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Clinical Trials in the USA / NCT07623993
Starting soon Observational

Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE)

NCT07623993 · tracked via the Priya Life Science USA tracker
Sponsor
THYROSCOPE INC
Phase
Observational
Started
2026-07-01
Last updated
2026-06-03

Condition(s) studied

Thyroid Eye Disease (TED)Graves OphthalmopathyThyroid Associated Ophthalmopathies

Investigational drug(s) / intervention(s)

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

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

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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults aged 19 years or older with a clinical diagnosis of thyroid eye disease (TED). * Patients with TED scheduled to initiate active non-surgical treatment, including but not limited to intravenous methylprednisolone, oral corticosteroids, radiotherapy, or biologic therapy. * Able to undergo baseline clinical assessment prior to initiation of the planned treatment course and expected routine follow-up evaluation during treatment, including an end-of-treatment assessment. * Able and willing to use their own smartphone to complete the study application-guided symptom questionnaire and capture standardized frontal facial images throughout the study period. * Willing to perform at least weekly home-based image capture and symptom reporting during the treatment course. * Able to participate in routine in-person follow-up visits and expected to provide at least two clinic-matched assessments, including baseline and at least one post-baseline assessment. * Voluntarily provides written informed consent to participate in the study. Exclusion Criteria: * Severe eyelid deformities, facial deformities, or other facial/periocular conditions that may interfere with standardized image acquisition or reliable AI-based image analysis. * Unable to use the study application or smartphone-based image capture procedure adequately for protocol-required self-monitoring. * Undergoing or planning to undergo surgical treatment for TED as the primary treatment modality during the study period. * History of ocular, eyelid, or orbital surgery within 3 months prior to enrollment. * Any medical, psychiatric, cognitive, or other condition that, in the investigator's judgment, may compromise protocol compliance, study participation, or data integrity. * Any other condition that the investigator judges to make the patient inappropriate for participation.

Primary outcome measure(s)

  • Agreement between Glandy CAS and clinician-assessed CAS total score — At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
    Agreement between AI-derived Clinical Activity Score (Glandy CAS) and clinician-assessed CAS total score at clinic-matched visits, using intraclass correlation coefficient (ICC), correlation analysis, and Bland-Altman analysis.
  • Agreement between Glandy EXO and Hertel exophthalmometry — At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
    Agreement between AI-derived image-based exophthalmometric estimate (Glandy EXO, mm) and clinician-measured Hertel exophthalmometry absolute value (mm) at clinic-matched visits, using ICC, correlation, and Bland-Altman analysis.
  • Agreement between Glandy LID and clinician-measured MRD1/MRD2 — At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
    Agreement between AI-derived eyelid parameters (Glandy LID: MRD1 and MRD2 equivalents, mm) and clinician-measured MRD1 and MRD2 (mm) at clinic-matched visits, using ICC, correlation, and Bland-Altman analysis.

Trial sites (1)

FacilityCityRegionStatus
3003 North First Street #221 San Jose California

More THYROSCOPE INC. trials in the USA

Clinical Validation of AI-Based Quantitative Eye Movement Analysis From Smartphone 9-Gaze Videos (Glandy EOM) Starting soon
Evaluating an AI Tool for Detecting Thyrotoxic States Recruiting

Other trials for the same condition

A Study of VV-14305 for the Treatment of Thyroid Eye Disease Recruiting
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease Recruiting
A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07623993 on ClinicalTrials.gov ↗ ← All trials in the USA