Clinical Validation of AI-Based Quantitative Eye Movement Analysis From Smartphone 9-Gaze Videos (Glandy EOM)

NCT07623837 | Not Yet Recruiting FDA Device

• 1 other identifier: THYROSCOPE-EOM-2026-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ocular Motility Disorders; Thyroid Eye Disease; Strabismus; Extraocular Muscle Dysfunction

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At study visit (single visit)

Secondary Outcomes (4)

• Correlation between AI-derived metrics (assistant-aided recording) and clinician-assessed 9-gaze grading

  At study visit (single visit)

• Correlation between AI-derived metrics (patient self-recorded) and clinician-assessed 9-gaze grading

  At study visit (single visit)

• Agreement between AI-derived metrics from patient self-recorded vs. assistant-aided recordings

  At study visit (single visit)

• Linear association and absolute error: patient self-recorded vs. assistant-aided

  At study visit (single visit)

Study Arms (1)

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.

Device: Glandy EOM (AI-based quantitative eye movement analysis software)

Interventions

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.

Ocular motility abnormality cohort (single cohort)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• THYROSCOPE INC.: lead

Study Sites (1)

3003 North First Street #221

San Jose, California, 95134, United States

Location

MeSH Terms

Conditions

Ocular Motility Disorders; Strabismus; Graves Ophthalmopathy; Diplopia

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jaemin Park

CONTACT

+82-52-264-4154; jaemin.park@thyroscope.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: June 3, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)