Nctid:
NCT06233500
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012167", "term"=>"Retinal Perforations"}], "ancestors"=>[{"id"=>"D012164", "term"=>"Retinal Diseases"}, {"id"=>"D005128", "term"=>"Eye Diseases"}], "browseLeaves"=>[{"id"=>"M15002", "name"=>"Retinal Perforations", "asFound"=>"Macular Hole", "relevance"=>"HIGH"}, {"id"=>"M14999", "name"=>"Retinal Diseases", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M16974", "name"=>"Triamcinolone", "relevance"=>"LOW"}, {"id"=>"M16975", "name"=>"Triamcinolone Acetonide", "relevance"=>"LOW"}, {"id"=>"M237966", "name"=>"Triamcinolone hexacetonide", "relevance"=>"LOW"}, {"id"=>"M209573", "name"=>"Triamcinolone diacetate", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"This study will include 28 eyes with idiopathic full thickness macular hole; All eyes in this study will be subjected to pars plana vitrectomy procedure, they will be divided into two groups:\n\nGroup A: 16 eyes will be treated with only wide internal limiting membrane (ILM) peeling up to the arcades without ILM flap Group B : 16 eyes will be treated by ILM peeling with ILM flap."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>28}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2021-12-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-03-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-03-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"visual acuity", "timeFrame"=>"It will be measured preoperative and at 1 and 6 months post-operative", "description"=>"Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis"}, {"measure"=>"Fovea avascular zone FAZ", "timeFrame"=>"It will be measured preoperative and at 1 and 6 months post-operative", "description"=>"Optical coherence tomography angiography used to measure FAZ area in mm2 (mm square)"}], "secondaryOutcomes"=>[{"measure"=>"central retinal thickness", "timeFrame"=>"It will be measured preoperative and at 1 and 6 months post-operative", "description"=>"Standard Optical coherence tomography of the macula using (SD-OCT) scans (512 A-scans, 20°×20°) to measure central retinal thickness in µm"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["macular hole", "ILM peeling", "Temporal flap", "OCTA", "Optical Coherence Tomography Angiography"], "conditions"=>["Macular Holes"]}, "referencesModule"=>{"references"=>[{"pmid"=>"29183023", "type"=>"BACKGROUND", "citation"=>"Demirel S, Degirmenci MFK, Bilici S, Yanik O, Batioglu F, Ozmert E, Alp N. The Recovery of Microvascular Status Evaluated by Optical Coherence Tomography Angiography in Patients after Successful Macular Hole Surgery. Ophthalmic Res. 2018;59(1):53-57. doi: 10.1159/000484092. Epub 2017 Nov 29."}, {"pmid"=>"2025167", "type"=>"BACKGROUND", "citation"=>"Kelly NE, Wendel RT. Vitreous surgery for idiopathic macular holes. Results of a pilot study. Arch Ophthalmol. 1991 May;109(5):654-9. doi: 10.1001/archopht.1991.01080050068031."}, {"pmid"=>"17420702", "type"=>"BACKGROUND", "citation"=>"Lai MM, Williams GA. Anatomical and visual outcomes of idiopathic macular hole surgery with internal limiting membrane removal using low-concentration indocyanine green. Retina. 2007 Apr-May;27(4):477-82. doi: 10.1097/01.iae.0000247166.11120.21."}, {"pmid"=>"28129215", "type"=>"BACKGROUND", "citation"=>"Casini G, Mura M, Figus M, Loiudice P, Peiretti E, De Cilla S, Fuentes T, Nasini F. INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE FOR MACULAR HOLE SURGERY WITHOUT EXTRA MANIPULATION OF THE FLAP. Retina. 2017 Nov;37(11):2138-2144. doi: 10.1097/IAE.0000000000001470."}, {"pmid"=>"28744658", "type"=>"BACKGROUND", "citation"=>"Yun C, Ahn J, Kim M, Kim JT, Hwang SY, Kim SW, Oh J. Characteristics of retinal vessels in surgically closed macular hole: an optical coherence tomography angiography study. Graefes Arch Clin Exp Ophthalmol. 2017 Oct;255(10):1923-1934. doi: 10.1007/s00417-017-3742-6. Epub 2017 Jul 25."}, {"pmid"=>"25673252", "type"=>"BACKGROUND", "citation"=>"Woon WH, Greig D, Savage MD, Wilson MC, Grant CA, Mokete B, Bishop F. Movement of the inner retina complex during the development of primary full-thickness macular holes: implications for hypotheses of pathogenesis. Graefes Arch Clin Exp Ophthalmol. 2015 Dec;253(12):2103-9. doi: 10.1007/s00417-015-2951-0. Epub 2015 Feb 13."}, {"pmid"=>"24736052", "type"=>"BACKGROUND", "citation"=>"Itoh Y, Inoue M, Rii T, Ando Y, Hirakata A. Asymmetrical recovery of cone outer segment tips line and foveal displacement after successful macular hole surgery. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):3003-11. doi: 10.1167/iovs.14-13973."}, {"pmid"=>"25317632", "type"=>"BACKGROUND", "citation"=>"Spaide RF, Klancnik JM Jr, Cooney MJ. Retinal vascular layers imaged by fluorescein angiography and optical coherence tomography angiography. JAMA Ophthalmol. 2015 Jan;133(1):45-50. doi: 10.1001/jamaophthalmol.2014.3616."}, {"pmid"=>"27296485", "type"=>"BACKGROUND", "citation"=>"Lupidi M, Coscas F, Cagini C, Fiore T, Spaccini E, Fruttini D, Coscas G. Automated Quantitative Analysis of Retinal Microvasculature in Normal Eyes on Optical Coherence Tomography Angiography. Am J Ophthalmol. 2016 Sep;169:9-23. doi: 10.1016/j.ajo.2016.06.008. Epub 2016 Jun 11."}, {"pmid"=>"26469536", "type"=>"BACKGROUND", "citation"=>"Samara WA, Say EA, Khoo CT, Higgins TP, Magrath G, Ferenczy S, Shields CL. CORRELATION OF FOVEAL AVASCULAR ZONE SIZE WITH FOVEAL MORPHOLOGY IN NORMAL EYES USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2188-95. doi: 10.1097/IAE.0000000000000847."}, {"pmid"=>"28982954", "type"=>"BACKGROUND", "citation"=>"Kim YJ, Jo J, Lee JY, Yoon YH, Kim JG. Macular capillary plexuses after macular hole surgery: an optical coherence tomography angiography study. Br J Ophthalmol. 2018 Jul;102(7):966-970. doi: 10.1136/bjophthalmol-2017-311132. Epub 2017 Oct 5."}]}, "descriptionModule"=>{"briefSummary"=>"The goal of this prospective interventional study is to to compare the micro vascular and structural changes between surgery with and without ILM flap to repair macular hole.\n\nThe main questions it aims to answer are:\n\n* What are the macular micro vascular and structural changes pre and post repair of idiopathic full thickness macular hole and what is the correlation between these changes and visual recovery.\n* Is there are any prognostic values of the micro vascular status of the macula could be assessed preoperatively.\n* What are the differences regarding these micro vascular and structural changes between repair with and without ILM flap.\n\nParticipants will be:\n\n* Subjected to pars plana vitrectomy to repair macular hole.\n* Examined by optical coherence tomography angiography pre and post operative\n\nResearchers will compare:\n\nGroup A: eyes treated without ILM flap Group B : eyes treated by ILM flap to see if there are differences regarding the micro vascular and structural changes in the macular area.", "detailedDescription"=>"This study will include 28 eyes with idiopathic full thickness macular hole; they will be divided into two groups:\n\nGroup A: 14 eyes will be treated without ILM flap Group B : 14 eyes will be treated by ILM flap\n\n* Sample size: 28 eyes. (based on ELM recovery rate in ILM flap 70% versus 21.4% with inverted flap (Iwasaki et al., 2019), and at power of study 80% and confidence level 95%, sample size is calculated using openEpi software to be 14 eyes in each group\n* Study setting: Ophthalmology Department, Fayoum University and the Research Institute of Ophthalmology\n* Data Collection :\n\n * History :\n\n 1. Demographic data ( age , gender )\n 2. General medical history ( DM, HTN )\n 3. Symptom duration\n 4. Previous ocular history\n * Clinical examination:\n\n 1. Best corrected visual acuity using snellen chart (converted to log MAR for statiscal analysis).\n 2. Slit lamp biomicroscopy for anterior segment examination.\n 3. Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)\n 4. Axial length measurement\n * Optical Coherence Tomography:\n\nWe use SD- OCT and OCTA for pre and post-operative evaluation of retinal layers microstructure and vasculature.\n\n* Surgical Procedure\n\nAll eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps:\n\n* 23 G trocar system will be used\n* Posterior vitreous detachment will be induced with the aid of triamcinolone acetate injection, and core vitrectomy will be done\n* Brilliant blue stain will be injected, and ILM forceps will be used for ILM peeling\n\nPatients will be divided then into two groups:\n\nGroup A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done\n\n* Shaving of the vitreous base, and then fluid air exchange\n* SF 6 gas tamponade will be used\n\n • Study procedures:\n\n o Regular clinical assessment pre and at 1 and 6 months post-operative including:\n* Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis\n* Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)\n\n * Standard Optical coherence tomography of the macula at 1 and 6 months post-operative using (SD-OCT) scans (512 A-scans, 20°×20°) with the following protocol:\n\nMacula thickness map for measurement of central retinal thickness, and photoreceptor inner segment/outer segment complex.\n\no Optical coherence tomography angiography of the macula at 1 and 6 months post-operative studying Superficial Capillary plexus, Deep Capillary plexus and Fovea avascular zone."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Idiopathic full thickness Macular hole without retinal detachment\n\nExclusion Criteria:\n\n* Previous pars plana vitrectomy\n* High myopia with axial length ≥ 26 mm.\n* Uncertain symptom duration or ≥ 6 month .\n* History of same eye trauma\n* Poor image quality.\n* Patients with diabetic retinopathy or other retinal diseases, e.g. ischemic, inflammatory.\n* Any patient with significant cataract which needs combined phaco-vitrectomy."}, "identificationModule"=>{"nctId"=>"NCT06233500", "briefTitle"=>"Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study", "organization"=>{"class"=>"OTHER", "fullName"=>"Fayoum University"}, "officialTitle"=>"Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study", "orgStudyIdInfo"=>{"id"=>"FayoumU_28"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Group A: eyes will be treated without ILM flap", "description"=>"Group A: Only wide ILM peeling up to the arcades well be done", "interventionNames"=>["Procedure: pars plana vitrectomy"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Group B : eyes will be treated by ILM flap", "description"=>"Group B: ILM peeling with flap well be done", "interventionNames"=>["Procedure: pars plana vitrectomy"]}], "interventions"=>[{"name"=>"pars plana vitrectomy", "type"=>"PROCEDURE", "otherNames"=>["PPV with ILM peeling"], "description"=>"All eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps:\n\n* 23 G trocar system will be used\n* Posterior vitreous detachment will be induced with the aid of triamcinolone acetate injection, and core vitrectomy will be done\n* Brilliant blue stain will be injected, and ILM forceps will be used for ILM peeling\n\nPatients will be divided then into two groups:\n\nGroup A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done\n\n* Shaving of the vitreous base, and then fluid air exchange\n* SF 6 gas tamponade will be used", "armGroupLabels"=>["Group A: eyes will be treated without ILM flap", "Group B : eyes will be treated by ILM flap"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"12511", "city"=>"Giza", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Abeer Salem", "role"=>"CONTACT", "email"=>"A.salem@Rio.edu.eg", "phone"=>"+201125666006"}, {"name"=>"Heba Ahmed", "role"=>"CONTACT", "email"=>"heba_rio2000@yahoo.com", "phone"=>"+201020020157"}], "facility"=>"research institute of ophthalmology, Egypt", "geoPoint"=>{"lat"=>30.00808, "lon"=>31.21093}}], "centralContacts"=>[{"name"=>"Mohamed Husssein", "role"=>"CONTACT", "email"=>"mhmm1004@hotmail.com", "phone"=>"+201015479856"}], "overallOfficials"=>[{"name"=>"Islam Mohalhal, MD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Research Institute of Ophthalmology, Egypt"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF"], "timeFrame"=>"data will become available before the end of 2024 and will be available for 1 year", "ipdSharing"=>"YES", "description"=>"IPD that underlie results in a publication", "accessCriteria"=>"it will be shared via E-mail"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fayoum University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Research Institute of Ophthalmology, Egypt", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Dr.", "investigatorFullName"=>"Mohamed Hussein", "investigatorAffiliation"=>"Fayoum University"}}}}
