Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-25 @ 3:05 PM
Study NCT ID:
NCT06707168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-27
First Post:
2024-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D051517', 'term': 'Digital Rectal Examination'}], 'ancestors': [{'id': 'D010173', 'term': 'Palpation'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-24', 'studyFirstSubmitDate': '2024-11-24', 'studyFirstSubmitQcDate': '2024-11-24', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure measurement', 'timeFrame': 'From enrolment to end of treatment at 8 weeks', 'description': "Intraocular pressure accuracy between surgeons' estimate and tonometer IOP measurement."}], 'secondaryOutcomes': [{'measure': 'Intraocular pressure measuring agreement', 'timeFrame': 'From enrolment to end of treatment at 8 weeks', 'description': '1. Intraocular pressure surgeon measuring agreement with digital palpation.\n2. Intraocular pressure surgeon measuring agreement with short wooden stick cotton swab.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['intraocular pressure', 'pars plana vitrectomy'], 'conditions': ['Pars Plana Vitrectomy']}, 'referencesModule': {'references': [{'pmid': '18398355', 'type': 'BACKGROUND', 'citation': 'Acar N, Kapran Z, Unver YB, Altan T, Ozdogan S. Early postoperative hypotony after 25-gauge sutureless vitrectomy with straight incisions. Retina. 2008 Apr;28(4):545-52. doi: 10.1097/IAE.0b013e318162b008.'}, {'pmid': '32488595', 'type': 'BACKGROUND', 'citation': 'Wilde C, Bhardwaj P, King A, Kumudhan D, Foss A, Orr G, Zaman A. First postoperative day review in eyes undergoing pars plana vitrectomy, encirclement and endotamponade to check intraocular pressure: Is it necessary? Int Ophthalmol. 2020 Oct;40(10):2577-2583. doi: 10.1007/s10792-020-01438-w. Epub 2020 Jun 1.'}, {'pmid': '26315702', 'type': 'BACKGROUND', 'citation': 'Alexander P, Michaels L, Newsom R. Is day-1 postoperative review necessary after pars plana vitrectomy? Eye (Lond). 2015 Nov;29(11):1489-94. doi: 10.1038/eye.2015.134. Epub 2015 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'Intraocular pressure is measured regularly at any and all visits with your eye doctor or optometrist.\n\nThe purpose of this study is to compare measurements of eye pressure at the end of the surgery, comparing the ability of a gloved finger or sterile cotton-tipped applicator ("Q-tip") to accurately measure intraocular pressure against a standardized instrument designed for this purpose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients undergoing Pars Plana Vitrectomy between June 25, 2024 - and December 30, 2024, will be included.\n2. Patients aged 18 years or older\n3. Patients able to give informed consent\n\nExclusion Criteria:\n\n1. Patients with complicated Pars Plana Vitrectomy (choroidal hemorrhage, retrobulbar hemorrhage)\n2. Patients with irregular cornea surface will be excluded (keratoconus, band keratopathy, corneal edema, corneal transplant, cornea scarring)\n3. Patients undergoing combined scleral buckling at time of surgery\n4. Patients with previous glaucoma filtration surgery (ie. trabeculectomy or tube shunt surgery)'}, 'identificationModule': {'nctId': 'NCT06707168', 'briefTitle': 'INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'ACCURACY of DIGITAL INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY SURGERY', 'orgStudyIdInfo': {'id': '6310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Surgeon #1', 'description': 'One by digital palpation over the limbal area; and the other using a short wooden cotton-tipped applicator (CTA) over the limbal area.', 'interventionNames': ['Diagnostic Test: Digital palpation', 'Diagnostic Test: Cotton-tipped applicator (CTA)']}, {'type': 'OTHER', 'label': 'Surgeon #2', 'description': 'One by digital palpation over the limbal area; and the other using a short wooden cotton-tipped applicator (CTA) over the limbal area.', 'interventionNames': ['Diagnostic Test: Digital palpation', 'Diagnostic Test: Cotton-tipped applicator (CTA)']}], 'interventions': [{'name': 'Digital palpation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Digital palpation for IOP measurement', 'armGroupLabels': ['Surgeon #1', 'Surgeon #2']}, {'name': 'Cotton-tipped applicator (CTA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cotton-tipped applicator (CTA) for IOP measurement', 'armGroupLabels': ['Surgeon #1', 'Surgeon #2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kenneth Eng, MD', 'role': 'CONTACT', 'email': 'Kenneth.Eng@sunnybrook.ca', 'phone': '416-480-4688'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No identifying information will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Ophthalmology', 'investigatorFullName': 'Dr. Kenneth Eng', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}