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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 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

200

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Agreement between Glandy CAS and clinician-assessed CAS total score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Longitudinal change in AI-derived TED parameters
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Descriptive analysis of additional image-derived periocular parameters
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

THYROSCOPE INC.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

18 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2026

Eerst geplaatst (Werkelijk)

3 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

28 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • THYROSCOPE-TED-2026-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

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