Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT04312620
Status:
UNKNOWN
Last Update Posted:
2020-03-18
First Post:
2020-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of OCT and Visual Field Changes After Vitrectomy and ILM Peeling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-04-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-03-16', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BCVA', 'timeFrame': '6 months', 'description': 'ILM peeling'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ILM Peeling']}, 'referencesModule': {'references': [{'pmid': '18631327', 'type': 'BACKGROUND', 'citation': 'Noma H, Funatsu H, Sakata K, Harino S, Mimura T, Hori S. Macular microcirculation in hypertensive patients with and without branch retinal vein occlusion. Acta Ophthalmol. 2009 Sep;87(6):638-42. doi: 10.1111/j.1755-3768.2008.01318.x. Epub 2008 Jul 8.'}, {'pmid': '26814541', 'type': 'RESULT', 'citation': 'Higashide T, Ohkubo S, Hangai M, Ito Y, Shimada N, Ohno-Matsui K, Terasaki H, Sugiyama K, Chew P, Li KK, Yoshimura N. Influence of Clinical Factors and Magnification Correction on Normal Thickness Profiles of Macular Retinal Layers Using Optical Coherence Tomography. PLoS One. 2016 Jan 27;11(1):e0147782. doi: 10.1371/journal.pone.0147782. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'To evulate changes in VF and OCT after viterctomy associated with ILM peeling.', 'detailedDescription': 'Macular epiretinal membrane (ERM) is a disorder of the vitreomacular interface characterized by fibrocellular proliferation on the anterior surface of the internal limiting membrane (ILM) of the macula. Pars plana vitrectomy with ERM removal and inner limiting membrane peeling is the standard surgical treatment for an ERM. ILM peeling is performed to eliminate the scaffold for myofibroblast proliferation and any microscopic ERM in order to prevent ERM recurrence. ILM peeling is indicated for other pathologies other than ERM such as, diabetic macular edema, and macular hole. ILM peeling is a traumatic procedure that may have many effects on the underlying inner retinal layers that may lead to changes in retinal function.\n\nRetinal edema, eccentric scotoma, dissociation of the nerve fiber layer, iatrogenic punctuate chorioretinopathy, and subretinal, retinal, and vitreous hemorrhage are well described secondary to the surgical trauma of peeling in addition to stain toxicity. Investigation of these changes may assist in aiding the development of minimally traumatic techniques for ILM removal .\n\nEvaluation of functional changes may include visual field and Multifocal electroretinography assessment. Visual field defect after vitrectomy a well known post operative complication usually in eyes that underwent fluid air exchange, the cause of visual field defect remain unclear.\n\nOptical Coherence Tomography (OCT), imaging is done to evaluate inner retinal layers after ILM peeling,High myopic eyes might develop more severe, "scattered" inner retinal defects after ILM peeling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients withIdiopathic ERM,Primary full thickness macular hole,Lamellar macular hole, andVitromacular traction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 1-Idiopathic ERM,\n2. Primary full thickness macular hole,\n3. Lamellar macular hole, and\n4. Vitromacular traction.\n\nExclusion Criteria:\n\n* 1-Patients with a secondary ERM,\n\n 1. diabetic retinopathy,\n 2. venous occlusion,\n 3. retinal detachment,\n 4. uveitis, and\n 5. trauma. 2-Other ocular pathologies that could interfere with the functional results\n\n <!-- -->\n\n 1. dense cataract ,\n 2. glaucoma, and\n 3. previous retinal surgery.'}, 'identificationModule': {'nctId': 'NCT04312620', 'briefTitle': 'Evaluation of OCT and Visual Field Changes After Vitrectomy and ILM Peeling', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of OCT and Visual Field Changes After Vitrectomy and ILM Peeling', 'orgStudyIdInfo': {'id': 'ILM peeling'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'almoatz bellah zohier mohamm,ed, master', 'role': 'CONTACT', 'email': 'moatazmoh58@gmail.com', 'phone': '01099490013'}, {'name': 'magady mostafa, professor', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Almoatz bellah zohier Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}