Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal change in AI-derived TED parameters | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive analysis of additional image-derived periocular parameters | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adults (≥19 years) with clinically diagnosed TED who are scheduled to initiate active non-surgical treatment at participating ophthalmology sites.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaemin Park | Contact | +82 52-264-4154 | jaemin.park@thyroscope.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3003 North First Street #221 | San Jose | California | 95134 | United States |
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 | 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 | 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 | 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 | 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 | 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) |
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 | 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) |
| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided