Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-09 @ 1:22 PM
Study NCT ID:
NCT03287102
Status:
UNKNOWN
Last Update Posted:
2018-01-30
First Post:
2017-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap (MARTIAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012167', 'term': 'Retinal Perforations'}], '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': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2017-09-15', 'studyFirstSubmitQcDate': '2017-09-15', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of dimples on optical coherence tomography', 'timeFrame': '3 months after surgery', 'description': 'Incidence of DONFL appearance'}], 'secondaryOutcomes': [{'measure': 'Retinal sensitivity on microperimetry testing (decibel)', 'timeFrame': '3 months after surgery'}, {'measure': 'Macular hole closure rate on optical coherence tomography', 'timeFrame': '3 months after surgery'}, {'measure': 'Visual acuity (Logarithm of the Minimum Angle of Resolution)', 'timeFrame': '3 months after surgery'}, {'measure': 'Ellipsoide zone defect on optical coherence tomography', 'timeFrame': '3 months after surgery'}, {'measure': 'External limiting membrane defect on optical coherence tomography', 'timeFrame': '3 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Macula Hole']}, 'referencesModule': {'references': [{'pmid': '25946691', 'type': 'BACKGROUND', 'citation': 'Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Adelman RA, Nawrocki J. TEMPORAL INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE VERSUS CLASSIC INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE: A Comparative Study. Retina. 2015 Sep;35(9):1844-50. doi: 10.1097/IAE.0000000000000555.'}, {'pmid': '24263468', 'type': 'BACKGROUND', 'citation': 'Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Nawrocki J. Inverted internal limiting membrane flap technique for surgical repair of myopic macular holes. Retina. 2014 Apr;34(4):664-9. doi: 10.1097/IAE.0000000000000042.'}, {'pmid': '23077227', 'type': 'BACKGROUND', 'citation': 'Tadayoni R, Svorenova I, Erginay A, Gaudric A, Massin P. Decreased retinal sensitivity after internal limiting membrane peeling for macular hole surgery. Br J Ophthalmol. 2012 Dec;96(12):1513-6. doi: 10.1136/bjophthalmol-2012-302035. Epub 2012 Oct 17.'}, {'pmid': '20541263', 'type': 'BACKGROUND', 'citation': 'Michalewska Z, Michalewski J, Adelman RA, Nawrocki J. Inverted internal limiting membrane flap technique for large macular holes. Ophthalmology. 2010 Oct;117(10):2018-25. doi: 10.1016/j.ophtha.2010.02.011. Epub 2010 Jun 11.'}, {'pmid': '11733271', 'type': 'BACKGROUND', 'citation': 'Tadayoni R, Paques M, Massin P, Mouki-Benani S, Mikol J, Gaudric A. Dissociated optic nerve fiber layer appearance of the fundus after idiopathic epiretinal membrane removal. Ophthalmology. 2001 Dec;108(12):2279-83. doi: 10.1016/s0161-6420(01)00856-9.'}]}, 'descriptionModule': {'briefSummary': 'Since 1991, idiopathic macular holes (MH) can benefit from an effective treatment initially involving pars plana vitrectomy, stripping of epiretinal membranes and intraocular gas tamponade followed by facedown positioning. The initial 58% success rate has further increased to 85-100% with internal limiting membrane (ILM) peeling. However, complete ILM removal has been shown to lead to anatomic changes causing the retina to have the appearance of a dissociated optic nerve fiber layer (DONFL). Moreover, it has been associated with decreased retinal sensitivity that may cause visual discomfort despite good visual acuity. Nawrocki et al. recently suggested to reduce the area of peeled ILM (temporal inverted ILM flap technique) in order to minimize iatrogenic trauma while maintaining satisfactory surgical outcomes. The aim of this study is to compare the incidence of DONFL appearance and retinal sensitivity after macular hole surgery in eyes that underwent temporal inverted ILM flap technique and eyes that had complete ILM peeling'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years old\n\nExclusion Criteria:\n\n* Underage patients\n* History of intraocular surgery (except for cataract surgery)\n* Macular hole secondary to trauma, diabetic retinopathy, uveitis or associated with retinal detachment\n* Concurrent macular disease (diabetic maculopathy, age-related macular degeneration)'}, 'identificationModule': {'nctId': 'NCT03287102', 'acronym': 'MARTIAL', 'briefTitle': 'Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap (MARTIAL)', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Dissociated Optic Nerve Fiber Layer Appearance and Retinal Sensitivity After Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap Technique', 'orgStudyIdInfo': {'id': '2017-A02061-52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Temporal inverted ILM peeling group', 'description': 'The internal limiting membrane is peeled from the temporal side of the fovea only', 'interventionNames': ['Procedure: Macular hole surgery']}, {'type': 'OTHER', 'label': 'Complete ILM peeling group', 'description': 'The internal limiting membrane is completely removed around the fovea', 'interventionNames': ['Procedure: Macular hole surgery']}], 'interventions': [{'name': 'Macular hole surgery', 'type': 'PROCEDURE', 'description': 'Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade', 'armGroupLabels': ['Complete ILM peeling group', 'Temporal inverted ILM peeling group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'contacts': [{'name': 'Jean-Baptiste CONART', 'role': 'CONTACT', 'email': 'jbconart@hotmail.com', 'phone': '+33383155203'}], 'facility': 'Brabois Hospital', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Jean-Baptiste CONART', 'role': 'CONTACT', 'email': 'jbconart@hotmail.com', 'phone': '+33383155203'}], 'overallOfficials': [{'name': 'Jean-Baptiste CONART', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brabois Hospital, Nancy, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}