Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:44 AM
Study NCT ID:
NCT07346560
Status:
RECRUITING
Last Update Posted:
2026-01-16
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
1ry Versus 2ry ILM Peeling in RD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012163', 'term': 'Retinal Detachment'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-01-15', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of complications', 'timeFrame': 'From enrollment till 3 months postoperative'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retinal detachment', 'ILM peeling', 'Proliferative vitroretinopathy'], 'conditions': ['Retinal Detachment Rhegmatogenous', 'ILM Peeling']}, 'descriptionModule': {'briefSummary': 'Patients with uncomplicated rhegmatogenous retinal detachment will be recruited. All eyes will underwent 23G PPV with silicon oil tamponade. The eyes will be classified into two groups according to the timing of ILM peeling. Group A, ILM peelin will be performed during the first intervention, while in group B, it will be done at the time of silicon oil extraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with uncomplicated rhegmatogenous retinal detcahment.\n\nExclusion Criteria:\n\n* PVR\n* Recurrent RD\n* Tractional RD\n* Macular hole RD\n* Scleral buckling is indicated\n* Macular scarring\n* Previous PPV'}, 'identificationModule': {'nctId': 'NCT07346560', 'briefTitle': '1ry Versus 2ry ILM Peeling in RD', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Primary Versus Secondary Internal Limiting Membrane Peeling in Uncomplicated Retinal Detachment', 'orgStudyIdInfo': {'id': 'Soh-Med-25-12-8PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (Primary ILM peeling)', 'description': 'ILM peeling during PPV for rRD', 'interventionNames': ['Procedure: Primary ILM peeling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'ILM peeling at time of silicon oil extraction', 'interventionNames': ['Procedure: Secondary ILM peeling']}], 'interventions': [{'name': 'Primary ILM peeling', 'type': 'PROCEDURE', 'description': 'ILM peeling during the 1st surgical intervention for rRD', 'armGroupLabels': ['Group A (Primary ILM peeling)']}, {'name': 'Secondary ILM peeling', 'type': 'PROCEDURE', 'description': 'ILM peeling is delayed for the time of silicon oil extraction', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82511', 'city': 'Sohag', 'state': 'Sohag Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Alaa Sinjab', 'role': 'CONTACT', 'email': 'alaa.abdelsadek@med.sohag.edu.eg', 'phone': '+20-01064037382'}], 'facility': 'Sohag Faculty of Medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Alaa Sinjab, MD', 'role': 'CONTACT', 'email': 'alaa.abdelsadek@med.sohag.edu.eg', 'phone': '+20-01064037382'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'From enrollment and forever.', 'ipdSharing': 'YES', 'description': 'All IPD will be available for other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Ophthalmology', 'investigatorFullName': 'Alaa Abdalsadek Ahmed Sinjab', 'investigatorAffiliation': 'Sohag University'}}}}