[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638476":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":10,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":80,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"THYROSCOPE INC.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ocular motility abnormality cohort (single cohort)",null,"Adults with suspected or confirmed ocular motility abnormalities scheduled for clinical 9-gaze examination at participating ophthalmology sites. No separate healthy-volunteer control cohort is enrolled; some participants may ultimately be clinically judged to have no abnormality on formal evaluation but remain part of the study population.",[13],"Device: Glandy EOM (AI-based quantitative eye movement analysis software)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Glandy EOM (AI-based quantitative eye movement analysis software)","Glandy EOM is an investigational software-only medical device developed by THYROSCOPE INC. It has not yet received regulatory approval and is used for research purposes only in this study. Glandy EOM processes smartphone-recorded 9-gaze facial videos to generate AI-derived quantitative eye movement metrics:\n\n* Corneal center displacement (mm)\n* Angular deviation (degrees) Video acquisition in this study includes (a) an assistant-aided recording using a standardized smartphone setup in the clinical environment and (b) a patient self-recorded video acquired through the study mobile application. A calibration marker of known size placed on the glabella is used for rater-derived reference measurements only and is NOT used by the AI algorithm.\n\nAI outputs are generated for research analysis and are NOT used to guide real-time clinical decisions during the study.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Jaemin Park","CONTACT","+82-52-264-4154","jaemin.park@thyroscope.com",[27],{"facility":28,"status":10,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"3003 North First Street #221","San Jose","California","95134","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-121.89496,37.33939,{"lat":38,"lon":37},[41],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"type":43,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100638476","clinical-validation-of-ai-based-quantitative-eye-movement-analysis-from-smartphone-9-gaze-videos-glandy-eom-100638476",false,"NCT07623837","Clinical Validation of AI-Based Quantitative Eye Movement Analysis From Smartphone 9-Gaze Videos (Glandy EOM)","Prospective Multicenter Observational Study for Clinical Validation of AI-Based Quantitative Eye Movement Analysis Using Smartphone-Recorded 9-Gaze Videos","GLANDY-EOM-VAL","Inclusion Criteria:\n\n* Adults who have reached the legal age of consent for research participation in the applicable jurisdiction.\n* Subjects with suspected or known ocular motility abnormalities.\n* Subjects who are able to understand and follow gaze instructions required for the 9-gaze examination, as judged by the investigator.\n* Subjects who are able to undergo facial video recording using a smartphone.\n* Subjects who provide written informed consent.\n\nExclusion Criteria:\n\n* Conditions that prevent reliable detection of ocular landmarks in video recordings (e.g., severe ptosis, corneal opacity, or significant occlusion of the eyes).\n* Ocular or facial conditions that, in the opinion of the investigator, may significantly interfere with image-based analysis.\n* Subjects who are unable to comply with study procedures.","ALL","22 Years",{"count":55,"type":56},1000,"ESTIMATED","OBSERVATIONAL","This prospective, multicenter, multinational observational study evaluates the clinical validity of an AI-based quantitative eye movement analysis system (Glandy EOM) that analyzes smartphone-recorded 9-gaze videos. Approximately 200 adults per site with suspected or confirmed ocular motility abnormalities will undergo a single study visit consisting of a standard clinical 9-gaze examination, an assistant-aided smartphone video recording, and a patient self-recorded video acquisition using a mobile application. Because the study population is defined by clinical suspicion or diagnosis of ocular motility abnormality rather than confirmed disease at enrollment, some participants may be clinically judged to have no abnormality on formal evaluation; such subjects remain part of the study population and are not considered healthy volunteers. AI-derived quantitative eye movement metrics (corneal center displacement in millimeters and angular deviation) will be compared with rater-derived measurements obtained from the same videos using a calibrated reference approach, and with clinician-assessed 9-gaze grading. The investigational device is used solely for video acquisition and analysis and does not influence clinical decision-making.",[60,61,62,63],"Ocular Motility Disorders","Strabismus","Extraocular Muscle Dysfunction","Thyroid Eye Disease",[65,66,67,68,69,70,71,72,73,61,74,75,76,77,78,79],"Ocular motility","Eye movement","9-gaze examination","Artificial intelligence","Smartphone video","Quantitative analysis","Corneal center displacement","Angular deviation","Extraocular muscle","Diplopia","Glandy EOM","Software as a Medical Device","SaMD","Digital health","Clinical validation","NOT_YET_RECRUITING","2026-05-28",{"date":83,"type":84},"2026-06-03","ACTUAL",{"date":86,"type":56},"2026-07-01",{"date":88,"type":56},"2027-12-31",{"name":5,"class":6},1]