[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514257":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":33,"responsibleParty":58,"collaborators":20,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":20,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Fondazione G.B. Bietti, IRCCS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"inherited retinal dystrophies with macular oedema","EXPERIMENTAL","Laser treatment will be performed in patients with macular edema in IRD (experimental arm) who:\n\n* underwent treatment with diuretics or nutritional drainage products for 3 months and subsequent 'wash-out' of one month 17,18 and had no reduction in macular oedema, in terms of central retinal thickness, of at least 20% compared with the initial assessment\n* they have had an intravitreal injection of anti-VEGF or steroids, and after 3 months there is no reduction in central retinal thickness (CRT) of at least 20% compared to the initial assessment\n* have after 3 months a thickness reduction \\\u003C10% compared to baseline assessment, following initial treatment with micropulsed laser, and may be candidates for repeating treatment;\n* are not eligible for diuretic therapy due to the presence of comorbidities.",[13],"Device: subthreshold treatment with micropulsed laser",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","subthreshold treatment with micropulsed laser","The laser instrument used is the Q 577® Laser System, Iridex, wavelength 577 yellow. The standard pattern used is:\n\n* Power: 5% Duty Cycle\n* Power 250 mw\n* Pulse duration 200 ms\n* Spot size 100 micron\n* Pattern spacing 0.0 confluente, griglie 7x7",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Lucia Ziccardi, MD, PhD","IRCCS Fondazione G.B. Bietti","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+390684009486","neuger@fondazionebietti.it",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":30},"Federica Petrocchi, Orthoptist",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"IRCSS Fondazione G:B:Bietti","RECRUITING","Rome","RM","00194","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],12.51133,41.89193,{"lat":46,"lon":45},[49,50,51,54,56],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":32,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":52,"role":53,"phone":20,"phoneExt":20,"email":20},"Lucilla Barbano","SUB_INVESTIGATOR",{"name":55,"role":25,"phone":20,"phoneExt":20,"email":20},"Mariacristina Parravano",{"name":57,"role":25,"phone":20,"phoneExt":20,"email":20},"Lucia Ziccardi",{"type":25,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"lucia ziccardi","Principal Investigator","100514257","micropulsed-laser-in-patients-with-macular-oedema-in-retinal-dystrophies-100514257",false,"NCT05976139","Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies","Treatment of Macular Oedema in Patients With Hereditary Retinal Dystrophies by Applying the Micropulsed Subthreshold Laser","Inclusion Criteria:\n\n* Patients with inherited retinal disease\n* Age between 18 and 80 years\n* Conclusive molecular genetic study for IRD\n* Male or female patient\n* Presence of macular oedema assessed by sd-OCT with reduction ≤ 20% after 3 months of diuretics or draining supplements or 4 months after last anti-VEGF or steroid injection\n* Phakic and pseudophakic patients\n* Central Retinal thickness \\> 320 microns in men and \\> 305 microns in women\n* Informed consent freely granted and acquired before the start of the study\n* Participant has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures.\n\nExclusion Criteria:\n\n* Patients with cataract extraction prior to 6 months\n* Patients with IOP ≥ 20 mmHg\n* Patients with a clinical diagnosis of retinal dystrophy of unproven genetic origin\n* Patients with diabetes\n* Patients with central serous chorioretinosis, retinal vein occlusion, age-related degeneration\n* Patients with current or previous vitreo-retinal pathology or with indication for vitreo-retinal surgical therapy (tractional oedema)\n* Patients with a lack of target fixation at 32 cm\n* Pregnant women","ALL","18 Years","80 Years",{"count":72,"type":73},10,"ESTIMATED","INTERVENTIONAL",[76],"NA","The purpose of this study is to investigate whether subthreshold treatment with micropulsed laser can be effective in resolving macular edema in patients with inherited retinal dystrophy.\n\nVisits will be performed after 1, 3, 6, 9, 12, 18, and 24 months after treatment. Laser treatment will be performed on the day of the first visit, and its repetition at subsequent visits between months 3 and 12 will be evaluated.\n\nEvaluations of treatment effects will include:\n\n* comprehensive ophthalmologic examination\n* multifocal electroretinogram\n* OCT examination\n* OCT-angiography examination\n* retinography\n\nPrimary endpoint.\n\n\\- central retinal thickness, measured by OCT",[79,80,81],"Macular Edema","Inherited Retinal Dystrophy","Laser Retinopathy",[83,84,85,79],"Visual Acuity","Retinal Function","IRD","2025-02-26",{"date":88,"type":89},"2025-02-28","ACTUAL",{"date":91,"type":89},"2023-09-06",{"date":93,"type":73},"2025-07-30",{"name":5,"class":6},1]