Prospective Observational Study of Smartphone-Based AI Self-Monitoring During Non-Surgical Treatment for Thyroid Eye Disease (THYROSCOPE) (THYROSCOPE-TED)
Prospective Observational Study of Smartphone-Based Self-Monitoring Using an Artificial Intelligence Solution During Non-Surgical Treatment for Thyroid Eye Disease
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jaemin Park
- 電話番号：+82 52-264-4154
- メール：jaemin.park@thyroscope.com
研究場所
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California
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San Jose、California、アメリカ、95134
- 3003 North First Street #221
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コンタクト：
- Jaemin Park CEO
- 電話番号：+82-52-264-4154
- メール：jaemin.park@thyroscope.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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.
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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:
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Agreement between Glandy CAS and clinician-assessed CAS total score
時間枠：At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
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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.
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At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
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Agreement between Glandy EXO and Hertel exophthalmometry
時間枠：At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
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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.
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At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
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Agreement between Glandy LID and clinician-measured MRD1/MRD2
時間枠：At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
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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.
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At each clinic-matched visit (baseline through end-of-treatment, up to 12 months)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Longitudinal change in AI-derived TED parameters
時間枠：Weekly home monitoring from baseline to end-of-treatment (up to 12 months)
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Descriptive longitudinal change in Glandy CAS, Glandy EXO, and Glandy LID obtained from serial home-monitoring data during the non-surgical treatment course.
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Weekly home monitoring from baseline to end-of-treatment (up to 12 months)
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Concordance between AI-derived longitudinal trends and interval clinical change
時間枠：From baseline to end-of-treatment (up to 12 months)
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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.
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From baseline to end-of-treatment (up to 12 months)
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Feasibility: adherence to weekly home-based image capture
時間枠：Throughout treatment period (up to 12 months)
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Proportion of participants performing at least weekly home-based facial image capture using the study application.
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Throughout treatment period (up to 12 months)
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Feasibility: adherence to symptom reporting
時間枠：Throughout treatment period (up to 12 months)
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Number and proportion of completed in-app symptom reports (diplopia, VAS pain) relative to expected weekly submissions.
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Throughout treatment period (up to 12 months)
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Feasibility: completion of clinic-matched assessments
時間枠：Throughout treatment period (up to 12 months)
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Number and proportion of participants completing ≥2 clinic-matched assessments including baseline and at least one post-baseline assessment.
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Throughout treatment period (up to 12 months)
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Relationship between patient-reported symptoms and AI-derived measurements
時間枠：Throughout treatment period (up to 12 months)
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Association between patient-reported diplopia and VAS pain with AI-derived parameters over time, explored descriptively and with regression / mixed-effects models where appropriate.
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Throughout treatment period (up to 12 months)
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Clinical utility of serial AI-based monitoring between clinic visits
時間枠：Throughout treatment period (up to 12 months)
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Ability of serial AI-derived monitoring to provide clinically useful adjunctive information regarding early improvement or interval worsening between routine clinic visits (descriptive).
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Throughout treatment period (up to 12 months)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Descriptive analysis of additional image-derived periocular parameters
時間枠：Throughout treatment period (up to 12 months)
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Ocular surface area (OSA), radial MRD-related parameters, and other eyelid-related image metrics obtained from patient-captured smartphone images.
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Throughout treatment period (up to 12 months)
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Exploratory AI-derived trend vs. treatment response
時間枠：Throughout treatment period (up to 12 months)
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Exploratory assessment of whether AI-derived home-monitoring trends reflect treatment response over the course of non-surgical treatment.
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Throughout treatment period (up to 12 months)
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Real-world image data completeness and analyzability
時間枠：Throughout treatment period (up to 12 months)
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Descriptive characterization of data completeness and AI-analyzable rate of patient-captured smartphone facial images in a real-world treatment setting.
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Throughout treatment period (up to 12 months)
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- THYROSCOPE-TED-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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