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

28 mai 2026 mis à jour par: THYROSCOPE INC.

Prospective Observational Study of Smartphone-Based Self-Monitoring Using an Artificial Intelligence Solution During Non-Surgical Treatment for Thyroid Eye Disease

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Thyroid eye disease (TED) is an autoimmune inflammatory disorder most commonly associated with Graves' disease. Clinical manifestations include conjunctival injection, eyelid swelling, eyelid retraction, proptosis, diplopia, and altered ocular appearance. TED typically progresses through an active inflammatory phase of approximately 6-12 months before transitioning to a relatively inactive phase, although interval worsening may occur. Because treatment response can change dynamically, timely assessment of disease activity and severity is important for monitoring.

In current practice, TED activity and severity are primarily assessed during in-person visits using the Clinical Activity Score (CAS), Hertel exophthalmometry, and eyelid measurements (MRD1/MRD2). These assessments are episodic and may not capture interval change between visits.

Recent advances in AI have enabled image-based quantification of TED-related features from facial or periocular photographs. The AI-based monitoring system evaluated here has three analytic components: Glandy CAS (CAS-related outputs from photographs + symptom input), Glandy EXO (image-based exophthalmometric estimate), and Glandy LID (eyelid-related parameters including MRD measurements).

This prospective observational study will enroll approximately 200 adults with TED scheduled to initiate non-surgical treatment (intravenous methylprednisolone, oral corticosteroids, radiotherapy, or biologic therapy). Participants will perform at least weekly home-based self-monitoring (symptom entry + standardized frontal facial image) using their own smartphones and the study application. Baseline and end-of-treatment data will be required. At routine clinic visits, app-based image capture and symptom entry will also be performed to create clinic-matched assessments; AI-derived outputs will be compared with clinician-assessed TED parameters obtained the same day. At least two clinic-matched assessments per participant will be required for longitudinal evaluation. AI-generated outputs will not be used for real-time clinical decision-making.

Type d'étude

Observationnel

Inscription (Estimé)

200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • San Jose, California, États-Unis, 95134
        • 3003 North First Street #221
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adults (≥19 years) with clinically diagnosed TED who are scheduled to initiate active non-surgical treatment at participating ophthalmology sites.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
TED - Non-surgical treatment cohort
Adults with TED initiating non-surgical treatment who perform smartphone-based self-monitoring (weekly symptom entry + facial image capture) during the treatment course, with clinic-matched assessments at routine visits.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Agreement between Glandy CAS and clinician-assessed CAS total score
Délai: 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.
At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
Agreement between Glandy EXO and Hertel exophthalmometry
Délai: 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.
At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
Agreement between Glandy LID and clinician-measured MRD1/MRD2
Délai: 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.
At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Longitudinal change in AI-derived TED parameters
Délai: Weekly home monitoring from baseline to end-of-treatment (up to 12 months)
Descriptive longitudinal change in Glandy CAS, Glandy EXO, and Glandy LID obtained from serial home-monitoring data during the non-surgical treatment course.
Weekly home monitoring from baseline to end-of-treatment (up to 12 months)
Concordance between AI-derived longitudinal trends and interval clinical change
Délai: From baseline to end-of-treatment (up to 12 months)
Concordance between longitudinal AI-derived parameter trends and interval clinical change observed at routine follow-up, analyzed with descriptive paired comparisons and repeated-measures / mixed-effects approaches as appropriate.
From baseline to end-of-treatment (up to 12 months)
Feasibility: adherence to weekly home-based image capture
Délai: Throughout treatment period (up to 12 months)
Proportion of participants performing at least weekly home-based facial image capture using the study application.
Throughout treatment period (up to 12 months)
Feasibility: adherence to symptom reporting
Délai: Throughout treatment period (up to 12 months)
Number and proportion of completed in-app symptom reports (diplopia, VAS pain) relative to expected weekly submissions.
Throughout treatment period (up to 12 months)
Feasibility: completion of clinic-matched assessments
Délai: Throughout treatment period (up to 12 months)
Number and proportion of participants completing ≥2 clinic-matched assessments including baseline and at least one post-baseline assessment.
Throughout treatment period (up to 12 months)
Relationship between patient-reported symptoms and AI-derived measurements
Délai: Throughout treatment period (up to 12 months)
Association between patient-reported diplopia and VAS pain with AI-derived parameters over time, explored descriptively and with regression / mixed-effects models where appropriate.
Throughout treatment period (up to 12 months)
Clinical utility of serial AI-based monitoring between clinic visits
Délai: Throughout treatment period (up to 12 months)
Ability of serial AI-derived monitoring to provide clinically useful adjunctive information regarding early improvement or interval worsening between routine clinic visits (descriptive).
Throughout treatment period (up to 12 months)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Descriptive analysis of additional image-derived periocular parameters
Délai: Throughout treatment period (up to 12 months)
Ocular surface area (OSA), radial MRD-related parameters, and other eyelid-related image metrics obtained from patient-captured smartphone images.
Throughout treatment period (up to 12 months)
Exploratory AI-derived trend vs. treatment response
Délai: Throughout treatment period (up to 12 months)
Exploratory assessment of whether AI-derived home-monitoring trends reflect treatment response over the course of non-surgical treatment.
Throughout treatment period (up to 12 months)
Real-world image data completeness and analyzability
Délai: Throughout treatment period (up to 12 months)
Descriptive characterization of data completeness and AI-analyzable rate of patient-captured smartphone facial images in a real-world treatment setting.
Throughout treatment period (up to 12 months)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

THYROSCOPE INC.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

30 juin 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

18 avril 2026

Première soumission répondant aux critères de contrôle qualité

28 mai 2026

Première publication (Réel)

3 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • THYROSCOPE-TED-2026-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

The dataset includes patient-captured smartphone facial photographs, which are inherently identifiable biometric data. Public sharing of individual participant data (IPD) would pose a substantial risk of re-identification that cannot be fully mitigated by standard de-identification of tabular variables alone. The informed consent obtained from participants and the IRB-approved protocol do not authorize broad third-party sharing of these facial images or associated individual-level records. In addition, the study is conducted in the Republic of Korea and is subject to the Personal Information Protection Act (PIPA) and the Bioethics and Safety Act, which restrict external transfer of identifiable health and biometric information. For these reasons, individual-level data will not be shared publicly. Reasonable requests for scientifically justified collaborative analyses may be considered on a case-by-case basis, subject to a data-use agreement, sponsor approval, and applicable ethics appr

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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