[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643945":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":29,"locations":23,"responsibleParty":37,"collaborators":23,"id":39,"slug":23,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":23,"enrollmentInfo":49,"targetDuration":23,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":65,"whyStopped":23,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":23},{"fullName":5,"class":6},"Fondazione G.B. Bietti, IRCCS","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Glaucoma Patients","Participants with diagnosed glaucoma (primary open-angle, primary angle-closure or secondary glaucoma) undergoing standard ophthalmological examination and AI-based image analysis.",[12],"Device: GlaukomAI (Sens-vue GlaukomAI)",{"label":14,"type":6,"description":15,"interventionNames":16},"Healthy Controls","Participants without ocular pathology and with normal ophthalmological examination undergoing standard ophthalmological examination and AI-based image analysis.",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","GlaukomAI (Sens-vue GlaukomAI)","GlaukomAI is an AI-based diagnostic software (Sens-vue ApS) that analyzes standard fundus photographs to detect glaucomatous changes. The system uses deep learning with Convolutional Neural Network and Transformer architecture to evaluate key glaucoma biomarkers, including neuroretinal rim appearance in the inferior and superior sectors. It accepts standard fundus images acquired with conventional fundus cameras or portable devices and provides a diagnostic classification (Referable Glaucoma \u002F Non-Referable Glaucoma) within 2-8 seconds per image. The system is not CE-marked. Fundus images are acquired using a widefield TrueColor Confocal fundus imaging system (iCare DRS Plus), pseudonymized, and uploaded to the GlaukomAI secure platform by an operator blinded to the clinical diagnosis.",[9,14],null,[25],{"name":26,"affiliation":27,"role":28},"Francesco Oddone, MD, PhD","IRCCS Fondazione G. B. Bietti, Rome, Italy","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":23,"email":33},"CONTACT","+39 06 84009442","francesco.oddone@fondazionebietti.it",{"name":35,"role":31,"phone":32,"phoneExt":23,"email":36},"Carmela Carnevale, MD","carmela.carnevale@fondazionebietti.it",{"type":38,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","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":50,"type":51},1200,"ESTIMATED","INTERVENTIONAL",[54],"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.",[57],"Glaucoma",[57,59,60,61,62,63,64],"Artificial Intelligence","Fundus Photography","Glaucoma Screening","Early Diagnosis","Optic Nerve","GlaukomAI","NOT_YET_RECRUITING","2026-06-19",{"date":68,"type":69},"2026-06-25","ACTUAL",{"date":71,"type":51},"2026-06",{"date":73,"type":51},"2028-05",{"name":5,"class":6}]