattaching the macula early'}, {'measure': 'Visual acuity', 'timeFrame': '1, 3 and 6 months post intervention', 'description': 'ETDRS'}, {'measure': 'Primary anatomical success', 'timeFrame': '1, 3 and 6 months post intervention', 'description': 'Complete reattachment of retina via clinical fundus examination and optos fundus photography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pneumatic Retinopexy', 'Steamroll', 'Direct to break'], 'conditions': ['Rhegmatogenous Retinal Detachment']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial comparing displacement of macula and the rapidity of reattachment of macula between two different positioning techniques after pneumatic retinopexy : Direct technique (patient is positioned so that the bubble is immediately placed directly over the retina break) and Steamroller technique (patient is initially positioned face down for 4-6 hours and subsequently changes their head position so that the bubble is then placed directly over the retina break).', 'detailedDescription': 'Pneumatic retinopexy (PR) is an established treatment for rhegmatogenous retinal detachment (RRD). In our centre, PR is the most commonly performed procedure for primary RRD repair with a high retinal reattachment success rate. In this procedure, patients are required to position according to the site of pathology following injection of an intravitreal gas bubble. Some practitioners position the patient so that the gas bubble is immediately apposed directly against the retinal break (direct technique). Others favour the steamroller technique whereby the patient is initially positioned face down, then after 4-6 hours, the position is changed sequentially so that the bubble is rolled over the retina towards the break responsible for the detachment (steamroller technique). Variable visual acuity (VA) outcomes and metamorphopsia are common post-procedure complaints despite successful RRD repair with PR. It has been suggested that variability in functional outcomes may be associated with the timing and ease of reattachment of macula. The purpose of this prospective study is to evaluate whether the steamroller technique is superior to the direct technique in faster reattachment of macula with less macula displacement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary RRD\n* Causative breaks over superior 8 clock hours\n* Single break or group of breaks\n* No or min proliferative vitreoretinopathy (PVR) (Grade A or B)\n* Other breaks or lattice in attached retina are allowed\n\nExclusion Criteria:\n\n* Retinal break in the inferior 4 clock hours in detached retina\n* PVR Grade C or worse\n* Significant media opacity (Vitreous hemorrhage, dense cataract, cornea scar, etc)\n* Pre-existing ocular pathology \\[macula hole (MH), epiretinal membrane (ERM), cystoid macula edema (CME), age-related macula degeneration, myopic degeneration, advanced glaucoma, uveitis, amblyopia etc\\] or previous eye trauma with poor baseline vision\n* Previous pars plana vitrectomy\n* Age ≤18years old\n* Inadequate physical or mental competence to maintain the required postoperative head position'}, 'identificationModule': {'nctId': 'NCT04723420', 'briefTitle': 'Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not', 'orgStudyIdInfo': {'id': '270-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Steamroller Technique', 'description': 'Following intravitreal gas injection, patient positioned face down for 4-6 hours and subsequently patient changes the position of the head so that the bubble is then placed directly over the retina break.', 'interventionNames': ['Other: Steamroller technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Direct Technique', 'description': 'Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.', 'interventionNames': ['Other: Direct technique']}], 'interventions': [{'name': 'Steamroller technique', 'type': 'OTHER', 'description': 'Following intravitreal gas injection, patient positioned face down for 4-6 hours and subsequently patient changes the position of the head so that the bubble is then placed directly over the retina break.', 'armGroupLabels': ['Steamroller Technique']}, {'name': 'Direct technique', 'type': 'OTHER', 'description': 'Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.', 'armGroupLabels': ['Direct Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Kenneth Eng, MD FRCSC', 'role': 'CONTACT', 'email': 'kenneth.eng@sunnybrook.ca', 'phone': '416-480-4688'}, {'name': 'Kenneth Eng, MD FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Peter Kertes, MD FRCSC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'Cindy.Rutz@sunnybrook.ca', 'phone': '416-480-5091'}], 'overallOfficials': [{'name': 'Kenneth Eng, MD FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not', 'investigatorFullName': 'Dr. Kenneth Eng', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}