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Thyroid Eye Disease (TED)Digital healthDevice

What this study is

This prospective observational study evaluates the feasibility and clinical utility of a smartphone-based artificial intelligence (AI) self-monitoring system in adults with thyroid eye disease (TED) undergoing non-surgical treatment. Eligible participants will use their own smartphones and the study application (Glandy) to perform at least weekly home monitoring consisting of a symptom questionnaire (diplopia, pain on visual analog scale) and a standardized frontal facial photograph. AI-derived outputs (Glandy CAS, Glandy EXO, Glandy LID) obtained at routine clinic visits will be compared with standard clinician assessments (CAS total score, Hertel exophthalmometry, MRD1/MRD2). AI outputs will not be used for real-time clinical decision-making during the study.

What's being tested

  • Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID)

    Intervention · DEVICE

    A smartphone application through which participants complete a symptom questionnaire (diplopia; pain by visual analog scale) and capture a standardized frontal facial photograph at least weekly during the treatment course, and additionally at each routine clinic visit. Submitted images are transmitted to a central analysis system for AI-based processing that generates three analytic outputs: * Glandy CAS - CAS-related output derived from periocular signs and symptom input * Glandy EXO - image-based exophthalmometric estimate (surrogate of Hertel) * Glandy LID - eyelid-related parameters including MRD1/MRD2 equivalents AI outputs are used for research analysis only and are NOT returned to the treating clinician for real-time decision-making during the study.

Study details

Official title
Prospective Observational Study of Smartphone-Based Self-Monitoring Using an Artificial Intelligence Solution During Non-Surgical Treatment for Thyroid Eye Disease
Sponsor
THYROSCOPE INC.
Conditions
Thyroid Eye Disease (TED) · Graves Ophthalmopathy · Thyroid Associated Ophthalmopathies
Enrolling
200 people
Starts
2026-07-01
Est. completion
2027-12-31
Record
View on ClinicalTrials.gov ↗