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

Part of paid clinical trials in San Jose, California.

Sponsor
THYROSCOPE INC.
Study ID
NCT07623837
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Agreement between AI-derived and rater-derived corneal center displacement (distance, mm) [ Time Frame: At study visit (single visit) ]

Central Contacts

Locations (1)

FacilityCityStateZIP
3003 North First Street #221San JoseCalifornia95134

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3003 North First Street #221· San Jose, CA

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