Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05543018
Status:
UNKNOWN
Last Update Posted:
2022-09-16
First Post:
2022-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Intraocular Tamponade on Visual Perception
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012163', 'term': 'Retinal Detachment'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004596', 'term': 'Electroretinography'}], 'ancestors': [{'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-10-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-13', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'Baseline and monthly after surgery till 6 months of follow up.', 'description': 'Changes in visual acuity measured in LogMAR units.'}, {'measure': 'Retinal function amplitude', 'timeFrame': 'Baseline and monthly after surgery till 6 months of follow up.', 'description': 'Changes in electroretinogram amplitude parameters in microvolt/second measured by roland consult retinal function device.'}, {'measure': 'Retinal function implicit time.', 'timeFrame': 'Baseline and monthly after surgery till 6 months of follow up.', 'description': 'Changes in electroretinogram implicit time in millisecond measured by roland consult retinal function device.'}], 'secondaryOutcomes': [{'measure': 'Intraocular pressure', 'timeFrame': 'Baseline and monthly after surgery till 6 months of follow up.', 'description': 'Changes in intraocular pressure measured by goldman applanation tonometry in millimeter mercury.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitrectomy', 'Retinal detachment', 'Intraocular Tamponade', 'Silicon oil', 'Air tamponade'], 'conditions': ['Retinal Detachment', 'Optic Neuropathy', 'Glaucoma']}, 'descriptionModule': {'briefSummary': 'Intraocular tamponade used in vitrectomy operations may affects retinal function in various mechanisms.', 'detailedDescription': 'Various intraocular tamponade are being used in vitrectomy operations as gases, fluids and silicon oil. The effects of these intraocular tamponade may affects the final visual outcome of the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary retinal detachment patients.\n* patients eligible for 23 gauge pars-plana vitrectomy operation.\n\nExclusion Criteria:\n\n* patients with axial length more than 30 millimeter that may have severe chorioretinal degenerations that may affects retinal function.\n* patients with macular diseases that may affects final visual outcome as macular holes and choroidal neovascular membranes.'}, 'identificationModule': {'nctId': 'NCT05543018', 'briefTitle': 'Effect of Intraocular Tamponade on Visual Perception', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Effect of Intraocular Tamponade on Visual Function in the Human Eyes', 'orgStudyIdInfo': {'id': 'RC-10-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Silicon oil group', 'description': 'Patients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade.', 'interventionNames': ['Diagnostic Test: Electroretinogram', 'Procedure: Vitrectomy operation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Air tamponade', 'description': 'Patients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade.', 'interventionNames': ['Diagnostic Test: Electroretinogram', 'Procedure: Vitrectomy operation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-expansile gas', 'description': 'Patients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride).', 'interventionNames': ['Diagnostic Test: Electroretinogram', 'Procedure: Vitrectomy operation']}], 'interventions': [{'name': 'Electroretinogram', 'type': 'DIAGNOSTIC_TEST', 'description': 'Retinal function assessment using electroretinogram', 'armGroupLabels': ['Air tamponade', 'Non-expansile gas', 'Silicon oil group']}, {'name': 'Vitrectomy operation', 'type': 'PROCEDURE', 'description': 'Vitrectomy operation to treat retinal detachment', 'armGroupLabels': ['Air tamponade', 'Non-expansile gas', 'Silicon oil group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'Benha', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed A Tabl', 'role': 'CONTACT', 'email': 'ahmad4lg@gmail.com', 'phone': '01222328766'}, {'name': 'Marwa Abdelshafy, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ahmed Abdelshafy Tabl', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'centralContacts': [{'name': 'Ahmed A Tabl, MD', 'role': 'CONTACT', 'email': 'ahmad4lg@gmail.com', 'phone': '01222328766'}], 'overallOfficials': [{'name': 'Ahmed A Tabl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Ophthalmology', 'investigatorFullName': 'Ahmed Abdelshafy', 'investigatorAffiliation': 'Benha University'}}}}