Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT05538156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-09-13
First Post:
2022-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Internal Limiting Membrane Peeling in Retinal Detachment Surgery
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-09', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary anatomical success rate', 'timeFrame': '12 months after surgery', 'description': 'Primary retinal reattachment rate'}], 'secondaryOutcomes': [{'measure': 'Functional outcomes #1', 'timeFrame': '12 months after surgery', 'description': 'Visual acuity (Logarithm of the Minimum Angle of Resolution)'}, {'measure': 'Functional outcomes #2', 'timeFrame': '12 months after surgery', 'description': 'Degree of metamorphopsia (M-CHARTS)'}, {'measure': 'Anatomical outcomes #1', 'timeFrame': '12 months after surgery', 'description': 'Integrity of the photoreceptor layer on Spectral Domain Optical Coherence Tomography'}, {'measure': 'Anatomical outcomes #2', 'timeFrame': '12 months after surgery', 'description': 'Incidence of epiretinal membrane'}, {'measure': 'Anatomical outcomes #3', 'timeFrame': '12 months after surgery', 'description': 'Incidence of cystoid macular edema'}, {'measure': 'Anatomical outcomes #4', 'timeFrame': '12 months after surgery', 'description': 'Incidence of DONFL appearance'}, {'measure': 'Functional outcomes #3', 'timeFrame': '12 months after surgery', 'description': 'Retinal sensitivity on microperimetry testing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retinal Detachment', 'Proliferative Vitreoretinopathy']}, 'referencesModule': {'references': [{'pmid': '31126280', 'type': 'RESULT', 'citation': 'Borowicz D, Nowomiejska K, Nowakowska D, Brzozowska A, Toro MD, Avitabile T, Junemann AG, Rejdak R. Functional and morphological results of treatment of macula-on and macula-off rhegmatogenous retinal detachment with pars plana vitrectomy and sulfur hexafluoride gas tamponade. BMC Ophthalmol. 2019 May 24;19(1):118. doi: 10.1186/s12886-019-1120-3.'}, {'pmid': '7488586', 'type': 'RESULT', 'citation': 'Charteris DG. Proliferative vitreoretinopathy: pathobiology, surgical management, and adjunctive treatment. Br J Ophthalmol. 1995 Oct;79(10):953-60. doi: 10.1136/bjo.79.10.953. No abstract available.'}, {'pmid': '29299741', 'type': 'RESULT', 'citation': 'Eissa MGAM, Abdelhakim MASE, Macky TA, Khafagy MM, Mortada HA. Functional and structural outcomes of ILM peeling in uncomplicated macula-off RRD using microperimetry & en-face OCT. Graefes Arch Clin Exp Ophthalmol. 2018 Feb;256(2):249-257. doi: 10.1007/s00417-017-3875-7. Epub 2018 Jan 3.'}, {'pmid': '30024983', 'type': 'RESULT', 'citation': 'Fallico M, Russo A, Longo A, Pulvirenti A, Avitabile T, Bonfiglio V, Castellino N, Cennamo G, Reibaldi M. Internal limiting membrane peeling versus no peeling during primary vitrectomy for rhegmatogenous retinal detachment: A systematic review and meta-analysis. PLoS One. 2018 Jul 19;13(7):e0201010. doi: 10.1371/journal.pone.0201010. eCollection 2018.'}, {'pmid': '29621507', 'type': 'RESULT', 'citation': 'Foveau P, Leroy B, Berrod JP, Conart JB. Internal Limiting Membrane Peeling in Macula-off Retinal Detachment Complicated by Grade B Proliferative Vitreoretinopathy. Am J Ophthalmol. 2018 Jul;191:1-6. doi: 10.1016/j.ajo.2018.03.037. Epub 2018 Apr 3.'}, {'pmid': '29282562', 'type': 'RESULT', 'citation': 'Steel DH, Joussen AM, Wong D. ILM peeling in rhegmatogenous retinal detachment; does it improve the outcome? Graefes Arch Clin Exp Ophthalmol. 2018 Feb;256(2):247-248. doi: 10.1007/s00417-017-3876-6. Epub 2017 Dec 27. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Despite advances in surgical techniques over the recent decades, proliferative vitreoretinopathy (PVR) remains the main obstacle to successful rhegmatogenous retinal detachment (RRD) repair, accounting for nearly 75% of all primary surgical failures. It is characterized by the growth and contraction of cellular membranes within the vitreous cavity and on both surfaces of the detached retina as well as intraretinal fibrosis.\n\nThe Retina Society classification, modified in 1991 and currently the most widely used, divided PVR into three grades. Grade A is limited to the presence of vitreous haze and pigment clumps. Grade B includes rolled or irregular edges of tear and/or inner retinal surface wrinkling with possible retinal stiffness and vessel tortuosity. Grade C is defined as the presence of full-thickness fixed retinal folds and is further subdivided based on the number of hours involved and the location.\n\nRecently, Foveau et al., in a retrospective comparative case series, have demonstrated that performing internal limiting membrane (ILM) peeling during RRD surgery may increase the anatomical success rate for this indication.\n\nThe aim of this multi-center, prospective, randomized controlled clinical trial study is to evaluate the effectiveness of ILM peeling on surgical outcomes in patients with primary macula-off RRD complicated by grade B PVR.', 'detailedDescription': 'Despite advances in surgical techniques over the recent decades, proliferative vitreoretinopathy (PVR) remains the main obstacle to successful rhegmatogenous retinal detachment (RRD) repair, accounting for nearly 75% of all primary surgical failures. It is characterized by the growth and contraction of cellular membranes within the vitreous cavity and on both surfaces of the detached retina as well as intraretinal fibrosis.\n\nThe Retina Society classification, modified in 1991 and currently the most widely used, divided PVR into three grades. Grade A is limited to the presence of vitreous haze and pigment clumps. Grade B includes rolled or irregular edges of tear and/or inner retinal surface wrinkling with possible retinal stiffness and vessel tortuosity. Grade C is defined as the presence of full-thickness fixed retinal folds and is further subdivided based on the number of hours involved and the location.\n\nGrade B PVR is thought to represent an immature form of PVR with a definite potential for progression to further stages of PVR. Specific treatment for moderate PVR seems to be essential to halt the disease process and to reduce the risk of postoperative re-detachment. However, there is currently no consensus regarding the management of grade PVR. In macula-off RRD, vitrectomy with gas tamponade is often used as a primary option, with a retinal reattachment rate of 60%.\n\nRecently, Foveau et al., in a retrospective comparative case series, have demonstrated that performing internal limiting membrane (ILM) peeling during RRD surgery may increase the anatomical success rate for this indication.\n\nThe aim of this multi-center, prospective, randomized controlled clinical trial study is to evaluate the effectiveness of ILM peeling on surgical outcomes in patients with primary macula-off RRD complicated by grade B PVR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years old\n* With macula-off retinal detachment complicated by grade B proliferative vitreoretinopathy\n\nExclusion Criteria:\n\n* Underage patients\n* History of retinal detachment\n* History of intraocular surgery (except for cataract surgery)\n* Traumatic retinal detachment\n* Macular hole-associated retinal detachment\n* Concurrent macular disease (diabetic maculopathy, age-related macular degeneration)'}, 'identificationModule': {'nctId': 'NCT05538156', 'acronym': 'IMPURITY', 'briefTitle': 'Internal Limiting Membrane Peeling in Retinal Detachment Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Internal Limiting Membrane Peeling in Macula-off Retinal Detachment With Grade B Proliferative Vitreoretinopathy', 'orgStudyIdInfo': {'id': '2022-A00665-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control group', 'description': 'The internal limiting membrane is not removed', 'interventionNames': ['Procedure: Control group']}, {'type': 'OTHER', 'label': 'Intervention group', 'description': 'The internal limiting membrane of the posterior pole is removed', 'interventionNames': ['Procedure: Intervention group']}], 'interventions': [{'name': 'Control group', 'type': 'PROCEDURE', 'description': 'Vitrectomy and gas tamponade without internal limiting membrane peeling', 'armGroupLabels': ['Control group']}, {'name': 'Intervention group', 'type': 'PROCEDURE', 'description': 'Vitrectomy, internal limiting membrane peeling and gas tamponade', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jean-Baptiste CONART, Prof', 'role': 'CONTACT', 'email': 'jbconart@hotmail.com', 'phone': '+33383155101'}], 'overallOfficials': [{'name': 'Jean-Baptiste CONART, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brabois Hospital, Nancy, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}