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NCT07623837
Clinical Validation of AI-Based Quantitative Eye Movement Analysis From Smartphone 9-Gaze Videos (Glandy EOM)
Conditions: Ocular Motility Disorders, Strabismus, Extraocular Muscle Dysfunction, Thyroid Eye Disease
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: THYROSCOPE INC.
Location: 3003 North First Street #221 San Jose California
Summary
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.
Eligibility Criteria
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 opacity, or significant occlusion of the eyes).
* Ocular or facial conditions that, in the opinion of the investigator, may significantly interfere with image-based analysis.
* Subjects who are unable to comply with study procedures.
Source: ClinicalTrials.gov (NCT07623837). StuddyBuddy aggregates publicly available trial information.
