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

NCT07623993 | Not Yet Recruiting FDA Device

• 1 other identifier: THYROSCOPE-TED-2026-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Eye Disease (TED); Graves Ophthalmopathy; Thyroid Associated Ophthalmopathies

Keywords

Thyroid eye disease; TED; Graves orbitopathy; Artificial intelligence; Smartphone; Self-monitoring; Clinical Activity Score; CAS; Exophthalmometry; MRD1; MRD2; Remote monitoring; Digital health; Telemedicine

Outcome Measures

Primary Outcomes (3)

• Agreement between Glandy CAS and clinician-assessed CAS total score

  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

  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

  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)

Secondary Outcomes (7)

• Longitudinal change in AI-derived TED parameters

  Weekly home monitoring from baseline to end-of-treatment (up to 12 months)

• Concordance between AI-derived longitudinal trends and interval clinical change

  From baseline to end-of-treatment (up to 12 months)

• Feasibility: adherence to weekly home-based image capture

  Throughout treatment period (up to 12 months)

• Feasibility: adherence to symptom reporting

  Throughout treatment period (up to 12 months)

• Feasibility: completion of clinic-matched assessments

  Throughout treatment period (up to 12 months)

Other Outcomes (3)

• Descriptive analysis of additional image-derived periocular parameters

  Throughout treatment period (up to 12 months)

• Exploratory AI-derived trend vs. treatment response

  Throughout treatment period (up to 12 months)

• Real-world image data completeness and analyzability

  Throughout treatment period (up to 12 months)

Study Arms (1)

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.

Device: Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID)

Interventions

Smartphone-based AI self-monitoring application (Glandy CAS/EXO/LID) DEVICE

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.

TED - Non-surgical treatment cohort

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• THYROSCOPE INC.: lead

Study Sites (1)

3003 North First Street #221

San Jose, California, 95134, United States

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Jaemin Park

CONTACT

+82 52-264-4154; jaemin.park@thyroscope.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: June 3, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)