Ocular Motility DisordersGLANDY-EOM-VALNCT07623837
Clinical Validation of AI-Based Quantitative Eye Movement Analysis From Smartphone 9-Gaze Videos (Glandy EOM)
An observational study of Ocular Motility Disorders and Strabismus, run by THYROSCOPE INC. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Ocular Motility Disorders, Strabismus, Extraocular Muscle Dysfunction
- What is being tested?
- Glandy EOM (AI-based quantitative eye movement analysis software)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
3003 North First Street #221
San Jose, California, 95134
Jaemin Park, +82-52-264-4154, jaemin.park@thyroscope.com
About this study
Official title: Prospective Multicenter Observational Study for Clinical Validation of AI-Based Quantitative Eye Movement Analysis Using Smartphone-Recorded 9-Gaze Videos
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.
Read the detailed description
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.
- Conditions
- Ocular Motility Disorders, Strabismus, Extraocular Muscle Dysfunction, Thyroid Eye Disease
- Being tested
- Glandy EOM (AI-based quantitative eye movement analysis software)
- Keywords
- Ocular motility, Eye movement, 9-gaze examination, Artificial intelligence, Smartphone video, Quantitative analysis, Corneal center displacement, Angular deviation, Extraocular muscle, Strabismus, Diplopia, Glandy EOM, Software as a Medical Device, SaMD, Digital health, Clinical validation
- Medical subject headings
- Ocular Motility Disorders, Strabismus, Graves Ophthalmopathy, Diplopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glandy EOM (AI-based quantitative eye movement analysis software)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Ocular motility abnormality cohort (single cohort) | 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. Receives: Device: Glandy EOM (AI-based quantitative eye movement analysis software) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At study visit (single visit)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At study visit (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Motility DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- THYROSCOPE INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623837
- Sponsor's protocol ID
- THYROSCOPE-EOM-2026-01
- Acronym
- GLANDY-EOM-VAL
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Study for Clinical Validation of AI-Based Quantitative Eye Movement Analysis Using Smartphone-Recorded 9-Gaze Videos
- ClinicalTrials.gov ID
- NCT07623837
- Acronym / sponsor ID
- GLANDY-EOM-VAL / THYROSCOPE-EOM-2026-01
- Conditions
- Ocular Motility Disorders, Strabismus, Extraocular Muscle Dysfunction, Thyroid Eye Disease
- Keywords
- Ocular motility, Eye movement, 9-gaze examination, Artificial intelligence, Smartphone video, Quantitative analysis, Corneal center displacement, Angular deviation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- THYROSCOPE INC.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ocular motility abnormality cohort (single cohort) | – | Device: Glandy EOM (AI-based quantitative eye movement analysis software)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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Ocular motility abnormality cohort (single cohort) |
Primary outcome
Agreement between AI-derived and rater-derived corneal center displacement (distance, mm)
Time frame: At study visit (single visit)
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.
Agreement between AI-derived and rater-derived angular deviation (degrees)
Time frame: At study visit (single visit)
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.
Linear association and absolute error vs. rater-derived reference
Time frame: At study visit (single visit)
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.
4 secondary outcomes
Correlation between AI-derived metrics (assistant-aided recording) and clinician-assessed 9-gaze grading
Time frame: At study visit (single visit)
Correlation between AI-derived metrics (patient self-recorded) and clinician-assessed 9-gaze grading
Time frame: At study visit (single visit)
Agreement between AI-derived metrics from patient self-recorded vs. assistant-aided recordings
Time frame: At study visit (single visit)
Linear association and absolute error: patient self-recorded vs. assistant-aided
Time frame: At study visit (single visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Motility Disorders and Strabismus, run by THYROSCOPE INC. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaemin Park (+82-52-264-4154, jaemin.park@thyroscope.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between AI-derived and rater-derived corneal center displacement (distance, mm) (time frame: At study visit (single visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.