[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"THYROSCOPE INC.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":118},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100640670","prospective-observational-study-of-smartphone-based-ai-self-monitoring-during-non-surgical-treatment-for-thyroid-eye-disease-thyroscope-100640670",false,"NCT07623993","Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE)","Prospective Observational Study of Smartphone-Based Self-Monitoring Using an Artificial Intelligence Solution During Non-Surgical Treatment for Thyroid Eye Disease","THYROSCOPE-TED","Inclusion Criteria:\n\n* Adults aged 19 years or older with a clinical diagnosis of thyroid eye disease (TED).\n* Patients with TED scheduled to initiate active non-surgical treatment, including but not limited to intravenous methylprednisolone, oral corticosteroids, radiotherapy, or biologic therapy.\n* Able to undergo baseline clinical assessment prior to initiation of the planned treatment course and expected routine follow-up evaluation during treatment, including an end-of-treatment assessment.\n* Able and willing to use their own smartphone to complete the study application-guided symptom questionnaire and capture standardized frontal facial images throughout the study period.\n* Willing to perform at least weekly home-based image capture and symptom reporting during the treatment course.\n* Able to participate in routine in-person follow-up visits and expected to provide at least two clinic-matched assessments, including baseline and at least one post-baseline assessment.\n* Voluntarily provides written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Severe eyelid deformities, facial deformities, or other facial\u002Fperiocular conditions that may interfere with standardized image acquisition or reliable AI-based image analysis.\n* Unable to use the study application or smartphone-based image capture procedure adequately for protocol-required self-monitoring.\n* Undergoing or planning to undergo surgical treatment for TED as the primary treatment modality during the study period.\n* History of ocular, eyelid, or orbital surgery within 3 months prior to enrollment.\n* Any medical, psychiatric, cognitive, or other condition that, in the investigator's judgment, may compromise protocol compliance, study participation, or data integrity.\n* Any other condition that the investigator judges to make the patient inappropriate for participation.","ALL","22 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","This prospective observational study evaluates the feasibility and clinical utility of a smartphone-based artificial intelligence (AI) self-monitoring system in adults with thyroid eye disease (TED) undergoing non-surgical treatment. Eligible participants will use their own smartphones and the study application (Glandy) to perform at least weekly home monitoring consisting of a symptom questionnaire (diplopia, pain on visual analog scale) and a standardized frontal facial photograph. AI-derived outputs (Glandy CAS, Glandy EXO, Glandy LID) obtained at routine clinic visits will be compared with standard clinician assessments (CAS total score, Hertel exophthalmometry, MRD1\u002FMRD2). AI outputs will not be used for real-time clinical decision-making during the study.",[25,26,27],"Thyroid Eye Disease (TED)","Graves Ophthalmopathy","Thyroid Associated Ophthalmopathies",[29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Thyroid eye disease","TED","Graves orbitopathy","Artificial intelligence","Smartphone","Self-monitoring","Clinical Activity Score","CAS","Exophthalmometry","MRD1","MRD2","Remote monitoring","Digital health","Telemedicine","NOT_YET_RECRUITING","2026-05-28",{"date":46,"type":47},"2026-06-03","ACTUAL",{"date":49,"type":21},"2026-07-01",{"date":51,"type":21},"2027-12-31",{"name":53,"class":54},"THYROSCOPE INC.","INDUSTRY",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":66,"conditions":67,"keywords":72,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":89,"locationsCount":55},"100638476","clinical-validation-of-ai-based-quantitative-eye-movement-analysis-from-smartphone-9-gaze-videos-glandy-eom-100638476","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.",{"count":65,"type":21},1000,"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.",[68,69,70,71],"Ocular Motility Disorders","Strabismus","Extraocular Muscle Dysfunction","Thyroid Eye Disease",[73,74,75,32,76,77,78,79,80,69,81,82,83,84,41,85],"Ocular motility","Eye movement","9-gaze examination","Smartphone video","Quantitative analysis","Corneal center displacement","Angular deviation","Extraocular muscle","Diplopia","Glandy EOM","Software as a Medical Device","SaMD","Clinical validation",{"date":46,"type":47},{"date":49,"type":21},{"date":51,"type":21},{"name":53,"class":54},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":97,"targetDuration":99,"studyType":22,"phases":4,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":55},"100594320","evaluating-an-ai-tool-for-detecting-thyrotoxic-states-100594320","NCT07017907","Evaluating an AI Tool for Detecting Thyrotoxic States","Performance Evaluation of the Software Medical Device to Detect the Thyrotoxic State in Patients With Hyperthyroidism","Inclusion Criteria:\n\n* Adults aged 22 years or older, regardless of sex.\n* Individuals who are newly diagnosed with Graves' disease or currently undergoing treatment for it.\n* Individuals who have received sufficient explanation about the investigational software and are able to use it appropriately.\n* Individuals who voluntarily agree to participate in the study and have signed informed consent, either directly or via a legally authorized representative.\n\nExclusion Criteria:\n\n* Individuals with cardiac conditions such as arrhythmia or heart failure.\n* Individuals taking medications that significantly affect heart rate, including antiarrhythmics or antihistamines. (Intermittent short-acting beta-blockers are allowed.)\n* Pregnant or breastfeeding individuals, or those planning pregnancy during the study period or not using appropriate contraception.\n* Individuals with significant comorbidities that interfere with follow-up or study compliance.\n* Individuals with severe psychiatric disorders, substance use disorder, or alcohol dependence.\n* Individuals deemed ineligible at the discretion of the investigator for safety or ethical concerns.",{"count":98,"type":21},15,"12 Weeks","This observational study aims to evaluate the performance of a software-based medical device, Glandy HYPER, in detecting the thyrotoxic state in patients with hyperthyroidism. The device utilizes heart rate data collected from commercially available wearable devices and compares it with thyroid function test results. The study will enroll patients diagnosed with Graves' disease, monitoring their heart rate during sleep and correlating these measurements with free T4 levels obtained through serial blood testing. No investigational device output will be disclosed to participants, and the study will not alter standard clinical care.",[102,103],"Graves Disease","Hyperthyroidism\u002FThyrotoxicosis",[105,106,107,32,108,84,109],"Graves disease","Hyperthyroidism","Thyrotoxicosis","Heart rate","wearable device","RECRUITING",{"date":112,"type":47},"2026-06-01",{"date":114,"type":47},"2026-01-09",{"date":116,"type":21},"2026-12-31",{"name":53,"class":54},""]