Clinical Validation of AI-Based Quantitative Eye Movement Analysis From Smartphone 9-Gaze Videos (Glandy EOM)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorTHYROSCOPE INC.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adults of legal age of consent with suspected or confirmed ocular motility abnormalities, recruited at participating ophthalmology sites. Some enrolled participants may ultimately be clinically judged to have no abnormality on formal evaluation; these subjects remain part of the study population and are not considered healthy volunteers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Glandy EOM (AI-based quantitative eye movement analysis software)
DeviceGlandy 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.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Ocular motility abnormality cohort (single cohort)1 intervention
Trial outcomes
Primary outcomes
1
Agreement between AI-derived and rater-derived corneal center displacement (distance, mm)
Agreement between AI-derived and rater-derived measurements of corneal center displacement expressed as distance (mm) across 9 gaze positions, assessed by intraclass correlation coefficient (ICC) and Bland-Altman analysis.
Time frame
At study visit (single visit)2
Agreement between AI-derived and rater-derived angular deviation (degrees)
Agreement between AI-derived and rater-derived measurements of corneal center displacement expressed as angular deviation (degrees) across 9 gaze positions, assessed by ICC and Bland-Altman analysis.
Time frame
At study visit (single visit)3
Linear association and absolute error vs. rater-derived reference
Linear association and absolute error between AI-derived and rater-derived measurements (both distance and angular deviation), assessed by Pearson correlation coefficient and mean absolute error (MAE), respectively.
Time frame
At study visit (single visit)Secondary outcomes
1
Correlation between AI-derived metrics (assistant-aided recording) and clinician-assessed 9-gaze grading
Correlation between AI-derived eye movement metrics obtained from assistant-aided smartphone recordings and clinician-assessed 9-gaze grading (-4 to +4), assessed using Spearman correlation.
Time frame
At study visit (single visit)2
Correlation between AI-derived metrics (patient self-recorded) and clinician-assessed 9-gaze grading
Correlation between AI-derived eye movement metrics obtained from patient self-recorded smartphone videos and clinician-assessed 9-gaze grading (-4 to +4), assessed using Spearman correlation.
Time frame
At study visit (single visit)3
Agreement between AI-derived metrics from patient self-recorded vs. assistant-aided recordings
Agreement between AI-derived metrics obtained from patient self-recorded and assistant-aided smartphone videos, assessed using ICC and Bland-Altman analysis.
Time frame
At study visit (single visit)4
Linear association and absolute error: patient self-recorded vs. assistant-aided
Linear association and absolute error between AI-derived metrics from patient self-recorded and assistant-aided smartphone videos, assessed using Pearson correlation coefficient and mean absolute error (MAE).
Time frame
At study visit (single visit)Sponsors and contacts
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Source ClinicalTrials.gov
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