[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione G.B. Bietti, IRCCS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":189},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,48,74,98,121,142,170],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100643945","glaukomai-clinical-validation-of-an-ai-system-for-early-glaucoma-screening-100643945",false,"NCT07668193","GlaukomAI: Clinical Validation of an AI System for Early Glaucoma Screening","GlaukomAI: Clinical Validation of an Artificial Intelligence-Based System for Early Glaucoma Screening and Diagnosis - A Case-Control Study and Referral Accuracy Assessment","GlaukomAIcare","Inclusion Criteria for all patients:\n\n* Age \\>18 years\n* Freely given informed consent obtained prior to study initiation\n* The participant has the capacity to understand and the willingness to follow study instructions and is likely to complete all required visits and procedures\n\nInclusion Criteria for glaucoma patients:\n\nPatients affected by any type of glaucoma (primary open-angle, primary angle-closure, secondary glaucoma) on pharmacological therapy\n\nInclusion Criteria for healthy controls:\n\n* Absence of ocular pathologies\n* IOP \\\u003C21 mmHg\n* Visual field and OCT within normal limits\n* Optic disc of normal appearance on clinical evaluation\n\nExclusion Criteria:\n\n* Presence of media opacities preventing the acquisition of adequate quality fundus imaging (e.g., advanced cataract, vitreous hemorrhage, severe corneal opacities)\n* Retinal or optic nerve pathologies that could confound the diagnosis (e.g., non-glaucomatous optic neuropathies (ischemic, inflammatory, compressive), moderate-to-severe diabetic retinopathy, advanced macular degeneration, retinal vascular occlusions)\n* Having undergone any ocular surgery in the past 3 months\n* Inability to cooperate with perimetric examination",true,"ALL","18 Years",{"count":21,"type":22},1200,"ESTIMATED","INTERVENTIONAL",[25],"NA","Glaucoma is one of the leading causes of irreversible blindness worldwide. Early diagnosis is crucial to prevent vision loss, but current diagnostic pathways require multiple specialist visits and tests, leading to long waiting times and delayed diagnosis.\n\nThis study aims to evaluate the accuracy of GlaukomAI, an artificial intelligence (AI)-based software that analyzes fundus photographs of the eye to detect glaucoma at an early stage.\n\nThe study is conducted at IRCCS Fondazione G. B. Bietti (Rome, Italy) and is structured in two phases:\n\n* Phase 1 enrolls 200 participants (100 with diagnosed glaucoma and 100 healthy controls) to assess how accurately GlaukomAI can distinguish between glaucoma and healthy eyes, compared to the judgment of a panel of three expert glaucoma specialists.\n* Phase 2 enrolls 1,000 consecutive outpatients to evaluate whether GlaukomAI can correctly identify patients who need referral to a glaucoma specialist, and to compare its performance with that of non-specialist ophthalmologists.\n\nParticipants undergo a single study visit including standard ophthalmic examinations (visual acuity, eye pressure measurement, visual field test, OCT, and fundus photography). No investigational drugs or invasive procedures are involved.\n\nThe results of this study will provide evidence to support the integration of AI-based tools into routine glaucoma screening pathways, with the goal of reducing diagnostic delays and improving access to care.",[28],"Glaucoma",[28,30,31,32,33,34,35],"Artificial Intelligence","Fundus Photography","Glaucoma Screening","Early Diagnosis","Optic Nerve","GlaukomAI","NOT_YET_RECRUITING","2026-06-19",{"date":39,"type":40},"2026-06-25","ACTUAL",{"date":42,"type":22},"2026-06",{"date":44,"type":22},"2028-05",{"name":46,"class":47},"Fondazione G.B. Bietti, IRCCS","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100631411","proteomic-biomarker-identification-in-age-related-macular-degeneration-diabetic-retinopathy-and-retinal-detachment-100631411","NCT07500324","Proteomic Biomarker Identification in Age-Related Macular Degeneration, Diabetic Retinopathy and Retinal Detachment","Identification And Validation Of Biomarkers In Ophthalmological Diseases (Age-Related Macular Degeneration, Diabetic Retinopathy And Retinal Detachment) Through Clinical Proteomic Approaches","PRO Project","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ability to understand the study procedures and provide written informed consent\n* Willingness and ability to comply with study procedures and visits\n\nFor case subjects:\n\n* Patients with age-related macular degeneration (intermediate or advanced, including geographic atrophy or neovascular AMD)\n* Patients with diabetic retinopathy (non-proliferative or proliferative, with or without diabetic macular edema)\n* Patients undergoing surgery for primary or recurrent retinal detachment\n\nFor control subjects:\n\n* Patients scheduled for cataract surgery with no documented retinal diseases (e.g., AMD, diabetic retinopathy, retinal vascular occlusions, or retinal epithelial disorders)\n* Outpatients with no documented retinal diseases\n* For retinal detachment subgroup: patients undergoing macular surgery (e.g., macular pucker or macular hole) or cataract surgery with attached retina\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Presence of infectious ocular diseases\n* Alterations in the electrophoretic profile of gamma globulins",{"count":57,"type":22},260,[25],"This prospective interventional translational study aims to identify and validate protein biomarkers associated with major ophthalmological diseases, including age-related macular degeneration, diabetic retinopathy (DR), and retinal detachment (RD). A total of approximately 260 participants (cases and controls) will be enrolled at a single center.\n\nBiological samples, including peripheral blood, tears, aqueous humor, vitreous humor, and subretinal fluid, will be collected during routine clinical and surgical procedures. Advanced clinical proteomics approaches will be applied to characterize molecular signatures associated with disease onset, progression, and response to treatment.\n\nThe study seeks to improve the understanding of disease pathophysiology and support the development of novel diagnostic and prognostic biomarkers in ophthalmology.",[61,62,63],"Age-Related Macular Degeneration (AMD)","Diabetic Retinopathy (DR)","Retinal Detachment","RECRUITING","2026-05-29",{"date":67,"type":40},"2026-06-02",{"date":69,"type":40},"2024-01-24",{"date":71,"type":22},"2027-01",{"name":46,"class":47},1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":18,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":73},"100585717","visual-rehabilitation-and-depression-in-visually-impaired-patients-with-amd-100585717","NCT06906003","Visual Rehabilitation and Depression in Visually Impaired Patients With AMD","Evaluation of the Impact of Visual Rehabilitation on Anxiety and Depression Severity of Visually Impaired Patients With Advanced Age Related Macular Degeneration","RET 06-24","Inclusion Criteria:\n\n1. Subjects ≥ 55 years\n2. Moderate and severe visual impairment (BCVA ≥1\u002F10 and ≤2\u002F10)\n3. Diagnosis of advanced non-exudative age-related macular degeneration (AMD)\n4. Informed consent freely granted and acquired before the start of the study\n5. Ability to understand and willingness to follow the study instructions and procedures\n\nExclusion Criteria:\n\n1. Visual impairment due to other ocular diseases\n2. Mild visual impairment or partial or total blindness\n3. Exudative age-related macular degeneration undergoing intravitreal drug treatment","55 Years",{"count":84,"type":22},22,"OBSERVATIONAL","Purpose: The aim of this study is to evaluate the impact of visual rehabilitation in visually impaired patients with advanced AMD by the use of questionnaires on the anxiety and depression status.\n\nStudy design: prospective observational study. The study is carried out at the IRCCS Fondazione G.B.Bietti and at the UO Visual Rehabilitation, S. Alessio - Margherita di Savoia.\n\nStudy procedures: Visit 1 (screening visit, at IRCCS Fondazione Bietti) After signing the informed consent, all patients received a complete ophthalmological examination, non-invasive diagnostic tests as optical coherence tomography, autofluorescence and microperimetry, and have to complete the questionnaires on the state of anxiety and depression (GAD-7 and PHQ-9).\n\nVisit 2 (at the Sant'Alessio Institute) for a 60-day visual rehabilitation program scheduled in 5 group meetings.\n\nVisit 3 (end-of-study visit, at IRCCS Fondazione G.B. Bietti) complete ophthalmological examination, as per clinical practice, non-invasive diagnostic tests such as microperimetry, optical coherence tomography and autofluorescence and administration of the Patient Health Questionnaire-9 (PHQ-9) questionnaires for depression and the General Anxiety Disorder (GAD-7) questionnaires for anxiety.",[88,89,90],"AMD - Age-Related Macular Degeneration","Anxiety","Depression Disorders",{"date":92,"type":40},"2026-06-01",{"date":94,"type":40},"2024-12-02",{"date":96,"type":22},"2026-12-02",{"name":46,"class":47},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":17,"sex":18,"minAge":106,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100641277","morpho-functional-evaluation-of-the-retina-and-choroid-using-multimodal-imaging-in-healthy-subjects-and-patients-with-retino-choroidal-diseases-100641277","NCT07615699","Morpho-functional Evaluation of the Retina and Choroid Using Multimodal Imaging in Healthy Subjects and Patients With Retino-choroidal Diseases","Valutazione Morfo-funzionale Della Retina e Della Coroide Mediante Imaging Multimodale in Soggetti Sani e in Pazienti Con Patologie Retino-coroideali","RET 05-26","Inclusion Criteria:\n\n* freely given informed consent acquired prior to the start of the study.\n* Participant's capacity to understand the informed consent and study procedures.\n* Age ≥ 6 years (with parental\u002Fguardian consent for minors).\n* Patients affected by any retino-choroidal disease.\n* Healthy subjects showing no retino-choroidal pathology.\n\nExclusion Criteria:\n\n* Patient unable and\u002For unwilling to cooperate.\n* Presence of media opacities (dioptric media) that prevent image acquisition or significantly reduce the quality of the obtained images.","6 Years",{"count":108,"type":22},125,"The purpose of this prospective, longitudinal, single-center observational study is to identify, describe, and measure the morpho-functional characteristics and modifications of the retina and choroid using advanced multimodal imaging techniques. The study will evaluate patients affected by retino-choroidal diseases and compare them with healthy controls over a 5-year follow-up period to track the evolution of these parameters over time.",[111,112,113],"Retinal Diseases","Choroidal Diseases","Healthy Subjects","2026-05-28",{"date":65,"type":40},{"date":117,"type":22},"2026-07-01",{"date":119,"type":22},"2033-06-01",{"name":46,"class":47},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":18,"minAge":129,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":23,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":139,"leadSponsor":141,"locationsCount":73},"100635592","photobiomodulation-laser-for-reticular-pseudodrusen-in-age-related-macular-degeneration-100635592","NCT07554690","Photobiomodulation Laser for Reticular Pseudodrusen in Age-Related Macular Degeneration","Photobiomodulation Laser in Reticular Pseudodrusen Secondary to Age-related Macular Degeneration","PBM in iAMD","Inclusion Criteria:\n\n* Age ≥ 50 years\n* Diagnosis of reticular pseudodrusen secondary to age-related macular degeneration in the study eye\n* Best-corrected visual acuity (BCVA) between 20\u002F20 and 20\u002F400 (inclusive)\n* Ability and willingness to comply with study procedures and visits\n* Written informed consent obtained prior to any study procedures\n\nExclusion Criteria:\n\n* Presence of geographic atrophy\n* Evidence of macular neovascularization\n* Any previous treatment for age-related macular degeneration, except for antioxidant supplementation\n* Media opacities that may interfere with retinal imaging assessments\n* Use of phototoxic medications (including certain antibiotics or chemotherapeutics) during PBM treatment\n* Any ocular or systemic treatment known to be toxic to the retina or optic nerve\n* History of uveitis (idiopathic or autoimmune)\n* Neovascular glaucoma\n* Glaucoma due to congenital anomalies\n* Glaucoma secondary to active uveitis\n* Any intraocular surgery within 3 months prior to enrollment in the study eye\n* Previous thermal laser treatment in the macular region of the study eye\n* History of vitrectomy, filtering surgery, corneal transplantation, or retinal detachment in the study eye\n* Previous therapeutic radiation to the ocular region or face\n* Women of childbearing potential not using effective contraception during the study treatment period","50 Years",{"count":131,"type":22},67,[25],"This study evaluates whether a low-energy laser treatment called photobiomodulation (PBM) can improve visual function and retinal structure in patients with age-related macular degeneration (AMD) who have reticular pseudodrusen. PBM is a non-invasive therapy that uses specific wavelengths of light to stimulate cellular activity and reduce inflammation without causing tissue damage.\n\nParticipants will be randomly assigned to receive either active PBM treatment or a sham (inactive) treatment. The study will assess changes in visual performance under low-light conditions and retinal structure over a 12-month period.\n\nThe goal is to determine whether PBM can slow disease progression and improve visual function in patients with early stages of AMD.",[88],"2026-04-28",{"date":137,"type":40},"2026-05-04",{"date":92,"type":22},{"date":140,"type":22},"2027-12-31",{"name":46,"class":47},{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":158,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":73},"100514257","micropulsed-laser-in-patients-with-macular-oedema-in-retinal-dystrophies-100514257","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","80 Years",{"count":151,"type":22},10,[25],"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",[155,156,157],"Macular Edema","Inherited Retinal Dystrophy","Laser Retinopathy",[159,160,161,155],"Visual Acuity","Retinal Function","IRD","2025-02-26",{"date":164,"type":40},"2025-02-28",{"date":166,"type":40},"2023-09-06",{"date":168,"type":22},"2025-07-30",{"name":46,"class":47},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100533576","evaluation-of-different-perimetric-grids-to-detect-central-visual-field-defect-in-glaucoma-patients-with-reduce-ganglion-cell-layer-thickness-measured-by-spectral-domain-oct-100533576","NCT06227611","Evaluation of Different Perimetric Grids to Detect Central Visual Field Defect in Glaucoma Patients with Reduce Ganglion Cell Layer Thickness Measured by Spectral Domain OCT.","Inclusion Criteria:\n\n* glaucoma patients with glaucomatous optic nerve head defect and reduced ganglion cell layer thickness\n\nExclusion Criteria:\n\n* age\\\u003C18 years\n* unable to read, understand and sign the written informed consent\n* unable to perform visual field test\n* advanced glaucoma with C\u002FD\\>0.7\n* other causes of optic neuropathies\n* retinal or macular diseases\n* lens or corneal opacities\n* spherical refractive defect \\>± 6D\n* cylindric refractive defect \\>± 3D",{"count":177,"type":22},16,"The aim of the study is to evaluate the agreement between three different grids in detecting central visual field defect in early glaucoma patients with reduced ganglion cell layer thickness.",[28],"2025-02-25",{"date":182,"type":40},"2025-02-27",{"date":184,"type":40},"2021-05-04",{"date":186,"type":22},"2025-05-04",{"name":46,"class":47},2,""]