[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643002":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":10,"centralContacts":44,"locations":50,"responsibleParty":65,"collaborators":10,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":10,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":10,"studyType":83,"phases":10,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":91,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Stuart Terry Eye Associates","OTHER",[8,14,18,22,26,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A, Healthy Subjects",null,"Subjects with no retinal disease present upon examination.",[13],"Device: XyCAM CRE Imaging",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B, Subjects with Moderate to Severe Glaucoma","Subjects diagnosed with moderate to severe glaucoma in at least one eye, as determined by the Hodapp-Anderson criteria for glaucomatous visual field loss.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group C, Glaucoma Suspect or Mild Glaucoma Subjects","Subjects diagnosed as glaucoma suspects or with mild glaucoma in at least one eye based on clinical findings including elevated intraocular pressure (IOP), suspicious optic nerve appearance, borderline or early visual field abnormalities, and\u002For retinal nerve fiber layer (RNFL) thinning identified by Optical Coherence Tomography (OCT).",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Group D, Subjects with AMD","The Subject has been diagnosed with AMD based on clinical diagnostic criteria for AMD",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Group E, Subjects with Diabetic Eye Disease","The Subject has been diagnosed via clinical diagnostic guidelines with diabetic eye disease, such as non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), and diabetes without significant ocular pathology visible on fundus examination.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Group F, Subjects with Hypertensive Retinopathy","The Subject has been diagnosed with Hypertensive Retinopathy based on clinical diagnostic criteria for Hypertensive Retinopathy.",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Group G, Pilot Subjects with other ocular pathologies and interventions","The Subject is determined by the Principal Investigator to have pathology or has undergone interventions that may significantly reduce or elevate ocular blood flow; and Subjects in this group are recruited on a pilot basis to assess the preliminary (with limited statistical power) promise of RBF monitoring in a diverse set of pathologies.",[13],[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":10},"DEVICE","XyCAM CRE Imaging","The investigational XyCAM CRE imaging system will be used to acquire retinal blood flow and structural imaging data. No therapeutic intervention is administered; the device is used for observational imaging and data collection only.",[9,15,19,23,27,31,35],[45],{"name":46,"role":47,"phone":48,"phoneExt":10,"email":49},"Yvette L Macias, BA in Biology and Chemistry","CONTACT","210-600-0040","yvettem@lenzaadmin.com",[51],{"facility":5,"status":10,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"San Antonio","Texas","78212","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-98.49363,29.42412,{"lat":61,"lon":60},[64],{"name":46,"role":47,"phone":48,"phoneExt":10,"email":49},{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Oday Alsheikh M.D.","Principal Investigator","100643002","collecting-data-on-retinal-blood-blood-flow-and-blood-vessel-shapeappearance-using-an-investigational-device-xycam-cre-and-to-then-compare-those-images-with-images-collected-from-a-patients-routine-clinical-examination-100643002",false,"NCT07641738","Collecting Data on Retinal Blood Blood Flow and Blood Vessel Shape\u002FAppearance Using an Investigational Device, XyCAM CRE, and to Then Compare Those Images With Images Collected From a Patient's Routine Clinical Examination.","Evaluation of Patients With Retinal Disorders Utilizing the XyCAM CRE Camera.","Inclusion Criteria:\n\n* The Subject present to the ophthalmology\u002Foptometry clinic for eye examination. A signed\u002Fdated consent form has been obtained from a Subject who is capable of giving informed consent and compliant with the restrictions and requirements if the protocol.\n\nThe Subject is 21 years old with binocular vision.\n\nExclusion Criteria:\n\n* The Subject has significant media opacity (eg: a significant corneal scar) The Subject's medical history or health status suggests that the Subject may have an adverse reaction to administration of tropicamide or fluorescein dye.\n\nThe Subject has more than 15 dioptors of refractive error. The Subject is less that 21 years of age. The Subject is unable to follow instructions or otherwise unable to complete the study procedures.\n\nThe Subject has medical conditions such as nystagmus that will likely prevent the Subject from being able to hold their gaze steady during imaging, reducing the likelihood that high quality data can be acquired from the Subject.\n\nThe Subject is pregnant.",true,"ALL","21 Years","100 Years",{"count":81,"type":82},350,"ESTIMATED","OBSERVATIONAL","The primary objective of the XyCAM CRE Camera Study is to evaluate retinal blood flow, choroidal blood flow, and retinal structural features and their association with the progression and characterization of retinal diseases using the XyCAM CRE Camera. The XyCAM CRE is an investigational, noninvasive optical imaging instrument manufactured by Vasoptic Medical, Inc.\n\nXyCAM CRE imaging data will be collected and compared with established retinal imaging modalities currently used in ophthalmic clinical practice, including Color Fundus Photography (CFP), Optical Coherence Tomography (OCT), Optical Coherence Tomography Angiography (OCTA), and Fluorescein Angiography (FA). Imaging data obtained from XyCAM CRE and reference modalities will be assessed to investigate correlations, agreement, and differences between measurements in order to evaluate the potential of XyCAM CRE to provide complementary diagnostic and disease management information in retinal disease.\n\nSecondary objectives of the study include:\n\nComparing image quality and image-derived information obtained from XyCAM CRE with other clinical reference imaging modalities across different operators and a diverse study population representative of the general population; Investigating the relationship between XyCAM CRE imaging data and established clinical indicators of glaucoma, macular degeneration, hypertensive retinopathy, diabetic retinopathy, inherited retinal disease, and retinal vascular disease.",[86,87],"Microvascular Disease","Retinal Disease",[89,90],"XyCAM CRE","XyCAM RI","NOT_YET_RECRUITING","2026-06-06",{"date":94,"type":95},"2026-06-11","ACTUAL",{"date":97,"type":82},"2026-06-15",{"date":99,"type":82},"2030-06-15",{"name":5,"class":6},1]