[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618964":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":45,"centralContacts":50,"locations":59,"responsibleParty":76,"collaborators":32,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":32,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":32,"enrollmentInfo":88,"targetDuration":32,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":32,"overallStatus":100,"whyStopped":32,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Heidelberg Engineering GmbH","INDUSTRY",[8,17,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational device R1","EXPERIMENTAL","Imaging with the investigational device R1",[13,14,15,16],"Device: Autofluorescence Imaging","Device: Infrared reflectance imaging","Device: OCT imaging","Device: OCTA imaging",{"label":18,"type":10,"description":19,"interventionNames":20},"HighRes OCT","Imaging with the investigational device HighRes OCT",[13,14,15,16],{"label":22,"type":23,"description":24,"interventionNames":25},"SPECTRALIS","OTHER","Imaging with the approved device SPECTRALIS",[13,14,15,16],[27,33,37,41],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","Autofluorescence Imaging","Autofluorescence imaging with blue and green light and, multicolor imaging",[18,9,22],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Infrared reflectance imaging","Infrared reflectance imaging, 30° Field of View",[18,9,22],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"OCT imaging","OCT Imaging Volume and Line Scans",[18,9,22],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"OCTA imaging","OCT Angiography, volume and SCOUT scan",[18,9,22],[46],{"name":47,"affiliation":48,"role":49},"Mariano Cozzi, MD","University of Milan, Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital","PRINCIPAL_INVESTIGATOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":32,"email":55},"Aike T. Schweda, PhD","CONTACT","+49 62216463387","Aike.Schweda@HeidelbergEngineering.com",{"name":57,"role":53,"phone":32,"phoneExt":32,"email":58},"Clinical Trials","clinical.trials@HeidelbergEngineering.com",[60],{"facility":61,"status":32,"city":62,"state":32,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan","Milan","20157","Italy","IT",{"type":67,"coordinates":68},"Point",[69,70],12.59836,42.78235,{"lat":70,"lon":69},[73],{"name":47,"role":53,"phone":74,"phoneExt":32,"email":75},"+39 0239042666","Mariano.cozzi@unimi.it",{"type":77,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100618964","high-resolution-imaging-oct-study-100618964",false,"NCT07338461","High Resolution Imaging OCT Study","High Resolution Imaging OCT Pilot Study","Inclusion Criteria:\n\n* All Able and willing to undergo the test procedures, give consent, and to follow instructions.\n\nSigned informed consent Age ≥ 18 years\n\n* Healthy Subjects without uncontrolled systemic conditions, as determined by the investigator Subjects without ocular disease, as determined by the investigator Corrected visual acuity ≥ 20\u002F40 No reported history of ocular surgical intervention (except for refractive or cataract surgery)\n* Age-related macular degeneration Subjects with a diagnosis of AMD as determined by the investigator, either early-intermediate, atrophic, or neovascular\n* Diabetic retinopathy Subjects with a diagnosis of diabetic retinopathy as determined by the investigator\n* Disease with expected altered autofluorescence pattern Subjects with a disease that can be expected to be associated with altered autofluorescence patterns as determined by the investigator\n\nExclusion Criteria:\n\n* Subjects unable to read or write\n* Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging\n* Subjects who cannot tolerate the imaging procedures\n* History of photosensitive epilepsy\n* Vulnerable subjects, i.e., individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.",true,"ALL","18 Years",{"count":89,"type":90},97,"ESTIMATED","INTERVENTIONAL",[93],"NA","The goal of this pilot study is to compare image quality between the investigational devices (R1 and HighRes OCT) and the SPECTRALIS (cleared) in adult participants with normal and\u002For pathology eyes.\n\nParticipants will be imaged with different imaging modalities and scan protocols on all study devices.",[96,97,98,99],"Normal Eyes","Age Related Macular Degeneration","Diabetic Retinopathy","Eyes With Retinal Diseases","NOT_YET_RECRUITING","2026-01-13",{"date":103,"type":104},"2026-01-15","ACTUAL",{"date":106,"type":90},"2026-01-12",{"date":108,"type":90},"2027-02-28",{"name":5,"class":6},1]