Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT05561569
Status:
UNKNOWN
Last Update Posted:
2022-09-30
First Post:
2022-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Air Versus Gas Tamponade in Primary Retinal Detachment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012163', 'term': 'Retinal Detachment'}, {'id': 'D018630', 'term': 'Vitreoretinopathy, Proliferative'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Recurrence of retinal detachment', 'timeFrame': 'Incidence of recurrent retinal detachment at 6th month.', 'description': 'Incidence of recurrent retinal detachment in each group assessed by indirect fundus ophthalmoscope.'}], 'primaryOutcomes': [{'measure': 'Improvement in visual acuity', 'timeFrame': 'Change from baseline visual acuity at 6th month.', 'description': 'Visual acuity changes measured by snellen chart and converted to LogMar units.'}], 'secondaryOutcomes': [{'measure': 'Changes in metamorphopsia', 'timeFrame': 'Change from baseline metamorphopsia at 6th month.', 'description': 'Changes in metamorphopsia after surgery assessed by M-chart that is specially designed to subjectively assess metamorphopsia, each 1 millimeter deviation from reference line is considered significant deviation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitrectomy', 'Retinal detachment'], 'conditions': ['Retinal Detachment', 'Proliferative Vitreoretinopathy']}, 'descriptionModule': {'briefSummary': 'Management of primary retinal detachment due to upper retinal break is one of controversial situation that may face ophthalmologists in vitreoretinal subspecialty.', 'detailedDescription': 'There is no single surgical plan for management of primary retinal detachment due to upper retinal break, some surgeons prefer scleral buckling over vitrectomy in cases with no traction over the retinal break, others prefer to perform primary pars-plana vitrectomy with either air or gas tamponade.\n\nIn this study we aim to compare the results of air and non-expansile gas tamponade in cases with upper retinal detachment with grade a or b proliferative vitreoretinopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary rhegmatogenous retinal detachment with upper break with proliferative vitreoretinopathy from grade a to b.\n\nExclusion Criteria:\n\n* cases with combined tractional retinal detachment.\n* cases with recurrent retinal detachment.\n* cases that are eligible for scleral buckling that have no traction on retinal break.'}, 'identificationModule': {'nctId': 'NCT05561569', 'briefTitle': 'Air Versus Gas Tamponade in Primary Retinal Detachment', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Randomized Trial Comparing Air Versus Gas Tamponade in Primary Retinal Detachment', 'orgStudyIdInfo': {'id': 'Rc.11-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Air tamponade group', 'description': 'Cases with primary upper retinal detachment that will be treated with air tamponade.', 'interventionNames': ['Procedure: Pars plana vitrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non expansile gas tamponade group', 'description': 'Cases with primary upper retinal detachment that will be treated with sulfur-hexafluoride 6 (SF-6) gas tamponade.', 'interventionNames': ['Procedure: Pars plana vitrectomy']}], 'interventions': [{'name': 'Pars plana vitrectomy', 'type': 'PROCEDURE', 'description': '23 gauge pars plana vitrectomy for managing primary retinal detachment.', 'armGroupLabels': ['Air tamponade group', 'Non expansile gas tamponade group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'QA', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Abdelshafy, MD', 'role': 'CONTACT', 'email': 'ahmad4lg@gmail.com', 'phone': '01222328766'}, {'name': 'Mahrous H Shaheen, MD', 'role': 'CONTACT', 'email': 'mha13@fayoum.edu.eg', 'phone': '0846300587'}, {'name': 'Mahrous H Shaheen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ahmed Abdelshafy', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'centralContacts': [{'name': 'Ahmed Abdelshafy, MD', 'role': 'CONTACT', 'email': 'ahmad4lg@gmail.com', 'phone': '01222328766'}, {'name': 'Mahrous Shaheen, MD', 'role': 'CONTACT', 'email': 'mha13@fayoum.edu.eg', 'phone': '0846300587'}], 'overallOfficials': [{'name': 'Ahmed A Abdelshafy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Ophthalmology', 'investigatorFullName': 'Ahmed Abdelshafy', 'investigatorAffiliation': 'Benha University'}}}}