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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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-b

Первичные конечные точки

• Agreement between Glandy CAS and clinician-assessed CAS total score [Срок оценки: At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)]
• Agreement between Glandy EXO and Hertel exophthalmometry [Срок оценки: At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)]
• Agreement between Glandy LID and clinician-measured MRD1/MRD2 [Срок оценки: At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)]

Вторичные конечные точки (7)

• Longitudinal change in AI-derived TED parameters [Срок оценки: Weekly home monitoring from baseline to end-of-treatment (up to 12 months)]
• Concordance between AI-derived longitudinal trends and interval clinical change [Срок оценки: From baseline to end-of-treatment (up to 12 months)]
• Feasibility: adherence to weekly home-based image capture [Срок оценки: Throughout treatment period (up to 12 months)]
• Feasibility: adherence to symptom reporting [Срок оценки: Throughout treatment period (up to 12 months)]
• Feasibility: completion of clinic-matched assessments [Срок оценки: Throughout treatment period (up to 12 months)]
• Relationship between patient-reported symptoms and AI-derived measurements [Срок оценки: Throughout treatment period (up to 12 months)]
• Clinical utility of serial AI-based monitoring between clinic visits [Срок оценки: Throughout treatment period (up to 12 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• 3003 North First Street #221 — San Jose

Идентификаторы

NCT: NCT07623993 · THYROSCOPE-TED-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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