[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617941":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":31,"locations":37,"responsibleParty":57,"collaborators":22,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":22,"enrollmentInfo":69,"targetDuration":22,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":40,"whyStopped":22,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Cassini Technologies","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All enrolled subjects","OTHER","All eligible subjects will undergo ocular biometry using three devices:\n\n1. the investigational optical biometer,\n2. Comparator Device A, and\n3. Comparator Device B. Measurements from all devices will be obtained at the same visit and used only for diagnostic comparison. No treatment assignment occurs.",[13,14,15],"Device: New Investigational Optical Biometer (Device)","Device: Comparator Device A (Cassini Ambient)","Device: omparator Device B (Argos)",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DEVICE","New Investigational Optical Biometer (Device)","Investigational optical biometer used to obtain axial length, keratometry, anterior chamber depth, lens thickness, and total corneal astigmatism. Device is being evaluated for measurement accuracy and agreement.",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Comparator Device A (Cassini Ambient)","FDA-cleared corneal topographer used as a reference standard comparator for keratometry.",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"omparator Device B (Argos)","FDA-cleared optical biometer used as a second comparator to assess agreement and measurement differences.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"Dr. Michael Petrik Petrik, OD","CONTACT","236-982-8672","m.petrik@cassini-technologies.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Bishop Eye Center","RECRUITING","Hilton Head Island","South Carolina","29926","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-80.73816,32.19382,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":22,"email":56},"Paul Bell Bell, MD","843-689-3937","paulmbell@gmail.com",{"type":58,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100617941","development-of-optical-biometer-100617941",false,"NCT07325162","Development of Optical Biometer","Development of a Next-Generation Optical Biometer for Eyes With Cataract","CH-0203","Inclusion criteria:\n\n* The presence of cataract in at least one eye.\n* Minimally 21 years of age.\n* Provided written informed consent.\n\nExclusion criteria:\n\n* The inability to properly fixate on a fixation target for several seconds\n* The inability to provide informed consent.","ALL","18 Years",{"count":70,"type":71},100,"ESTIMATED","INTERVENTIONAL",[74],"NA","The Helioscope (Cassini Technologies B.V.) is a novel device under development that aims at combining LED-based corneal topography and SS-OCT to provide accurate and fast measurements of both the corneal shape and the ocular biometry. To that end, the hardware and software of the Cassini color-LED topographer (Cassini Technologies B.V.) is combined with a novel SS-OCT device.\n\nWhile the new Helioscope can largely be evaluated using data acquired with healthy eyes, one of its main use-cases is providing input for IOL power formulae for cataract surgery. Thus, it is essential that the device can perform measurements in eyes with (dense) cataract. As cataract changes the optical properties of the crystalline lens and the OCT measurement is optical, this is not a given. This study therefore seeks a dataset of Helioscope measurements performed in eyes with cataract that can be used to develop the software algorithms of the Helioscope.",[77],"Cataract and IOL Surgery",[79,80],"Optical Biometer","SS-OCT","2026-01-06",{"date":83,"type":84},"2026-01-08","ACTUAL",{"date":86,"type":84},"2025-11-07",{"date":88,"type":71},"2026-03-30",{"name":5,"class":6},1]