Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT06324305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study Between Three Different Techniques in Drainage of SRF During PPV in RRD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011237', 'term': 'Predictive Value of Tests'}], 'ancestors': [{'id': 'D012680', 'term': 'Sensitivity and Specificity'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence versus absence of sub-macular fluid using each of the three different techniques in pars plana vitrectomy (PPV)', 'timeFrame': 'within 1 week and within 1 month from the PPV', 'description': 'optical coherence tomography (OCT) imaging after PPV'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['drainage techniquies', 'comparison', 'subretinal fluid'], 'conditions': ['Rhegmatogenous Retinal Detachment']}, 'referencesModule': {'references': [{'pmid': '36640144', 'type': 'BACKGROUND', 'citation': 'Warren A, Wang DW, Lim JI. Rhegmatogenous retinal detachment surgery: A review. Clin Exp Ophthalmol. 2023 Apr;51(3):271-279. doi: 10.1111/ceo.14205. Epub 2023 Jan 25.'}, {'pmid': '33078114', 'type': 'BACKGROUND', 'citation': 'Fu Y, Chen S, Gu ZH, Zhang YL, Li LY, Yang N. Natural history of persistent subretinal fluid following the successful repair of rhegmatogenous retinal detachment. Int J Ophthalmol. 2020 Oct 18;13(10):1621-1628. doi: 10.18240/ijo.2020.10.17. eCollection 2020.'}, {'pmid': '31241497', 'type': 'BACKGROUND', 'citation': 'Mimouni M, Jaouni T, Ben-Yair M, Almus S, Derman L, Ehrenberg S, Almeida D, Barak Y, Zayit-Soudry S, Averbukh E. PERSISTENT LOCULATED SUBRETINAL FLUID AFTER RHEGMATOGENOUS RETINAL DETACHMENT SURGERY. Retina. 2020 Jun;40(6):1153-1159. doi: 10.1097/IAE.0000000000002565.'}, {'pmid': '27429377', 'type': 'BACKGROUND', 'citation': 'Chen X, Zhang Y, Yan Y, Hong L, Zhu L, Deng J, Din Q, Huang Z, Zhou H. COMPLETE SUBRETINAL FLUID DRAINAGE IS NOT NECESSARY DURING VITRECTOMY SURGERY FOR MACULA-OFF RHEGMATOGENOUS RETINAL DETACHMENT WITH PERIPHERAL BREAKS: A Prospective, Nonrandomized Comparative Interventional Study. Retina. 2017 Mar;37(3):487-493. doi: 10.1097/IAE.0000000000001180.'}]}, 'descriptionModule': {'briefSummary': 'The study will investigate and compare the three techniques in drainage of subretinal fluid in patients with macula off RRD: namely using the original break, performing a posterior drainage retinotomy and using PFC with drainage through the original break or peripheral retinotomy regarding the presence of persistent sub-retnal fluid and related intra or postoperative complications', 'detailedDescription': "Rhegmatogenous retinal detachment (RRD) is a serious surgical condition with significant ocular morbidity if not managed properly. Approaches to the repair of RRD have greatly evolved over the years, leading to outstanding primary surgical success rates. The management of RRD is often a topic of great debate. Several factors may affect surgical success and dictate a surgeon's preference for the technique employed.\n\nScleral buckling, vitrectomy and pneumatic retinopexy have been used successfully for the treatment of RRD.\n\nUsing original breaks to drain subretinal fluid without perfluorocarbon liquid in cases of vitrectomy for RRD may be an effective and safe surgical technique for functional and anatomical recovery without serious complications. but it may leave some SRF at the macula (2) Posterior drainage retinotomy is a surgical technique that involves the creation of a small retinal hole to facilitate the removal of subretinal fluid (SRF), in conjunction with pars plana vitrectomy (PPV), for the treatment of rhegmatogenous retinal detachment (RRD) (3). First described by Machemer in 1981 as a technique for relaxing the retina in proliferative vitreoretinopathy (PVR) and trauma (4), retinotomy has since expanded to include more indications for its use (5). In addition, the use of drainage retinotomy aids the management of bullous RRD, because the complete drainage of fluid significantly decreases the likelihood of retinal fold formation (6). Although there are benefits with retinotomy, complications associated with its use include visual field scotomas and PVR at the endodrainage retinotomy sites .\n\nPerfluorocarbon liquid (PFC) has been a major milestone in vitrectomy surgery and is an invaluable tool in the repair of giant retinal tear-associated detachments (8). By stabilizing the mobile, detached retina, PFC reduces the risk of iatrogenic breaks, especially towards the periphery. PFC may also be useful to assist with subretinal fluid drainage in cases when the retinal break is anterior in order to avoid the need for a posterior drainage retinotomy.\n\nSubretinal fluid that persists after pars plana vitrectomy for RRD is defined by being persistent for more than one month. While mostly benign, SRF has been shown to exhibit complications. Those include the development of macular hole (MH), permanent disruption of the outer retinal layers, subretinal fibrosis, macular edema, and epiretinal membranes affecting the visual outcome.\n\nTo the best of our knowledge, very limited reports studied the comparison between the three techniques in an anatomical along with a functional way, presence of subretinal fluid that persists after (PPV) for macula off RRD, or related intra and postoperative complications and also relating them to the functional outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age: above 18 years old\n\n * Patients with rhegmatogenous retinal detachment (RRD) where the detachment is involving the macula.\n * Patients with proliferative vitreoretinopathy (PVR) no more than PVR -B.\n * Patients with peripheral break.\n * Duration of detachment: within one month.\n\nExclusion Criteria:\n\n* • Patients with macula on RRD.\n\n * Patients with tractional retinal detachment.\n * Patients with giant retinal tear.\n * Patients with proliferative vitreoretinopathy (PVR) more than PVR -B.\n * More than one month duration of detachment.\n * Patients with posterior staphyloma.\n * Patients with recurrent retinal detachment.\n * Patients with full thickness macular hole.'}, 'identificationModule': {'nctId': 'NCT06324305', 'briefTitle': 'Comparative Study Between Three Different Techniques in Drainage of SRF During PPV in RRD', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparative Study Between Three Different Techniques in Drainage of Sub-Retinal Fluid During Pars Plana Vitrectomy for Patients With Macula Off Rhegmatogenous Retinal Detachment', 'orgStudyIdInfo': {'id': 'SRF drainage techniques in RRD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'drainage of sub-retinal fluid from the original (primary) break', 'interventionNames': ['Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'drainage of sub-retinal fluid using perfluorocarbon (PFC) and removing sub-retinal fluid through the original break or peripheral retinotomy', 'interventionNames': ['Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'drainage of sub-retinal fluid through formation of a posterior drainage retinotomy only.', 'interventionNames': ['Procedure: Pars plana vitrectomy (PPV) and drainage of subretinal fluid']}], 'interventions': [{'name': 'Pars plana vitrectomy (PPV) and drainage of subretinal fluid', 'type': 'PROCEDURE', 'description': 'Drainage of subretinal fluid during Pars Plana Vitrectomy in patients with rhegmatogenous retinal detachment (RRD)', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': "Dina T Mohamed, master's", 'role': 'CONTACT', 'email': 'dina.tarek@med.asu.edu.eg', 'phone': '01067747874'}, {'name': 'Tamer F Elewa, MD', 'role': 'CONTACT', 'email': 'tamerfahmy@med.asu.edu.eg', 'phone': '01222421432'}], 'overallOfficials': [{'name': "Dina T Mohamed, master's", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AinShams University'}, {'name': 'Tamer F Elewa, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AinShams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dina kamel', 'investigatorFullName': 'Dina tarek mohamed kamel', 'investigatorAffiliation': 'Ain Shams University'}}}}