An observational study in Ocular Motility Disorders, Strabismus and Extraocular Muscle Dysfunction, sponsored by THYROSCOPE INC.. Not yet recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by THYROSCOPE INC. · 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.
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 reproducible quantitative measurement of eye movement. Glandy EOM is an investigational software-only medical device (SaMD) developed by THYROSCOPE INC. that processes smartphone-recorded 9-gaze videos to generate quantitative eye movement metrics. Glandy EOM has not yet received regulatory approval and is used for research purposes only in this study.
The study is a prospective, multicenter, multinational observational investigation designed to evaluate the clinical validity of Glandy EOM. The study population consists of adults with suspected or confirmed ocular motility abnormalities; healthy volunteers without any clinical indication for 9-gaze examination are not enrolled. Because eligibility is based on clinical suspicion or diagnosis of ocular motility abnormality rather than confirmed disease at enrollment, some participants may ultimately be clinically judged to have no abnormality on formal evaluation; such subjects remain part of the study population. Participants will undergo a single study visit consisting of (1) a standard clinical 9-gaze examination with clinician grading (-4 to +4), (2) a smartphone video recording performed with the assistance of a trained operator using a standardized setup, and (3) a patient self-recorded smartphone video acquired through the study mobile application.
For quantitative reference measurements, independent rater-derived measurements will be obtained from the recorded videos using a calibrated reference approach. A calibration marker of known size will be placed on the glabella during video acquisition to enable real-world scale estimation for the reference measurements. The calibration marker is used only for rater-based reference measurement and is not used by the AI algorithm.
The primary objective is to evaluate agreement between AI-derived quantitative eye movement metrics and rater-derived measurements of corneal center displacement, expressed as distance (mm) and angular deviation. Secondary objectives are to evaluate correlation between AI-derived metrics and clinician-assessed 9-gaze grading, and to evaluate whether AI-derived metrics obtained from patient self-recorded videos are comparable to those obtained from assistant-aided recordings. The investigational device is used solely for video acquisition and analysis and does not influence clinical decision-making during the study.
142 studies on the registry are indexed under Strabismus; 31 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 96 across 54 observational studies indexed under Strabismus.
Browse Strabismus studies →THYROSCOPE INC. is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Compared within Strabismus, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Ocular Motility Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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: * 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.
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)
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)
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)
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)
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)
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)
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)
Plan to share: No — The dataset includes patient-captured smartphone 9-gaze facial videos, which are inherently identifiable biometric data and carry a higher re-identification risk than static images. Public sharing of individual participant data (IPD) would therefore pose a substantial privacy risk that cannot be fully mitigated by standard de-identification of tabular variables alone. The informed consent obtained from participants and the IRB/EC-approved protocol do not authorize broad third-party sharing of these video recordings or associated individual-level records. As this is a multinational, multicenter study, the collected data are also subject to the personal data protection laws applicable in each participating jurisdiction, including the Republic of Korea's Personal Information Protection Act (PIPA), the EU General Data Protection Regulation (GDPR), and the US HIPAA where applicable, which restrict external transfer of identifiable health and biometric information. In addition, the investiga
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Start is estimated for Jul 2026; primary completion for Jun 2027, 11 months later.
Of 26 observational studies under Strabismus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 50. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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