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

2026. május 28. frissítette: 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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

200

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
Beavatkozás / kezelés
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.
Eszköz: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Agreement between Glandy CAS and clinician-assessed CAS total score
Időkeret: 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
Időkeret: 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
Időkeret: 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)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Longitudinal change in AI-derived TED parameters
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Descriptive analysis of additional image-derived periocular parameters
Időkeret: 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
Időkeret: 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
Időkeret: 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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

THYROSCOPE INC.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. július 1.

Elsődleges befejezés (Becsült)

2027. június 30.

A tanulmány befejezése (Becsült)

2027. december 31.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. április 18.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 28.

Első közzététel (Tényleges)

2026. június 3.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. június 3.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 28.

Utolsó ellenőrzés

2026. április 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • THYROSCOPE-TED-2026-01

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

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

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