THYROSCOPE INC.
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.
Ocular motility is commonly evaluated using the 9-gaze examination, which relies on clinician observation and semi-quantitative grading. This approach is inherently subjective and can show inter-observer variability and limited sensitivity to subtle changes over time. Objective, quantitative assessment of eye movement remains an unmet clinical need, particularly for monitoring disease progression and treatment response. Recent advances in artificial intelligence have enabled automated analysis of facial and ocular features from smartphone-recorded videos, offering the potential for reproducib…
Inclusion Criteria: * Adults who have reached the legal age of consent for research participation in the applicable jurisdiction. * Subjects with suspected or known ocular motility abnormalities. * Subjects who are able to understand and follow gaze instructions required for the 9-gaze examination, as judged by the investigator. * Subjects who are able to undergo facial video recording using a smartphone. * Subjects who provide written informed consent. Exclusion Criteria: * Conditions that prevent reliable detection of ocular landmarks in video recordings (e.g., severe ptosis, corneal opac…
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: * Corneal center displacement (mm) * 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. AI outputs are generated for research analysis and are NOT used to guide real-time clinical decisions during the study.